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Sample records for collaborative depression trial

  1. Clinical effectiveness of collaborative care for depression in UK primary care (CADET): cluster randomised controlled trial.

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    Richards, David A; Hill, Jacqueline J; Gask, Linda; Lovell, Karina; Chew-Graham, Carolyn; Bower, Peter; Cape, John; Pilling, Stephen; Araya, Ricardo; Kessler, David; Bland, J Martin; Green, Colin; Gilbody, Simon; Lewis, Glyn; Manning, Chris; Hughes-Morley, Adwoa; Barkham, Michael

    2013-08-19

    To compare the clinical effectiveness of collaborative care with usual care in the management of patients with moderate to severe depression. Cluster randomised controlled trial. 51 primary care practices in three primary care districts in the United Kingdom. 581 adults aged 18 years and older who met ICD-10 (international classification of diseases, 10th revision) criteria for a depressive episode on the revised Clinical Interview Schedule. We excluded acutely suicidal patients and those with psychosis, or with type I or type II bipolar disorder; patients whose low mood was associated with bereavement or whose primary presenting problem was alcohol or drug abuse; and patients receiving psychological treatment for their depression by specialist mental health services. We identified potentially eligible participants by searching computerised case records in general practices for patients with depression. Collaborative care, including depression education, drug management, behavioural activation, relapse prevention, and primary care liaison, was delivered by care managers. Collaborative care involved six to 12 contacts with participants over 14 weeks, supervised by mental health specialists. Usual care was family doctors' standard clinical practice. Depression symptoms (patient health questionnaire 9; PHQ-9), anxiety (generalised anxiety disorder 7; GAD-7), and quality of life (short form 36 questionnaire; SF-36) at four and 12 months; satisfaction with service quality (client satisfaction questionnaire; CSQ-8) at four months. 276 participants were allocated to collaborative care and 305 allocated to usual care. At four months, mean depression score was 11.1 (standard deviation 7.3) for the collaborative care group and 12.7 (6.8) for the usual care group. After adjustment for baseline depression, mean depression score was 1.33 PHQ-9 points lower (95% confidence interval 0.35 to 2.31, P=0.009) in participants receiving collaborative care than in those receiving usual

  2. Collaborative care for depression in general practice: study protocol for a randomised controlled trial.

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    Brinck-Claussen, Ursula Ødum; Curth, Nadja Kehler; Davidsen, Annette Sofie; Mikkelsen, John Hagel; Lau, Marianne Engelbrecht; Lundsteen, Merete; Csillag, Claudio; Christensen, Kaj Sparle; Hjorthøj, Carsten; Nordentoft, Merete; Eplov, Lene Falgaard

    2017-07-21

    Depression is a common illness with great human costs and a significant burden on the public economy. Previous studies have indicated that collaborative care (CC) has a positive effect on symptoms when provided to people with depression, but CC has not yet been applied in a Danish context. We therefore developed a model for CC (the Collabri model) to treat people with depression in general practice in Denmark. Since systematic identification of patients is an "active ingredient" in CC and some literature suggests case finding as the best alternative to standard detection, the two detection methods are examined as part of the study. The aim is to investigate if treatment according to the Collabri model has an effect on depression symptoms when provided to people with depression in general practice in Denmark, and to examine if case finding is a better method to detect depression in general practice than standard detection. The trial is a cluster-randomised, clinical superiority trial investigating the effect of treatment according to the Collabri model for CC, compared to treatment as usual for 480 participants diagnosed with depression in general practice in the Capital Region of Denmark. The primary outcome is depression symptoms (Beck's Depression Inventory (BDI-II)) after 6 months. Secondary outcomes include depression symptoms (BDI-II) after 15 months, anxiety symptoms (Beck's Anxiety Inventory (BAI)), level of functioning (Global Assessment of Function (GAF)) and psychological stress (Symptom Checklist-90-Revised (SCL-90-R)). In addition, case finding (with the recommended screening tool Major Depression Inventory (MDI)) and standard detection of depression is examined in a cluster-randomized controlled design. Here, the primary outcome is the positive predictive value of referral diagnosis. If the Collabri model is shown to be superior to treatment as usual, the study will contribute with important knowledge on how to improve treatment of depression in

  3. Collaborative care for sick-listed workers with major depressive disorder: a randomised controlled trial from the Netherlands Depression Initiative aimed at return to work and depressive symptoms.

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    Vlasveld, Moniek C; van der Feltz-Cornelis, Christina M; Adèr, Herman J; Anema, Johannes R; Hoedeman, Rob; van Mechelen, Willem; Beekman, Aartjan T F

    2013-04-01

    Major depressive disorder (MDD) is associated with absenteeism. In this study, the effectiveness of collaborative care, with a focus on return to work (RTW), was evaluated in its effect on depressive symptoms and the duration until RTW in sick-listed workers with MDD in the occupational health setting. In this randomised controlled trial, 126 sick-listed workers with MDD were randomised to usual care (N=61) or collaborative care (N=65). Collaborative care was applied by the occupational physician care manager, supported by a web-based tracking system and a consultant psychiatrist. Primary outcome measure was time to response. Secondary outcome measures were time to remission, depressive symptoms as continuous measure and the duration until full RTW. Collaborative care participants had a shorter time to response, with a difference of 2.8 months. However, no difference was found on time to remission or depressive symptoms as continuous measure. With a mean of 190 days in the collaborative care group, and 210 days in the usual care group, the groups did not differ significantly from each other in the duration until full RTW. Adherence to the collaborative care intervention was low. These results do not justify a widespread implementation of collaborative care in occupational healthcare, as it was operationalised in this study. However, since the study might have been underpowered for RTW and because treatment integrity was low, further research, with larger sample sizes, is needed to develop the best fitting (collaborative care) model for addressing RTW in depressed sick-listed workers. : ISRCTN78462860.

  4. Improving the quality of depression and pain care in multiple sclerosis using collaborative care: The MS-care trial protocol.

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    Ehde, Dawn M; Alschuler, Kevin N; Sullivan, Mark D; Molton, Ivan P; Ciol, Marcia A; Bombardier, Charles H; Curran, Mary C; Gertz, Kevin J; Wundes, Annette; Fann, Jesse R

    2018-01-01

    Evidence-based pharmacological and behavioral interventions are often underutilized or inaccessible to persons with multiple sclerosis (MS) who have chronic pain and/or depression. Collaborative care is an evidence-based patient-centered, integrated, system-level approach to improving the quality and outcomes of depression care. We describe the development of and randomized controlled trial testing a novel intervention, MS Care, which uses a collaborative care model to improve the care of depression and chronic pain in a MS specialty care setting. We describe a 16-week randomized controlled trial comparing the MS Care collaborative care intervention to usual care in an outpatient MS specialty center. Eligible participants with chronic pain of at least moderate intensity (≥3/10) and/or major depressive disorder are randomly assigned to MS Care or usual care. MS Care utilizes a care manager to implement and coordinate guideline-based medical and behavioral treatments with the patient, clinic providers, and pain/depression treatment experts. We will compare outcomes at post-treatment and 6-month follow up. We hypothesize that participants randomly assigned to MS Care will demonstrate significantly greater control of both pain and depression at post-treatment (primary endpoint) relative to those assigned to usual care. Secondary analyses will examine quality of care, patient satisfaction, adherence to MS care, and quality of life. Study findings will aid patients, clinicians, healthcare system leaders, and policy makers in making decisions about effective care for pain and depression in MS healthcare systems. (PCORI- IH-1304-6379; clinicaltrials.gov: NCT02137044). This trial is registered at ClinicalTrials.gov, protocol NCT02137044. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. A Remote Collaborative Care Program for Patients with Depression Living in Rural Areas: Open-Label Trial.

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    Rojas, Graciela; Guajardo, Viviana; Martínez, Pablo; Castro, Ariel; Fritsch, Rosemarie; Moessner, Markus; Bauer, Stephanie

    2018-04-30

    In the treatment of depression, primary care teams have an essential role, but they are most effective when inserted into a collaborative care model for disease management. In rural areas, the shortage of specialized mental health resources may hamper management of depressed patients. The aim was to test the feasibility, acceptability, and effectiveness of a remote collaborative care program for patients with depression living in rural areas. In a nonrandomized, open-label (blinded outcome assessor), two-arm clinical trial, physicians from 15 rural community hospitals recruited 250 patients aged 18 to 70 years with a major depressive episode (DSM-IV criteria). Patients were assigned to the remote collaborative care program (n=111) or to usual care (n=139). The remote collaborative care program used Web-based shared clinical records between rural primary care teams and a specialized/centralized mental health team, telephone monitoring of patients, and remote supervision by psychiatrists through the Web-based shared clinical records and/or telephone. Depressive symptoms, health-related quality of life, service use, and patient satisfaction were measured 3 and 6 months after baseline assessment. Six-month follow-up assessments were completed by 84.4% (221/250) of patients. The remote collaborative care program achieved higher user satisfaction (odds ratio [OR] 1.94, 95% CI 1.25-3.00) and better treatment adherence rates (OR 1.81, 95% CI 1.02-3.19) at 6 months compared to usual care. There were no statically significant differences in depressive symptoms between the remote collaborative care program and usual care. Significant differences between groups in favor of remote collaborative care program were observed at 3 months for mental health-related quality of life (beta 3.11, 95% CI 0.19-6.02). Higher rates of treatment adherence in the remote collaborative care program suggest that technology-assisted interventions may help rural primary care teams in the management

  6. A Randomized Trial of Collaborative Care for Perinatal Depression in Socioeconomically Disadvantaged Women: The Impact of Comorbid Posttraumatic Stress Disorder.

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    Grote, Nancy K; Katon, Wayne J; Russo, Joan E; Lohr, Mary Jane; Curran, Mary; Galvin, Erin; Carson, Kathy

    2016-11-01

    The comorbidity of posttraumatic stress disorder (PTSD) with antenatal depression poses increased risks for postpartum depression and may delay or diminish response to evidence-based depression care. In a secondary analysis of an 18-month study of collaborative care for perinatal depression, the authors hypothesized that pregnant, depressed, socioeconomically disadvantaged women with comorbid PTSD would show more improvement in the MOMCare intervention providing Brief Interpersonal Psychotherapy and/or antidepressants, compared to intensive public health Maternity Support Services (MSS-Plus). A multisite randomized controlled trial with blinded outcome assessment was conducted in the Seattle-King County Public Health System, July 2009-January 2014. Pregnant women were recruited who met criteria for a probable diagnosis of major depressive disorder (MDD) on the Patient Health Questionnaire-9 and/or dysthymia on the MINI-International Neuropsychiatric Interview (5.0.0). The primary outcome was depression severity at 3-, 6-, 12-and 18-month follow-ups; secondary outcomes included functional improvement, PTSD severity, depression response and remission, and quality of depression care. Sixty-five percent of the sample of 164 met criteria for probable comorbid PTSD. The treatment effect was significantly associated with PTSD status in a group-by-PTSD severity interaction, controlling for baseline depression severity (Wald χ²₁ = 4.52, P = .03). Over the 18-month follow-up, those with comorbid PTSD in MOMCare (n = 48), versus MSS-Plus (n = 58), showed greater improvement in depression severity (Wald χ²₁ = 8.51, P depression response (Wald χ²₁ = 4.13, P depression care had a greater impact on perinatal depressive outcomes for socioeconomically disadvantaged women with comorbid PTSD than for those without PTSD. Findings suggest that a stepped care treatment model for high-risk pregnant women with both MDD and PTSD could be integrated into public health systems in

  7. Characteristics of effective collaborative care for treatment of depression: a systematic review and meta-regression of 74 randomised controlled trials.

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    Peter A Coventry

    Full Text Available Collaborative care is a complex intervention based on chronic disease management models and is effective in the management of depression. However, there is still uncertainty about which components of collaborative care are effective. We used meta-regression to identify factors in collaborative care associated with improvement in patient outcomes (depressive symptoms and the process of care (use of anti-depressant medication.Systematic review with meta-regression. The Cochrane Collaboration Depression, Anxiety and Neurosis Group trials registers were searched from inception to 9th February 2012. An update was run in the CENTRAL trials database on 29th December 2013. Inclusion criteria were: randomised controlled trials of collaborative care for adults ≥18 years with a primary diagnosis of depression or mixed anxiety and depressive disorder. Random effects meta-regression was used to estimate regression coefficients with 95% confidence intervals (CIs between study level covariates and depressive symptoms and relative risk (95% CI and anti-depressant use. The association between anti-depressant use and improvement in depression was also explored. Seventy four trials were identified (85 comparisons, across 21,345 participants. Collaborative care that included psychological interventions predicted improvement in depression (β coefficient -0.11, 95% CI -0.20 to -0.01, p = 0.03. Systematic identification of patients (relative risk 1.43, 95% CI 1.12 to 1.81, p = 0.004 and the presence of a chronic physical condition (relative risk 1.32, 95% CI 1.05 to 1.65, p = 0.02 predicted use of anti-depressant medication.Trials of collaborative care that included psychological treatment, with or without anti-depressant medication, appeared to improve depression more than those without psychological treatment. Trials that used systematic methods to identify patients with depression and also trials that included patients with a chronic physical

  8. Remote Collaborative Depression Care Program for Adolescents in Araucanía Region, Chile: Randomized Controlled Trial

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    Martínez, Pablo; Zitko, Pedro; Irarrázaval, Matías; Luttges, Carolina; Araya, Ricardo

    2018-01-01

    Background Despite evidence on efficacious interventions, a great proportion of depressed adolescents do not receive evidence-based treatment and have no access to specialized mental health care. Remote collaborative depression care (RCDC) may help to reduce the gap between needs and specialized mental health services. Objective The objective of this study was to assess the feasibility, acceptability, and effectiveness of an RCDC intervention for adolescents with major depressive disorder (MDD) living in the Araucanía Region, Chile. Methods A cluster randomized, assessor-blind trial was carried out at 16 primary care centers in the Araucanía Region, Chile. Before randomization, all participating primary care teams were trained in clinical guidelines for the treatment of adolescent depression. Adolescents (N=143; 13-19 years) with MDD were recruited. The intervention group (RCDC, N=65) received a 3-month RCDC treatment that included continuous remote supervision by psychiatrists located in Santiago, Chile’s capital city, through shared electronic health records (SEHR) and phone patient monitoring. The control group (enhanced usual care or EUC; N=78) received EUC by clinicians who were encouraged to follow clinical guidelines. Recruitment and response rates and the use of the SEHR system were registered; patient adherence and satisfaction with the treatment and clinician satisfaction with RCDC were assessed at 12-week follow-up; and depressive symptoms and health-related quality of life (HRQoL) were evaluated at baseline and 12-weeks follow-up. Results More than 60.3% (143/237) of the original estimated sample size was recruited, and a response rate of 90.9% (130/143) was achieved at 12-week follow-up. A mean (SD) of 3.5 (4.0) messages per patient were written on the SEHR system by primary care teams. A third of the patients showed an optimal adherence to psychopharmacological treatment, and adolescents in the RCDC intervention group were more satisfied with

  9. A target-driven collaborative care model for Major Depressive Disorder is effective in primary care in the Netherlands. A randomized clinical trial from the depression initiative.

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    Huijbregts, Klaas M L; de Jong, Fransina J; van Marwijk, Harm W J; Beekman, Aartjan T F; Adèr, Herman J; Hakkaart-van Roijen, Leona; Unützer, Jürgen; van der Feltz-Cornelis, Christina M

    2013-04-25

    Practice variation in the primary care treatment of depression may be considerable in the Netherlands, due to relatively small and unregulated practices. We adapted the collaborative care model for the treatment of Major Depressive Disorder (MDD) to accommodate existing practice variation and tested whether this had added value over Care as Usual (CAU). A cluster randomized controlled trial was conducted to compare an adapted target driven collaborative care model with Care as Usual (CAU). Randomization was at the level of 18 (sub)urban primary care centers. The care manager and GP were supported by a web-based tracking and decision aid system that advised targeted treatment actions to achieve rapid response and if possible remission, and that warned the consultant psychiatrist if such treatment advice was not followed up. Eligible patients had a score of 10 or higher on the PHQ9, and met diagnostic criteria for major depression at the subsequent MINI Neuropsychiatric interview. A total of 93 patients were identified by screening. They received either collaborative care (CC) or CAU. Another 56 patients received collaborative care after identification by the GP. The outcome measures were response to treatment (50% or greater reduction of the PHQ9-total score from baseline) at three, six, nine and twelve months, and remission (a score of 0-4 on the PHQ9 at follow-up). Treatment response and remission in CAU were low. Collaborative care was more effective on achieving treatment response than CAU at three months for the total group of patients who received collaborative care [OR 5.2 ((1.41-16.09), NNT 2] and at nine months [OR 5.6 ((1.40-22.58)), NNT 3]. The effect was not statistically significant at 6 and 12 months. A relatively high percentage of patients (36.5%) did not return one or more follow-up questionnaires. There was no evidence for selective non response. Our adapted target driven CC was considerably more effective than CAU for MDD in primary care in the

  10. Cost-effectiveness of collaborative care for chronically ill patients with comorbid depressive disorder in the general hospital setting, a randomised controlled trial

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    Beekman Aartjan TF

    2007-02-01

    Full Text Available Abstract Background Depressive disorder is one of the most common disorders, and is highly prevalent in chronically ill patients. The presence of comorbid depression has a negative influence on quality of life, health care costs, self-care, morbidity, and mortality. Early diagnosis and well-organized treatment of depression has a positive influence on these aspects. Earlier research in the USA has reported good results with regard to the treatment of depression with a collaborative care approach and an antidepressant algorithm. In the UK 'Problem Solving Treatment' has proved to be feasible. However, in the general hospital setting this approach has not yet been evaluated. Methods/Design CC: DIM (Collaborative Care: Depression Initiative in the Medical setting is a two-armed randomised controlled trial with randomisation at patient level. The aim of the trial is to evaluate the treatment of depressive disorder in general hospitals in the Netherlands based on a collaborative care framework, including contracting, 'Problem Solving Treatment', antidepressant algorithm, and manual-guided self-help. 126 outpatients with diabetes mellitus, chronic obstructive pulmonary disease, or cardiovascular diseases will be randomised to either the intervention group or the control group. Patients will be included if they have been diagnosed with moderate to severe depression, based on the DSM-IV criteria in a two-step screening method. The intervention group will receive treatment based on the collaborative care approach; the control group will receive 'care as usual'. Baseline and follow-up measurements (after 3, 6, 9, and 12 months will be performed by means of questionnaires. The primary outcome measure is severity of depressive symptoms, as measured with the PHQ-9. The secondary outcome measure is the cost-effectiveness of these treatments according to the TiC-P, the EuroQol and the SF-36. Discussion Earlier research has indicated that depressive disorder is

  11. What work has to be done to implement collaborative care for depression? Process evaluation of a trial utilizing the Normalization Process Model

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    Lankshear Annette J

    2010-02-01

    Full Text Available Abstract Background There is a considerable evidence base for 'collaborative care' as a method to improve quality of care for depression, but an acknowledged gap between efficacy and implementation. This study utilises the Normalisation Process Model (NPM to inform the process of implementation of collaborative care in both a future full-scale trial, and the wider health economy. Methods Application of the NPM to qualitative data collected in both focus groups and one-to-one interviews before and after an exploratory randomised controlled trial of a collaborative model of care for depression. Results Findings are presented as they relate to the four factors of the NPM (interactional workability, relational integration, skill-set workability, and contextual integration and a number of necessary tasks are identified. Using the model, it was possible to observe that predictions about necessary work to implement collaborative care that could be made from analysis of the pre-trial data relating to the four different factors of the NPM were indeed borne out in the post-trial data. However, additional insights were gained from the post-trial interview participants who, unlike those interviewed before the trial, had direct experience of a novel intervention. The professional freedom enjoyed by more senior mental health workers may work both for and against normalisation of collaborative care as those who wish to adopt new ways of working have the freedom to change their practice but are not obliged to do so. Conclusions The NPM provides a useful structure for both guiding and analysing the process by which an intervention is optimized for testing in a larger scale trial or for subsequent full-scale implementation.

  12. What work has to be done to implement collaborative care for depression? Process evaluation of a trial utilizing the Normalization Process Model.

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    Gask, Linda; Bower, Peter; Lovell, Karina; Escott, Diane; Archer, Janine; Gilbody, Simon; Lankshear, Annette J; Simpson, Angela E; Richards, David A

    2010-02-10

    There is a considerable evidence base for 'collaborative care' as a method to improve quality of care for depression, but an acknowledged gap between efficacy and implementation. This study utilises the Normalisation Process Model (NPM) to inform the process of implementation of collaborative care in both a future full-scale trial, and the wider health economy. Application of the NPM to qualitative data collected in both focus groups and one-to-one interviews before and after an exploratory randomised controlled trial of a collaborative model of care for depression. Findings are presented as they relate to the four factors of the NPM (interactional workability, relational integration, skill-set workability, and contextual integration) and a number of necessary tasks are identified. Using the model, it was possible to observe that predictions about necessary work to implement collaborative care that could be made from analysis of the pre-trial data relating to the four different factors of the NPM were indeed borne out in the post-trial data. However, additional insights were gained from the post-trial interview participants who, unlike those interviewed before the trial, had direct experience of a novel intervention. The professional freedom enjoyed by more senior mental health workers may work both for and against normalisation of collaborative care as those who wish to adopt new ways of working have the freedom to change their practice but are not obliged to do so. The NPM provides a useful structure for both guiding and analysing the process by which an intervention is optimized for testing in a larger scale trial or for subsequent full-scale implementation.

  13. CASPER plus (CollAborative care in Screen-Positive EldeRs with major depressive disorder): study protocol for a randomised controlled trial.

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    Overend, Karen; Lewis, Helen; Bailey, Della; Bosanquet, Kate; Chew-Graham, Carolyn; Ekers, David; Gascoyne, Samantha; Hems, Deborah; Holmes, John; Keding, Ada; McMillan, Dean; Meer, Shaista; Meredith, Jodi; Mitchell, Natasha; Nutbrown, Sarah; Parrott, Steve; Richards, David; Traviss, Gemma; Trépel, Dominic; Woodhouse, Rebecca; Gilbody, Simon

    2014-11-19

    Depression accounts for the greatest disease burden of all mental health disorders, contributes heavily to healthcare costs, and by 2020 is set to become the second largest cause of global disability. Although 10% to 16% of people aged 65 years and over are likely to experience depressive symptoms, the condition is under-diagnosed and often inadequately treated in primary care. Later-life depression is associated with chronic illness and disability, cognitive impairment and social isolation. With a progressively ageing population it becomes increasingly important to refine strategies to identity and manage depression in older people. Currently, management may be limited to the prescription of antidepressants where there may be poor concordance; older people may lack awareness of psychosocial interventions and general practitioners may neglect to offer this treatment option. CASPER Plus is a multi-centre, randomised controlled trial of a collaborative care intervention for individuals aged 65 years and over experiencing moderate to severe depression. Selected practices in the North of England identify potentially eligible patients and invite them to participate in the study. A diagnostic interview is carried out and participants with major depressive disorder are randomised to either collaborative care or usual care. The recruitment target is 450 participants. The intervention, behavioural activation and medication management in a collaborative care framework, has been adapted to meet the complex needs of older people. It is delivered over eight to 10 weekly sessions by a case manager liaising with general practitioners. The trial aims to evaluate the clinical and cost effectiveness of collaborative care in addition to usual GP care versus usual GP care alone. The primary clinical outcome, depression severity, will be measured with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 4, 12 and 18 months. Cost effectiveness analysis will assess health

  14. Cost-effectiveness of collaborative care including PST and an antidepressant treatment algorithm for the treatment of major depressive disorder in primary care; a randomised clinical trial

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    Beekman Aartjan TF

    2007-03-01

    Full Text Available Abstract Background Depressive disorder is currently one of the most burdensome disorders worldwide. Evidence-based treatments for depressive disorder are already available, but these are used insufficiently, and with less positive results than possible. Earlier research in the USA has shown good results in the treatment of depressive disorder based on a collaborative care approach with Problem Solving Treatment and an antidepressant treatment algorithm, and research in the UK has also shown good results with Problem Solving Treatment. These treatment strategies may also work very well in the Netherlands too, even though health care systems differ between countries. Methods/design This study is a two-armed randomised clinical trial, with randomization on patient-level. The aim of the trial is to evaluate the treatment of depressive disorder in primary care in the Netherlands by means of an adapted collaborative care framework, including contracting and adherence-improving strategies, combined with Problem Solving Treatment and antidepressant medication according to a treatment algorithm. Forty general practices will be randomised to either the intervention group or the control group. Included will be patients who are diagnosed with moderate to severe depression, based on DSM-IV criteria, and stratified according to comorbid chronic physical illness. Patients in the intervention group will receive treatment based on the collaborative care approach, and patients in the control group will receive care as usual. Baseline measurements and follow up measures (3, 6, 9 and 12 months are assessed using questionnaires and an interview. The primary outcome measure is severity of depressive symptoms, according to the PHQ9. Secondary outcome measures are remission as measured with the PHQ9 and the IDS-SR, and cost-effectiveness measured with the TiC-P, the EQ-5D and the SF-36. Discussion In this study, an American model to enhance care for patients with a

  15. CollAborative care for Screen-Positive EldeRs with major depression (CASPER plus): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness.

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    Bosanquet, Katharine; Adamson, Joy; Atherton, Katie; Bailey, Della; Baxter, Catherine; Beresford-Dent, Jules; Birtwistle, Jacqueline; Chew-Graham, Carolyn; Clare, Emily; Delgadillo, Jaime; Ekers, David; Foster, Deborah; Gabe, Rhian; Gascoyne, Samantha; Haley, Lesley; Hamilton, Jahnese; Hargate, Rebecca; Hewitt, Catherine; Holmes, John; Keding, Ada; Lewis, Helen; McMillan, Dean; Meer, Shaista; Mitchell, Natasha; Nutbrown, Sarah; Overend, Karen; Parrott, Steve; Pervin, Jodi; Richards, David A; Spilsbury, Karen; Torgerson, David; Traviss-Turner, Gemma; Trépel, Dominic; Woodhouse, Rebecca; Gilbody, Simon

    2017-11-01

    Depression in older adults is common and is associated with poor quality of life, increased morbidity and early mortality, and increased health and social care use. Collaborative care, a low-intensity intervention for depression that is shown to be effective in working-age adults, has not yet been evaluated in older people with depression who are managed in UK primary care. The CollAborative care for Screen-Positive EldeRs (CASPER) plus trial fills the evidence gap identified by the most recent guidelines on depression management. To establish the clinical effectiveness and cost-effectiveness of collaborative care for older adults with major depressive disorder in primary care. A pragmatic, multicentred, two-arm, parallel, individually randomised controlled trial with embedded qualitative study. Participants were automatically randomised by computer, by the York Trials Unit Randomisation Service, on a 1 : 1 basis using simple unstratified randomisation after informed consent and baseline measures were collected. Blinding was not possible. Sixty-nine general practices in the north of England. A total of 485 participants aged ≥ 65 years with major depressive disorder. A low-intensity intervention of collaborative care, including behavioural activation, delivered by a case manager for an average of six sessions over 7-8 weeks, alongside usual general practitioner (GP) care. The control arm received only usual GP care. The primary outcome measure was Patient Health Questionnaire-9 items score at 4 months post randomisation. Secondary outcome measures included depression severity and caseness at 12 and 18 months, the EuroQol-5 Dimensions, Short Form questionnaire-12 items, Patient Health Questionnaire-15 items, Generalised Anxiety Disorder-7 items, Connor-Davidson Resilience Scale-2 items, a medication questionnaire, objective data and adverse events. Participants were followed up at 12 and 18 months. In total, 485 participants were randomised (collaborative

  16. Controlled trial of a collaborative primary care team model for patients with diabetes and depression: Rationale and design for a comprehensive evaluation

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    Johnson Jeffrey A

    2012-08-01

    Full Text Available Abstract Background When depression accompanies diabetes, it complicates treatment, portends worse outcomes and increases health care costs. A collaborative care case-management model, previously tested in an urban managed care organization in the US, achieved significant reduction of depressive symptoms, improved diabetes disease control and patient-reported outcomes, and saved money. While impressive, these findings need to be replicated and extended to other healthcare settings. Our objective is to comprehensively evaluate a collaborative care model for comorbid depression and type 2 diabetes within a Canadian primary care setting. Methods/design We initiated the TeamCare model in four Primary Care Networks in Northern Alberta. The intervention involves a nurse care manager guiding patient-centered care with family physicians and consultant physician specialists to monitor progress and develop tailored care plans. Patients eligible for the intervention will be identified using the Patient Health Questionnaire-9 as a screen for depressive symptoms. Care managers will then guide patients through three phases: 1 improving depressive symptoms, 2 improving blood glucose, blood pressure and cholesterol, and 3 improving lifestyle behaviors. We will employ the RE-AIM framework for a comprehensive and mixed-methods approach to our evaluation. Effectiveness will be assessed using a controlled “on-off” trial design, whereby eligible patients would be alternately enrolled in the TeamCare intervention or usual care on a monthly basis. All patients will be assessed at baseline, 6 and 12 months. Our primary analyses will be based on changes in two outcomes: depressive symptoms, and a multivariable, scaled marginal model for the combined outcome of global disease control (i.e., A1c, systolic blood pressure, LDL cholesterol. Our planned enrolment of 168 patients will provide greater than 80% power to observe clinically important improvements in all

  17. Multidisciplinary Collaborative Care for Depressive Disorder in the Occupational Health Setting: design of a randomised controlled trial and cost-effectiveness study

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    Beekman Aartjan TF

    2008-05-01

    Full Text Available Abstract Background Major depressive disorder (MDD has major consequences for both patients and society, particularly in terms of needlessly long sick leave and reduced functioning. Although evidence-based treatments for MDD are available, they show disappointing results when implemented in daily practice. A focus on work is also lacking in the treatment of depressive disorder as well as communication of general practitioners (GPs and other health care professionals with occupational physicians (OPs. The OP may play a more important role in the recovery of patients with MDD. Purpose of the present study is to tackle these obstacles by applying a collaborative care model, which has proven to be effective in the USA, with a focus on return to work (RTW. From a societal perspective, the (costeffectiveness of this collaborative care treatment, as a way of transmural care, will be evaluated in depressed patients on sick leave in the occupational health setting. Methods/Design A randomised controlled trial in which the treatment of MDD in the occupational health setting will be evaluated in the Netherlands. A transmural collaborative care model, including Problem Solving Treatment (PST, a workplace intervention, antidepressant medication and manual guided self-help will be compared with care as usual (CAU. 126 Patients with MDD on sick leave between 4 and 12 weeks will be included in the study. Care in the intervention group will be provided by a multidisciplinary team of a trained OP-care manager and a consultant psychiatrist. The treatment is separated from the sickness certification. Data will be collected by means of questionnaires at baseline and at 3, 6, 9 and 12 months after baseline. Primary outcome measure is reduction of depressive symptoms, secondary outcome measure is time to RTW, tertiary outcome measure is the cost effectiveness. Discussion The high burden of MDD and the high level of sickness absence among people with MDD contribute to

  18. Collaborative care for depression and anxiety disorders in patients with recent cardiac events: the Management of Sadness and Anxiety in Cardiology (MOSAIC) randomized clinical trial.

    Science.gov (United States)

    Huffman, Jeff C; Mastromauro, Carol A; Beach, Scott R; Celano, Christopher M; DuBois, Christina M; Healy, Brian C; Suarez, Laura; Rollman, Bruce L; Januzzi, James L

    2014-06-01

    Depression and anxiety are associated with adverse cardiovascular outcomes in patients with recent acute cardiac events. There has been minimal study of collaborative care (CC) management models for mental health disorders in high-risk cardiac inpatients, and no prior CC intervention has simultaneously managed depression and anxiety disorders. To determine the impact of a low-intensity CC intervention for depression, generalized anxiety disorder, and panic disorder among patients hospitalized for an acute cardiac illness. Single-blind randomized clinical trial, with study assessors blind to group assignment, from September 2010 through July 2013 of 183 patients admitted to inpatient cardiac units in an urban academic general hospital for acute coronary syndrome, arrhythmia, or heart failure and found to have clinical depression, generalized anxiety disorder, or panic disorder on structured assessment. Participants were randomized to 24 weeks of a low-intensity telephone-based multicomponent CC intervention targeting depression and anxiety disorders (n = 92) or to enhanced usual care (serial notification of primary medical providers; n = 91). The CC intervention used a social work care manager to coordinate assessment and stepped care of psychiatric conditions and to provide support and therapeutic interventions as appropriate. Improvement in mental health-related quality of life (Short Form-12 Mental Component Score [SF-12 MCS]) at 24 weeks, compared between groups using a random-effects model in an intent-to-treat analysis. Patients randomized to CC had significantly greater estimated mean improvements in SF-12 MCS at 24 weeks (11.21 points [from 34.21 to 45.42] in the CC group vs 5.53 points [from 36.30 to 41.83] in the control group; estimated mean difference, 5.68 points [95% CI, 2.14-9.22]; P = .002; effect size, 0.61). Patients receiving CC also had significant improvements in depressive symptoms and general functioning, and higher rates of

  19. Collaborative care intervention targeting violence risk behaviors, substance use, and posttraumatic stress and depressive symptoms in injured adolescents: a randomized clinical trial.

    Science.gov (United States)

    Zatzick, Douglas; Russo, Joan; Lord, Sarah Peregrine; Varley, Christopher; Wang, Jin; Berliner, Lucy; Jurkovich, Gregory; Whiteside, Lauren K; O'Connor, Stephen; Rivara, Frederick P

    2014-06-01

    Violence and injury risk behaviors, alcohol and drug use problems, and posttraumatic stress disorder (PTSD) and depressive symptoms occur frequently among adolescents presenting to acute care medical settings after traumatic physical injury. To test the effectiveness of a stepped collaborative care intervention targeting this constellation of risk behaviors and symptoms in randomly sampled hospitalized adolescents with and without traumatic brain injury. A pragmatic randomized clinical trial was conducted at a single US level I trauma center. Participants included 120 adolescents aged 12 to 18 years randomized to intervention (n = 59) and control (n = 61) conditions. Stepped collaborative care intervention included motivational interviewing elements targeting risk behaviors and substance use as well as medication and cognitive behavioral therapy elements targeting PTSD and depressive symptoms. Adolescents were assessed at baseline before randomization and 2, 5, and 12 months after injury hospitalization. Standardized instruments were used to assess violence risk behaviors, alcohol and drug use, and PTSD and depressive symptoms. The investigation attained more than 95% adolescent follow-up at each assessment point. At baseline, approximately one-third of the participants endorsed the violence risk behavior of carrying a weapon. Regression analyses demonstrated that intervention patients experienced significant reductions in weapon carrying compared with controls during the year after injury (group × time effect, F3,344 = 3.0; P = .03). At 12 months after the injury, 4 (7.3%) intervention patients vs 13 (21.3%) control patients reported currently carrying a weapon (relative risk, 0.31; 95% CI, 0.11-0.90). The intervention was equally effective in reducing the risk of weapon carrying among injured adolescents with and without traumatic brain injury. Other treatment targets, including alcohol and drug use problems and high levels of PTSD and

  20. Collaborative care for depression in general practice

    DEFF Research Database (Denmark)

    Brinck-Claussen, Ursula Ødum; Curth, Nadja Kehler; Davidsen, Annette Sofie

    2017-01-01

    Background: Depression is a common illness with great human costs and a significant burden on the public economy. Previous studies have indicated that collaborative care (CC) has a positive effect on symptoms when provided to people with depression, but CC has not yet been applied in a Danish...... context. We therefore developed a model for CC (the Collabri model) to treat people with depression in general practice in Denmark. Since systematic identification of patients is an “active ingredient” in CC and some literature suggests case finding as the best alternative to standard detection, the two...... detection methods are examined as part of the study. The aim is to investigate if treatment according to the Collabri model has an effect on depression symptoms when provided to people with depression in general practice in Denmark, and to examine if case finding is a better method to detect depression...

  1. Long-term cost-effectiveness of collaborative care (vs usual care) for people with depression and comorbid diabetes or cardiovascular disease: a Markov model informed by the COINCIDE randomised controlled trial.

    Science.gov (United States)

    Camacho, Elizabeth M; Ntais, Dionysios; Coventry, Peter; Bower, Peter; Lovell, Karina; Chew-Graham, Carolyn; Baguley, Clare; Gask, Linda; Dickens, Chris; Davies, Linda M

    2016-10-07

    To evaluate the long-term cost-effectiveness of collaborative care (vs usual care) for treating depression in patients with diabetes and/or coronary heart disease (CHD). 36 primary care general practices in North West England. 387 participants completed baseline assessment (collaborative care: 191; usual care: 196) and full or partial 4-month follow-up data were captured for 350 (collaborative care: 170; usual care: 180). 62% of participants were male, 14% were non-white. Participants were aged ≥18 years, listed on a Quality and Outcomes Framework register for CHD and/or type 1 or 2 diabetes mellitus, with persistent depressive symptoms. Patients with psychosis or type I/II bipolar disorder, actively suicidal, in receipt of services for substance misuse, or already in receipt of psychological therapy for depression were excluded. Collaborative care consisted of evidence-based low-intensity psychological treatments, delivered over 3 months and case management by a practice nurse and a Psychological Well Being Practitioner. As planned, the primary measure of cost-effectiveness was the incremental cost-effectiveness ratio (cost per quality-adjusted life year (QALY)). A Markov model was constructed to extrapolate the trial results from short-term to long-term (24 months). The mean cost per participant of collaborative care was £317 (95% CI 284 to 350). Over 24 months, it was estimated that collaborative care was associated with greater healthcare usage costs (net cost £674 (95% CI -30 953 to 38 853)) and QALYs (net QALY gain 0.04 (95% CI -0.46 to 0.54)) than usual care, resulting in a cost per QALY gained of £16 123, and a likelihood of being cost-effective of 0.54 (willingness to pay threshold of £20 000). Collaborative care is a potentially cost-effective long-term treatment for depression in patients with comorbid physical and mental illness. The estimated cost per QALY gained was below the threshold recommended by English decision

  2. Effectiveness and cost-effectiveness of transmural collaborative care with consultation letter (TCCCL) and duloxetine for major depressive disorder (MDD) and (sub)chronic pain in collaboration with primary care: design of a randomized placebo-controlled multi-Centre trial: TCC:PAINDIP.

    Science.gov (United States)

    de Heer, Eric W; Dekker, Jack; van Eck van der Sluijs, Jonna F; Beekman, Aartjan Tf; van Marwijk, Harm Wj; Holwerda, Tjalling J; Bet, Pierre M; Roth, Joost; Hakkaart-Van Roijen, Leona; Ringoir, Lianne; Kat, Fiona; van der Feltz-Cornelis, Christina M

    2013-05-24

    The comorbidity of pain and depression is associated with high disease burden for patients in terms of disability, wellbeing, and use of medical care. Patients with major and minor depression often present themselves with pain to a general practitioner and recognition of depression in such cases is low, but evolving. Also, physical symptoms, including pain, in major depressive disorder, predict a poorer response to treatment. A multi-faceted, patient-tailored treatment programme, like collaborative care, is promising. However, treatment of chronic pain conditions in depressive patients has, so far, received limited attention in research. Cost effectiveness of an integrated approach of pain in depressed patients has not been studied. This study is a placebo controlled double blind, three armed randomized multi centre trial. Patients with (sub)chronic pain and a depressive disorder are randomized to either a) collaborative care with duloxetine, b) collaborative care with placebo or c) duloxetine alone. 189 completers are needed to attain sufficient power to show a clinically significant effect of 0.6 SD on the primary outcome measures (PHQ-9 score). Data on depression, anxiety, mental and physical health, medication adherence, medication tolerability, quality of life, patient-doctor relationship, coping, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months. This study enables us to show the value of a closely monitored integrated treatment model above usual pharmacological treatment. Furthermore, a comparison with a placebo arm enables us to evaluate effectiveness of duloxetine in this population in a real life setting. Also, this study will provide evidence-based treatments and tools for their implementation in practice. This will facilitate generalization and implementation of results of this study. Moreover, patients included in this study are screened for pain symptoms, differentiating between nociceptive

  3. Social Support, a Mediator in Collaborative Depression Care for Cancer Patients

    Science.gov (United States)

    Oh, Hyunsung; Ell, Kathleen

    2015-01-01

    Objective: This study assessed whether perceived social support (PSS) is a factor in improving physical and functional well-being observed among cancer patients receiving collaborative depression care. Methods: A secondary analysis was conducted of data collected in a randomized clinical trial testing the effectiveness of collaborative depression…

  4. The Depression Inventory Development Workgroup: A Collaborative, Empirically Driven Initiative to Develop a New Assessment Tool for Major Depressive Disorder.

    Science.gov (United States)

    Vaccarino, Anthony L; Evans, Kenneth R; Kalali, Amir H; Kennedy, Sidney H; Engelhardt, Nina; Frey, Benicio N; Greist, John H; Kobak, Kenneth A; Lam, Raymond W; MacQueen, Glenda; Milev, Roumen; Placenza, Franca M; Ravindran, Arun V; Sheehan, David V; Sills, Terrence; Williams, Janet B W

    2016-01-01

    The Depression Inventory Development project is an initiative of the International Society for CNS Drug Development whose goal is to develop a comprehensive and psychometrically sound measurement tool to be utilized as a primary endpoint in clinical trials for major depressive disorder. Using an iterative process between field testing and psychometric analysis and drawing upon expertise of international researchers in depression, the Depression Inventory Development team has established an empirically driven and collaborative protocol for the creation of items to assess symptoms in major depressive disorder. Depression-relevant symptom clusters were identified based on expert clinical and patient input. In addition, as an aid for symptom identification and item construction, the psychometric properties of existing clinical scales (assessing depression and related indications) were evaluated using blinded datasets from pharmaceutical antidepressant drug trials. A series of field tests in patients with major depressive disorder provided the team with data to inform the iterative process of scale development. We report here an overview of the Depression Inventory Development initiative, including results of the third iteration of items assessing symptoms related to anhedonia, cognition, fatigue, general malaise, motivation, anxiety, negative thinking, pain and appetite. The strategies adopted from the Depression Inventory Development program, as an empirically driven and collaborative process for scale development, have provided the foundation to develop and validate measurement tools in other therapeutic areas as well.

  5. Comparative Effect of Collaborative Care, Pain Medication, and Duloxetine in the Treatment of Major Depressive Disorder and Comorbid (SubChronic Pain: Results of an Exploratory Randomized, Placebo-Controlled, Multicenter Trial (CC:PAINDIP

    Directory of Open Access Journals (Sweden)

    Eric W. de Heer

    2018-04-01

    Full Text Available ObjectiveEvidence exists for the efficacy of collaborative care (CC for major depressive disorder (MDD, for the efficacy of the consequent use of pain medication against pain, and for the efficacy of duloxetine against both MDD and neuropathic pain. Their relative effectiveness in comorbid MDD and pain has never been established so far. This study explores the effectiveness of CC with pain medication and duloxetine, and CC with pain medication and placebo, compared with duloxetine alone, on depressive and pain symptoms. This study was prematurely terminated because of massive reorganizations and reimbursement changes in mental health care in the Netherlands during the study period and is therefore of exploratory nature.MethodsThree-armed, randomized, multicenter, placebo-controlled trial at three specialized mental health outpatient clinics with patients who screened positive for MDD. Interventions lasted 12 weeks. Pain medication was administered according to an algorithm that avoids opiate prescription as much as possible, where paracetamol, COX inhibitors, and pregabalin are offered as steps before opiates are considered. Patients who did not show up for three or more sessions were registered as non-compliant. Explorative, intention-to-treat and per protocol, multilevel regression analyses were performed. The trial is listed in the trial registration (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1089; NTR number: NTR1089.ResultsSixty patients completed the study. Patients in all treatment groups reported significantly less depressive and pain symptoms after 12 weeks. CC with placebo condition showed the fastest decrease in depressive symptoms compared with the duloxetine alone group (b = −0.78; p = 0.01. Non-compliant patients (n = 31 did not improve over the 12-week period, in contrast to compliant patients (n = 29. Pain outcomes did not differ between the three groups.ConclusionIn MDD and pain, patient

  6. Multidisciplinary collaborative care for depressive disorder in the occupational health setting: design of a randomised controlled trial and cost-effectiveness study

    NARCIS (Netherlands)

    Vlasveld, M.C.; Anema, J.R.; Beekman, A.T.F.; van Mechelen, W.; Hoedeman, R.; van Marwijk, H.W.J.; Rutten, F.F.H.; Hakkaart-van Roijen, L.H.; van der Feltz-Cornelis, C.M.

    2008-01-01

    Background. Major depressive disorder (MDD) has major consequences for both patients and society, particularly in terms of needlessly long sick leave and reduced functioning. Although evidence-based treatments for MDD are available, they show disappointing results when implemented in daily practice.

  7. Effectiveness of Collaborative Care for Depression in Public-Sector Primary Care Clinics Serving Latinos.

    Science.gov (United States)

    Lagomasino, Isabel T; Dwight-Johnson, Megan; Green, Jennifer M; Tang, Lingqi; Zhang, Lily; Duan, Naihua; Miranda, Jeanne

    2017-04-01

    Quality improvement interventions for depression care have been shown to be effective for improving quality of care and depression outcomes in settings with primarily insured patients. The aim of this study was to determine the impact of a collaborative care intervention for depression that was tailored for low-income Latino patients seen in public-sector clinics. A total of 400 depressed patients from three public-sector primary care clinics were enrolled in a randomized controlled trial of a tailored collaborative care intervention versus enhanced usual care. Social workers without previous mental health experience served as depression care specialists for the intervention patients (N=196). Depending on patient preference, they delivered a cognitive-behavioral therapy (CBT) intervention or facilitated antidepressant medication given by primary care providers or both. In enhanced usual care, patients (N=204) received a pamphlet about depression, a letter for their primary care provider stating that they had a positive depression screen, and a list of local mental health resources. Intent-to-treat analyses examined clinical and process-of-care outcomes at 16 weeks. Compared with patients in the enhanced usual care group, patients in the intervention group had significantly improved depression, quality of life, and satisfaction outcomes (ppublic-sector clinics. Social workers without prior mental health experience can effectively provide CBT and manage depression care.

  8. Comparative effect of collaborative care, pain medication, and duloxetine in the treatment of major depressive disorder and comorbid (Sub)chronic pain: Results of an exploratory randomized, placebo-controlled, multicenter trial (CC:PAINDIP)

    NARCIS (Netherlands)

    de Heer, Eric W.; Dekker, Jack; Beekman, Aartjan T.F.; van Marwijk, Harm W.J.; Holwerda, Tjalling J.; Bet, Pierre M.; Roth, Joost; Timmerman, Lotte; van der Feltz-Cornelis, Christina M.

    2018-01-01

    Objective: Evidence exists for the efficacy of collaborative care (CC) for major depressive disorder (MDD), for the efficacy of the consequent use of pain medication against pain, and for the efficacy of duloxetine against both MDD and neuropathic pain. Their relative effectiveness in comorbid MDD

  9. Collaborative care for depression in European countries: a systematic review and meta-analysis.

    Science.gov (United States)

    Sighinolfi, Cecilia; Nespeca, Claudia; Menchetti, Marco; Levantesi, Paolo; Belvederi Murri, Martino; Berardi, Domenico

    2014-10-01

    This is a systematic review and meta-analysis of randomized controlled trials (RCTs) investigating the effectiveness of collaborative care compared to Primary Care Physician's (PCP's) usual care in the treatment of depression, focusing on European countries. A systematic review of English and non-English articles, from inception to March 2014, was performed using database PubMed, British Nursing Index and Archive, Ovid Medline (R), PsychINFO, Books@Ovid, PsycARTICLES Full Text, EMBASE Classic+Embase, DARE (Database of Abstract of Reviews of Effectiveness) and the Cochrane Library electronic database. Search term included depression, collaborative care, physician family and allied health professional. RCTs comparing collaborative care to usual care for depression in primary care were included. Titles and abstracts were independently examined by two reviewers, who extracted from the included trials information on participants' characteristics, type of intervention, features of collaborative care and type of outcome measure. The 17 papers included, regarding 15 RCTs, involved 3240 participants. Primary analyses showed that collaborative care models were associated with greater improvement in depression outcomes in the short term, within 3 months (standardized mean difference (SMD) -0.19, 95% CI=-0.33; -0.05; p=0.006), medium term, between 4 and 11 months (SMD -0.24, 95% CI=-0.39; -0.09; p=0.001) and medium-long term, from 12 months and over (SMD -0.21, 95% CI=-0.37; -0.04; p=0.01), compared to usual care. The present review, specifically focusing on European countries, shows that collaborative care is more effective than treatment as usual in improving depression outcomes. Copyright © 2014 Elsevier Inc. All rights reserved.

  10. Cost-utility of collaborative care for the treatment of comorbid major depressive disorder in outpatients with chronic physical conditions. A randomized controlled trial in the general hospital setting (CC-DIM

    Directory of Open Access Journals (Sweden)

    Goorden M

    2017-07-01

    Full Text Available Maartje Goorden,1 Christina M van der Feltz-Cornelis,2,3 Kirsten M van Steenbergen-Weijenburg,4 Eva K Horn,5 Aartjan TF Beekman,6,7 Leona Hakkaart-van Roijen1 1Institute of Health Policy and Management (iBMG/Institute for Medical Technology Assessment (iMTA, Erasmus University Rotterdam, Rotterdam, 2Tranzo Department, Tilburg University, 3Clinical Centre of Excellence for Body, Mind and Health, GGzBreburg, Tilburg, 4Trimbos Instituut, Utrecht, 5Viersprong Institute for Studies on Personality Disorders, Halsteren, 6Department of Psychiatry, 7EMGO+ Research Institute VUmc, VU University Medical Centre, Amsterdam, the Netherlands Purpose: Major depressive disorder (MDD is highly prevalent in patients with a chronic physical condition, and this comorbidity has a negative influence on quality of life, health care costs, self-care, morbidity, and mortality. Research has shown that collaborative care (CC may be a cost-effective treatment. However, its cost-effectiveness in this patient group has not yet been established. Therefore, the aim of this study was to evaluate the cost-utility of CC for the treatment of comorbid MDD in chronically ill patients in the outpatient general hospital setting. The study was conducted from a health care and societal perspective.Patients and methods: In this randomized controlled trial, 81 patients with moderate-to-severe MDD were included; 42 were randomly assigned to the CC group and 39 to the care as usual (CAU group. We applied the TiC-P, short-form Health-Related Quality of Life questionnaire, and EuroQol EQ-5D 3 level version, measuring the use of health care, informal care, and household work, respectively, at baseline and at 3, 6, 9, and 12 months follow-up.Results: The mean annual direct medical costs in the CC group were €6,718 (95% confidence interval [CI]: 3,541 to 10,680 compared to €4,582 (95% CI: 2,782 to 6,740 in the CAU group. The average quality-adjusted life years (QALYs gained were 0.07 higher

  11. Facilitating professional liaison in collaborative care for depression in UK primary care; a qualitative study utilising normalisation process theory.

    Science.gov (United States)

    Coupe, Nia; Anderson, Emma; Gask, Linda; Sykes, Paul; Richards, David A; Chew-Graham, Carolyn

    2014-05-01

    Collaborative care (CC) is an organisational framework which facilitates the delivery of a mental health intervention to patients by case managers in collaboration with more senior health professionals (supervisors and GPs), and is effective for the management of depression in primary care. However, there remains limited evidence on how to successfully implement this collaborative approach in UK primary care. This study aimed to explore to what extent CC impacts on professional working relationships, and if CC for depression could be implemented as routine in the primary care setting. This qualitative study explored perspectives of the 6 case managers (CMs), 5 supervisors (trial research team members) and 15 general practitioners (GPs) from practices participating in a randomised controlled trial of CC for depression. Interviews were transcribed verbatim and data was analysed using a two-step approach using an initial thematic analysis, and a secondary analysis using the Normalisation Process Theory concepts of coherence, cognitive participation, collective action and reflexive monitoring with respect to the implementation of CC in primary care. Supervisors and CMs demonstrated coherence in their understanding of CC, and consequently reported good levels of cognitive participation and collective action regarding delivering and supervising the intervention. GPs interviewed showed limited understanding of the CC framework, and reported limited collaboration with CMs: barriers to collaboration were identified. All participants identified the potential or experienced benefits of a collaborative approach to depression management and were able to discuss ways in which collaboration can be facilitated. Primary care professionals in this study valued the potential for collaboration, but GPs' understanding of CC and organisational barriers hindered opportunities for communication. Further work is needed to address these organisational barriers in order to facilitate

  12. Brain Tumor Trials Collaborative | Center for Cancer Research

    Science.gov (United States)

    Brain Tumor Trials Collaborative In Pursuit of a Cure The mission of the BTTC is to develop and perform state-of-the-art clinical trials in a collaborative and collegial environment, advancing treatments for patients with brain tumors, merging good scientific method with concern for patient well-being and outcome.

  13. Investigating the effect of collaborative care on depression, anxiety, and stress of patients after coronary angioplasty

    Directory of Open Access Journals (Sweden)

    Parastoo Rezapour

    2016-02-01

    Full Text Available Background: Coronary artery disease and its associated treatment interventions such as angioplasty can lead to emotional problems, including depression, anxiety, and stress, in patients and might have adverse effects on the recovery process. This study aimed to evaluate the effect of collaborative care model on depression, anxiety, and stress in patients after coronary angioplasty. Methods: This clinical trial was conducted on 50 patients undergoing coronary angioplasty, who were referred to intensive care unit and surgical ward of one of the hospitals of Isfahan, Iran, in 2015. Samples were selected through randomized convenience sampling and were divided into intervention and control group (n=25 for each group. Collaborative care model, consisting of four stages of motivation, preparation, engagement, and evaluation, was implemented for the intervention group through five 45-60 minute sessions and a three-month telephone follow-up. Data was collected using depression, anxiety, and stress scale (DASS-42 before and one month after the intervention from both groups. Data were analyzed using descriptive statistics, Chi-square, as well as independent and paired t-tests in SPSS, version 18. Results: In this study, mean score of depression was significantly decreased in the intervention group after the implementation of collaborative model (from 31.6±3.7 to 6.3±5.03 (P<0.001, and mean anxiety and stress scores were reduced from 32.6±3.04 and 32.2±3.3 to 6.2±4.1 and 8.5±4.8, respectively (P<0.001. In this regard, a significant difference was observed between the intervention and control groups (P<0.001. Conclusion: Implementation of collaborative care could be associated with lower depression, anxiety, and stress in patients after coronary angioplasty. Therefore, its application is recommended as an effective method for such patients.

  14. Enablers and barriers to implementing collaborative care for anxiety and depression: a systematic qualitative review.

    Science.gov (United States)

    Overbeck, Gritt; Davidsen, Annette Sofie; Kousgaard, Marius Brostrøm

    2016-12-28

    Collaborative care is an increasingly popular approach for improving quality of care for people with mental health problems through an intensified and structured collaboration between primary care providers and health professionals with specialized psychiatric expertise. Trials have shown significant positive effects for patients suffering from depression, but since collaborative care is a complex intervention, it is important to understand the factors which affect its implementation. We present a qualitative systematic review of the enablers and barriers to implementing collaborative care for patients with anxiety and depression. We developed a comprehensive search strategy in cooperation with a research librarian and performed a search in five databases (EMBASE, PubMed, PsycINFO, ProQuest, and CINAHL). All authors independently screened titles and abstracts and reviewed full-text articles. Studies were included if they were published in English and based on the original qualitative data on the implementation of a collaborative care intervention targeted at depression or anxiety in an adult patient population in a high-income country. Our subsequent analysis employed the normalization process theory (NPT). We included 17 studies in our review of which 11 were conducted in the USA, five in the UK, and one in Canada. We identified several barriers and enablers within the four major analytical dimensions of NPT. Securing buy-in among primary care providers was found to be critical but sometimes difficult. Enablers included physician champions, reimbursement for extra work, and feedback on the effectiveness of collaborative care. The social and professional skills of the care managers seemed critical for integrating collaborative care in the primary health care clinic. Day-to-day implementation was also found to be facilitated by the care managers being located in the clinic since this supports regular face-to-face interactions between physicians and care managers

  15. Multifaceted shared care intervention for late life depression in residential care: randomised controlled trial.

    Science.gov (United States)

    Llewellyn-Jones, R H; Baikie, K A; Smithers, H; Cohen, J; Snowdon, J; Tennant, C C

    1999-09-11

    To evaluate the effectiveness of a population based, multifaceted shared care intervention for late life depression in residential care. Randomised controlled trial, with control and intervention groups studied one after the other and blind follow up after 9.5 months. Population of residential facility in Sydney living in self care units and hostels. 220 depressed residents aged >/=65 without severe cognitive impairment. The shared care intervention included: (a) multidisciplinary consultation and collaboration, (b) training of general practitioners and carers in detection and management of depression, and (c) depression related health education and activity programmes for residents. The control group received routine care. Geriatric depression scale. Intention to treat analysis was used. There was significantly more movement to "less depressed" levels of depression at follow up in the intervention than control group (Mantel-Haenszel stratification test, P=0.0125). Multiple linear regression analysis found a significant intervention effect after controlling for possible confounders, with the intervention group showing an average improvement of 1.87 points on the geriatric depression scale compared with the control group (95% confidence interval 0.76 to 2.97, P=0.0011). The outcome of depression among elderly people in residential care can be improved by multidisciplinary collaboration, by enhancing the clinical skills of general practitioners and care staff, and by providing depression related health education and activity programmes for residents.

  16. The Bypassing the Blues treatment protocol: stepped collaborative care for treating post-CABG depression.

    Science.gov (United States)

    Rollman, Bruce L; Belnap, Bea Herbeck; LeMenager, Michelle S; Mazumdar, Sati; Schulberg, Herbert C; Reynolds, Charles F

    2009-02-01

    To present the design of the Bypassing the Blues (BtB) study to examine the impact of a collaborative care strategy for treating depression among patients with cardiac disease. Coronary artery bypass graft (CABG) surgery is one of the most common and costly medical procedures performed in the US. Up to half of post-CABG patients report depressive symptoms, and they are more likely to experience poorer health-related quality of life (HRQoL), worse functional status, continued chest pains, and higher risk of cardiovascular morbidity independent of cardiac status, medical comorbidity, and the extent of bypass surgery. BtB was designed to enroll 450 post-CABG patients from eight Pittsburgh-area hospitals including: (1) 300 patients who expressed mood symptoms preceding discharge and at 2 weeks post hospitalization (Patient Health Questionnaire (PHQ-9) >or=10); and (2) 150 patients who served as nondepressed controls (PHQ-9 Depressed patients were randomized to either an 8-month course of nurse-delivered telephone-based collaborative care supervised by a psychiatrist and primary care expert, or to their physicians' "usual care." The primary hypothesis will test whether the intervention can produce an effect size of >or=0.5 improvement in HRQoL at 8 months post CABG, as measured by the SF-36 Mental Component Summary score. Secondary hypotheses will examine the impact of our intervention on mood symptoms, cardiovascular morbidity, employment, health services utilization, and treatment costs. Not applicable. This effectiveness trial will provide crucial information on the impact of a widely generalizable evidence-based collaborative care strategy for treating depressed patients with cardiac disease.

  17. Depression care management for late-life depression in China primary care: Protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chiu Helen

    2011-05-01

    Full Text Available Abstract Background As a major public health issue in China and worldwide, late-life depression is associated with physical limitations, greater functional impairment, increased utilization and cost of health care, and suicide. Like other chronic diseases in elders such as hypertension and diabetes, depression is a chronic disease that the new National Health Policy of China indicates should be managed in primary care settings. Collaborative care, linking primary and mental health specialty care, has been shown to be effective for the treatment of late-life depression in primary care settings in Western countries. The primary aim of this project is to implement a depression care management (DCM intervention, and examine its effectiveness on the depressive symptoms of older patients in Chinese primary care settings. Methods/Design The trial is a multi-site, primary clinic based randomized controlled trial design in Hangzhou, China. Sixteen primary care clinics will be enrolled in and randomly assigned to deliver either DCM or care as usual (CAU (8 clinics each to 320 patients (aged ≥ 60 years with major depression (20/clinic; n = 160 in each treatment condition. In the DCM arm, primary care physicians (PCPs will prescribe 16 weeks of antidepressant medication according to the treatment guideline protocol. Care managers monitor the progress of treatment and side effects, educate patients/family, and facilitate communication between providers; psychiatrists will provide weekly group psychiatric consultation and CM supervision. Patients in both DCM and CAU arms will be assessed by clinical research coordinators at baseline, 4, 8, 12, 18, and 24 months. Depressive symptoms, functional status, treatment stigma and clients' satisfaction will be used to assess patients' outcomes; and clinic practices, attitudes/knowledge, and satisfaction will be providers' outcomes. Discussion This will be the first trial of the effectiveness of a collaborative care

  18. Cost Effectiveness of On-site versus Off-site Depression Collaborative Care in Rural Federally Qualified Health Centers

    Science.gov (United States)

    Pyne, Jeffrey M.; Fortney, John C.; Mouden, Sip; Lu, Liya; Hudson, Teresa J; Mittal, Dinesh

    2018-01-01

    Objective Collaborative care for depression is effective and cost-effective in primary care settings. However, there is minimal evidence to inform the choice of on-site versus off-site models. This study examined the cost-effectiveness of on-site practice-based collaborative care (PBCC) versus off-site telemedicine-based collaborative care (TBCC) for depression in Federally Qualified Health Centers (FQHCs). Methods Multi-site randomized pragmatic comparative cost-effectiveness trial. 19,285 patients were screened for depression, 14.8% (n=2,863) screened positive (PHQ9 ≥10) and 364 were enrolled. Telephone interview data were collected at baseline, 6-, 12-, and 18-months. Base case analysis used Arkansas FQHC healthcare costs and secondary analysis used national cost estimates. Effectiveness measures were depression-free days and quality-adjusted life years (QALYs) derived from depression-free days, Medical Outcomes Study SF-12, and Quality of Well Being scale (QWB). Nonparametric bootstrap with replacement methods were used to generate an empirical joint distribution of incremental costs and QALYs and acceptability curves. Results Mean base case FQHC incremental cost-effectiveness ratio (ICER) using depression-free days was $10.78/depression-free day. Mean base case ICERs using QALYs ranged from $14,754/QALY (depression-free day QALY) to $37,261/QALY (QWB QALY). Mean secondary national ICER using depression-free days was $8.43/depression-free day and using QALYs ranged from $11,532/QALY (depression-free day QALY) to $29,234/QALY (QWB QALY). Conclusions These results support the cost-effectiveness of the TBCC intervention in medically underserved primary care settings. Results can inform the decision about whether to insource (make) or outsource (buy) depression care management in the FQHC setting within the current context of Patient-Centered Medical Home, value-based purchasing, and potential bundled payments for depression care. The www.clinicaltrials.gov # for

  19. Clinical relevance of findings in trials of CBT for depression

    NARCIS (Netherlands)

    Lepping, P.; Whittington, R.; Sambhi, R.S.; Lane, S.; Poole, R.; Leucht, S.; Cuijpers, P.; McCabe, R.; Waheed, W.

    2017-01-01

    Cognitive behavioural therapy (CBT) is beneficial in depression. Symptom scores can be translated into Clinical Global Impression (CGI) scale scores to indicate clinical relevance. We aimed to assess the clinical relevance of findings of randomised controlled trials (RCTs) of CBT in depression. We

  20. Cost-utility of collaborative care for major depressive disorder in primary care in the Netherlands.

    Science.gov (United States)

    Goorden, Maartje; Huijbregts, Klaas M L; van Marwijk, Harm W J; Beekman, Aartjan T F; van der Feltz-Cornelis, Christina M; Hakkaart-van Roijen, Leona

    2015-10-01

    Major depression is a great burden on society, as it is associated with high disability/costs. The aim of this study was to evaluate the cost-utility of Collaborative Care (CC) for major depressive disorder compared to Care As Usual (CAU) in a primary health care setting from a societal perspective. A cluster randomized controlled trial was conducted, including 93 patients that were identified by screening (45-CC, 48-CAU). Another 57 patients were identified by the GP (56-CC, 1-CAU). The outcome measures were TiC-P, SF-HQL and EQ-5D, respectively measuring health care utilization, production losses and general health related quality of life at baseline three, six, nine and twelve months. A cost-utility analysis was performed for patients included by screening and a sensitivity analysis was done by also including patients identified by the GP. The average annual total costs was €1131 (95% C.I., €-3158 to €750) lower for CC compared to CAU. The average quality of life years (QALYs) gained was 0.02 (95% C.I., -0.004 to 0.04) higher for CC, so CC was dominant from a societal perspective. Taking a health care perspective, CC was less cost-effective due to higher costs, €1173 (95% C.I., €-216 to €2726), of CC compared to CAU which led to an ICER of 53,717 Euro/QALY. The sensitivity analysis showed dominance of CC. The cost-utility analysis from a societal perspective showed that CC was dominant to CAU. CC may be a promising treatment for depression in the primary care setting. Further research should explore the cost-effectiveness of long-term CC. Netherlands Trial Register ISRCTN15266438. Copyright © 2015 Elsevier Inc. All rights reserved.

  1. Evaluation of the effect of collaborative care on depression, anxiety and stress of patients after coronary angioplasty

    Directory of Open Access Journals (Sweden)

    Rezapour Parastoo

    2016-08-01

    Full Text Available Background and Objective: Coronary artery disease and its associated treatment interventions such as angioplasty can lead to emotional problems, including depression, anxiety, and stress, in patients and might have adverse effects on the recovery process. This study aimed to evaluate the effect of collaborative care model on depression, anxiety, and stress in patients after coronary angioplasty. Materials and Methods: This clinical trial was conducted on 50 patients undergoing coronary angioplasty, who were referred to intensive care unit and surgical ward of one of the hospitals of Isfahan, Iran, in 2015. Samples were selected through randomized convenience sampling and were divided into intervention and control group (n=25 for each group. Collaborative care model, consisting of four stages of motivation, preparation, engagement, and evaluation, was implemented for the intervention group through five 45-60 minute sessions and a three-month telephone follow-up. Data was collected using depression, anxiety, and stress scale (DASS-42 before and one month after the intervention from both groups. Data were analyzed using descriptive statistics, Chi-square, as well as independent and paired t-tests in SPSS, version 18. Results: In this study, mean score of depression was significantly decreased in the intervention group after the implementation of collaborative model (from 31.6±3.7 to 6.3±5.03 (P <0.001, and mean anxiety and stress scores were reduced from 32.6±3.04 and 32.2±3.3 to 6.2±4.1 and 8.5±4.8, respectively (P<0.001. In this regard, a significant difference was observed between the intervention and control groups (P<0.001. Conclusion: Implementation of collaborative care could be associated with lower depression, anxiety, and stress in patients after coronary angioplasty. Therefore, its application is recommended as an effective method for such patients.

  2. Staying well after depression: trial design and protocol

    Directory of Open Access Journals (Sweden)

    Duggan Danielle S

    2010-03-01

    Full Text Available Abstract Background Depression is often a chronic relapsing condition, with relapse rates of 50-80% in those who have been depressed before. This is particularly problematic for those who become suicidal when depressed since habitual recurrence of suicidal thoughts increases likelihood of further acute suicidal episodes. Therefore the question how to prevent relapse is of particular urgency in this group. Methods/Design This trial compares Mindfulness-Based Cognitive Therapy (MBCT, a novel form of treatment combining mindfulness meditation and cognitive therapy for depression, with both Cognitive Psycho-Education (CPE, an equally plausible cognitive treatment but without meditation, and treatment as usual (TAU. It will test whether MBCT reduces the risk of relapse in recurrently depressed patients and the incidence of suicidal symptoms in those with a history of suicidality who do relapse. It recruits participants, screens them by telephone for main inclusion and exclusion criteria and, if they are eligible, invites them to a pre-treatment session to assess eligibility in more detail. This trial allocates eligible participants at random between MBCT and TAU, CPE and TAU, and TAU alone in a ratio of 2:2:1, stratified by presence of suicidal ideation or behaviour and current anti-depressant use. We aim to recruit sufficient participants to allow for retention of 300 following attrition. We deliver both active treatments in groups meeting for two hours every week for eight weeks. We shall estimate effects on rates of relapse and suicidal symptoms over 12 months following treatment and assess clinical status immediately after treatment, and three, six, nine and twelve months thereafter. Discussion This will be the first trial of MBCT to investigate whether MCBT is effective in preventing relapse to depression when compared with a control psychological treatment of equal plausibility; and to explore the use of MBCT for the most severe recurrent

  3. A High School Depression and Suicide Prevention Program: A Collaboration between Health Education and Psychological Services.

    Science.gov (United States)

    Moilanen, Donna L.; Bradbury, Susan

    2002-01-01

    Examined a collaboration between health education and psychological services in generating a high school depression and suicide prevention program. The five-component program raised awareness of teen depression and suicide, increased communication about these issues within the school and community, and provided information about available…

  4. Developing an evaluation framework for consumer-centred collaborative care of depression using input from stakeholders.

    Science.gov (United States)

    McCusker, Jane; Yaffe, Mark; Sussman, Tamara; Kates, Nick; Mulvale, Gillian; Jayabarathan, Ajantha; Law, Susan; Haggerty, Jeannie

    2013-03-01

    To develop a framework for research and evaluation of collaborative mental health care for depression, which includes attributes or domains of care that are important to consumers. A literature review on collaborative mental health care for depression was completed and used to guide discussion at an interactive workshop with pan-Canadian participants comprising people treated for depression with collaborative mental health care, as well as their family members; primary care and mental health practitioners; decision makers; and researchers. Thematic analysis of qualitative data from the workshop identified key attributes of collaborative care that are important to consumers and family members, as well as factors that may contribute to improved consumer experiences. The workshop identified an overarching theme of partnership between consumers and practitioners involved in collaborative care. Eight attributes of collaborative care were considered to be essential or very important to consumers and family members: respectfulness; involvement of consumers in treatment decisions; accessibility; provision of information; coordination; whole-person care; responsiveness to changing needs; and comprehensiveness. Three inter-related groups of factors may affect the consumer experience of collaborative care, namely, organizational aspects of care; consumer characteristics and personal resources; and community resources. A preliminary evaluation framework was developed and is presented here to guide further evaluation and research on consumer-centred collaborative mental health care for depression.

  5. A stepped-wedge evaluation of an initiative to spread the collaborative care model for depression in primary care.

    Science.gov (United States)

    Solberg, Leif I; Crain, A Lauren; Maciosek, Michael V; Unützer, Jürgen; Ohnsorg, Kris A; Beck, Arne; Rubenstein, Lisa; Whitebird, Robin R; Rossom, Rebecca C; Pietruszewski, Pamela B; Crabtree, Benjamin F; Joslyn, Kenneth; Van de Ven, Andrew; Glasgow, Russell E

    2015-09-01

    Scale-up and spread of evidence-based practices is one of the most important challenges facing health care. We tested whether a statewide initiative, Depression Improvement Across Minnesota-Offering a New Direction (DIAMOND), to implement the collaborative care model for depression in 75 primary care clinics resulted in patient outcome improvements corresponding to those reported in randomized controlled trials. Health plans provided a new monthly payment to participating clinics after a 6-month intensive training program with ongoing data submission, networking, and consultation. Implementation was staggered, with 5 sequences of 10 to 40 clinics every 6 months. Payers provided weekly contact information for members from participating clinics who were filling antidepressant prescriptions, and we conducted baseline and 6-month surveys of 1,578 patients about their care and outcomes. There were 466 patients in DIAMOND clinics who received usual care before implementation (UCB), 559 who received usual care in DIAMOND clinics after implementation (UCA), 245 who received DIAMOND care after implementation (DCA), and 308 who received usual care in comparison clinics (UC). Patients who received DIAMOND care after implementation reported more collaborative care depression services than the 3 comparison groups (10.9 vs 6.4-6.7, on a scale of 0 of 14, where higher numbers indicate more services; P <.001) and more satisfaction with their care (4.0 vs 3.4 on a scale 1 to 5, in which higher scores indicate higher satisfaction; P ≤.001). Depression remission rates, however, were not significantly different among the 4 groups (36.4% DCA vs 35.8% UCB, 35.0% UCA, 33.9% UC; P = .94). Despite the incentive of a supporting payment change and intensive training and support for clinics volunteering to participate, no difference in depression outcomes was documented. Specific unmeasured actions present in trials but not present in these clinics may be critical for successful outcome

  6. Staying well after depression: trial design and protocol.

    Science.gov (United States)

    Williams, J Mark G; Russell, Ian T; Crane, Catherine; Russell, Daphne; Whitaker, Chris J; Duggan, Danielle S; Barnhofer, Thorsten; Fennell, Melanie J V; Crane, Rebecca; Silverton, Sarah

    2010-03-19

    Depression is often a chronic relapsing condition, with relapse rates of 50-80% in those who have been depressed before. This is particularly problematic for those who become suicidal when depressed since habitual recurrence of suicidal thoughts increases likelihood of further acute suicidal episodes. Therefore the question how to prevent relapse is of particular urgency in this group. This trial compares Mindfulness-Based Cognitive Therapy (MBCT), a novel form of treatment combining mindfulness meditation and cognitive therapy for depression, with both Cognitive Psycho-Education (CPE), an equally plausible cognitive treatment but without meditation, and treatment as usual (TAU). It will test whether MBCT reduces the risk of relapse in recurrently depressed patients and the incidence of suicidal symptoms in those with a history of suicidality who do relapse. It recruits participants, screens them by telephone for main inclusion and exclusion criteria and, if they are eligible, invites them to a pre-treatment session to assess eligibility in more detail. This trial allocates eligible participants at random between MBCT and TAU, CPE and TAU, and TAU alone in a ratio of 2:2:1, stratified by presence of suicidal ideation or behaviour and current anti-depressant use. We aim to recruit sufficient participants to allow for retention of 300 following attrition. We deliver both active treatments in groups meeting for two hours every week for eight weeks. We shall estimate effects on rates of relapse and suicidal symptoms over 12 months following treatment and assess clinical status immediately after treatment, and three, six, nine and twelve months thereafter. This will be the first trial of MBCT to investigate whether MCBT is effective in preventing relapse to depression when compared with a control psychological treatment of equal plausibility; and to explore the use of MBCT for the most severe recurrent depression--that in people who become suicidal when depressed.

  7. Long term effect of depression care management on mortality in older adults: follow-up of cluster randomized clinical trial in primary care

    OpenAIRE

    Gallo, Joseph J; Morales, Knashawn H; Bogner, Hillary R; Raue, Patrick J; Zee, Jarcy; Bruce, Martha L; Reynolds, Charles F

    2013-01-01

    Objective To investigate whether an intervention to improve treatment of depression in older adults in primary care modified the increased risk of death associated with depression. Design Long term follow-up of multi-site practice randomized controlled trial (PROSPECT?Prevention of Suicide in Primary Care Elderly: Collaborative Trial). Setting 20 primary care practices in New York City, Philadelphia, and Pittsburgh, USA, randomized to intervention or usual care. Participants 1226 participants...

  8. DIABETES, DEPRESSION, AND DEATH: A RANDOMIZED CONTROLLED TRIAL OF A DEPRESSION TREATMENT PROGRAM FOR OLDER ADULTS BASED IN PRIMARY CARE (PROSPECT)

    Science.gov (United States)

    Bogner, Hillary R; Morales, Knashawn H; Post, Edward P; Bruce, Martha L

    2009-01-01

    OBJECTIVE Our a priori hypothesis was that depressed patients with diabetes in practices implementing a depression management program would have a decreased risk of mortality compared to depressed patients with diabetes in usual care practices. RESEARCH DESIGN AND METHODS Multi-site practice-randomized controlled trial PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial) with patient recruitment from 5/99-8/01 and supplemented with a search of the National Death Index. Twenty primary care practices participated from New York City, Philadelphia, and Pittsburgh. In all, 584 participants who were identified though a two-stage, age-stratified (60-74; 75+) depression screening of randomly sampled patients and were classified as depressed with complete information on diabetes status are included in these analyses. Of all the 584 participants, 123 (21.2%) reported a history of diabetes. A depression care manager worked with primary care physicians to provide algorithm-based care. Vital status was assessed at 5 years. RESULTS After a median follow-up of 52.0 months, 110 depressed patients had died. Depressed patients with diabetes in the Intervention Condition were less likely to have died during the 5-year follow-up interval than were depressed persons with diabetes in Usual Care after accounting for baseline differences among patients (adjusted hazard ratio 0.49, 95% CI [0.24, 0.98]). CONCLUSIONS Older depressed primary care patients with diabetes in practices implementing depression care management were less likely to die over the course of a 5-year interval than were depressed patients with diabetes in usual care practices. PMID:17717284

  9. Randomised controlled trial of the clinical and cost effectiveness of a specialist team for managing refractory unipolar depressive disorder

    Directory of Open Access Journals (Sweden)

    Fox Richard

    2010-11-01

    Full Text Available Abstract Background Around 40 per cent of patients with unipolar depressive disorder who are treated in secondary care mental health services do not respond to first or second line treatments for depression. Such patients have 20 times the suicide rate of the general population and treatment response becomes harder to achieve and sustain the longer they remain depressed. Despite this there are no randomised controlled trials of community based service delivery interventions delivering both algorithm based pharmacotherapy and psychotherapy for patients with chronic depressive disorder in secondary care mental health services who remain moderately or severely depressed after six months treatment. Without such trials evidence based guidelines on services for such patients cannot be derived. Methods/design Single blind individually randomised controlled trial of a specialist depression disorder team (psychiatrist and psychotherapist jointly assessing and providing algorithm based drug and psychological treatment versus usual secondary care treatment. We will recruit 174 patients with unipolar depressive disorder in secondary mental health services with a Hamilton Depression Rating Scale (HDRS score ≥ 16 and global assessment of function (GAF ≤ 60 after ≥ 6 months treatment. The primary outcome measures will be the HDRS and GAF supplemented by economic analysis incuding the EQ5 D and analysis of barriers to care, implementation and the process of care. Audits to benchmark both treatment arms against national standards of care will aid the interpretation of the results of the study. Discussion This trial will be the first to assess the effectiveness and implementation of a community based specialist depression disorder team. The study has been specially designed as part of the CLAHRC Nottinghamshire, Derbyshire and Lincolnshire joint collaboration between university, health and social care organisations to provide information of direct relevance

  10. Systematic reviews of randomised clinical trials examining the effects of psychotherapeutic interventions versus "no intervention" for acute major depressive disorder and a randomised trial examining the effects of "third wave" cognitive therapy versus mentalization-based treatment for acute major

    DEFF Research Database (Denmark)

    Jakobsen, Janus Christian

    2014-01-01

    systematic reviews with meta-analyses and trial sequential analyses using The Cochrane Collaboration methodology examining the effects of cognitive therapy and psycho-dynamic therapy for major depressive disorder. We developed a thorough treatment protocol for a randomised trial with low risks of bias...... therapy versus mentalisation-based treatment for major depressive disorder. The first systematic review included five randomised trials examining the effects of psychodynamic therapy versus "no intervention' for major depressive disorder. Altogether the five trials randomised 365 participants who in each...... this result. The second systematic review included 12 randomised trials examining the effects of cognitive therapy versus "no intervention" for major depressive disorder. Altogether a total of 669 participants were randomised. All trials had high risk of bias. Meta-analysis showed that cognitive therapy...

  11. Sampling bias in an internet treatment trial for depression.

    Science.gov (United States)

    Donkin, L; Hickie, I B; Christensen, H; Naismith, S L; Neal, B; Cockayne, N L; Glozier, N

    2012-10-23

    Internet psychological interventions are efficacious and may reduce traditional access barriers. No studies have evaluated whether any sampling bias exists in these trials that may limit the translation of the results of these trials into real-world application. We identified 7999 potentially eligible trial participants from a community-based health cohort study and invited them to participate in a randomized controlled trial of an online cognitive behavioural therapy programme for people with depression. We compared those who consented to being assessed for trial inclusion with nonconsenters on demographic, clinical and behavioural indicators captured in the health study. Any potentially biasing factors were then assessed for their association with depression outcome among trial participants to evaluate the existence of sampling bias. Of the 35 health survey variables explored, only 4 were independently associated with higher likelihood of consenting-female sex (odds ratio (OR) 1.11, 95% confidence interval (CI) 1.05-1.19), speaking English at home (OR 1.48, 95% CI 1.15-1.90) higher education (OR 1.67, 95% CI 1.46-1.92) and a prior diagnosis of depression (OR 1.37, 95% CI 1.22-1.55). The multivariate model accounted for limited variance (C-statistic 0.6) in explaining participation. These four factors were not significantly associated with either the primary trial outcome measure or any differential impact by intervention arm. This demonstrates that, among eligible trial participants, few factors were associated with the consent to participate. There was no indication that such self-selection biased the trial results or would limit the generalizability and translation into a public or clinical setting.

  12. Impact of Collaborative Care on Absenteeism for Depressed Employees Seen in Primary Care Practices: A Retrospective Cohort Study.

    Science.gov (United States)

    Adaji, Akuh; Newcomb, Richard D; Wang, Zhen; Williams, Mark

    2018-01-01

    The impact of "real world" collaborative care on depression and absenteeism for depressed employees seen in primary care practices using objective employer absence data. A retrospective cohort study comparing depressed employees seen in primary care practices who enrolled for a "real world" collaborative care program to practice as usual (PAU) on objective absence days and depression response and remission at 6, and 12-month time periods. Absence days were more in the collaborative care group compared with the PAU group at 3 and 6 months but at 12 months the difference was no longer statistically significant. Collaborative care led to better response and remission depression scores compared with PAU at 12 months. Collaborative care led to faster improvement in depression symptoms but did not translate to less time away from work.

  13. Moving beyond Depression: A Collaborative Approach to Treating Depressed Mothers in Home Visiting Programs

    Science.gov (United States)

    Ammerman, Robert T.; Putnam, Frank W.; Teeters, Angelique R.; Van Ginkel, Judith B.

    2014-01-01

    Research indicates that up to half of mothers in home visiting experience clinically significant levels of depression during their participation in services. Depression alters maternal life course, negatively impacts child development, and contributes to poorer home visiting outcomes. This article describes the Moving Beyond Depression (MBD)…

  14. Why Collaborative Care for Depressed Patients is so Difficult: A Belgian Qualitative Study

    Directory of Open Access Journals (Sweden)

    Kris Van den Broeck

    2017-06-01

    Full Text Available Although current guidelines recommend collaborative care for severely depressed patients, few patients get adequate treatment. In this study we aimed to identify the thresholds for interdisciplinary collaboration amongst practitioners when treating severely depressed patients. In addition, we aimed to identify specific and feasible steps that may add to improved collaboration amongst first and second level Belgian health care providers when treating depressed patients. In two standard focus groups (n = 8; n = 12, general practitioners and psychiatrists first outlined current practice and its shortcomings. In a next phase, the same participants were gathered in nominal groups to identify and prioritise steps that could give rise to improved collaboration. Thematic analyses were performed. Though some barriers for interdisciplinary collaboration may seem easy to overcome, participants stressed the importance of certain boundary conditions on a macro- (e.g., financing of care, secure communication technology and meso-level (e.g., support for first level practitioner. Findings are discussed against the background of frameworks on collaboration in healthcare and recent developments in mental health care.

  15. COLLABORATIVE TRIAL AND QUALITY CONTROL IN CHEMICAL ANALYSIS

    Directory of Open Access Journals (Sweden)

    Narsito Narsito

    2010-06-01

    Full Text Available Abstract                                                             This paper deals with some practical problems related to the quality of analytical chemical data usually met in practice. Special attention is given to the topic of quality control in analytical chemistry, since analytical data is one of the primary information from which some important scientifically based decision are to be made. The present paper starts with brief description on some fundamental aspects associated with quality of analytical data, such as sources of variation of analytical data, criteria for quality of analytical method, quality assurance in chemical analysis. The assessment of quality parameter for analytical method like the use of standard materials as well as standard methods is given. Concerning with the quality control of analytical data, the use of several techniques, such as control samples and control charts, in monitoring analytical data in quality control program are described qualitatively.  In the final part of this paper, some important remarks for the preparation of collaborative trials, including the evaluation of accuracy and reproducibility of analytical method are also given Keywords: collaborative trials, quality control, analytical data Abstract                                                             This paper deals with some practical problems related to the quality of analytical chemical data usually met in practice. Special attention is given to the topic of quality control in analytical chemistry, since analytical data is one of the primary information from which some important scientifically based decision are to be made. The present paper starts with brief description on some fundamental aspects associated with quality of analytical data, such as sources of variation of analytical data, criteria for quality of

  16. Comparative Studies of Collaborative Team Depression Care Adoption in Safety Net Clinics

    Science.gov (United States)

    Ell, Kathleen; Wu, Shinyi; Guterman, Jeffrey; Schulman, Sandra-Gross; Sklaroff, Laura; Lee, Pey-Jiuan

    2018-01-01

    Purpose: To evaluate three approaches adopting collaborative depression care model in Los Angeles County safety net clinics with predominantly Latino type 2 diabetes patients. Methods: Pre-post differences in treatment rates and symptom reductions were compared between baseline, 6-month, and 12-month follow-ups for each approach: (a) Multifaceted…

  17. The Depression in Visual Impairment Trial (DEPVIT: trial design and protocol

    Directory of Open Access Journals (Sweden)

    Margrain Tom H

    2012-07-01

    Full Text Available Abstract Background The prevalence of depression in people with a visual disability is high but screening for depression and referral for treatment is not yet an integral part of visual rehabilitation service provision. One reason for this may be that there is no good evidence about the effectiveness of treatments in this patient group. This study is the first to evaluate the effect of depression treatments on people with a visual impairment and co morbid depression. Methods /design The study is an exploratory, multicentre, individually randomised waiting list controlled trial. Participants will be randomised to receive Problem Solving Therapy (PST, a ‘referral to the GP’ requesting treatment according to the NICE’s ‘stepped care’ recommendations or the waiting list arm of the trial. The primary outcome measure is change (from randomisation in depressive symptoms as measured by the Beck’s Depression Inventory (BDI-II at 6 months. Secondary outcomes include change in depressive symptoms at 3 months, change in visual function as measured with the near vision subscale of the VFQ-48 and 7 item NEI-VFQ at 3 and 6 months, change in generic health related quality of life (EQ5D, the costs associated with PST, estimates of incremental cost effectiveness, and recruitment rate estimation. Discussion Depression is prevalent in people with disabling visual impairment. This exploratory study will establish depression screening and referral for treatment in visual rehabilitation clinics in the UK. It will be the first to explore the efficacy of PST and the effectiveness of NICE’s ‘stepped care’ approach to the treatment of depression in people with a visual impairment. Trial registration ISRCTN46824140

  18. Detecting irradiation of seeds using microgel electrophoresis (a collaborative trial)

    International Nuclear Information System (INIS)

    Cerda, H.; Haine, H.E.; Jones, J.L.

    1995-06-01

    Preservation of certain foods by irradiation is permitted in the United Kingdom. However, all irradiated foods must be labelled as such, to ensure consumer choice. To help enforce labelling, a variety of methods have been developed for distinguishing between irradiated and non-irradiated foods. In preliminary trials, microgel electrophoresis -a simple method of assessing DNA damage - has shown considerable promise in this respect. This report describes microgel electrophoresis, and details results obtained in a blind trial carried out in collaboration with the Swedish University of Agricultural Sciences. Microgel electrophoresis facilitates analysis of the leakage of DNA from cells extracted from food material. In irradiated samples, the DNA is fragmented and will leak from cells in an electric current. This leakage can be seen as a 'comet' when the stained gel is viewed with a microscope. The size and shape of the comet can be used to estimate the irradiation dose administered to the sample. In non-irradiated samples the DNA is less fragmented, will tend not to leak from the cells and will not form a comet. (author)

  19. Randomised controlled trial of the clinical and cost effectiveness of a specialist team for managing refractory unipolar depressive disorder.

    Science.gov (United States)

    Morriss, Richard; Marttunnen, Sarah; Garland, Anne; Nixon, Neil; McDonald, Ruth; Sweeney, Tim; Flambert, Heather; Fox, Richard; Kaylor-Hughes, Catherine; James, Marilyn; Yang, Min

    2010-11-29

    Around 40 per cent of patients with unipolar depressive disorder who are treated in secondary care mental health services do not respond to first or second line treatments for depression. Such patients have 20 times the suicide rate of the general population and treatment response becomes harder to achieve and sustain the longer they remain depressed. Despite this there are no randomised controlled trials of community based service delivery interventions delivering both algorithm based pharmacotherapy and psychotherapy for patients with chronic depressive disorder in secondary care mental health services who remain moderately or severely depressed after six months treatment. Without such trials evidence based guidelines on services for such patients cannot be derived. Single blind individually randomised controlled trial of a specialist depression disorder team (psychiatrist and psychotherapist jointly assessing and providing algorithm based drug and psychological treatment) versus usual secondary care treatment. We will recruit 174 patients with unipolar depressive disorder in secondary mental health services with a Hamilton Depression Rating Scale (HDRS) score ≥ 16 and global assessment of function (GAF) ≤ 60 after ≥ 6 months treatment. The primary outcome measures will be the HDRS and GAF supplemented by economic analysis including the EQ5 D and analysis of barriers to care, implementation and the process of care. Audits to benchmark both treatment arms against national standards of care will aid the interpretation of the results of the study. This trial will be the first to assess the effectiveness and implementation of a community based specialist depression disorder team. The study has been specially designed as part of the CLAHRC Nottinghamshire, Derbyshire and Lincolnshire joint collaboration between university, health and social care organisations to provide information of direct relevance to decisions on commissioning, service provision and

  20. What are the barriers and facilitators to implementing Collaborative Care for depression? A systematic review.

    Science.gov (United States)

    Wood, Emily; Ohlsen, Sally; Ricketts, Thomas

    2017-05-01

    Collaborative Care is an evidence-based approach to the management of depression within primary care services recommended within NICE Guidance. However, uptake within the UK has been limited. This review aims to investigate the barriers and facilitators to implementing Collaborative Care. A systematic review of the literature was undertaken to uncover what barriers and facilitators have been reported by previous research into Collaborative Care for depression in primary care. The review identified barriers and facilitators to successful implementation of Collaborative Care for depression in 18 studies across a range of settings. A framework analysis was applied using the Collaborative Care definition. The most commonly reported barriers related to the multi-professional approach, such as staff and organisational attitudes to integration, and poor inter-professional communication. Facilitators to successful implementation particularly focussed on improving inter-professional communication through standardised care pathways and case managers with clear role boundaries and key underpinning personal qualities. Not all papers were independent title and abstract screened by multiple reviewers thus limiting the reliability of the selected studies. There are many different frameworks for assessing the quality of qualitative research and little consensus as to which is most appropriate in what circumstances. The use of a quality threshold led to the exclusion of six papers that could have included further information on barriers and facilitators. Although the evidence base for Collaborative Care is strong, and the population within primary care with depression is large, the preferred way to implement the approach has not been identified. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  1. Clinical relevance of findings in trials of CBT for depression.

    Science.gov (United States)

    Lepping, P; Whittington, R; Sambhi, R S; Lane, S; Poole, R; Leucht, S; Cuijpers, P; McCabe, R; Waheed, W

    2017-09-01

    Cognitive behavioural therapy (CBT) is beneficial in depression. Symptom scores can be translated into Clinical Global Impression (CGI) scale scores to indicate clinical relevance. We aimed to assess the clinical relevance of findings of randomised controlled trials (RCTs) of CBT in depression. We identified RCTs of CBT that used the Hamilton Rating Scale for Depression (HAMD). HAMD scores were translated into Clinical Global Impression - Change scale (CGI-I) scores to measure clinical relevance. One hundred and seventy datasets from 82 studies were included. The mean percentage HAMD change for treatment arms was 53.66%, and 29.81% for control arms, a statistically significant difference. Combined active therapies showed the biggest improvement on CGI-I score, followed by CBT alone. All active treatments had better than expected HAMD percentage reduction and CGI-I scores. CBT has a clinically relevant effect in depression, with a notional CGI-I score of 2.2, indicating a significant clinical response. The non-specific or placebo effect of being in a psychotherapy trial was a 29% reduction of HAMD. Copyright © 2017. Published by Elsevier Masson SAS.

  2. Better together? a naturalistic qualitative study of inter-professional working in collaborative care for co-morbid depression and physical health problems.

    Science.gov (United States)

    Knowles, Sarah E; Chew-Graham, Carolyn; Coupe, Nia; Adeyemi, Isabel; Keyworth, Chris; Thampy, Harish; Coventry, Peter A

    2013-09-20

    Mental-physical multi-morbidities pose challenges for primary care services that traditionally focus on single diseases. Collaborative care models encourage inter-professional working to deliver better care for patients with multiple chronic conditions, such as depression and long-term physical health problems. Successive trials from the United States have shown that collaborative care effectively improves depression outcomes, even in people with long-term conditions (LTCs), but little is known about how to implement collaborative care in the United Kingdom. The aim of the study was to explore the extent to which collaborative care was implemented in a naturalistic National Health Service setting. A naturalistic pilot study of collaborative care was undertaken in North West England. Primary care mental health professionals from IAPT (Increasing Access to Psychological Therapies) services and general practice nurses were trained to collaboratively identify and manage patients with co-morbid depression and long-term conditions. Qualitative interviews were performed with health professionals at the beginning and end of the pilot phase. Normalization Process Theory guided analysis. Health professionals adopted limited elements of the collaborative care model in practice. Although benefits of co-location in primary care practices were reported, including reduced stigma of accessing mental health treatment and greater ease of disposal for identified patients, existing norms around the division of mental and physical health work in primary care were maintained, limiting integration of the mental health practitioners into the practice setting. Neither the mental health practitioners nor the practice nurses perceived benefits to joint management of patients. Established divisions between mental and physical health may pose particular challenges for multi-morbidity service delivery models such as collaborative care. Future work should explore patient perspectives about

  3. Developing a national dissemination plan for collaborative care for depression: QUERI Series

    Directory of Open Access Journals (Sweden)

    Rubenstein Lisa V

    2008-12-01

    Full Text Available Abstract Background Little is known about effective strategies for disseminating and implementing complex clinical innovations across large healthcare systems. This paper describes processes undertaken and tools developed by the U.S. Department of Veterans Affairs (VA Mental Health Quality Enhancement Research Initiative (MH-QUERI to guide its efforts to partner with clinical leaders to prepare for national dissemination and implementation of collaborative care for depression. Methods An evidence-based quality improvement (EBQI process was used to develop an initial set of goals to prepare the VA for national dissemination and implementation of collaborative care. The resulting product of the EBQI process is referred to herein as a "National Dissemination Plan" (NDP. EBQI participants included: a researchers with expertise on the collaborative care model for depression, clinical quality improvement, and implementation science, and b VA clinical and administrative leaders with experience and expertise on how to adapt research evidence to organizational needs, resources and capacity. Based on EBQI participant feedback, drafts of the NDP were revised and refined over multiple iterations before a final version was approved by MH-QUERI leadership. 'Action Teams' were created to address each goal. A formative evaluation framework and related tools were developed to document processes, monitor progress, and identify and act upon barriers and facilitators in addressing NDP goals. Results The National Dissemination Plan suggests that effectively disseminating collaborative care for depression in the VA will likely require attention to: Guidelines and Quality Indicators (4 goals, Training in Clinical Processes and Evidence-based Quality Improvement (6 goals, Marketing (7 goals, and Informatics Support (1 goal. Action Teams are using the NDP as a blueprint for developing infrastructure to support system-wide adoption and sustained implementation of

  4. Perceptions of hatha yoga amongst persistently depressed individuals enrolled in a trial of yoga for depression.

    Science.gov (United States)

    Uebelacker, Lisa A; Kraines, Morganne; Broughton, Monica K; Tremont, Geoffrey; Gillette, L Tom; Epstein-Lubow, Gary; Abrantes, Ana M; Battle, Cynthia; Miller, Ivan W

    2017-10-01

    To understand depressed individuals' experiences in a 10-week hatha yoga program. In a randomized controlled trial, participants were assigned to either 10 weeks of hatha yoga classes or a health education control group. This report includes responses from participants in yoga classes. At the start of classes, average depression symptom severity level was moderate. After 10 weeks of yoga classes, we asked participants (n=50) to provide written responses to open-ended questions about what they liked about classes, what they did not like or did not find helpful, and what they learned. We analyzed qualitative data using thematic analysis. Elements of yoga classes that may increase acceptability for depressed individuals include having instructors who promote a non-competitive and non-judgmental atmosphere, who are knowledgeable and able to provide individualized attention, and who are kind and warm. Including depression-related themes in classes, teaching mindfulness, teaching breathing exercises, and providing guidance for translating class into home practice may help to make yoga effective for targeting depression. Participants' comments reinforced the importance of aspects of mindfulness, such as attention to the present moment and acceptance of one's self and one's experience, as potential mechanisms of action. Other potential mechanisms include use of breathing practices in everyday life and the biological mechanisms that underlie the positive impact of yogic breathing. The most serious concern highlighted by a few participants was the concern that the yoga classes were too difficult given their physical abilities. Copyright © 2017 Elsevier Ltd. All rights reserved.

  5. Quality improvement in depression care in the Netherlands: the Depression Breakthrough Collaborative. A quality improvement report.

    NARCIS (Netherlands)

    Franx, G.C.; Meeuwissen, J.A.; Sinnema, H.; Spijker, J.; Huyser, J.; Wensing, M.J.P.; Lange, J.

    2009-01-01

    BACKGROUND: Improving the healthcare for patients with depression is a priority health policy across the world. Roughly, two major problems can be identified in daily practice: (1) the content of care is often not completely consistent with recommendations in guidelines and (2) the organization of

  6. Mental health treatment associated with community-based depression screening: considerations for planning multidisciplinary collaborative care.

    Science.gov (United States)

    Winchester, Bruce R; Watkins, Sarah C; Brahm, Nancy C; Harrison, Donald L; Miller, Michael J

    2013-06-01

    antidepressant prescribing and referral for behavioral health care. It is critical for policy planners to recognize changes in follow-up depression care when implementing screening programs to ensure adequate capacity. Pharmacists are poised to assume a role in collaborative depression care, particularly with antidepressant medication therapy management.

  7. [Primary care and mental health care collaboration in patients with depression: Evaluation of a pilot experience].

    Science.gov (United States)

    Calderón, Carlos; Balagué, Laura; Iruin, Álvaro; Retolaza, Ander; Belaunzaran, Jon; Basterrechea, Javier; Mosquera, Isabel

    2016-01-01

    To implement and assess a collaborative experience between Primary Care (PC) and Mental Health (MH) in order to improve the care of patients with depression. Pilot collaborative project from a participatory action research approach during 2013. Basque Country. Osakidetza (Basque Health Service). Bizkaia and Gipuzkoa. The study included 207 professionals from general practice, nursing, psychiatry, psychiatric nursing, psychology and social work of 9 health centres and 6 mental health centres of Osakidetza. Shared design and development of four axes of intervention: 1) Communication and knowledge between PC and MH professionals, 2) Improvement of diagnostic coding and referral of patients, 3) Training programmes with meetings and common Clinical Practice Guidelines, and 4) Evaluation. Intervention and control questionnaires to professionals of the centres on the knowledge and satisfaction in the PC-MH relationship, joint training activities, and assessment of the experience. Osakidetza registers of prevalences, referrals and treatments. Follow-up meetings. Improvement in the 4 axes of intervention in the participant centres compared with the controls. Identification of factors to be considered in the development and sustainability of PC-MH collaborative care. The pilot experience confirms that collaborative projects promoted by PC and MH can improve depression care and the satisfaction of professionals. They are complex projects that need simultaneous interventions adjusted to the particularities of the health services. Multidisciplinary and continuous participation and management and information system support are necessary for their implementation. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  8. Clinical trial quality: From supervision to collaboration and beyond.

    Science.gov (United States)

    Meeker-O'Connell, Ann; Glessner, Coleen

    2018-02-01

    Over the past decade, clinical trial quality has evolved from an after-the-fact, reactive activity to one focused on the important work of evidence generation from well-designed trials. This article explores the role the Clinical Trials Transformation Initiative has played in advancing quality as a core element of clinical trial design, through project work that initially focused on monitoring but evolved into a holistic, prospective, and comprehensive quality by design approach to clinical trial design and conduct.

  9. Technology-facilitated depression care management among predominantly Latino diabetes patients within a public safety net care system: comparative effectiveness trial design.

    Science.gov (United States)

    Wu, Shinyi; Ell, Kathleen; Gross-Schulman, Sandra G; Sklaroff, Laura Myerchin; Katon, Wayne J; Nezu, Art M; Lee, Pey-Jiuan; Vidyanti, Irene; Chou, Chih-Ping; Guterman, Jeffrey J

    2014-03-01

    Health disparities in minority populations are well recognized. Hispanics and Latinos constitute the largest ethnic minority group in the United States; a significant proportion receives their care via a safety net. The prevalence of diabetes mellitus and comorbid depression is high among this group, but the uptake of evidence-based collaborative depression care management has been suboptimal. The study design and baseline characteristics of the enrolled sample in the Diabetes-Depression Care-management Adoption Trial (DCAT) establishes a quasi-experimental comparative effectiveness research clinical trial aimed at accelerating the adoption of collaborative depression care in safety net clinics. The study was conducted in collaboration with the Los Angeles County Department of Health Services at eight county-operated clinics. DCAT has enrolled 1406 low-income, predominantly Hispanic/Latino patients with diabetes to test a translational model of depression care management. This three-group study compares usual care with a collaborative care team support model and a technology-facilitated depression care model that provides automated telephonic depression screening and monitoring tailored to patient conditions and preferences. Call results are integrated into a diabetes disease management registry that delivers provider notifications, generates tasks, and issues critical alerts. All subjects receive comprehensive assessments at baseline, 6, 12, and 18 months by independent English-Spanish bilingual interviewers. Study outcomes include depression outcomes, treatment adherence, satisfaction, acceptance of assessment and monitoring technology, social and economic stress reduction, diabetes self-care management, health care utilization, and care management model cost and cost-effectiveness comparisons. DCAT's goal is to optimize depression screening, treatment, follow-up, outcomes, and cost savings to reduce health disparities. Copyright © 2013 Elsevier Inc. All rights

  10. Sleep disorders in patients with depression or schizophrenia: A randomized controlled trial using acupuncture treatment

    NARCIS (Netherlands)

    Bosch, M.P.C.; Noort, M.W.M.L. van den; Staudte, H.; Lim, S.; Yeo, S.; Coenen, A.M.L.; Luijtelaar, E.L.J.M. van

    2016-01-01

    Introduction: The purpose of this preliminary clinical trial was to investigate whether acupuncture has a positive influence on sleep and symptomatology in patients with schizophrenia or depression. Methods: A randomized controlled trial was used. One hundred participants were recruited: 40

  11. An Academic-Marketing Collaborative to Promote Depression Care: A Tale of Two Cultures

    Science.gov (United States)

    Kravitz, Richard L.; Epstein, Ronald M.; Bell, Robert A.; Rochlen, Aaron B.; Duberstein, Paul; Riby, Caroline H.; Caccamo, Anthony F.; Slee, Christina K.; Cipri, Camille S.; Paterniti, Debora A.

    2011-01-01

    Objectives Commercial advertising and patient education have separate theoretical underpinnings, approaches, and practitioners. This paper aims to describe a collaboration between academic researchers and a marketing firm working to produce demographically targeted public service anouncements (PSAs) designed to enhance depression care-seeking in primary care. Methods An interdisciplinary group of academic researcherss contracted with a marketing firm in Rochester, NY to produce PSAs that would help patients with depressive symptoms engage more effectively with their primary care physicians (PCPs). The researchers brought perspectives derived from clinical experience and the social sciences and conducted empirical research using focus groups, conjoint analysis, and a population-based survey. Results were shared with the marketing firm, which produced four PSA variants targeted to gender and socioeconomic position. Results There was no simple, one-to-one relationship between research results and the form, content, or style of the PSAs. Instead, empirical findings served as a springboard for discussion and kept the creative process tethered to the experiences, attitudes, and opinions of actual patients. Reflecting research findings highlighting patients’ struggles to recognize, label, and disclose depressive symptoms, the marketing firm generated communication objectives that emphasized: a) educating the patient to consider and investigate the possibility of depression; b) creating the belief that the PCP is interested in discussing depression and capable of offering helpful treatment; and c) modelling different ways of communicating with physicians about depression. Before production, PSA prototypes were vetted with additional focus groups. The winning prototype, “Faces,” involved a multi-ethnic montage of formerly depressed persons talking about how depression affected them and how they improved with treatment, punctuated by a physician who provided clinical

  12. An academic-marketing collaborative to promote depression care: a tale of two cultures.

    Science.gov (United States)

    Kravitz, Richard L; Epstein, Ronald M; Bell, Robert A; Rochlen, Aaron B; Duberstein, Paul; Riby, Caroline H; Caccamo, Anthony F; Slee, Christina K; Cipri, Camille S; Paterniti, Debora A

    2013-03-01

    Commercial advertising and patient education have separate theoretical underpinnings, approaches, and practitioners. This paper aims to describe a collaboration between academic researchers and a marketing firm working to produce demographically targeted public service anouncements (PSAs) designed to enhance depression care-seeking in primary care. An interdisciplinary group of academic researchers contracted with a marketing firm in Rochester, NY to produce PSAs that would help patients with depressive symptoms engage more effectively with their primary care physicians (PCPs). The researchers brought perspectives derived from clinical experience and the social sciences and conducted empirical research using focus groups, conjoint analysis, and a population-based survey. Results were shared with the marketing firm, which produced four PSA variants targeted to gender and socioeconomic position. There was no simple, one-to-one relationship between research results and the form, content, or style of the PSAs. Instead, empirical findings served as a springboard for discussion and kept the creative process tethered to the experiences, attitudes, and opinions of actual patients. Reflecting research findings highlighting patients' struggles to recognize, label, and disclose depressive symptoms, the marketing firm generated communication objectives that emphasized: (a) educating the patient to consider and investigate the possibility of depression; (b) creating the belief that the PCP is interested in discussing depression and capable of offering helpful treatment; and (c) modelling different ways of communicating with physicians about depression. Before production, PSA prototypes were vetted with additional focus groups. The winning prototype, "Faces," involved a multi-ethnic montage of formerly depressed persons talking about how depression affected them and how they improved with treatment, punctuated by a physician who provided clinical information. A member of the

  13. Implementation of collaborative depression management at community-based primary care clinics: an evaluation.

    Science.gov (United States)

    Bauer, Amy M; Azzone, Vanessa; Goldman, Howard H; Alexander, Laurie; Unützer, Jürgen; Coleman-Beattie, Brenda; Frank, Richard G

    2011-09-01

    This study evaluated a large demonstration project of collaborative care of depression at community health centers by examining the role of clinic site on two measures of quality care (early follow-up and appropriate pharmacotherapy) and on improvement of symptoms (score on Patient Health Questionnaire-9 reduced by 50% or ≤ 5). A quasi-experimental study examined data on the treatment of 2,821 patients aged 18 and older with depression symptoms between 2006 and 2009 at six community health organizations selected in a competitive process to implement a model of collaborative care. The model's key elements were use of a Web-based disease registry to track patients, care management to support primary care providers and offer proactive follow-up of patients, and organized psychiatric consultation. Across all sites, a plurality of patients achieved meaningful improvement in depression, and in many sites, improvement occurred rapidly. After adjustment for patient characteristics, multivariate logistic regression models revealed significant differences across clinics in the probability of receiving early follow-up (range .34-.88) or appropriate pharmacotherapy (range .27-.69) and in experiencing improvement (.36 to .84). Similarly, after adjustment for patient characteristics, Cox proportional hazards models revealed that time elapsed between first evaluation and the occurrence of improvement differed significantly across clinics (pquality indicators and outcomes. Sites that performed better on quality indicators had better outcomes, and the differences were not attributable to patients' characteristics.

  14. Interdisciplinary Team Collaboration during Discharge of Depressed Older Persons: A Norwegian Qualitative Implementation Study

    Directory of Open Access Journals (Sweden)

    Anne Lise Holm

    2013-01-01

    Full Text Available In order to deliver effective care, it is necessary to organise interdisciplinary activities for older persons who suffer from depressive disorders. This paper evaluated the interdisciplinary team members’ perceptions of cooperation in the discharge planning of depressed older persons based on the Chronic Care Model (CCM. A qualitative implementation design was used, data were collected by means of multistage focus groups, and a thematic analysis was performed. Three themes emerged: lack of effective team leadership in the community, the need to change the delivery system, and enhancing self-management support for depressed older persons as well as the participation of their families. It was concluded that nurse managers must find ways of supporting the depressed older persons by better structuring the care, increasing cooperation with organisational leadership, and creating an environment characterised by trust and mutual respect. Distrust can have serious implications for discharge planning collaboration. The development of a common vision of transparency in the organization is important as is a policy of change among leadership and in clinical practice.

  15. Enablers and barriers to implementing collaborative care for anxiety and depression

    DEFF Research Database (Denmark)

    Overbeck, Gritt; Davidsen, Annette Sofie; Kousgaard, Marius Brostrøm

    2016-01-01

    shown significant positive effects for patients suffering from depression, but since collaborative care is a complex intervention, it is important to understand the factors which affect its implementation. We present a qualitative systematic review of the enablers and barriers to implementing...... employed the normalization process theory (NPT). RESULTS: We included 17 studies in our review of which 11 were conducted in the USA, five in the UK, and one in Canada. We identified several barriers and enablers within the four major analytical dimensions of NPT. Securing buy-in among primary care...... collaborative care interventions: effective educational programs, especially for care managers; issues of reimbursement in relation to primary care providers; good systems for communication and monitoring; and promoting face-to-face interaction between care managers and physicians, preferably through co...

  16. A randomized controlled trial of vitamin D supplementation on perinatal depression: in Iranian pregnant mothers

    OpenAIRE

    Vaziri, Farideh; Nasiri, Samira; Tavana, Zohreh; Dabbaghmanesh, Mohammad Hossein; Sharif, Farkhondeh; Jafari, Peyman

    2016-01-01

    Background Mood disorders in pregnancy and post-partum period are common and considered as a public health issue. Researchers have studied the relationship between low serum vitamin D concentration and perinatal depression, although no clinical trial has been conducted on vitamin D?s effects on depression related to childbirth. This study evaluated the effect of vitamin D3 supplementation on perinatal depression scores. Methods This randomized clinical trial was done in pregnant women who wer...

  17. Treatments for acute bipolar depression: meta-analyses of placebo-controlled, monotherapy trials of anticonvulsants, lithium and antipsychotics.

    Science.gov (United States)

    Selle, V; Schalkwijk, S; Vázquez, G H; Baldessarini, R J

    2014-03-01

    Optimal treatments for bipolar depression, and the relative value of specific drugs for that purpose, remain uncertain, including agents other than antidepressants. We searched for reports of placebo-controlled, monotherapy trials of mood-stabilizing anticonvulsants, second-generation antipsychotics, or lithium for acute major depressive episodes in patients diagnosed with type I or II bipolar disorder and applied random-effects meta-analysis to evaluate their efficacy, comparing outcomes based on standardized mean drug-placebo differences (SMD) in improvement, relative response rates (RR), and number-needed-to-treat (NNT). We identified 24 trials of 10 treatments (lasting 7.5 weeks, with ≥ 50 collaborating sites/trial) that met eligibility criteria: lamotrigine (5 trials), quetiapine (5), valproate (4), 2 each for aripiprazole, olanzapine, ziprasidone, and 1 each for carbamazepine, lithium, lurasidone, and olanzapine-fluoxetine. Overall, pooled drug-over-placebo responder-rate superiority (RR) was moderate (29% [CI: 19-40%]), and NNT was 8.2 (CI: 6.4-11). By SMD, apparent efficacy ranked: olanzapine + fluoxetine ≥ valproate > quetiapine > lurasidone > olanzapine, aripiprazole, and carbamazepine; ziprasidone was ineffective, and lithium remains inadequately studied. Notably, drugs were superior to placebo in only 11/24 trials (5/5 with quetiapine, 2/4 with valproate), and only lamotrigine, quetiapine and valproate had > 2 trials. Treatment-associated mania-like reactions were uncommon (drugs: 3.7%; placebo: 4.7%). Controlled trials of non-antidepressant treatments for bipolar depression remain scarce, but findings with olanzapine-fluoxetine, lurasidone, quetiapine, and perhaps carbamazepine and valproate were encouraging; lithium requires adequate testing. © Georg Thieme Verlag KG Stuttgart · New York.

  18. Collaborative care to improve the management of depressive disorders: a community guide systematic review and meta-analysis.

    Science.gov (United States)

    Thota, Anilkrishna B; Sipe, Theresa Ann; Byard, Guthrie J; Zometa, Carlos S; Hahn, Robert A; McKnight-Eily, Lela R; Chapman, Daniel P; Abraido-Lanza, Ana F; Pearson, Jane L; Anderson, Clinton W; Gelenberg, Alan J; Hennessy, Kevin D; Duffy, Farifteh F; Vernon-Smiley, Mary E; Nease, Donald E; Williams, Samantha P

    2012-05-01

    To improve the quality of depression management, collaborative care models have been developed from the Chronic Care Model over the past 20 years. Collaborative care is a multicomponent, healthcare system-level intervention that uses case managers to link primary care providers, patients, and mental health specialists. In addition to case management support, primary care providers receive consultation and decision support from mental health specialists (i.e., psychiatrists and psychologists). This collaboration is designed to (1) improve routine screening and diagnosis of depressive disorders; (2) increase provider use of evidence-based protocols for the proactive management of diagnosed depressive disorders; and (3) improve clinical and community support for active client/patient engagement in treatment goal-setting and self-management. A team of subject matter experts in mental health, representing various agencies and institutions, conceptualized and conducted a systematic review and meta-analysis on collaborative care for improving the management of depressive disorders. This team worked under the guidance of the Community Preventive Services Task Force, a nonfederal, independent, volunteer body of public health and prevention experts. Community Guide systematic review methods were used to identify, evaluate, and analyze available evidence. An earlier systematic review with 37 RCTs of collaborative care studies published through 2004 found evidence of effectiveness of these models in improving depression outcomes. An additional 32 studies of collaborative care models conducted between 2004 and 2009 were found for this current review and analyzed. The results from the meta-analyses suggest robust evidence of effectiveness of collaborative care in improving depression symptoms (standardized mean difference [SMD]=0.34); adherence to treatment (OR=2.22); response to treatment (OR=1.78); remission of symptoms (OR=1.74); recovery from symptoms (OR=1.75); quality of

  19. The influence of multiple trials and computer-mediated communication on collaborative and individual semantic recall.

    Science.gov (United States)

    Hinds, Joanne M; Payne, Stephen J

    2018-04-01

    Collaborative inhibition is a phenomenon where collaborating groups experience a decrement in recall when interacting with others. Despite this, collaboration has been found to improve subsequent individual recall. We explore these effects in semantic recall, which is seldom studied in collaborative retrieval. We also examine "parallel CMC", a synchronous form of computer-mediated communication that has previously been found to improve collaborative recall [Hinds, J. M., & Payne, S. J. (2016). Collaborative inhibition and semantic recall: Improving collaboration through computer-mediated communication. Applied Cognitive Psychology, 30(4), 554-565]. Sixty three triads completed a semantic recall task, which involved generating words beginning with "PO" or "HE" across three recall trials, in one of three retrieval conditions: Individual-Individual-Individual (III), Face-to-face-Face-to-Face-Individual (FFI) and Parallel-Parallel-Individual (PPI). Collaborative inhibition was present across both collaborative conditions. Individual recall in Recall 3 was higher when participants had previously collaborated in comparison to recalling three times individually. There was no difference between face-to-face and parallel CMC recall, however subsidiary analyses of instance repetitions and subjective organisation highlighted differences in group members' approaches to recall in terms of organisation and attention to others' contributions. We discuss the implications of these findings in relation to retrieval strategy disruption.

  20. Long-Term Collaboration Network Based on ClinicalTrials.gov Database in the Pharmaceutical Industry

    Directory of Open Access Journals (Sweden)

    Heyoung Yang

    2018-01-01

    Full Text Available Increasing costs, risks, and productivity problems in the pharmaceutical industry are important recent issues in the biomedical field. Open innovation is proposed as a solution to these issues. However, little statistical analysis related to collaboration in the pharmaceutical industry has been conducted so far. Meanwhile, not many cases have analyzed the clinical trials database, even though it is the information source with the widest coverage for the pharmaceutical industry. The purpose of this study is to test the clinical trials information as a probe for observing the status of the collaboration network and open innovation in the pharmaceutical industry. This study applied the social network analysis method to clinical trials data from 1980 to 2016 in ClinicalTrials.gov. Data were divided into four time periods—1980s, 1990s, 2000s, and 2010s—and the collaboration network was constructed for each time period. The characteristic of each network was investigated. The types of agencies participating in the clinical trials were classified as a university, national institute, company, or other, and the major players in the collaboration networks were identified. This study showed some phenomena related to the pharmaceutical industry that could provide clues to policymakers about open innovation. If follow-up studies were conducted, the utilization of the clinical trial database could be further expanded, which is expected to help open innovation in the pharmaceutical industry.

  1. The Impact of Posttraumatic Stress Disorder on the 6-Month Outcomes in Collaborative Care Management for Depression.

    Science.gov (United States)

    Angstman, Kurt B; Marcelin, Alberto; Gonzalez, Cesar A; Kaufman, Tara K; Maxson, Julie A; Williams, Mark D

    2016-07-01

    Posttraumatic stress disorder (PTSD) has symptoms that exist along a spectrum that includes depression and the 2 disorders may coexist. Collaborative care management (CCM) has been successfully used in outpatient mental health management (especially depression and anxiety) with favorable outcomes. Despite this, there exist limited data on clinical impact of a diagnosis of PTSD on depression outcomes in CCM. The present study used a retrospective cohort design to examine the association of PTSD with depression outcomes among 2121 adult patients involved in CCM in a primary care setting. Using standardized self-report measures, baseline depression scores and 6-month outcome scores were evaluated. Seventy-six patients had a diagnosis of PTSD documented in their electronic medical record. Patients with PTSD reported more severe depressive symptoms at baseline (Patient Health Questionnaire-9 score of 17.9 vs 15.4, P depressive symptoms at 6 months after CCM. When coexisting with depression, a diagnosis of PTSD was associated with worse depression outcomes, when managed with CCM in primary care. Opportunities still exist for more aggressive management of depression in these patients to help improve remission as well as reduce persistent depressive symptoms. © The Author(s) 2016.

  2. Low vision depression prevention trial in age-related macular degeneration: a randomized clinical trial.

    Science.gov (United States)

    Rovner, Barry W; Casten, Robin J; Hegel, Mark T; Massof, Robert W; Leiby, Benjamin E; Ho, Allen C; Tasman, William S

    2014-11-01

    To compare the efficacy of behavior activation (BA) + low vision rehabilitation (LVR) with supportive therapy (ST) + LVR to prevent depressive disorders in patients with age-related macular degeneration (AMD). Single-masked, attention-controlled, randomized, clinical trial with outcome assessment at 4 months. Patients with AMD and subsyndromal depressive symptoms attending retina practices (n = 188). Before randomization, all subjects had 2 outpatient LVR visits, and were then randomized to in-home BA+LVR or ST+LVR. Behavior activation is a structured behavioral treatment that aims to increase adaptive behaviors and achieve valued goals. Supportive therapy is a nondirective, psychological treatment that provides emotional support and controls for attention. The Diagnostic and Statistical Manual IV defined depressive disorder based on the Patient Health Questionnaire-9 (primary outcome), Activities Inventory, National Eye Institute Vision Function Questionnaire-25 plus Supplement (NEI-VFQ), and NEI-VFQ quality of life (secondary outcomes). At 4 months, 11 BA+LVR subjects (12.6%) and 18 ST+LVR subjects (23.4%) developed a depressive disorder (relative risk [RR], 0.54; 95% CI, 0.27-1.06; P = 0.067). In planned adjusted analyses the RR was 0.51 (95% CI, 0.27-0.98; P = 0.04). A mediational analysis suggested that BA+LVR prevented depression to the extent that it enabled subjects to remain socially engaged. In addition, BA+LVR was associated with greater improvements in functional vision than ST+LVR, although there was no significant between-group difference. There was no significant change or between-group difference in quality of life. An integrated mental health and low vision intervention halved the incidence of depressive disorders relative to standard outpatient LVR in patients with AMD. As the population ages, the number of persons with AMD and the adverse effects of comorbid depression will increase. Promoting interactions between ophthalmology, optometry

  3. Parents' experiences of collaboration between welfare professionals regarding children with anxiety or depression - an explorative study

    Directory of Open Access Journals (Sweden)

    Catharina Widmark

    2013-10-01

    Full Text Available Introduction: Well-functioning collaboration between professionals in the welfare sector has a strong influence on the contact with parents of children and adolescents with mental illness, and it is a precondition for the availability of support for these parents. This paper reports how such parents experience collaboration between professionals in mental health care, social services, and schools.Methods: Data were collected by in-depth interviews with seven parents of children and adolescents diagnosed with anxiety and depression. The families were selected from the Child and Adolescent Mental Health (CAMH patient records kept by the Stockholm County Council (Sweden, and they all lived in a catchment area for CAMH outpatient services in Stockholm.Results and discussion: We conclude that when the encounter between parents and professionals is characterized by structure and trust, it is supportive and serves as a holding environment. Coordination and communication links are needed in the collaboration between the professionals, along with appropriately scheduled and well-performed network meetings to create structure in the parent-professional encounter. Indeed, establishment of trust in this interaction is promoted if individual professionals are available, provide the parents with adequate information, are skilled, and show empathy and commitment. 

  4. Parents' experiences of collaboration between welfare professionals regarding children with anxiety or depression - an explorative study

    Directory of Open Access Journals (Sweden)

    Catharina Widmark

    2013-10-01

    Full Text Available Introduction: Well-functioning collaboration between professionals in the welfare sector has a strong influence on the contact with parents of children and adolescents with mental illness, and it is a precondition for the availability of support for these parents. This paper reports how such parents experience collaboration between professionals in mental health care, social services, and schools. Methods: Data were collected by in-depth interviews with seven parents of children and adolescents diagnosed with anxiety and depression. The families were selected from the Child and Adolescent Mental Health (CAMH patient records kept by the Stockholm County Council (Sweden, and they all lived in a catchment area for CAMH outpatient services in Stockholm. Results and discussion: We conclude that when the encounter between parents and professionals is characterized by structure' and trust', it is supportive and serves as a holding environment'. Coordination and communication links are needed 'in the collaboration between the professionals, along with appropriately scheduled and well-performed network meetings 'to create structure in the parent-professional encounter. Indeed, establishment of trust in this interaction is promoted if individual professionals are available, provide the parents with adequate information, are skilled, and show empathy and commitment. 

  5. Collaboration

    Science.gov (United States)

    King, Michelle L.

    2010-01-01

    This article explores collaboration between library media educators and regular classroom teachers. The article focuses on the context of the issue, positions on the issue, the impact of collaboration, and how to implement effective collaboration into the school system. Various books and professional journals are used to support conclusions…

  6. Reconsidering the definition of Major Depression based on Collaborative Psychiatric Epidemiology Surveys.

    Science.gov (United States)

    Rosenström, Tom; Jokela, Markus

    2017-01-01

    Diagnostic definitions for depressive disorders remain a debated topic, despite their central role in clinical practice and research. We use both recent evidence and nationally representative data to derive an empirically-based modification of DSM-IV/-5 Major Depressive Disorder (MDD). A modified MDD diagnosis was derived by analyzing data from Collaborative Psychiatric Epidemiology Surveys, a multistage probability sample of adults (n=20 013; age ≥ 18 years) in coterminous USA, Alaska and Hawaii. The old and the newly suggested MDD definitions were compared for their associated disability (WHO Disability Assessment Schedule and number of disability days in past month), suicide attempt, and other covariates. Our data-driven definition for major depression was "lack of interest to all or most things" plus four other symptoms from the set {weight gain, weight loss, insomnia, psychomotor retardation, fatigue, feelings of worthlessness, diminished ability to think/concentrate, suicidal ideation/attempt}. The new definition captured all the disability implied by MDD and excluded cases that showed no greater disability than the general population nor increased risk of suicide attempts. The lifetime prevalence of the new diagnosis was 14.7% (95% CI=14-15.4%) of the population, slightly less than for the old definition (16.4%; CI=15.4-17.3%). Only conservative modifications of MDD could be studied, because of restrictions in the symptom data. With only small adjusting, the new definition for major depression may be more clinically relevant than the old one, and could serve as a conservative replacement for the old definition. Copyright © 2016 Elsevier B.V. All rights reserved.

  7. Cost-Effectiveness of a Collaborative Care Depression and Anxiety Treatment Program in Patients with Acute Cardiac Illness.

    Science.gov (United States)

    Celano, Christopher M; Healy, Brian; Suarez, Laura; Levy, Douglas E; Mastromauro, Carol; Januzzi, James L; Huffman, Jeff C

    2016-01-01

    To use data from a randomized trial to determine the cost-effectiveness of a collaborative care (CC) depression and anxiety treatment program and to assess effects of the CC program on health care utilization. The CC intervention's impact on health-related quality of life, depression-free days (DFDs), and anxiety-free days (AFDs) over the 24-week postdischarge period was calculated and compared with the enhanced usual care (EUC) condition using independent samples t tests and random-effects regression models. Costs for both the CC and EUC conditions were calculated on the basis of staff time, overhead expenses, and treatment materials. Using this information, incremental cost-effectiveness ratios were calculated. A cost-effectiveness acceptability plot was created using nonparametric bootstrapping with 10,000 replications, and the likelihood of the CC intervention's cost-effectiveness was assessed using standard cutoffs. As a secondary analysis, we determined whether the CC intervention led to reductions in postdischarge health care utilization and costs. The CC intervention was more costly than the EUC intervention ($209.86 vs. $34.59; z = -11.71; P < 0.001), but was associated with significantly greater increases in quality-adjusted life-years (t = -2.49; P = 0.01) and DFDs (t = -2.13; P = 0.03), but not AFDs (t = -1.92; P = 0.057). This translated into an incremental cost-effectiveness ratio of $3337.06 per quality-adjusted life-year saved, $13.36 per DFD, and $13.74 per AFD. Compared with the EUC intervention, the CC intervention was also associated with fewer emergency department visits but no differences in overall costs. This CC intervention was associated with clinically relevant improvements, was cost-effective, and was associated with fewer emergency department visits in the 24 weeks after discharge. Copyright © 2016. Published by Elsevier Inc.

  8. The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression

    DEFF Research Database (Denmark)

    Krogh, Jesper; Saltin, Bengt; Gluud, Christian

    2009-01-01

    OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners or psych......: Our findings do not support a biologically mediated effect of exercise on symptom severity in depressed patients, but they do support a beneficial effect of strength training on work capacity. TRIAL REGISTRATION: (ClinicalTrials.gov) Identifier: NCT00103415....

  9. Effectiveness of liaison psychiatric nursing in older medical inpatients with depression: a randomised controlled trial.

    Science.gov (United States)

    Cullum, Sarah; Tucker, Sue; Todd, Chris; Brayne, Carol

    2007-07-01

    To compare liaison psychiatric nursing with usual medical care in the management of older medical inpatients who screen positive for depression. Pragmatic randomised controlled trial. Medical wards of UK district general hospital in rural East Anglia. One hundred and thirty-eight medical inpatients aged 65+ screened positive on the 15-item geriatric depression scale (GDS). One hundred and twenty-one out of 138 screen positives entered the trial (58/121 fulfilled criteria for depressive disorder at baseline). (i) A liaison psychiatric nurse assessed participants, formulated a care plan for treatment of their depression, ensured its implementation through liaison with appropriate agencies, and monitored participants' mood and response to treatment for up to 12 weeks. (ii) Usual treatment by hospital and primary care staff. ICD-10 depressive disorder, change in GDS-15 score, quality-adjusted life weeks (QALWs) and patient satisfaction rating. Eighty-six out of 121 participants completed the 16-week trial. Participants in the intervention group were more satisfied with their care, but no significant differences in depressive disorder, depression rating or QALWs gained were found between groups. However, there was a trend towards improvement in the intervention group and effect sizes were higher in the subgroup with depressive disorder. This study is the first RCT to evaluate liaison psychiatric nursing specifically for depression in older medical inpatients; the findings suggest improvement in mental health and quality of life, but a larger trial is required to provide convincing evidence.

  10. Internet delivered cognitive behavior therapy for antenatal depression: A randomised controlled trial.

    Science.gov (United States)

    Forsell, Erik; Bendix, Marie; Holländare, Fredrik; Szymanska von Schultz, Barbara; Nasiell, Josefine; Blomdahl-Wetterholm, Margareta; Eriksson, Caroline; Kvarned, Sara; Lindau van der Linden, Johanna; Söderberg, Elin; Jokinen, Jussi; Wide, Katarina; Kaldo, Viktor

    2017-10-15

    Major depression occurs in 5-10% of pregnancies and is associated with many negative effects for mother and child, yet treatment options are scarce. To our knowledge, this is the first published randomised controlled trial on Internet delivered Cognitive Behavior Therapy (ICBT) for this group. To test the efficacy of a pregnancy adapted version of an existing 10-week ICBT-program for depression as well as assessing acceptability and adherence DESIGN: Randomised controlled trial. Online and telephone. Self-referred pregnant women (gestational week 10-28 at intake) currently suffering from major depressive disorder. 42 pregnant women (gestational week 12-28) with major depression were randomised to either treatment as usual (TAU) provided at their antenatal clinic or to ICBT as an add-on to usual care. The primary outcome was depressive symptoms measured with the Montgomery-Åsberg depression rating scale-self report (MADRS-S). The Edinburgh Postnatal Depression Scale and measures of anxiety and sleep were used. Credibility, satisfaction, adherence and utilization were also assessed. The ICBT group had significantly lower levels of depressive symptoms post treatment (p treatment credibility, satisfaction, utilization, and adherence were comparable to implemented ICBT for depression. Small sample size and no long-term evaluation. Pregnancy adapted ICBT for antenatal depression is feasible, acceptable and efficacious. These results need to be replicated in larger trials to validate these promising findings. Copyright © 2017. Published by Elsevier B.V.

  11. Impact of collaborative care for depression on clinical, functional, and work outcomes: a practice-based evaluation.

    Science.gov (United States)

    Shippee, Nathan D; Shah, Nilay D; Angstman, Kurt B; DeJesus, Ramona S; Wilkinson, John M; Bruce, Steven M; Williams, Mark D

    2013-01-01

    The impact of collaborative care (CC) on depression and work productivity in routine, nonresearch primary care settings remains unclear due to limited evidence. This prospective study examined depression and work outcomes (eg, absenteeism, presenteeism) for 165 individuals in CC for depression versus 211 patients in practice as usual in a multisite primary care practice. CC predicted greater adjusted 6-month improvements in treatment response, remission, and absenteeism versus practice as usual. Response/remission increased productivity overall. CC increased clinical and work improvements in a nonresearch care setting. Insurers and employers should consider CC's work benefits in developing payment structures.

  12. Defendant’s free will in legal collaboration and its relation with pre-trial detention

    Directory of Open Access Journals (Sweden)

    Antonio Henrique Graciano Suxberger

    2017-03-01

    Full Text Available The legal collaboration, a type of evidence used on organized crime prosecutions, demands free will of the defendant. Appraising the defendant’s free will, many critics cover the deals made with an arrested defendant during the negotiation of the legal collaboration. These two institutes — legal collaboration and pre-trial detention —, although they do not present themselves as a cause-effect relation, commonly are approached in practice as associated. This essay intends to evaluate the defendant’s free will during pre-trial detention and the legal collaboration’s bargaining. It asserts a strict and clear relation between pre-trial detention and the legal collaboration bargaining. Identifying occasional problems do not imply the conclusion on the existence of a structural problem to legal collaboration institute. This consideration is relevant to avoid superficial solutions that could fragilize even more the held defendant. Methodologically, from a literature review and document analysis about the subject, the paper clarifies what is a “criminal case” and what it means to the study.

  13. Mind the gap in clinical trials: A participatory action analysis with citizen collaborators.

    Science.gov (United States)

    Price, Amy; Liew, Su May; Kirkpatrick, Jo; Price, Jazmin; Lopreto, Taylor; Nelken, Yasmin

    2017-02-01

    What are the strengths, gaps, expectations, and barriers to research engagement in clinical trials as communicated through social media? Clinical trials test treatments to provide reliable information for safety and effectiveness. Trials are building blocks in which what is learned in earlier research can be used to improve treatments, compare alternatives, and improve quality of life. For 20 years, the percentages of clinical trials volunteers have decreased whereas the costs of running clinical trials have multiplied. Participants enroll in trials to access latest treatments, to help others, and to advance science, but there is growing unrest. The priorities of those running the trials differ from those of the participants, and the roles for public research involvement lack clarity. Changes to bridge these gaps in the research culture are proposed through the use of participatory action research (PAR) in which stakeholders collaborate to improve research methodology, galvanize citizen participation, multiply health knowledge, problem-solve barriers to access, and explore the value of research volunteers as collaborators. PAR enabled the inclusion of citizens as full collaborators. Social media data were gathered for 120 days until saturation was reached. De-identified data were organized into a Strengths Weaknesses, Opportunities and Threats framework and coded into themes for analysis. After the analysis, the authors prioritized potential solutions for improving research engagement. Strengths and opportunities remained constant through trial phases, disease burdens, and interventions. Threats included alienation, litigation, disparity, and shaming. Poor management and barriers to inclusion were identified as weaknesses. Opportunities included improving resource management and information quality. Barriers were minimized when relationships between staff and participants were inclusive, respectful, tolerant, and open to change. Participants' communications

  14. Collaboration among Grandparents and Professionals with Discrete Trial Training in the Treatment for Traumatic Brain Injury

    Science.gov (United States)

    Devlin, Sandra D.; Krenzer, Daniels J.; Edwards, Jennifer

    2009-01-01

    This study evaluated the impact of collaborative efforts of grandparents and school professionals in the treatment of Traumatic Brain Injury in a six-year-old boy. The method of treatment was discrete trial training across settings (e.g., home and school) and the change agents were the child's grandparents, special education teacher, and a teacher…

  15. Multicenter Collaborative Trial Evaluation of a Method for Detection of Human Adenoviruses in Berry Fruit

    NARCIS (Netherlands)

    Agostino, D' C.; Cook, N.; Bartolo, Di I.; Ruggeri, F.M.; Berto, A.; Martelli, F.; Banks, M.; Vasickova, P.; Kralik, P.; Pavlik, I.; Kokkinos, P.; Vantarakis, A.; Söderberg, K.; Maunula, L.; Verhaelen, K.; Rutjes, S.; Roda Husman, De A.M.; Hakze-van der Honing, van der R.W.; Poel, van der W.H.M.; Kaupke, A.; Kozyra, I.; Rzezutka, A.; Prodanov, J.; Lazic, S.; Petrovic, T.; Carratala, A.; Gironés, R.; Diez-Valcarce, M.; Hernandez, M.; Rodriguez-Lazaro, D.

    2012-01-01

    The qualitative performance characteristics of a qPCR-based method to detect human adenoviruses in raspberries were determined through a collaborative trial involving 11 European laboratories. The method incorporated a sample process control (murine norovirus) and an internal amplification control.

  16. Tele-Interpersonal Psychotherapy Acutely Reduces Depressive Symptoms in Depressed HIV-Infected Rural Persons: A Randomized Clinical Trial.

    Science.gov (United States)

    Heckman, Timothy G; Heckman, Bernadette D; Anderson, Timothy; Lovejoy, Travis I; Markowitz, John C; Shen, Ye; Sutton, Mark

    2017-01-01

    Human immunodeficiency virus (HIV)-positive rural individuals carry a 1.3-times greater risk of a depressive diagnosis than their urban counterparts. This randomized clinical trial tested whether telephone-administered interpersonal psychotherapy (tele-IPT) acutely relieved depressive symptoms in 132 HIV-infected rural persons from 28 states diagnosed with Diagnostic and Statistical Manual of Mental Disorders-IV major depressive disorder (MDD), partially remitted MDD, or dysthymic disorder. Patients were randomized to either 9 sessions of one-on-one tele-IPT (n = 70) or standard care (SC; n = 62). A series of intent-to-treat (ITT), therapy completer, and sensitivity analyses assessed changes in depressive symptoms, interpersonal problems, and social support from pre- to postintervention. Across all analyses, tele-IPT patients reported significantly lower depressive symptoms and interpersonal problems than SC controls; 22% of tele-IPT patients were categorized as a priori "responders" who reported 50% or higher reductions in depressive symptoms compared to only 4% of SC controls in ITT analyses. Brief tele-IPT acutely decreased depressive symptoms and interpersonal problems in depressed rural people living with HIV.

  17. Case Study of Resilient Baton Rouge: Applying Depression Collaborative Care and Community Planning to Disaster Recovery

    Directory of Open Access Journals (Sweden)

    Robin Keegan

    2018-06-01

    Full Text Available Background: Addressing behavioral health impacts of major disasters is a priority of increasing national attention, but there are limited examples of implementation strategies to guide new disaster responses. We provide a case study of an effort being applied in response to the 2016 Great Flood in Baton Rouge. Methods: Resilient Baton Rouge was designed to support recovery after major flooding by building local capacity to implement an expanded model of depression collaborative care for adults, coupled with identifying and responding to local priorities and assets for recovery. For a descriptive, initial evaluation, we coupled analysis of documents and process notes with descriptive surveys of participants in initial training and orientation, including preliminary comparisons among licensed and non-licensed participants to identify training priorities. Results: We expanded local behavioral health service delivery capacity through subgrants to four agencies, provision of training tailored to licensed and non-licensed providers and development of advisory councils and partnerships with grassroots and government agencies. We also undertook initial efforts to enhance national collaboration around post-disaster resilience. Conclusion: Our partnered processes and lessons learned may be applicable to other communities that aim to promote resilience, as well as planning for and responding to post-disaster behavioral health needs.

  18. Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Three Depression Prevention Programs

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2010-01-01

    Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…

  19. Medical comorbidity in complicated grief: Results from the HEAL collaborative trial.

    Science.gov (United States)

    Robbins-Welty, Gregg; Stahl, Sarah; Zhang, Jun; Anderson, Stewart; Schenker, Yael; Shear, M Katherine; Simon, Naomi M; Zisook, Sidney; Skritskaya, Natalia; Mauro, Christina; Lebowitz, Barry D; Reynolds, Charles F

    2018-01-01

    To describe medical comorbidity in persons with Complicated Grief (CG) and to test whether medical comorbidity in individuals with CG is associated with the severity and duration of CG, after adjusting for age, sex, race, and current depressive symptoms. In exploratory analyses, we compared data from participants in an NIMH-sponsored multisite clinical trial of CG ("HEAL": "Healing Emotions After Loss") to archival data from participants matched on age, gender, and race/ethnicity, stratified by the presence or absence of current major depression. We used the Cumulative Illness Rating Scale for Geriatrics (CIRS-G) as a measure of medical polymorbidity. We investigated the association between CG and medical comorbidity via multiple linear regression, adjusting for sociodemographic and clinical variables, including severity of depressive symptoms. Chronological age and severity of co-occurring symptoms of major depression correlated with cumulative medical polymorbidity in persons with Complicated Grief. The severity of CG and the time since loss did not correlate with global medical polymorbidity (CIRS-G score). Nor was there an interaction between severity of depressive symptoms and severity of CG symptoms in predicting global CIRS-G score. Cumulative medical comorbidity, as measured by CIRS-G scores, was greater in subjects with current major depression ("DEPRESSED") than in CG subjects, and both DEPRESSED and CG subjects had greater medical morbidity than CONTROLS. Medical comorbidity is prevalent in Complicated Grief, associated with increasing age and co-occurring depressive symptoms but apparently not with chronicity and severity of Complicated Grief per se. This observation suggests that treating depression in the context of CG may be important to managing medical conditions in individuals with Complicated Grief to attenuate or prevent the long-term medical sequelae of CG. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. The TrueBlue study: Is practice nurse-led collaborative care effective in the management of depression for patients with heart disease or diabetes?

    Directory of Open Access Journals (Sweden)

    Coates Michael

    2009-06-01

    Full Text Available Abstract Background In the presence of type 2 diabetes (T2DM or coronary heart disease (CHD, depression is under diagnosed and under treated despite being associated with worse clinical outcomes. Our earlier pilot study demonstrated that it was feasible, acceptable and affordable for practice nurses to extend their role to include screening for and monitoring of depression alongside biological and lifestyle risk factors. The current study will compare the clinical outcomes of our model of practice nurse-led collaborative care with usual care for patients with depression and T2DM or CHD. Methods This is a cluster-randomised intervention trial. Eighteen general practices from regional and metropolitan areas agreed to join this study, and were allocated randomly to an intervention or control group. We aim to recruit 50 patients with co-morbid depression and diabetes or heart disease from each of these practices. In the intervention group, practice nurses (PNs will be trained for their enhanced roles in this nurse-led collaborative care study. Patients will be invited to attend a practice nurse consultation every 3 months prior to seeing their usual general practitioner. The PN will assess psychological, physiological and lifestyle parameters then work with the patient to set management goals. The outcome of this assessment will form the basis of a GP Management Plan document. In the control group, the patients will continue to receive their usual care for the first six months of the study before the PNs undergo the training and switch to the intervention protocol. The primary clinical outcome will be a reduction in the depression score. The study will also measure the impact on physiological measures, quality of life and on patient attitude to health care delivered by practice nurses. Conclusion The strength of this programme is that it provides a sustainable model of chronic disease management with monitoring and self-management assistance for

  1. Treatment of depressive disorders in primary care - protocol of a multiple treatment systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Linde Klaus

    2011-11-01

    Full Text Available Abstract Background Several systematic reviews have summarized the evidence for specific treatments of primary care patients suffering from depression. However, it is not possible to answer the question how the available treatment options compare with each other as review methods differ. We aim to systematically review and compare the available evidence for the effectiveness of pharmacological, psychological, and combined treatments for patients with depressive disorders in primary care. Methods/Design To be included, studies have to be randomized trials comparing antidepressant medication (tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs, hypericum extracts, other agents and/or psychological therapies (e.g. interpersonal psychotherapy, cognitive therapy, behavioural therapy, short dynamically-oriented psychotherapy with another active therapy, placebo or sham intervention, routine care or no treatment in primary care patients in the acute phase of a depressive episode. Main outcome measure is response after completion of acute phase treatment. Eligible studies will be identified from available systematic reviews, from searches in electronic databases (Medline, Embase and Central, trial registers, and citation tracking. Two reviewers will independently extract study data and assess the risk of bias using the Cochrane Collaboration's corresponding tool. Meta-analyses (random effects model, inverse variance weighting will be performed for direct comparisons of single interventions and for groups of similar interventions (e.g. SSRIs vs. tricyclics and defined time-windows (up to 3 months and above. If possible, a global analysis of the relative effectiveness of treatments will be estimated from all available direct and indirect evidence that is present in a network of treatments and comparisons. Discussion Practitioners do not only want to know whether there is evidence that a specific treatment is more effective than

  2. Impact of Personality Disorder Cluster on Depression Outcomes Within Collaborative Care Management Model of Care.

    Science.gov (United States)

    George, Merit P; Garrison, Gregory M; Merten, Zachary; Heredia, Dagoberto; Gonzales, Cesar; Angstman, Kurt B

    2018-01-01

    Previous studies have suggested that having a comorbid personality disorder (PD) along with major depression is associated with poorer depression outcomes relative to those without comorbid PD. However, few studies have examined the influence of specific PD cluster types. The purpose of the current study is to compare depression outcomes between cluster A, cluster B, and cluster C PD patients treated within a collaborative care management (CCM), relative to CCM patients without a PD diagnosis. The overarching goal was to identify cluster types that might confer a worse clinical prognosis. This retrospective chart review study examined 2826 adult patients with depression enrolled in CCM. The cohort was divided into 4 groups based on the presence of a comorbid PD diagnosis (cluster A/nonspecified, cluster B, cluster C, or no PD). Baseline clinical and demographic variables, along with 6-month follow-up Patient Health Questionnaire-9 (PHQ-9) scores were obtained for all groups. Depression remission was defined as a PHQ-9 score cluster A or nonspecified PD diagnosis, 122 patients (4.3%) had a cluster B diagnosis, 35 patients (1.2%) had a cluster C diagnosis, and 2610 patients (92.4%) did not have any PD diagnosis. The presence of a cluster A/nonspecified PD diagnosis was associated with a 62% lower likelihood of remission at 6 months (AOR = 0.38; 95% CI 0.20-0.70). The presence of a cluster B PD diagnosis was associated with a 71% lower likelihood of remission at 6 months (AOR = 0.29; 95% CI 0.18-0.47). Conversely, having a cluster C diagnosis was not associated with a significantly lower likelihood of remission at 6 months (AOR = 0.83; 95% CI 0.42-1.65). Increased odds of having PDS at 6-month follow-up were seen with cluster A/nonspecified PD patients (AOR = 3.35; 95% CI 1.92-5.84) as well as cluster B patients (AOR = 3.66; 95% CI 2.45-5.47). However, cluster C patents did not have significantly increased odds of experiencing persistent depressive symptoms at 6-month

  3. DeLLITE Depression in late life: an intervention trial of exercise. Design and recruitment of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Keeling Sally

    2008-05-01

    Full Text Available Abstract Background Physical activity shows potential in combating the poor outcomes associated with depression in older people. Meta-analyses show gaps in the research with poor trial design compromising certainty in conclusions and few programmes showing sustained effects. Methods/design The Depression in Late Life: an Intervention Trial of Exercise (DeLLITE is a 12 month randomised controlled trial of a physical activity intervention to increase functional status in people aged 75 years and older with depressive symptoms. The intervention involves an individualised activity programme based on goal setting and progression of difficulty of activities delivered by a trained nurse during 8 home visits over 6 months. The control group received time matched home visits to discuss social contacts and networks. Baseline, 6 and 12 months measures were assessed in face to face visits with the primary outcome being functional status (SPPB, NEADL. Secondary outcomes include depressive symptoms (Geriatric Depression Scale, quality of life (SF-36, physical activity (AHS Physical Activity Questionnaire and falls (self report. Discussion Due to report in 2008 the DeLLITE study has recruited 70% of those eligible and tests the efficacy of a home based, goal setting physical activity programme in improving function, mood and quality of life in older people with depressive symptomatology. If successful in improving function and mood this trial could prove for the first time that there are long term health benefit of physical activity, independent of social activity, in this high risk group who consume excess health related costs. Trial registration Australian and New Zealand Clinical Trials Register ACTRN12605000475640

  4. Development and assessment of an active strategy for the implementation of a collaborative care approach for depression in primary care (the INDI·i project).

    Science.gov (United States)

    Aragonès, Enric; Palao, Diego; López-Cortacans, Germán; Caballero, Antonia; Cardoner, Narcís; Casaus, Pilar; Cavero, Myriam; Monreal, José Antonio; Pérez-Sola, Víctor; Cirera, Miquel; Loren, Maite; Bellerino, Eva; Tomé-Pires, Catarina; Palacios, Laura

    2017-12-13

    Primary care is the principal clinical setting for the management of depression. However, significant shortcomings have been detected in its diagnosis and clinical management, as well as in patient outcomes. We developed the INDI collaborative care model to improve the management of depression in primary care. This intervention has been favorably evaluated in terms of clinical efficacy and cost-effectiveness in a clinical trial. Our aim is to bring this intervention from the scientific context into clinical practice. Objective: To test for the feasibility and impact of a strategy for implementing the INDI model for depression in primary care. A quasi-experiment conducted in primary care. Several areas will be established to implement the new program and other, comparable areas will serve as control group. The study constitutes the preliminary phase preceding generalization of the model in the Catalan public healthcare system. The target population of the intervention are patients with major depression. The implementation strategy will also involve healthcare professionals, primary care centers, as well as management departments and the healthcare organization itself in the geographical areas where the study will be conducted: Camp de Tarragona and Vallès Occidental (Catalonia). The INDI model is a program for improving the management of depression involving clinical, instructional, and organizational interventions including the participation of nurses as care managers, the efficacy and efficiency of which has been proven in a clinical trial. We will design an active implementation strategy for this model based on the PARIHS (Promoting Action on Research Implementation in Health Services) framework. Qualitative and quantitative measures will be used to evaluate variables related to the successful implementation of the model: acceptability, utility, penetration, sustainability, and clinical impact. This project tests the transferability of a healthcare intervention

  5. Diagnostic conversion to bipolar disorder in unipolar depressed patients participating in trials on antidepressants.

    Science.gov (United States)

    Holmskov, J; Licht, R W; Andersen, K; Bjerregaard Stage, T; Mørkeberg Nilsson, F; Bjerregaard Stage, K; Valentin, J B; Bech, P; Ernst Nielsen, R

    2017-02-01

    In unipolar depressed patients participating in trials on antidepressants, we investigated if illness characteristics at baseline could predict conversion to bipolar disorder. A long-term register-based follow-up study of 290 unipolar depressed patients with a mean age of 50.8 years (SD=11.9) participating in three randomized trials on antidepressants conducted in the period 1985-1994. The independent effects of explanatory variables were examined by applying Cox regression analyses. The overall risk of conversion was 20.7%, with a mean follow-up time of 15.2 years per patient. The risk of conversion was associated with an increasing number of previous depressive episodes at baseline, [HR 1.18, 95% CI (1.10-1.26)]. No association with gender, age, age at first depressive episode, duration of baseline episode, subtype of depression or any of the investigated HAM-D subscales included was found. The patients were followed-up through the Danish Psychiatric Central Research Register, which resulted in inherent limitations such as possible misclassification of outcome. In a sample of middle-aged hospitalized unipolar depressed patients participating in trials on antidepressants, the risk of conversion was associated with the number of previous depressive episodes. Therefore, this study emphasizes that unipolar depressed patients experiencing a relatively high number of recurrences should be followed more closely, or at least be informed about the possible increased risk of conversion. Copyright © 2016. Published by Elsevier Masson SAS.

  6. Diagnostic conversion to bipolar disorder in unipolar depressed patients participating in trials on antidepressants

    DEFF Research Database (Denmark)

    Holmskov, J; Licht, R W; Andersen, K

    2017-01-01

    OBJECTIVE: In unipolar depressed patients participating in trials on antidepressants, we investigated if illness characteristics at baseline could predict conversion to bipolar disorder. METHOD: A long-term register-based follow-up study of 290 unipolar depressed patients with a mean age of 50.......8 years (SD=11.9) participating in three randomized trials on antidepressants conducted in the period 1985-1994. The independent effects of explanatory variables were examined by applying Cox regression analyses. RESULTS: The overall risk of conversion was 20.7%, with a mean follow-up time of 15.2 years...... per patient. The risk of conversion was associated with an increasing number of previous depressive episodes at baseline, [HR 1.18, 95% CI (1.10-1.26)]. No association with gender, age, age at first depressive episode, duration of baseline episode, subtype of depression or any of the investigated HAM...

  7. A social marketing approach to implementing evidence-based practice in VHA QUERI: the TIDES depression collaborative care model.

    Science.gov (United States)

    Luck, Jeff; Hagigi, Fred; Parker, Louise E; Yano, Elizabeth M; Rubenstein, Lisa V; Kirchner, JoAnn E

    2009-09-28

    Collaborative care models for depression in primary care are effective and cost-effective, but difficult to spread to new sites. Translating Initiatives for Depression into Effective Solutions (TIDES) is an initiative to promote evidence-based collaborative care in the U.S. Veterans Health Administration (VHA). Social marketing applies marketing techniques to promote positive behavior change. Described in this paper, TIDES used a social marketing approach to foster national spread of collaborative care models. The approach relied on a sequential model of behavior change and explicit attention to audience segmentation. Segments included VHA national leadership, Veterans Integrated Service Network (VISN) regional leadership, facility managers, frontline providers, and veterans. TIDES communications, materials and messages targeted each segment, guided by an overall marketing plan. Depression collaborative care based on the TIDES model was adopted by VHA as part of the new Primary Care Mental Health Initiative and associated policies. It is currently in use in more than 50 primary care practices across the United States, and continues to spread, suggesting success for its social marketing-based dissemination strategy. Development, execution and evaluation of the TIDES marketing effort shows that social marketing is a promising approach for promoting implementation of evidence-based interventions in integrated healthcare systems.

  8. A social marketing approach to implementing evidence-based practice in VHA QUERI: the TIDES depression collaborative care model

    Science.gov (United States)

    2009-01-01

    Abstract Collaborative care models for depression in primary care are effective and cost-effective, but difficult to spread to new sites. Translating Initiatives for Depression into Effective Solutions (TIDES) is an initiative to promote evidence-based collaborative care in the U.S. Veterans Health Administration (VHA). Social marketing applies marketing techniques to promote positive behavior change. Described in this paper, TIDES used a social marketing approach to foster national spread of collaborative care models. TIDES social marketing approach The approach relied on a sequential model of behavior change and explicit attention to audience segmentation. Segments included VHA national leadership, Veterans Integrated Service Network (VISN) regional leadership, facility managers, frontline providers, and veterans. TIDES communications, materials and messages targeted each segment, guided by an overall marketing plan. Results Depression collaborative care based on the TIDES model was adopted by VHA as part of the new Primary Care Mental Health Initiative and associated policies. It is currently in use in more than 50 primary care practices across the United States, and continues to spread, suggesting success for its social marketing-based dissemination strategy. Discussion and conclusion Development, execution and evaluation of the TIDES marketing effort shows that social marketing is a promising approach for promoting implementation of evidence-based interventions in integrated healthcare systems. PMID:19785754

  9. Collaborative care for panic disorder, generalised anxiety disorder and social phobia in general practice: study protocol for three cluster-randomised, superiority trials.

    Science.gov (United States)

    Curth, Nadja Kehler; Brinck-Claussen, Ursula Ødum; Davidsen, Annette Sofie; Lau, Marianne Engelbrecht; Lundsteen, Merete; Mikkelsen, John Hagel; Csillag, Claudio; Hjorthøj, Carsten; Nordentoft, Merete; Eplov, Lene Falgaard

    2017-08-16

    People with anxiety disorders represent a significant part of a general practitioner's patient population. However, there are organisational obstacles for optimal treatment, such as a lack of coordination of illness management and limited access to evidence-based treatment such as cognitive behavioral therapy. A limited number of studies suggest that collaborative care has a positive effect on symptoms for people with anxiety disorders. However, most studies are carried out in the USA and none have reported results for social phobia or generalised anxiety disorder separately. Thus, there is a need for studies carried out in different settings for specific anxiety populations. A Danish model for collaborative care (the Collabri model) has been developed for people diagnosed with depression or anxiety disorders. The model is evaluated through four trials, of which three will be outlined in this protocol and focus on panic disorder, generalised anxiety disorder and social phobia. The aim is to investigate whether treatment according to the Collabri model has a better effect than usual treatment on symptoms when provided to people with anxiety disorders. Three cluster-randomised, clinical superiority trials are set up to investigate treatment according to the Collabri model for collaborative care compared to treatment-as-usual for 364 patients diagnosed with panic disorder, generalised anxiety disorder and social phobia, respectively (total n = 1092). Patients are recruited from general practices located in the Capital Region of Denmark. For all trials, the primary outcome is anxiety symptoms (Beck Anxiety Inventory (BAI)) 6 months after baseline. Secondary outcomes include BAI after 15 months, depression symptoms (Beck Depression Inventory) after 6 months, level of psychosocial functioning (Global Assessment of Functioning) and general psychological symptoms (Symptom Checklist-90-R) after 6 and 15 months. Results will add to the limited pool of information about

  10. Efficacy and cost-effectiveness of a specialist depression service versus usual specialist mental health care to manage persistent depression: a randomised controlled trial.

    Science.gov (United States)

    Morriss, Richard; Garland, Anne; Nixon, Neil; Guo, Boliang; James, Marilyn; Kaylor-Hughes, Catherine; Moore, Richard; Ramana, Rajini; Sampson, Christopher; Sweeney, Timothy; Dalgleish, Tim

    2016-09-01

    Persistent moderate or severe unipolar depression is common and expensive to treat. Clinical guidelines recommend combined pharmacotherapy and psychotherapy. Such treatments can take up to 1 year to show an effect, but no trials of suitable duration have been done. We investigated the efficacy and cost-effectiveness of outpatient-based, specialist depression services (SDS) versus treatment as usual (TAU) on depression symptoms and function. We did a multicentre, single-blind, patient-level, parallel, randomised controlled trial (RCT), as part of the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) study, in three mental health outpatient settings in England. Eligible participants were in secondary care, were older than 18 years, had unipolar depression (with a current major depressive episode, a 17-item Hamilton Depression Rating Scale [HDRS17] score of ≥16, and a Global Assessment of Function [GAF] score of ≤60), and had not responded to 6 months or more of treatment for depression. Randomisation was stratified by site with allocation conveyed to a trial administrator, with research assessors masked to outcome. Patients were randomised (1:1) using a computer-generated pseudo-random code with random permuted blocks of varying sizes of two, four, or six to either SDS (collaborative care approach between psychiatrists and cognitive behavioural therapists for 12 months, followed by graduated transfer of care up to 15 months) or to the TAU group. Intention-to-treat primary outcome measures were changes in HDRS17 and GAF scores between baseline and 6, 12, and 18 months' follow-up. We will separately publish follow-up outcomes for months 24 and 36. Clinical efficacy and cost-effectiveness were examined from health and social care persp ectives at 18 months, as recommended by the National Institute for Health and Care Excellence. This trial is registered at ClinicalTrials.gov (NCT01047124) and the

  11. Cost-effectiveness of collaborative care for the treatment of depressive disorders in primary care: a systematic review.

    Directory of Open Access Journals (Sweden)

    Thomas Grochtdreis

    Full Text Available For the treatment of depressive disorders, the framework of collaborative care has been recommended, which showed improved outcomes in the primary care sector. Yet, an earlier literature review did not find sufficient evidence to draw robust conclusions on the cost-effectiveness of collaborative care.To systematically review studies on the cost-effectiveness of collaborative care, compared with usual care for the treatment of patients with depressive disorders in primary care.A systematic literature search in major databases was conducted. Risk of bias was assessed using the Cochrane Collaboration's tool. Methodological quality of the articles was assessed using the Consensus on Health Economic Criteria (CHEC list. To ensure comparability across studies, cost data were inflated to the year 2012 using country-specific gross domestic product inflation rates, and were adjusted to international dollars using purchasing power parities (PPP.In total, 19 cost-effectiveness analyses were reviewed. The included studies had sample sizes between n = 65 to n = 1,801, and time horizons between six to 24 months. Between 42% and 89% of the CHEC quality criteria were fulfilled, and in only one study no risk of bias was identified. A societal perspective was used by five studies. Incremental costs per depression-free day ranged from dominance to US$PPP 64.89, and incremental costs per QALY from dominance to US$PPP 874,562.Despite our review improved the comparability of study results, cost-effectiveness of collaborative care compared with usual care for the treatment of patients with depressive disorders in primary care is ambiguous depending on willingness to pay. A still considerable uncertainty, due to inconsistent methodological quality and results among included studies, suggests further cost-effectiveness analyses using QALYs as effect measures and a time horizon of at least 1 year.

  12. Easy rider wheelchair biking. A nursing-recreation therapy clinical trial for the treatment of depression.

    Science.gov (United States)

    Fitzsimmons, S

    2001-05-01

    Depression is a common condition among long-term care residents with limited treatment options available. There are few nonpharmacological interventions available to this population. This study examined the use of a prescribed, therapeutic recreation-nursing intervention, wheelchair biking, for treatment of symptoms of depression in older adults in a long-term care setting. A classical experimental design was used and was guided by the Roy Adaptation Model. Forty residents were pretested for depression and randomly assigned to two groups. A 2-week trial of biking therapy was provided to the treatment group. All participants were posttested. Findings indicated there was a statistically significant improvement in depression scores for the treatment group and no significant change for the control group. This study contributes to the body of knowledge of nursing regarding options for the treatment of depression in older adults, and is an encouraging indicator that psychosocial interventions may be effective in reducing depression.

  13. Resource Utilisation and Costs of Depressive Patients in Germany: Results from the Primary Care Monitoring for Depressive Patients Trial

    Directory of Open Access Journals (Sweden)

    Christian Krauth

    2014-01-01

    Full Text Available Background. Depression is the most common type of mental disorder in Germany. It is associated with a high level of suffering for individuals and imposes a significant burden on society. The aim of this study was to estimate the depression related costs in Germany taking a societal perspective. Materials and Methods. Data were collected from the primary care monitoring for depressive patients trial (PRoMPT of patients with major depressive disorder who were treated in a primary care setting. Resource utilisation and days of sick leave were observed and analysed over a 1-year period. Results. Average depression related costs of €3813 were calculated. Significant differences in total costs due to sex were demonstrated. Male patients had considerable higher total costs than female patients, whereas single cost categories did not differ significantly. Further, differences in costs according to severity of disease and age were observed. The economic burden to society was estimated at €15.6 billion per year. Conclusion. The study results show that depression poses a significant economic burden to society. There is a high potential for prevention, treatment, and patient management innovations to identify and treat patients at an early stage.

  14. Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

    Science.gov (United States)

    Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

    2008-12-01

    Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

  15. Computerised CBT for depressed adolescents: Randomised controlled trial.

    Science.gov (United States)

    Smith, Patrick; Scott, Rebecca; Eshkevari, Ertimiss; Jatta, Fatoumata; Leigh, Eleanor; Harris, Victoria; Robinson, Alex; Abeles, Paul; Proudfoot, Judy; Verduyn, Chrissie; Yule, William

    2015-10-01

    Depression in adolescents is a common and impairing problem. Effective psychological therapies for depression are not accessed by most adolescents. Computerised therapy offers huge potential for improving access to treatment. To test the efficacy of Stressbusters, a Computerised-CBT (C-CBT) programme for depression in young people. Multi-site, schools-based, RCT of C-CBT compared to Waiting List, for young people (N = 112; aged 12-16) with significant symptoms of depression, using multiple-informants (adolescents, parents, teachers), with follow-up at 3 and 6 months. Relative to being on a Waiting List, C-CBT was associated with statistically significant and clinically meaningful improvements in symptoms of depression and anxiety according to adolescent self-report; and with a trend towards improvements in depression and anxiety according to parent-report. Improvements were maintained at follow-up. Treatment gains were similar for boys and girls across the participating age range. Treatment effect was partially mediated by changes in ruminative thinking. Teachers rated adolescents as having few emotional or behavioural problems, both before and after intervention. C-CBT had no detectable effect on academic attainment. In the month after intervention, young people who received C-CBT had significantly fewer absences from school than those on the Waiting List. C-CBT shows considerable promise for the treatment of mild-moderate depression in adolescents. Copyright © 2015 Elsevier Ltd. All rights reserved.

  16. Internet treatment addressing either insomnia or depression, for patients with both diagnoses: a randomized trial.

    Science.gov (United States)

    Blom, Kerstin; Jernelöv, Susanna; Kraepelien, Martin; Bergdahl, Malin Olséni; Jungmarker, Kristina; Ankartjärn, Linda; Lindefors, Nils; Kaldo, Viktor

    2015-02-01

    To compare treatment effects when patients with insomnia and depression receive treatment for either insomnia or depression. A 9-w randomized controlled trial with 6- and 12-mo follow-up. Internet Psychiatry Clinic, Stockholm, Sweden. Forty-three adults in whom comorbid insomnia and depression were diagnosed, recruited via media and assessed by psychiatrists. Guided Internet-delivered cognitive behavior therapy (ICBT) for either insomnia or depression. Primary outcome measures were symptom self-rating scales (Insomnia Severity Index [ISI] and the Montgomery Åsberg Depression Rating Scale [MADRS-S]), assessed before and after treatment with follow-up after 6 and 12 mo. The participants' use of sleep medication and need for further treatment after completion of ICBT was also investigated. The insomnia treatment was more effective than the depression treatment in reducing insomnia severity during treatment (P = 0.05), and equally effective in reducing depression severity. Group differences in insomnia severity were maintained during the 12-mo follow-up period. Post treatment, participants receiving treatment for insomnia had significantly less self-rated need for further insomnia treatment (P treatment for depression. The need for depression treatment was similar in both groups. In this study, Internet-delivered treatment with cognitive behavior therapy (ICBT) for insomnia was more effective than ICBT for depression for patients with both diagnoses. This indicates, in line with previous research, that insomnia when comorbid with depression is not merely a symptom of depression, but needs specific treatment. The trial was registered at Clinicaltrials.gov, registration ID: NCT01256099. © 2015 Associated Professional Sleep Societies, LLC.

  17. Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chen Yuan-Fang

    2013-01-01

    Full Text Available Abstract Background More than 70% of patients with depression who see their doctors experience insomnia. Insomnia treatment is a very important link for depression treatment. Furthermore, antidepression treatment is also important for depression insomnia. In acupuncture, LU-7 (Lie Que and KID-6 (Zhao Hai, which are two of the eight confluence points in meridian theory, are used as main points. An embedded needle technique is used, alternately, at two groups of points to consolidate the treatment effect. These two groups of points are BL-15 (Xin Shu with BL-23 (Shen Shu and BL-19 (Dan Shu with N-HN-54 (An Mian. The effectiveness of these optimized acupuncture formulas is well proven in the practice by our senior acupuncturists in Guangdong Provincial Hospital of TCM. This study has been designed to examine whether this set of optimized clinical formulas is able to increase the clinical efficacy of depression insomnia treatment. Methods/design In this randomized controlled multicenter trial, all the eligible participants are diagnosed with depression insomnia. All participants are randomly assigned to one of two groups in a ratio of 1:1 and receive either conventional acupuncture treatment or optimized acupuncture treatment. Patients are evaluated using the Pittsburgh Sleep Quality Index(PSQIand the Hamilton rating scale(HAMD for depression. The use of antidepression and hypnotics drugs is also considered. Results are obtained at the start of treatment, 1 and 2 months after treatment has begun, and at the end of treatment. The entire duration of the study will be approximately 36 months. Discussion A high quality of trial methodologies is utilized in the study, and the results may provide better evidence for the effectiveness of acupuncture as a treatment for depression insomnia. The optimized acupuncture formula has potential benefits in increasing the efficacy of treating depression insomnia. Trial registration The trial was registered in

  18. Collaborative care for patients with bipolar disorder: a randomised controlled trial.

    Science.gov (United States)

    van der Voort, Trijntje Y G; van Meijel, Berno; Goossens, Peter J J; Renes, Janwillem; Beekman, Aartjan T F; Kupka, Ralph W

    2011-08-17

    Bipolar disorder is a severe mental illness with serious consequences for daily living of patients and their caregivers. Care as usual primarily consists of pharmacotherapy and supportive treatment. However, a substantial number of patients show a suboptimal response to treatment and still suffer from frequent episodes, persistent interepisodic symptoms and poor social functioning. Both psychiatric and somatic comorbid disorders are frequent, especially personality disorders, substance abuse, cardiovascular diseases and diabetes. Multidisciplinary collaboration of professionals is needed to combine all expertise in order to achieve high-quality integrated treatment. 'Collaborative Care' is a treatment method that could meet these needs. Several studies have shown promising effects of these integrated treatment programs for patients with bipolar disorder. In this article we describe a research protocol concerning a study on the effects of Collaborative Care for patients with bipolar disorder in the Netherlands. The study concerns a two-armed cluster randomised clinical trial to evaluate the effectiveness of Collaborative Care (CC) in comparison with Care as usual (CAU) in outpatient clinics for bipolar disorder or mood disorders in general. Collaborative Care includes individually tailored interventions, aimed at personal goals set by the patient. The patient, his caregiver, the nurse and the psychiatrist all are part of the Collaborative Care team. Elements of the program are: contracting and shared decision making; psycho education; problem solving treatment; systematic relapse prevention; monitoring of outcomes and pharmacotherapy. Nurses coordinate the program. Nurses and psychiatrists in the intervention group will be trained in the intervention. The effects will be measured at baseline, 6 months and 12 months. Primary outcomes are psychosocial functioning, psychiatric symptoms, and quality of life. Caregiver outcomes are burden and satisfaction with care

  19. A trial map and GIS class on junior high school with university collaboration in Yokohama, Japan

    Science.gov (United States)

    Tabe, Toshimitsu; Ohnishi, Koji

    2018-05-01

    On the new curriculum of high school in Japan, geography will be compulsory subject in Japan from 2022. The indexes of new high school geography as compulsory subject will be 1. Using of maps and GIS, 2. Understanding of the world and International collaboration: Life and culture, issues of world, 3. Disaster prevention and ESD: natural environment and disaster, and construction of ideal society. The instruction of the GIS will be one of the issues for social studies teachers in the new curriculum. The aim of this study is to make the utilize map and GIS education content through trial class in junior high school. Trial class was done on Tsurugamine junior high school in Yokohama city with university and Yokohama city school board collaboration. In the trial class, the teacher indicated the old and new topographical maps to students and asked them to consider the characteristics of the area and the land use change. Transparent sheets overlaying is useful this activity. Transparent usage indicated the GIS function of overlay. It is good activity for students to understand the function of GIS. After the considering land use changes, they considered the future of their town. The several unused lands are spread in this area. Students present their opinions how to develop them. The important thing to carry out map and GIS class through neighborhood area is preparation of adequate maps. For this preparation, collaboration with university geography stuffs or undergraduate students are effective.

  20. Depression screening with patient-targeted feedback in cardiology: DEPSCREEN-INFO randomised clinical trial.

    Science.gov (United States)

    Löwe, Bernd; Blankenberg, Stefan; Wegscheider, Karl; König, Hans-Helmut; Walter, Dirk; Murray, Alexandra M; Gierk, Benjamin; Kohlmann, Sebastian

    2017-02-01

    International guidelines advocate depression screening in patients with coronary heart disease (CHD) and other chronic illnesses, but evidence is lacking. To test the differential efficacy of written patient-targeted feedback v. no written patient feedback after depression screening. Patients with CHD or hypertension from three cardiology settings were randomised and screened for depression (ClinicalTrials.gov Identifier: NCT01879111). Compared with the control group, where only cardiologists received written feedback, in the intervention group both cardiologists and patients received written feedback regarding depression status. Depression severity was measured 1 month (primary outcome) and 6 months after screening. The control group (n = 220) and the patient-feedback group (n = 155) did not differ in depression severity 1 month after screening. Six months after screening, the patient-feedback group showed significantly greater improvements in depression severity and was twice as likely to seek information about depression compared with the control group. Patient-targeted feedback in addition to screening has a significant but small effect on depression severity after 6 months and may encourage patients to take an active role in the self-management of depression. © The Royal College of Psychiatrists 2017.

  1. Learning pathology using collaborative vs. individual annotation of whole slide images: a mixed methods trial.

    Science.gov (United States)

    Sahota, Michael; Leung, Betty; Dowdell, Stephanie; Velan, Gary M

    2016-12-12

    Students in biomedical disciplines require understanding of normal and abnormal microscopic appearances of human tissues (histology and histopathology). For this purpose, practical classes in these disciplines typically use virtual microscopy, viewing digitised whole slide images in web browsers. To enhance engagement, tools have been developed to enable individual or collaborative annotation of whole slide images within web browsers. To date, there have been no studies that have critically compared the impact on learning of individual and collaborative annotations on whole slide images. Junior and senior students engaged in Pathology practical classes within Medical Science and Medicine programs participated in cross-over trials of individual and collaborative annotation activities. Students' understanding of microscopic morphology was compared using timed online quizzes, while students' perceptions of learning were evaluated using an online questionnaire. For senior medical students, collaborative annotation of whole slide images was superior for understanding key microscopic features when compared to individual annotation; whilst being at least equivalent to individual annotation for junior medical science students. Across cohorts, students agreed that the annotation activities provided a user-friendly learning environment that met their flexible learning needs, improved efficiency, provided useful feedback, and helped them to set learning priorities. Importantly, these activities were also perceived to enhance motivation and improve understanding. Collaborative annotation improves understanding of microscopic morphology for students with sufficient background understanding of the discipline. These findings have implications for the deployment of annotation activities in biomedical curricula, and potentially for postgraduate training in Anatomical Pathology.

  2. Prevention of depression in patients with acute coronary syndrome (DECARD) randomized trial

    DEFF Research Database (Denmark)

    Hjorthøj, Carsten Rygaard; Hansen, Baiba Hedegaard; Hanash, Jamal Abed

    2015-01-01

    .02-0.99) ) than in the full sample of patients (HR = 0.20 (0.04-0.90) ), although not statistically significant. CONCLUSIONS: The SF-36 may be too broad an outcome measure in trials or treatments that seek to prevent depression following acute coronary syndrome. The SF-36 may, however, indicate who is more likely......AIM: Escitalopram may prevent depression following acute coronary syndrome. We sought to estimate the effects of escitalopram on self-reported health and to identify subgroups with higher efficacy. METHODS: This is a secondary analysis of a 12-month double-blind clinical trial randomizing non-depressed...... acute coronary syndrome patients to escitalopram (n = 120) or matching placebo (n = 120). The main outcomes were mean scores on Short Form 36 Health Survey (SF-36) domains, and diagnosis of depression was adjusted for baseline SF-36 scores. RESULTS: Escitalopram did not yield different SF-36...

  3. Recruitment to Online Therapies for Depression: Pilot Cluster Randomized Controlled Trial

    OpenAIRE

    Jones, Ray B; Goldsmith, Lesley; Hewson, Paul; Williams, Christopher J

    2013-01-01

    Background Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake. Objective To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues....

  4. Adjunctive minocycline treatment for major depressive disorder: A proof of concept trial.

    Science.gov (United States)

    Dean, Olivia M; Kanchanatawan, Buranee; Ashton, Melanie; Mohebbi, Mohammadreza; Ng, Chee Hong; Maes, Michael; Berk, Lesley; Sughondhabirom, Atapol; Tangwongchai, Sookjaroen; Singh, Ajeet B; McKenzie, Helen; Smith, Deidre J; Malhi, Gin S; Dowling, Nathan; Berk, Michael

    2017-08-01

    Conventional antidepressant treatments result in symptom remission in 30% of those treated for major depressive disorder, raising the need for effective adjunctive therapies. Inflammation has an established role in the pathophysiology of major depressive disorder, and minocycline has been shown to modify the immune-inflammatory processes and also reduce oxidative stress and promote neuronal growth. This double-blind, randomised, placebo-controlled trial examined adjunctive minocycline (200 mg/day, in addition to treatment as usual) for major depressive disorder. This double-blind, randomised, placebo-controlled trial investigated 200 mg/day adjunctive minocycline (in addition to treatment as usual) for major depressive disorder. A total of 71 adults with major depressive disorder ( Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition) were randomised to this 12-week trial. Outcome measures included the Montgomery-Asberg Depression Rating Scale (primary outcome), Clinical Global Impression-Improvement and Clinical Global Impression-Severity, Hamilton Anxiety Rating Scale, Quality of Life Enjoyment and Satisfaction Questionnaire, Social and Occupational Functioning Scale and the Range of Impaired Functioning Tool. The study was registered on the Australian and New Zealand Clinical Trials Register: www.anzctr.org.au , #ACTRN12612000283875. Based on mixed-methods repeated measures analysis of variance at week 12, there was no significant difference in Montgomery-Asberg Depression Rating Scale scores between groups. However, there were significant differences, favouring the minocycline group at week 12 for Clinical Global Impression-Improvement score - effect size (95% confidence interval) = -0.62 [-1.8, -0.3], p = 0.02; Quality of Life Enjoyment and Satisfaction Questionnaire score - effect size (confidence interval) = -0.12 [0.0, 0.2], p minocycline may be a useful adjunct to improve global experience, functioning and quality of life in people with

  5. Comparison between herbal medicine and fluoxetine for depression: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Ren, Yi; Zhu, Chenjun; Wu, Jianjun; Zheng, Ruwen; Cao, Huijaun

    2015-10-01

    To evaluate the effectiveness and safety of Chinese herbal medicine (CHM) versus fluoxetine on depression. A systematic review of randomized controlled trials (RCTs). RCT with two parallel groups that compared CHM and fluoxetine on treatment of depression with reported decreased Hamilton Depression Scale (HAMD) and adverse events during treatment were included after searching through six electric-databases. The methodological quality of RCTs was assessed according to the Cochrane risk of bias tool. Meta-analysis was conducted using RevMan 5.3 software with pooled mean difference (MD) or risk ratio (RR) and their 95% confidence interval (CI) if no significant heterogeneity was detected. A SOF table was generated using GRADEPro software to evaluate the overall quality of the evidence. Twenty-six trials with 3294 participants were included in the review. Most of them had high risk of bias during conducting and reporting. The results achieved weak evidence which showed CHM had similar effect to fluoxetine (20mg/day) on relieving depression according to HAMD assessment (for primary depression: MD=-0.08, 95%CI -0.98-0.82; for secondary depression: MD=-0.36, 95%CI -1.55-0.83), but fewer incidences of adverse events than the drug (for primary depression: RR=0.31, 95%CI 0.17-0.59; for post-stroke depression: RR=0.04, 95%CI 0.00-0.25). No serious adverse event was found in neither CHM nor fluoxetine group. Due to the poor quality of included trials and the potential publication bias of this review, no confirmed conclusion could be draw to evaluate the effectiveness and safety of CHM for depression compared with fluoxetine. Copyright © 2015 Elsevier Ltd. All rights reserved.

  6. An evaluation of the quick inventory of depressive symptomatology and the hamilton rating scale for depression: a sequenced treatment alternatives to relieve depression trial report.

    Science.gov (United States)

    Rush, A John; Bernstein, Ira H; Trivedi, Madhukar H; Carmody, Thomas J; Wisniewski, Stephen; Mundt, James C; Shores-Wilson, Kathy; Biggs, Melanie M; Woo, Ada; Nierenberg, Andrew A; Fava, Maurizio

    2006-03-15

    Nine DSM-IV-TR criterion symptom domains are evaluated to diagnose major depressive disorder (MDD). The Quick Inventory of Depressive Symptomatology (QIDS) provides an efficient assessment of these domains and is available as a clinician rating (QIDS-C16), a self-report (QIDS-SR16), and in an automated, interactive voice response (IVR) (QIDS-IVR16) telephone system. This report compares the performance of these three versions of the QIDS and the 17-item Hamilton Rating Scale for Depression (HRSD17). Data were acquired at baseline and exit from the first treatment step (citalopram) in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. Outpatients with nonpsychotic MDD who completed all four ratings within +/-2 days were identified from the first 1500 STAR*D subjects. Both item response theory and classical test theory analyses were conducted. The three methods for obtaining QIDS data produced consistent findings regarding relationships between the nine symptom domains and overall depression, demonstrating interchangeability among the three methods. The HRSD17, while generally satisfactory, rarely utilized the full range of item scores, and evidence suggested multidimensional measurement properties. In nonpsychotic MDD outpatients without overt cognitive impairment, clinician assessment of depression severity using either the QIDS-C16 or HRSD17 may be successfully replaced by either the self-report or IVR version of the QIDS.

  7. Family psychoeducation for major depressive disorder - study protocol for a randomized controlled trial

    DEFF Research Database (Denmark)

    Timmerby, Nina; Austin, Stephen F; Ussing, Kristian

    2016-01-01

    BACKGROUND: Major depressive disorder has been shown to affect many domains of family life including family functioning. Conversely, the influence of the family on the course of the depression, including the risk of relapse, is one reason for targeting the family in interventions. The few studies...... will investigate the effect of family psychoeducation compared to social support on the course of the illness in patients with major depressive disorder. METHOD/DESIGN: The study is designed as a dual center, two-armed, observer-blinded, randomized controlled trial. Relatives are randomized to participate in one...

  8. Marketing depression care management to employers: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Marshall Donna

    2010-03-01

    Full Text Available Abstract Background Randomized trials demonstrate that depression care management can improve clinical and work outcomes sufficiently for selected employers to realize a return on investment. Employers can now purchase depression products that provide depression care management, defined as employee screening, education, monitoring, and clinician feedback for all depressed employees. We developed an intervention to encourage employers to purchase a depression product that offers the type, intensity, and duration of care management shown to improve clinical and work outcomes. Methods In a randomized controlled trial conducted with 360 employers of 30 regional business coalitions, the research team proposes to compare the impact of a value-based marketing intervention to usual-care marketing on employer purchase of depression products. The study will also identify mediators and organizational-level moderators of intervention impact. Employers randomized to the value-based condition receive a presentation encouraging them to purchase depression products scientifically shown to benefit the employee and the employer. Employers randomized to the usual-care condition receive a presentation encouraging them to monitor and improve quality indicators for outpatient depression treatment. Because previous research demonstrates that the usual-care intervention will have little to no impact on employer purchasing, depression product purchasing rates in the usual-care condition capture vendor efforts to market depression products to employers in both conditions while the value-based intervention is being conducted. Employers in both conditions are also provided free technical assistance to undertake the actions each presentation encourages. The research team will use intent-to-treat models of all available data to evaluate intervention impact on the purchase of depression products using a cumulative incidence analysis of 12- and 24-month data. Discussion By

  9. A randomized controlled trial of vitamin D supplementation on perinatal depression: in Iranian pregnant mothers.

    Science.gov (United States)

    Vaziri, Farideh; Nasiri, Samira; Tavana, Zohreh; Dabbaghmanesh, Mohammad Hossein; Sharif, Farkhondeh; Jafari, Peyman

    2016-08-20

    Mood disorders in pregnancy and post-partum period are common and considered as a public health issue. Researchers have studied the relationship between low serum vitamin D concentration and perinatal depression, although no clinical trial has been conducted on vitamin D's effects on depression related to childbirth. This study evaluated the effect of vitamin D3 supplementation on perinatal depression scores. This randomized clinical trial was done in pregnant women who were under prenatal care in a teaching hospital in Shiraz, Iran. The inclusion criteria were: being 18 years or older, no history of mental illness and internal diseases, a singleton live fetus, without any pregnancy complications, gestational age of 26-28 weeks upon enrollment, and depression score of 0 to 13. The Edinburgh Postnatal Depression scale was used to evaluate depression scores. A total of 169 participants were assigned to the two groups of placebo and vitamin D through block randomization design. Vitamin D group received 2000 IU vitamin D3 daily from 26 to 28 weeks of gestation until childbirth. Maternal serum 25-hydroxyvitamin D concentrations were measured at baseline and childbirth. Besides, depression scores were evaluated four times: at 26-28 and 38-40 weeks of gestation, and finally at 4 and 8 weeks after birth. The two groups were similar in relation to baseline 25-hydroxyvitamin D concentrations. However, at childbirth, the vitamin D group had significantly higher 25-hydroxyvitamin D concentration in comparison to the control group (p depression score (r = 0.13, p = 0.09). There was no significant difference between the two study groups in relation to the baseline depression score. While, the vitamin D group had greater reduction in depression scores than the control group at 38-40 weeks of gestation (p = 0.01) also, at 4 and 8 weeks after birth (p depression levels. We suggest further clinical trial in pregnant mothers who are at risk for postnatal depression

  10. Factors affecting recruitment into depression trials: Systematic review, meta-synthesis and conceptual framework.

    Science.gov (United States)

    Hughes-Morley, Adwoa; Young, Bridget; Waheed, Waquas; Small, Nicola; Bower, Peter

    2015-02-01

    Depression is common and clinical trials are crucial for evaluating treatments. Difficulties in recruiting participants into depression trials are well-documented, yet no study has examined the factors affecting recruitment. This review aims to identify the factors affecting recruitment into depression trials and to develop a conceptual framework through systematic assessment of published qualitative research. Systematic review and meta-synthesis of published qualitative studies. Meta-synthesis involves a synthesis of themes across a number of qualitative studies to produce findings that are "greater than the sum of the parts". ASSIA, CINAHL, Embase, Medline and PsychInfo were searched up to April 2013. Reference lists of included studies, key publications and relevant reviews were also searched. Quality appraisal adopted the "prompts for appraising qualitative research". 7977 citations were identified, and 15 studies were included. Findings indicate that the decision to enter a depression trial is made by patients and gatekeepers based on the patient׳s health state at the time of being approached to participate; on their attitude towards the research and trial interventions; and on the extent to which patients become engaged with the trial. Our conceptual framework highlights that the decision to participate by both the patient and the gatekeeper involves a judgement between risk and reward. Only English language publications were included in this review. Findings from this review have implications for the design of interventions to improve recruitment into depression trials. Such interventions may aim to diminish the perceived risks and increase the perceived rewards of participation. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

  11. Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder.

    Science.gov (United States)

    Schneider, Kristin L; Bodenlos, Jamie S; Ma, Yunsheng; Olendzki, Barbara; Oleski, Jessica; Merriam, Philip; Crawford, Sybil; Ockene, Ira S; Pagoto, Sherry L

    2008-09-15

    Obesity is often comorbid with depression and individuals with this comorbidity fare worse in behavioral weight loss treatment. Treating depression directly prior to behavioral weight loss treatment might bolster weight loss outcomes in this population, but this has not yet been tested in a randomized clinical trial. This randomized clinical trial will examine whether behavior therapy for depression administered prior to standard weight loss treatment produces greater weight loss than standard weight loss treatment alone. Obese women with major depressive disorder (N = 174) will be recruited from primary care clinics and the community and randomly assigned to one of the two treatment conditions. Treatment will last 2 years, and will include a 6-month intensive treatment phase followed by an 18-month maintenance phase. Follow-up assessment will occur at 6-months and 1- and 2 years following randomization. The primary outcome is weight loss. The study was designed to provide 90% power for detecting a weight change difference between conditions of 3.1 kg (standard deviation of 5.5 kg) at 1-year assuming a 25% rate of loss to follow-up. Secondary outcomes include depression, physical activity, dietary intake, psychosocial variables and cardiovascular risk factors. Potential mediators (e.g., adherence, depression, physical activity and caloric intake) of the intervention effect on weight change will also be examined. Treating depression before administering intensive health behavior interventions could potentially boost the impact on both mental and physical health outcomes. NCT00572520.

  12. Collaborative care for patients with bipolar disorder: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Beekman Aartjan TF

    2011-08-01

    Full Text Available Abstract Background Bipolar disorder is a severe mental illness with serious consequences for daily living of patients and their caregivers. Care as usual primarily consists of pharmacotherapy and supportive treatment. However, a substantial number of patients show a suboptimal response to treatment and still suffer from frequent episodes, persistent interepisodic symptoms and poor social functioning. Both psychiatric and somatic comorbid disorders are frequent, especially personality disorders, substance abuse, cardiovascular diseases and diabetes. Multidisciplinary collaboration of professionals is needed to combine all expertise in order to achieve high-quality integrated treatment. 'Collaborative Care' is a treatment method that could meet these needs. Several studies have shown promising effects of these integrated treatment programs for patients with bipolar disorder. In this article we describe a research protocol concerning a study on the effects of Collaborative Care for patients with bipolar disorder in the Netherlands. Methods/design The study concerns a two-armed cluster randomised clinical trial to evaluate the effectiveness of Collaborative Care (CC in comparison with Care as usual (CAU in outpatient clinics for bipolar disorder or mood disorders in general. Collaborative Care includes individually tailored interventions, aimed at personal goals set by the patient. The patient, his caregiver, the nurse and the psychiatrist all are part of the Collaborative Care team. Elements of the program are: contracting and shared decision making; psycho education; problem solving treatment; systematic relapse prevention; monitoring of outcomes and pharmacotherapy. Nurses coordinate the program. Nurses and psychiatrists in the intervention group will be trained in the intervention. The effects will be measured at baseline, 6 months and 12 months. Primary outcomes are psychosocial functioning, psychiatric symptoms, and quality of life. Caregiver

  13. Effects of a Patient-Provider, Collaborative, Medication-Planning Tool: A Randomized, Controlled Trial

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    James F. Graumlich

    2016-01-01

    Full Text Available Among patients with various levels of health literacy, the effects of collaborative, patient-provider, medication-planning tools on outcomes relevant to self-management are uncertain. Objective. Among adult patients with type II diabetes mellitus, we tested the effectiveness of a medication-planning tool (Medtable™ implemented via an electronic medical record to improve patients’ medication knowledge, adherence, and glycemic control compared to usual care. Design. A multicenter, randomized controlled trial in outpatient primary care clinics. 674 patients received either the Medtable tool or usual care and were followed up for up to 12 months. Results. Patients who received Medtable had greater knowledge about indications for medications in their regimens and were more satisfied with the information about their medications. Patients’ knowledge of drug indication improved with Medtable regardless of their literacy status. However, Medtable did not improve patients’ demonstrated medication use, regimen adherence, or glycemic control (HbA1c. Conclusion. The Medtable tool supported provider/patient collaboration related to medication use, as reflected in patient satisfaction with communication, but had limited impact on patient medication knowledge, adherence, and HbA1c outcomes. This trial is registered with ClinicalTrials.gov NCT01296633.

  14. Acupoints Stimulation for Anxiety and Depression in Cancer Patients: A Quantitative Synthesis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Tao Wang

    2016-01-01

    Full Text Available This study aims at concluding the current evidence on the therapeutic effects of acupoints stimulation for cancer patients with anxiety and depression. Randomized controlled trials using acupoints stimulation for relieving anxiety and/or depression in cancer patients were searched, and 11 studies were finally included, of which eight trials compared acupoints stimulation with standard methods of treatment/care, and acupoints stimulation showed significantly better effects in improving depression than using standard methods of treatment/care. Four studies compared true acupoints stimulation with sham methods, and no significant differences can be found between groups for either depression or anxiety, although the pooled effects still favored true intervention. For the five studies that evaluated sleep quality, the results were conflicting, with three supporting the superiority of acupoints stimulation in improving sleep quality and two demonstrating no differences across groups. Acupoints stimulation seems to be an effective approach in relieving depression and anxiety in cancer patients, and placebo effects may partially contribute to the benefits. However, the evidence is not conclusive due to the limited number of included studies and the clinical heterogeneity identified among trials. More rigorous designed randomized, sham-controlled studies are necessary in future research.

  15. Brief Behavioral Activation and Problem-Solving Therapy for Depressed Breast Cancer Patients: Randomized Trial

    Science.gov (United States)

    Hopko, Derek R.; Armento, Maria E. A.; Robertson, Sarah M. C.; Ryba, Marlena M.; Carvalho, John P.; Colman, Lindsey K.; Mullane, Christen; Gawrysiak, Michael; Bell, John L.; McNulty, James K.; Lejuez, Carl W.

    2011-01-01

    Objective: Major depression is the most common psychiatric disorder among breast cancer patients and is associated with substantial impairment. Although some research has explored the utility of psychotherapy with breast cancer patients, only 2 small trials have investigated the potential benefits of behavior therapy among patients with…

  16. Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial

    Science.gov (United States)

    Emslie, Graham J.; Ventura, Daniel; Korotzer, Andrew; Tourkodimitris, Stavros

    2009-01-01

    A randomized, double-blind, placebo-controlled trial that involves 312 male and female patients aged 12-17 reveal the effectiveness of escitalopram in the treatment of depressed adolescents. Eighty-three percent of the participants or 259 participants completed the 8 weeks therapy period.

  17. Randomized Controlled Trial of Problem-Solving Therapy for Minor Depression in Home Care

    Science.gov (United States)

    Gellis, Zvi D.; McGinty, Jean; Tierney, Lynda; Jordan, Cindy; Burton, Jean; Misener, Elizabeth

    2008-01-01

    Objective: Data are presented from a pilot research program initiated to develop, refine, and test the outcomes of problem-solving therapy that targets the needs of older adults with minor depression in home care settings. Method: A pilot randomized clinical trial compares the impact of problem-solving therapy for home care to treatment as usual…

  18. The impact of life review on depression in older adults: a randomized controlled trial

    NARCIS (Netherlands)

    Pot, A.M.; Bohlmeijer, E.T.; Onrust, S.; Melenhorst, A.S.; Veerbeek, M.A.; de Vries, W.

    2010-01-01

    Background: We developed an indicated preventive life-review course, Looking for Meaning, based on the assumption that reminiscence styles influence coping with depressive symptoms. This study describes the impact of this course in a pragmatic randomized controlled trial. Methods: Inclusion criteria

  19. The impact of life review on depression in older adults: a randomized controlled trial

    NARCIS (Netherlands)

    Pot, Anne Margriet; Bohlmeijer, Ernst Thomas; Onrust, Simone; Melenhorst, Anne-Sophie; Veerbeek, Marjolein; de Vries, Wilma

    2010-01-01

    Background: We developed an indicated preventive life-review course, “Looking for Meaning”, based on the assumption that reminiscence styles influence coping with depressive symptoms. This study describes the impact of this course in a pragmatic randomized controlled trial. Methods: Inclusion

  20. Treatment of post-myocardial infarction depressive disorder : A randomized, placebo-controlled trial with mirtazapine

    NARCIS (Netherlands)

    Honig, Adriaan; Kuyper, Astrid M. G.; Schene, Aart H.; van Melle, Joost P.; De Jonge, Peter; Tulner, Dorien M.; Schins, Annique; Crijns, Harry J. G. M.; Kuijpers, Petra M. J. C.; Vossen, Helen; Lousberg, Richel; Ormel, Johan

    Objective: To examine the antidepressant efficacy of a dual-acting antidepressant (mirtazapine) in patients with post-myocardial infarction (MI) depressive disorder. Antidepressants used in post MI trials with a randomized, double-blind, placebo-controlled design have been restricted to selective

  1. Physical activity as a treatment for depression: the TREAD randomised trial protocol

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    Lawlor Debbie A

    2010-11-01

    Full Text Available Abstract Background Depression is one of the most common reasons for consulting a General Practitioner (GP within the UK. Whilst antidepressants have been shown to be clinically effective, many patients and healthcare professionals would like to access other forms of treatment as an alternative or adjunct to drug therapy for depression. A recent systematic review presented some evidence that physical activity could offer one such option, although further investigation is needed to test its effectiveness within the context of the National Health Service. The aim of this paper is to describe the protocol for a randomised, controlled trial (RCT designed to evaluate an intervention developed to increase physical activity as a treatment for depression within primary care. Methods/design The TREAD study is a pragmatic, multi-centre, two-arm RCT which targets patients presenting with a new episode of depression. Patients were approached if they were aged 18-69, had recently consulted their GP for depression and, where appropriate, had been taking antidepressants for less than one month. Only those patients with a confirmed diagnosis of a depressive episode as assessed by the Clinical Interview Schedule-Revised (CIS-R, a Beck Depression Inventory (BDI score of at least 14 and informed written consent were included in the study. Eligible patients were individually randomised to one of two treatment groups; usual GP care or usual GP care plus facilitated physical activity. The primary outcome of the trial is clinical symptoms of depression assessed using the BDI four months after randomisation. A number of secondary outcomes are also measured at the 4-, 8- and 12-month follow-up points including quality of life, attitude to and involvement in physical activity and antidepressant use/adherence. Outcomes will be analysed on an intention-to-treat (ITT basis and will use linear and logistic regression models to compare treatments. Discussion The results of

  2. The coping with depression course: Short term outcomes and mediating effects of a randomized controlled trial in the treatment of subclinical depression

    NARCIS (Netherlands)

    Allart-van Dam, E.; Hosman, C.M.H.; Hoogduin, C.A.L.; Schaap, C.P.D.R.

    2003-01-01

    This article reports on a randomized controlled trial investigating the short-term effectiveness of the Coping With Depression course in a sample of adults seriously at risk of developing major depression. In addition, possible mediating properties of several proximal outcome variables were

  3. The Coping with Depression course : Short-term outcomes and mediating effects of a randomized controlled trial in the treatment of subclinical depression

    NARCIS (Netherlands)

    Allart-van Dam, E; Hosman, CMH; Hoogduin, CAL; Schaap, CPDR

    2003-01-01

    This article reports on a randomized controlled trial investigating the short-term effectiveness of the Coping With Depression course in a sample of adults seriously at risk of developing major depression. In addition, possible mediating properties of several proximal outcome variables were

  4. A randomized clinical trial to evaluate the effects of rasagiline on depressive symptoms in non-demented Parkinson's disease patients

    OpenAIRE

    Barone, P; Santangelo, G.; Morgante, L.; Onofrj, M.; Meco, G.; Abbruzzese, G.; Bonuccelli, U.; Cossu, G.; Pezzoli, G.; Stanzione, P.; Lopiano, Leonardo; Antonini, A.; Tinazzi, M.

    2015-01-01

    Background and purpose Depressed mood is a common psychiatric problem associated with Parkinson?s disease (PD), and studies have suggested a benefit of rasagiline treatment. Methods ACCORDO (see the 1) was a 12-week, double-blind, placebo-controlled trial to evaluate the effects of rasagiline 1?mg/day on depressive symptoms and cognition in non-demented PD patients with depressive symptoms. The primary efficacy variable was the change from baseline to week 12 in depressive symptoms measured b...

  5. Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder

    Directory of Open Access Journals (Sweden)

    Crawford Sybil

    2008-09-01

    Full Text Available Abstract Background Obesity is often comorbid with depression and individuals with this comorbidity fare worse in behavioral weight loss treatment. Treating depression directly prior to behavioral weight loss treatment might bolster weight loss outcomes in this population, but this has not yet been tested in a randomized clinical trial. Methods and design This randomized clinical trial will examine whether behavior therapy for depression administered prior to standard weight loss treatment produces greater weight loss than standard weight loss treatment alone. Obese women with major depressive disorder (N = 174 will be recruited from primary care clinics and the community and randomly assigned to one of the two treatment conditions. Treatment will last 2 years, and will include a 6-month intensive treatment phase followed by an 18-month maintenance phase. Follow-up assessment will occur at 6-months and 1- and 2 years following randomization. The primary outcome is weight loss. The study was designed to provide 90% power for detecting a weight change difference between conditions of 3.1 kg (standard deviation of 5.5 kg at 1-year assuming a 25% rate of loss to follow-up. Secondary outcomes include depression, physical activity, dietary intake, psychosocial variables and cardiovascular risk factors. Potential mediators (e.g., adherence, depression, physical activity and caloric intake of the intervention effect on weight change will also be examined. Discussion Treating depression before administering intensive health behavior interventions could potentially boost the impact on both mental and physical health outcomes. Trial registration NCT00572520

  6. A community-integrated home based depression intervention for older African Americans: descripton of the Beat the Blues randomized trial and intervention costs

    Directory of Open Access Journals (Sweden)

    Gitlin Laura N

    2012-02-01

    Full Text Available Abstract Background Primary care is the principle setting for depression treatment; yet many older African Americans in the United States fail to report depressive symptoms or receive the recommended standard of care. Older African Americans are at high risk for depression due to elevated rates of chronic illness, disability and socioeconomic distress. There is an urgent need to develop and test new depression treatments that resonate with minority populations that are hard-to-reach and underserved and to evaluate their cost and cost-effectiveness. Methods/Design Beat the Blues (BTB is a single-blind parallel randomized trial to assess efficacy of a non-pharmacological intervention to reduce depressive symptoms and improve quality of life in 208 African Americans 55+ years old. It involves a collaboration with a senior center whose care management staff screen for depressive symptoms (telephone or in-person using the Patient Health Questionnaire (PHQ-9. Individuals screened positive (PHQ-9 ≥ 5 on two separate occasions over 2 weeks are referred to local mental health resources and BTB. Interested and eligible participants who consent receive a baseline home interview and then are randomly assigned to receive BTB immediately or 4 months later (wait-list control. All participants are interviewed at 4 (main study endpoint and 8 months at home by assessors masked to study assignment. Licensed senior center social workers trained in BTB meet with participants at home for up to 10 sessions over 4 months to assess care needs, make referrals/linkages, provide depression education, instruct in stress reduction techniques, and use behavioral activation to identify goals and steps to achieve them. Key outcomes include reduced depressive symptoms (primary, reduced anxiety and functional disability, improved quality of life, and enhanced depression knowledge and behavioral activation (secondary. Fidelity is enhanced through procedure manuals and staff

  7. Symptom specificity in the acute treatment of Major Depressive Disorder: a re-analysis of the treatment of depression collaborative research program.

    Science.gov (United States)

    Stewart, Jeremy G; Harkness, Kate L

    2012-03-01

    Antidepressant medications, Cognitive-Behavioral Therapy (CBT) and Interpersonal Psychotherapy (IPT) are equally efficacious in the acute treatment of Major Depressive Disorder (MDD). Nevertheless, remission rates remain unacceptably low. Examining the differential time course of remission of specific symptom clusters across treatments may provide a basis for assigning patients to treatments that have the highest chance of being effective. This study re-analyzed data from the NIMH Treatment of Depression Collaborative Research Project (TDCRP), which included 250 adult outpatients with MDD randomized to 16 weeks of CBT, IPT, imipramine+clinical management (IMI-CM), or pill placebo (PLA-CM). We derived four symptom factors from the 23-item Hamilton Depression Rating Scale, and three symptom factors from the Beck Depression Inventory. Within-subject hierarchical regression models were specified to examine the linear and quadratic patterns of symptom remission over five assessment points. IMI-CM produced a more rapid rate of remission than CBT or IPT for both the somatic/vegetative and cognitive-affective symptoms of MDD. There were no statistically significant differences in the rates of improvement of any of the symptom factors between the IMI-CM and PLA-CM groups. Some core symptoms of depression were excluded due to low factor loadings. Past research has argued that the CBT arm in the TDCRP may have been weak. We failed to find evidence that treatments act preferentially on specific symptom clusters. Therefore, the symptoms of MDD may be inter-dependent when it comes to their courses of remission in treatment. Copyright © 2011 Elsevier B.V. All rights reserved.

  8. Time to improve and recover from depressive symptoms and interpersonal problems in a clinical trial.

    Science.gov (United States)

    Lopes, Rodrigo T; Gonçalves, Miguel M; Fassnacht, Daniel; Machado, Paulo P P; Sousa, Inês

    2015-01-01

    Results from an earlier clinical trial comparing narrative therapy with cognitive-behavioural therapy (Lopes et al., 2013) suggested that narrative therapy is efficacious for depression. However, there were significant differences in symptom reduction on the Beck Depression Inventory-II, favouring cognitive-behavioural therapy, if dropouts were included in the analysis, suggesting that time to recovery or improvement would differ in both treatments. Contrarily, results showed that treatment assignment was not a predictor for differential effect. Using a survival analytic approach, it was found that four sessions were necessary for 50% improvement and 16 sessions for 50% recovery. Additionally, depressive symptoms changes occurred significantly faster than interpersonal changes, again regardless of treatment assignment. These results support previous findings of the dose-response literature and of the phase model of change, with the advantage of being specific to psychotherapy with depressive clients. Copyright © 2013 John Wiley & Sons, Ltd.

  9. A Novel Religious/Spiritual Group Psychotherapy Reduces Depressive Symptoms in a Randomized Clinical Trial.

    Science.gov (United States)

    Chida, Yoichi; Schrempft, Stephanie; Steptoe, Andrew

    2016-10-01

    This randomized controlled trial aimed to examine the effect of the Happy Science doctrine-based group psychotherapy on depressive symptoms in 118 Japanese mental disorder outpatients. The treatment group (n = 58) took part in five 90-min sessions at one-week intervals, while the control group (n = 60) received standard care including medication. Depressive symptoms were assessed before the intervention, 5 weeks after the intervention, and at 3-month follow-up. Compared to the control group, the treatment group showed a significant reduction in depressive symptoms both at post-intervention and at 3-month follow-up. In conclusion, this group psychotherapy might be of benefit in treating depressive symptoms.

  10. Psychotherapy for bulimia nervosa on symptoms of depression: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Linardon, Jake; Wade, Tracey; de la Piedad Garcia, Xochitl; Brennan, Leah

    2017-10-01

    Depressive symptoms are an important risk factor and consequence of binge eating and purging behavior in bulimia nervosa (BN). Although psychotherapy is effective in reducing symptoms of BN in the short- and long-term, it is unclear whether psychotherapy for BN is also effective in reducing depressive symptoms. This meta-analysis examined the efficacy of psychotherapy for BN on depressive symptoms in the short- and long-term. Randomized controlled trials (RCTs) on BN that assessed depressive symptoms as an outcome were identified. Twenty-six RCTs were included. Psychotherapy was more efficacious at reducing symptoms of depression at post-treatment (g = 0.47) than wait-lists. This effect was strongest when studies delivered therapist-led, rather than guided self-help, treatment. No significant differences were observed between psychotherapy and antidepressants. There was no significant post-treatment difference between CBT and other active psychological comparisons at reducing symptoms of depression. However, when only therapist-led CBT was analyzed, therapist-led CBT was significantly more efficacious (g = 0.25) than active comparisons at reducing depressive symptoms. The magnitude of the improvement in depressive symptoms was predicted by the magnitude of the improvement in BN symptoms. These findings suggest that psychotherapy is effective for reducing depressive symptoms in BN in the short-term. Whether these effects are sustained in the long-term is yet to be determined, as too few studies conducted follow-up assessments. Moreover, findings demonstrate that, in addition to being the front-running treatment for BN symptoms, CBT might also be the most effective psychotherapy for improving the symptoms of depression that commonly co-occur in BN. © 2017 Wiley Periodicals, Inc.

  11. Effect of Probiotics on Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Ruixue Huang

    2016-08-01

    Full Text Available It has been reported that gut probiotics play a major role in the bidirectional communication between the gut and the brain. Probiotics may be essential to people with depression, which remains a global health challenge, as depression is a metabolic brain disorder. However, the efficacy of probiotics for depression is controversial. This study aimed to systematically review the existing evidence on the effect of probiotics-based interventions on depression. Randomized, controlled trials, identified through screening multiple databases and grey literature, were included in the meta-analysis. The meta-analysis was performed using Review Manager 5.3 software using a fixed-effects model. The meta-analysis showed that probiotics significantly decreased the depression scale score (MD (depressive disorder = −0.30, 95% CI (−0.51–−0.09, p = 0.005 in the subjects. Probiotics had an effect on both the healthy population (MD = −0.25, 95% CI (−0.47–−0.03, p = 0.03 and patients with major depressive disorder (MDD (MD = −0.73, 95% CI (−1.37–−0.09, p = 0.03. Probiotics had an effect on the population aged under 60 (MD = −0.43, 95% CI (−0.72–−0.13, p = 0.005, while it had no effect on people aged over 65 (MD = −0.18, 95% CI (−0.47–0.11, p = 0.22. This is the first systematic review and meta-analysis with the goal of determining the effect of probiotics on depression. We found that probiotics were associated with a significant reduction in depression, underscoring the need for additional research on this potential preventive strategy for depression.

  12. Effect of Probiotics on Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Huang, Ruixue; Wang, Ke; Hu, Jianan

    2016-08-06

    It has been reported that gut probiotics play a major role in the bidirectional communication between the gut and the brain. Probiotics may be essential to people with depression, which remains a global health challenge, as depression is a metabolic brain disorder. However, the efficacy of probiotics for depression is controversial. This study aimed to systematically review the existing evidence on the effect of probiotics-based interventions on depression. Randomized, controlled trials, identified through screening multiple databases and grey literature, were included in the meta-analysis. The meta-analysis was performed using Review Manager 5.3 software using a fixed-effects model. The meta-analysis showed that probiotics significantly decreased the depression scale score (MD (depressive disorder) = -0.30, 95% CI (-0.51--0.09), p = 0.005) in the subjects. Probiotics had an effect on both the healthy population (MD = -0.25, 95% CI (-0.47--0.03), p = 0.03) and patients with major depressive disorder (MDD) (MD = -0.73, 95% CI (-1.37--0.09), p = 0.03). Probiotics had an effect on the population aged under 60 (MD = -0.43, 95% CI (-0.72--0.13), p = 0.005), while it had no effect on people aged over 65 (MD = -0.18, 95% CI (-0.47-0.11), p = 0.22). This is the first systematic review and meta-analysis with the goal of determining the effect of probiotics on depression. We found that probiotics were associated with a significant reduction in depression, underscoring the need for additional research on this potential preventive strategy for depression.

  13. Demographic variables, design characteristics, and effect sizes of randomized, placebo-controlled, monotherapy trials of major depressive disorder and bipolar depression.

    Science.gov (United States)

    Papakostas, George I; Martinson, Max A; Fava, Maurizio; Iovieno, Nadia

    2016-05-01

    The aim of this work is to compare the efficacy of pharmacologic agents for the treatment of major depressive disorder (MDD) and bipolar depression. MEDLINE/PubMed databases were searched for studies published in English between January 1980 and September 2014 by cross-referencing the search term placebo with each of the antidepressant agents identified and with bipolar. The search was supplemented by manual bibliography review. We selected double-blind, randomized, placebo-controlled trials of antidepressant monotherapies for the treatment of MDD and of oral drug monotherapies for the treatment of bipolar depression. 196 trials in MDD and 19 trials in bipolar depression were found eligible for inclusion in our analysis. Data were extracted by one of the authors and checked for accuracy by a second one. Data extracted included year of publication, number of patients randomized, probability of receiving placebo, duration of the trial, baseline symptom severity, dosing schedule, study completion rates, and clinical response rates. Response rates for drug versus placebo in trials of MDD and bipolar depression were 52.7% versus 37.5% and 54.7% versus 40.5%, respectively. The random-effects meta-analysis indicated that drug therapy was more effective than placebo in both MDD (risk ratio for response = 1.373; P depression (risk ratio = 1.257; P depression trials in favor of MDD (P = .008). Although a statistically significantly greater treatment effect size was noted in MDD relative to bipolar depression studies, the absolute magnitude of the difference was numerically small. Therefore, the present study suggests no clinically significant differences in the overall short-term efficacy of pharmacologic monotherapies for MDD and bipolar depression. © Copyright 2016 Physicians Postgraduate Press, Inc.

  14. Anti-depressive effectiveness of olanzapine, quetiapine, risperidone and ziprasidone: a pragmatic, randomized trial

    Directory of Open Access Journals (Sweden)

    Løberg Else-Marie

    2011-08-01

    Full Text Available Abstract Background Efficacy studies indicate anti-depressive effects of at least some second generation antipsychotics (SGAs. The Bergen Psychosis Project (BPP is a 24-month, pragmatic, industry-independent, randomized, head-to-head comparison of olanzapine, quetiapine, risperidone and ziprasidone in patients acutely admitted with psychosis. The aim of the study is to investigate whether differential anti-depressive effectiveness exists among SGAs in a clinically relevant sample of patients acutely admitted with psychosis. Methods Adult patients acutely admitted to an emergency ward for psychosis were randomized to olanzapine, quetiapine, risperidone or ziprasidone and followed for up to 2 years. Participants were assessed repeatedly using the Positive and Negative Syndrome Scale - Depression factor (PANSS-D and the Calgary Depression Scale for Schizophrenia (CDSS. Results A total of 226 patients were included. A significant time-effect showing a steady decline in depressive symptoms in all medication groups was demonstrated. There were no substantial differences among the SGAs in reducing the PANSS-D score or the CDSS sum score. Separate analyses of groups with CDSS sum scores > 6 or ≤6, respectively, reflecting degree of depressive morbidity, revealed essentially identical results to the primary analyses. There was a high correlation between the PANSS-D and the CDSS sum score (r = 0.77; p Conclusions There was no substantial difference in anti-depressive effectiveness among olanzapine, quetiapine, risperidone or ziprasidone in this clinically relevant sample of patients acutely admitted to hospital for symptoms of psychosis. Based on our findings we can make no recommendations concerning choice of any particular SGA for targeting symptoms of depression in a patient acutely admitted with psychosis. Trial Registration ClinicalTrials.gov ID; URL: http://www.clinicaltrials.gov/: NCT00932529

  15. Pilot trial of a dissonance-based cognitive-behavioral group depression prevention with college students.

    Science.gov (United States)

    Rohde, Paul; Stice, Eric; Shaw, Heather; Gau, Jeff M

    2016-07-01

    Conduct a pilot trial testing whether a new cognitive-behavioral (CB) group prevention program that incorporated cognitive-dissonance change principles was feasible and appeared effective in reducing depressive symptoms and major depressive disorder onset relative to a brochure control condition in college students with elevated depressive symptoms. 59 college students (M age = 21.8, SD = 2.3; 68% female, 70% White) were randomized to the 6-session Change Ahead group or educational brochure control condition, completing assessments at pretest, posttest, and 3-month follow-up. Recruitment and screening methods were effective and intervention attendance was high (86% attended all 6 sessions). Change Ahead participants showed medium-large reductions in depressive symptoms at posttest (M d = 0.64), though the effect attenuated by 3-month follow-up. Incidence of major depression onset at 3-month follow-up was 4% for Change Ahead participants versus 13% (difference ns). Change Ahead appears highly feasible and showed positive indications of reduced acute phase depressive symptoms and MDD onset relative to a minimal intervention control in this initial pilot. Given the brevity of the intervention, its apparent feasibility, and the lack of evidence-based depression prevention programs for college students, continued evaluation of Change Ahead appears warranted. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Marketing depression care management to employers: design of a randomized controlled trial.

    Science.gov (United States)

    Rost, Kathryn M; Marshall, Donna

    2010-03-16

    Randomized trials demonstrate that depression care management can improve clinical and work outcomes sufficiently for selected employers to realize a return on investment. Employers can now purchase depression products that provide depression care management, defined as employee screening, education, monitoring, and clinician feedback for all depressed employees. We developed an intervention to encourage employers to purchase a depression product that offers the type, intensity, and duration of care management shown to improve clinical and work outcomes. In a randomized controlled trial conducted with 360 employers of 30 regional business coalitions, the research team proposes to compare the impact of a value-based marketing intervention to usual-care marketing on employer purchase of depression products. The study will also identify mediators and organizational-level moderators of intervention impact. Employers randomized to the value-based condition receive a presentation encouraging them to purchase depression products scientifically shown to benefit the employee and the employer. Employers randomized to the usual-care condition receive a presentation encouraging them to monitor and improve quality indicators for outpatient depression treatment. Because previous research demonstrates that the usual-care intervention will have little to no impact on employer purchasing, depression product purchasing rates in the usual-care condition capture vendor efforts to market depression products to employers in both conditions while the value-based intervention is being conducted. Employers in both conditions are also provided free technical assistance to undertake the actions each presentation encourages. The research team will use intent-to-treat models of all available data to evaluate intervention impact on the purchase of depression products using a cumulative incidence analysis of 12- and 24-month data. By addressing the 'value to whom?' question, the study advances

  17. Intervention impact on depression product appraisal and purchasing behavior by employers: a randomized trial.

    Science.gov (United States)

    Rost, Kathryn M; Marshall, Donna; Xu, Stanley

    2014-09-24

    Employers can purchase high quality depression products that provide the type, intensity and duration of depression care management shown to improve work outcomes sufficiently for many employers to achieve a return on investment. The purpose of this randomized controlled trial was to test an intervention to encourage employers to purchase a high quality depression product for their workforce. Twenty nine organizations recruited senior health benefit professional members representing public or private employers who had not yet purchased a depression product for all 100+ workers in their company. The research team used randomization blocked by company size to assign eligible employers to: (1) a presentation encouraging employers to purchase a high quality depression product accompanied by a scientifically-derived return on investment estimate, or (2) a presentation encouraging employers to work with their most subscribed health plan to improve depression treatment quality indicators. Two hundred ninety three employers (82.3% of 356) completed baseline data immediately before learning that 140 employers had been randomized to the evidence-based (EB) depression product presentation and 153 had been randomized to the usual care (UC) depression treatment quality indicator presentation. Analysis of 250 (85.3% of 293) employers who completed web-based interviews at 12 and/or 24 months was conducted to determine presentation impact on depression product appraisal and purchasing behavior. The intervention had no impact on depression product appraisal in 232 subjects (F = 2.36, p = .07) or depression product purchasing (chisquare = 1.82, p = .44) in 250 subjects. Depression product appraisal increased in companies with greater health benefit generosity whose benefit professionals were male. Depression product purchasing behavior increased in small companies compared to large companies, companies who knew a vendor that sold depression products at baseline, companies with

  18. Physical activity as a treatment for depression: the TREAD randomised trial protocol.

    Science.gov (United States)

    Baxter, Helen; Winder, Rachel; Chalder, Melanie; Wright, Christine; Sherlock, Sofie; Haase, Anne; Wiles, Nicola J; Montgomery, Alan A; Taylor, Adrian H; Fox, Ken R; Lawlor, Debbie A; Peters, Tim J; Sharp, Deborah J; Campbell, John; Lewis, Glyn

    2010-11-12

    Depression is one of the most common reasons for consulting a General Practitioner (GP) within the UK. Whilst antidepressants have been shown to be clinically effective, many patients and healthcare professionals would like to access other forms of treatment as an alternative or adjunct to drug therapy for depression. A recent systematic review presented some evidence that physical activity could offer one such option, although further investigation is needed to test its effectiveness within the context of the National Health Service.The aim of this paper is to describe the protocol for a randomised, controlled trial (RCT) designed to evaluate an intervention developed to increase physical activity as a treatment for depression within primary care. The TREAD study is a pragmatic, multi-centre, two-arm RCT which targets patients presenting with a new episode of depression. Patients were approached if they were aged 18-69, had recently consulted their GP for depression and, where appropriate, had been taking antidepressants for less than one month. Only those patients with a confirmed diagnosis of a depressive episode as assessed by the Clinical Interview Schedule-Revised (CIS-R), a Beck Depression Inventory (BDI) score of at least 14 and informed written consent were included in the study. Eligible patients were individually randomised to one of two treatment groups; usual GP care or usual GP care plus facilitated physical activity. The primary outcome of the trial is clinical symptoms of depression assessed using the BDI four months after randomisation. A number of secondary outcomes are also measured at the 4-, 8- and 12-month follow-up points including quality of life, attitude to and involvement in physical activity and antidepressant use/adherence. Outcomes will be analysed on an intention-to-treat (ITT) basis and will use linear and logistic regression models to compare treatments. The results of the trial will provide information about the effectiveness of

  19. Randomized controlled trial of behavioral treatment for comorbid obesity and depression in women: the Be Active Trial.

    Science.gov (United States)

    Pagoto, S; Schneider, K L; Whited, M C; Oleski, J L; Merriam, P; Appelhans, B; Ma, Y; Olendzki, B; Waring, M E; Busch, A M; Lemon, S; Ockene, I; Crawford, S

    2013-11-01

    Depression is associated with increased risk for obesity and worse weight loss treatment outcomes. The purpose of the present study was to test the hypothesis that delivering evidence-based behavior therapy for depression before a lifestyle weight loss intervention improves both weight loss and depression. In a randomized controlled trial, obese women with major depressive disorder (N=161, mean age=45.9 (s.d.: 10.8) years) were randomized to brief behavior therapy for depression treatment followed by a lifestyle intervention (BA) or a lifestyle intervention only (LI). Follow-up occurred at 6 and 12 months. Main outcome measures included weight loss and depression symptoms. Intention-to-treat analyses revealed both conditions lost significant weight, but no differences between conditions in weight change at 6 months (BA=-3.0%, s.e.=-0.65%; LI=-3.7%, s.e.=0.63%; P=0.48) or 12 months (BA=-2.6%, s.e.=0.77%; LI=-3.1%, s.e.=0.74%; P=0.72). However, the BA condition evidenced significantly greater improvement in Beck Depression Inventory-II scores relative to the LI condition at both 6 months (BA mean change=-12.5, s.d.=0.85; LI mean change=-9.2, s.d.=0.80, P=0.005) and 12 months (BA mean change=-12.6, s.d.=0.97; LI mean change=-9.9, s.d.=0.93; P=0.045). Participants who experienced depression remission by 6 months (61.2%) lost greater weight (mean=-4.31%; s.e.=0.052) than those who did not (39.7%; mean=-2.47%, s.e.=0.53; P=.001). Adding behavior therapy to a lifestyle intervention results in greater depression remission but does not improve weight loss within 1 year. Improvement in depression is associated with greater weight loss.

  20. The effectiveness of a Supported Self-management task-shifting intervention for adult depression in Vietnam communities: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Murphy, Jill; Goldsmith, Charles H; Jones, Wayne; Oanh, Pham Thi; Nguyen, Vu Cong

    2017-05-05

    Depressive disorders are one of the leading causes of disease and disability worldwide. In Vietnam, although epidemiological evidence suggests that depression rates are on par with global averages, services for depression are very limited. In a feasibility study that was implemented from 2013 to 2015, we found that a Supported Self-management (SSM) intervention showed promising results for adults with depression in the community in Vietnam. This paper describes the Mental Health in Adults and Children: Frugal Innovations (MAC-FI) trial protocol that will assess the effectiveness of the SSM intervention, delivered by primary care and social workers, to community-based populations of adults with depression in eight Vietnamese provinces. The MAC-FI program will be assessed using a stepped-wedge, randomized controlled trial. Study participants are adults aged 18 years and over in eight provinces of Vietnam. Study participants will be screened at primary care centres and in the community by health and social workers using the Self-reporting Questionnaire-20 (SRQ-20). Patients scoring >7, indicating depression caseness, will be invited to participate in the study in either the SSM intervention group or the enhanced treatment as usual control group. Recruited participants will be further assessed using the World Health Organization's Disability Assessment Scale (WHODAS 2.0) and the Cut-down, Annoyed, Guilty, Eye-opener (CAGE) Questionnaire for alcohol misuse. Intervention-group participants will receive the SSM intervention, delivered with the support of a social worker or social collaborator, for a period of 2 months. Control- group participants will receive treatment as usual and a leaflet with information about depression. SRQ-20, WHODAS 2.0 and CAGE scores will be taken by blinded outcome assessors at baseline, after 1 month and after 2 months. The primary analysis method will be intention-to-treat. This study has the potential to add to the knowledge base about

  1. Transcranial direct current stimulation for depression in Alzheimer's disease: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Narita, Zui; Yokoi, Yuma

    2017-06-19

    Patients with Alzheimer's disease frequently elicit neuropsychiatric symptoms as well as cognitive deficits. Above all, depression is one of the most common neuropsychiatric symptoms in Alzheimer's disease but antidepressant drugs have not shown significant beneficial effects on it. Moreover, electroconvulsive therapy has not ensured its safety for potential severe adverse events although it does show beneficial clinical effect. Transcranial direct current stimulation can be the safe alternative of neuromodulation, which applies weak direct electrical current to the brain. Although transcranial direct current stimulation has plausible evidence for its effect on depression in young adult patients, no study has explored it in older subjects with depression in Alzheimer's disease. Therefore, we present a study protocol designed to evaluate the safety and clinical effect of transcranial direct current stimulation on depression in Alzheimer's disease in subjects aged over 65 years. This is a two-arm, parallel-design, randomized controlled trial, in which patients and assessors will be blinded. Subjects will be randomized to either an active or a sham transcranial direct current stimulation group. Participants in both groups will be evaluated at baseline, immediately, and 2 weeks after the intervention. This study investigates the safety and effect of transcranial direct current stimulation that may bring a significant impact on both depression and cognition in patients with Alzheimer's disease, and may be useful to enhance their quality of life. ClinicalTrials.gov, NCT02351388 . Registered on 27 January 2015. Last updated on 30 May 2016.

  2. A randomized controlled trial of internet-based therapy in depression.

    Science.gov (United States)

    Moritz, Steffen; Schilling, Lisa; Hauschildt, Marit; Schröder, Johanna; Treszl, András

    2012-08-01

    Depression is among the most prevalent disorders worldwide. In view of numerous treatment barriers, internet-based interventions are increasingly adopted to "treat the untreated". The present trial (registered as NCT01401296) was conducted over the internet and aimed to assess the efficacy of an online self-help program for depression (Deprexis). In random order, participants with elevated depression symptoms received program access or were allocated to a wait-list control condition. After eight weeks, participants were invited to take part in an online re-assessment. To compensate for common problems of online studies, such as low completion rates and unclear diagnostic status, reminders and incentives were used, and clinical diagnoses were externally confirmed in a subgroup of 29% of participants. Relative to the wait-list group, program users experienced significant symptom decline on the Beck Depression Inventory (BDI; primary outcome), the Dysfunctional Attitudes Scale (DAS), the Quality of Life scale (WHOQOL-BREF) and the Rosenberg Self-Esteem Scale (RSE). Compared to wait-list participants, symptom decline was especially pronounced among those with moderate symptoms at baseline as well as those not currently consulting a therapist. Completion (82%) and re-test reliability of the instruments (r = .72-.87) were good. The results of this trial suggest that online treatment can be beneficial for people with depression, particularly for those with moderate symptoms. Copyright © 2012 Elsevier Ltd. All rights reserved.

  3. Duloxetine in the treatment of binge eating disorder with depressive disorders: a placebo-controlled trial.

    Science.gov (United States)

    Guerdjikova, Anna I; McElroy, Susan L; Winstanley, Erin L; Nelson, Eric B; Mori, Nicole; McCoy, Jessica; Keck, Paul E; Hudson, James I

    2012-03-01

    This study evaluated duloxetine in the treatment of binge eating disorder (BED) with comorbid current depressive disorders. In this 12-week, double-blind, placebo-controlled trial, 40 patients with Diagnostic and Statistical Manual of Mental Disorders-IV-TR BED and a comorbid current depressive disorder received duloxetine (N = 20) or placebo (N = 20). The primary outcome measure was weekly binge eating day frequency. In the primary analysis, duloxetine (mean 78.7 mg/day) was superior to placebo in reducing weekly frequency of binge eating days (p = .04), binge eating episodes (p = .02), weight (p = .04), and Clinical Global Impression-Severity of Illness ratings for binge eating (p = .02) and depressive disorders (p = .01). Changes in body mass index and measures of eating pathology, depression, and anxiety did not differ between the two groups. Duloxetine may be effective for reducing binge eating, weight, and global severity of illness in BED with a comorbid current depressive disorder, but this finding needs confirmation in larger, placebo-controlled trials. Copyright © 2011 Wiley Periodicals, Inc.

  4. A randomized trial of the effect of prayer on depression and anxiety.

    Science.gov (United States)

    Boelens, Peter A; Reeves, Roy R; Replogle, William H; Koenig, Harold G

    2009-01-01

    To investigate the effect of direct contact person-to-person prayer on depression, anxiety, positive emotions, and salivary cortisol levels. Cross-over clinical trial with depression or anxiety conducted in an office setting. Following randomization to the prayer intervention or control groups, subjects (95% women) completed Hamilton Rating Scales for Depression and Anxiety, Life Orientation Test, Daily Spiritual Experiences Scale, and underwent measurement of cortisol levels. Individuals in the direct person-to-person prayer contact intervention group received six weekly 1-hour prayer sessions while those in the control group received none. Rating scales and cortisol levels were repeated for both groups after completion of the prayer sessions, and a month later. ANOVAs were used to compare pre- and post-prayer measures for each group. At the completion of the trial, participants receiving the prayer intervention showed significant improvement of depression and anxiety, as well as increases of daily spiritual experiences and optimism compared to controls (p prayer group maintained these significant improvements (p prayer session. Participants in the control group did not show significant changes during the study. Cortisol levels did not differ significantly between intervention and control groups, or between pre- and post-prayer conditions. Direct contact person-to-person prayer may be useful as an adjunct to standard medical care for patients with depression and anxiety. Further research in this area is indicated.

  5. A smartphone application for treating depressive symptoms: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Deady, M; Johnston, D A; Glozier, N; Milne, D; Choi, I; Mackinnon, A; Mykletun, A; Calvo, R A; Gayed, A; Bryant, R; Christensen, H; Harvey, S B

    2018-06-01

    Depression is a commonly occurring disorder linked to diminished role functioning and quality of life. The development of treatments that overcome barriers to accessing treatment remains an important area of clinical research as most people delay or do not receive treatment at an appropriate time. The workplace is an ideal setting to roll-out an intervention, particularly given the substantial psychological benefits associated with remaining in the workforce. Mobile health (mhealth) interventions utilising smartphone applications (apps) offer novel solutions to disseminating evidence based programs, however few apps have undergone rigorous testing. The present study aims to evaluate the effectiveness of a smartphone app designed to treat depressive symptoms in workers. The present study is a multicentre randomised controlled trial (RCT), comparing the effectiveness of the intervention to that of an attention control. The primary outcome measured will be reduced depressive symptoms at 3 months. Secondary outcomes such as wellbeing and work performance will also be measured. Employees from a range of industries will be recruited via a mixture of targeted social media advertising and Industry partners. Participants will be included if they present with likely current depression at baseline. Following baseline assessment (administered within the app), participants will be randomised to receive one of two versions of the Headgear application: 1) Intervention (a 30-day mental health intervention focusing on behavioural activation and mindfulness), or 2) attention control app (mood monitoring for 30 days). Participants will be blinded to their allocation. Analyses will be conducted within an intention to treat framework using mixed modelling. The results of this trial will provide valuable information about the effectiveness of mhealth interventions in the treatment of depressive symptoms in a workplace context. The current trial is registered with the Australian and

  6. Preventing Adolescent Social Anxiety and Depression and Reducing Peer Victimization: Intervention Development and Open Trial

    Science.gov (United States)

    La Greca, Annette M.; Ehrenreich-May, Jill; Mufson, Laura; Chan, Sherilynn

    2016-01-01

    Background Social anxiety disorder (SAD) and depression are common among adolescents, frequently comorbid, and resistant to change. Prevention programs for adolescent SAD are scant, and depression prevention programs do not fully address peer-risk factors. One critical peer-risk factor for SAD and depression is peer victimization. We describe the development and initial evaluation of a transdiagnostic school-based preventive intervention for adolescents with elevated symptoms of social anxiety and/or depression and elevated peer victimization. We modified Interpersonal Psychotherapy-Adolescent Skills Training for depression, incorporating strategies for dealing with social anxiety and peer victimization. Objective Our open trial assessed the feasibility, acceptability, and preliminary benefit of the modified program (called UTalk) for adolescents at risk for SAD or depression and who also reported peer victimization. Method Adolescents (N=14; 13–18 years; 79% girls; 86% Hispanic) were recruited and completed measures of peer victimization, social anxiety, and depression both pre- and post-intervention and provided ratings of treatment satisfaction. Independent evaluators (IEs) rated youths’ clinical severity. The intervention (3 individual and 10 group sessions) was conducted weekly during school. Results Regarding feasibility, 86% of the adolescents completed the intervention (M attendance=11.58 sessions). Satisfaction ratings were uniformly positive. Intention-to-treat analyses revealed significant declines in adolescent- and IE-rated social anxiety and depression and in reports of peer victimization. Additional secondary benefits were observed. Conclusions Although further evaluation is needed, the UTalk intervention appears feasible to administer in schools, with high satisfaction and preliminary benefit. Implications for research on the prevention of adolescent SAD and depression are discussed. PMID:27857509

  7. Adjunctive yoga v. health education for persistent major depression: a randomized controlled trial.

    Science.gov (United States)

    Uebelacker, L A; Tremont, G; Gillette, L T; Epstein-Lubow, G; Strong, D R; Abrantes, A M; Tyrka, A R; Tran, T; Gaudiano, B A; Miller, I W

    2017-09-01

    The objective of this study was to determine whether hatha yoga is an efficacious adjunctive intervention for individuals with continued depressive symptoms despite antidepressant treatment. We conducted a randomized controlled trial of weekly yoga classes (n = 63) v. health education classes (Healthy Living Workshop; HLW; n = 59) in individuals with elevated depression symptoms and antidepressant medication use. HLW served as an attention-control group. The intervention period was 10 weeks, with follow-up assessments 3 and 6 months afterwards. The primary outcome was depression symptom severity assessed by blind rater at 10 weeks. Secondary outcomes included depression symptoms over the entire intervention and follow-up periods, social and role functioning, general health perceptions, pain, and physical functioning. At 10 weeks, we did not find a statistically significant difference between groups in depression symptoms (b = -0.82, s.e. = 0.88, p = 0.36). However, over the entire intervention and follow-up period, when controlling for baseline, yoga participants showed lower levels of depression than HLW participants (b = -1.38, s.e. = 0.57, p = 0.02). At 6-month follow-up, 51% of yoga participants demonstrated a response (⩾50% reduction in depression symptoms) compared with 31% of HLW participants (odds ratio = 2.31; p = 0.04). Yoga participants showed significantly better social and role functioning and general health perceptions over time. Although we did not see a difference in depression symptoms at the end of the intervention period, yoga participants showed fewer depression symptoms over the entire follow-up period. Benefits of yoga may accumulate over time.

  8. Blended care vs. usual care in the treatment of depressive symptoms and disorders in general practice [BLENDING]: study protocol of a non-inferiority randomized trial.

    Science.gov (United States)

    Massoudi, Btissame; Blanker, Marco H; van Valen, Evelien; Wouters, Hans; Bockting, Claudi L H; Burger, Huibert

    2017-06-13

    The majority of patients with depressive disorders are treated by general practitioners (GPs) and are prescribed antidepressant medication. Patients prefer psychological treatments but they are under-used, mainly due to time constraints and limited accessibility. A promising approach to deliver psychological treatment is blended care, i.e. guided online treatment. However, the cost-effectiveness of blended care formatted as an online psychological treatment supported by the patients' own GP or general practice mental health worker (MHW) in routine primary care is unknown. We aim to demonstrate non-inferiority of blended care compared with usual care in patients with depressive symptoms or a depressive disorder in general practice. Additionally, we will explore the real-time course over the day of emotions and affect, and events within individuals during treatment. This is a pragmatic non-inferiority trial including 300 patients with depressive symptoms, recruited by collaborating GPs and MHWs. After inclusion, participants are randomized to either blended care or usual care in routine general practice. Blended care consists of the 'Act and Feel' treatment: an eight-week web-based program based on behavioral activation with integrated monitoring of depressive symptomatology and automatized feedback. GPs or their MHWs coach the participants through regular face-to-face or telephonic consultations with at least three sessions. Depressive symptomatology, health status, functional impairment, treatment satisfaction, daily activities and resource use are assessed during a follow-up period of 12 months. During treatment, real-time fluctuations in emotions and affect, and daily events will be rated using ecological momentary assessment. The primary outcome is the reduction of depressive symptoms from baseline to three months follow-up. We will conduct intention-to-treat analyses and supplementary per-protocol analyses. This trial will show whether blended care might be an

  9. GENetic and clinical Predictors Of treatment response in Depression: the GenPod randomised trial protocol

    Directory of Open Access Journals (Sweden)

    O'Donovan Michael

    2008-05-01

    Full Text Available Abstract Background The most effective pharmacological treatments for depression inhibit the transporters that reuptake serotonin (Selective Serotonin Reuptake Inhibitors – SSRIs and noradrenaline (Noradrenaline Reuptake Inhibitors – NaRIs into the presynaptic terminal. There is evidence to suggest that noradrenaline and serotonin enhancing drugs work through separate mechanisms to produce their clinical antidepressant action. Although most of the current evidence suggests there is little difference in overall efficacy between SSRIs and NaRIs, there are patients who respond to one class of compounds and not another. This suggests that treatment response could be predicted by genetic and/or clinical characteristics. Firstly, this study aims to investigate the influence of a polymorphism (SLC6A4 in the 5HT transporter in altering response to SSRI medication. Secondly, the study will investigate whether those with more severe depression have a better response to NaRIs than SSRIs. Methods/design The GenPod trial is a multi-centre randomised controlled trial. GPs referred patients aged between 18–74 years presenting with a new episode of depression, who did not have any medical contraindications to antidepressant medication and who had no history of psychosis or alcohol/substance abuse. Patients were interviewed to ascertain their suitability for the study. Eligible participants (with a primary diagnosis of depression according to ICD10 criteria and a Beck Depression Inventory (BDI score > 14 were randomised to receive one of two antidepressant treatments, either the SSRI Citalopram or the NaRI Reboxetine, stratified according to severity. The final number randomised to the trial was 601. Follow-up assessments took place at 2, 6 and 12 weeks following randomisation. Primary outcome was measured at 6 weeks by the BDI. Outcomes will be analysed on an intention-to-treat basis and will use multiple regression models to compare treatments

  10. The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression

    DEFF Research Database (Denmark)

    Krogh, Jesper; Saltin, Bengt; Gluud, Christian

    2009-01-01

    OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners......: Our findings do not support a biologically mediated effect of exercise on symptom severity in depressed patients, but they do support a beneficial effect of strength training on work capacity. TRIAL REGISTRATION: (ClinicalTrials.gov) Identifier: NCT00103415....... or psychiatrists and were eligible if they fulfilled the International Classification of Diseases, Tenth Revision, criteria for unipolar depression and were aged between 18 and 55 years. Patients (N = 165) were allocated to supervised strength, aerobic, or relaxation training during a 4-month period. The primary...

  11. Systematic reviews of randomised clinical trials examining the effects of psychotherapeutic interventions versus "no intervention" for acute major depressive disorder and a randomised trial examining the effects of "third wave" cognitive therapy versus mentalization-based treatment for acute major depressive disorder.

    Science.gov (United States)

    Jakobsen, Janus Christian

    2014-10-01

    Major depressive disorder afflicts an estimated 17% of individuals during their lifetimes at tremendous suffering and costs. Cognitive therapy and psychodynamic therapy may be effective treatment options for major depressive disorder, but the effects have only had limited assessment in systematic reviews. The two modern forms of psychotherapy, "third wave" cognitive therapy and mentalization-based treatment, have both gained some ground as treatments of psychiatric disorders. No randomised trial has compared the effects of these two interventions for major depressive disorder. We performed two systematic reviews with meta-analyses and trial sequential analyses using The Cochrane Collaboration methodology examining the effects of cognitive therapy and psycho-dynamic therapy for major depressive disorder. We developed a thorough treatment protocol for a randomised trial with low risks of bias (systematic error) and low risks of random errors ("play of chance") examining the effects of third wave' cognitive therapy versus mentalization-based treatment for major depressive disorder. We conducted a randomised trial according to good clinical practice examining the effects of "third wave" cognitive therapy versus mentalisation-based treatment for major depressive disorder. The first systematic review included five randomised trials examining the effects of psychodynamic therapy versus "no intervention' for major depressive disorder. Altogether the five trials randomised 365 participants who in each trial received similar antidepressants as co-interventions. All trials had high risk of bias. Four trials assessed "interpersonal psychotherapy" and one trial "short psychodynamic supportive psychotherapy". Both of these interventions are different forms of psychodynamic therapy. Meta-analysis showed that psychodynamic therapy significantly reduced depressive symptoms on the Hamilton Depression Rating Scale (HDRS) compared with "no intervention" (mean difference -3.01 (95

  12. Help from home for depression: A randomised controlled trial comparing internet-delivered cognitive behaviour therapy with bibliotherapy for depression

    Directory of Open Access Journals (Sweden)

    Jessica Smith

    2017-09-01

    Full Text Available Major Depressive Disorder (MDD is a leading cause of the Global Burden of Disease. Cognitive Behavioural Therapy (CBT is an effective treatment for MDD, but access can be impaired due to numerous barriers. Internet-delivered CBT (iCBT can be utilised to overcome treatment barriers and is an effective treatment for depression, but has never been compared to bibliotherapy. This Randomised Controlled Trial (RCT included participants meeting diagnostic criteria for MDD (n = 270 being randomised to either: iCBT (n = 61, a CBT self-help book (bCBT (n = 77, a meditation self-help book (bMED (n = 64 or wait-list control (WLC (n = 68. The primary outcome was the Patient Health Questionnaire 9-item scale (PHQ-9 at 12-weeks (post-treatment. All three active interventions were significantly more effective than WLC in reducing depression at post-treatment, but there were no significant differences between the groups. All three interventions led to large within-group reductions in PHQ-9 scores at post-treatment (g = 0.88–1.69, which were maintained at 3-month follow-up, although there was some evidence of relapse in the bMED group (within-group g [post to follow-up] = 0.09–1.04. Self-help based interventions could be beneficial in treating depression, however vigilance needs to be applied when selecting from the range of materials available. Replication of this study with a larger sample is required.

  13. The Effect of Interpersonal Counseling for Subthreshold Depression in Undergraduates: An Exploratory Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Ami Yamamoto

    2018-01-01

    Full Text Available Background. Subthreshold depression and poor stress coping strategies are major public health problems among undergraduates. Interpersonal counseling (IPC is a brief structured psychological intervention originally designed for use in primary care to treat depressive patients whose symptoms arose from current life stress. Objectives. This study examined the efficacy of IPC in treating subthreshold depression and coping strategies among undergraduates in school counseling. Materials and Methods. We carried out an exploratory randomized controlled trial comparing the efficacy of IPC with counseling as usual (CAU. Participants were 31 undergraduates exhibiting depression without a psychiatric diagnosis. Results. The Zung Self-Rating Depression Scale total score decreased significantly in the IPC group (n=15; Z=-2.675, p=.007, but not in the CAU group (n=16. The task-oriented coping score of the Coping Inventory for Stressful Situations showed a tendency towards a greater increase in the IPC group than in the CAU group (t=1.919, df=29, p=.065. Conclusions. The IPC might be more useful for student counseling because it can teach realistic coping methods and reduce depressive symptoms in a short period. Further studies using more participants are required.

  14. Depression treatment for impoverished mothers by point-of-care providers: A randomized controlled trial.

    Science.gov (United States)

    Segre, Lisa S; Brock, Rebecca L; O'Hara, Michael W

    2015-04-01

    Depression in low-income, ethnic-minority women of childbearing age is prevalent and compromises infant and child development. Yet numerous barriers prevent treatment delivery. Listening Visits (LV), an empirically supported intervention developed for delivery by British home-visiting nurses, could address this unmet mental health need. This randomized controlled trial (RCT) evaluated the effectiveness of LV delivered at a woman's usual point-of-care, including home visits or an ob-gyn office. Listening Visits were delivered to depressed pregnant women or mothers of young children by their point-of-care provider (e.g., home visitor or physician's assistant), all of whom had low levels of prior counseling experience. Three quarters of the study's participants were low-income. Of those who reported ethnicity, all identified themselves as minorities. Participants from 4 study sites (N = 66) were randomized in a 2:1 ratio, to LV or a wait-list control group (WLC). Assessments, conducted at baseline and 8 weeks, evaluated depression, quality of life, and treatment satisfaction. Depressive severity, depressive symptoms, and quality of life significantly improved among LV recipients as compared with women receiving standard social/health services. Women valued LV as evidenced by their high attendance rates and treatment satisfaction ratings. In a stepped model of depression care, LV can provide an accessible, acceptable, and effective first-line treatment option for at-risk women who otherwise are unlikely to receive treatment. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  15. Selective serotonin reuptake inhibitors (SSRIs) for post-partum depression (PPD): a systematic review of randomized clinical trials.

    Science.gov (United States)

    De Crescenzo, Franco; Perelli, Federica; Armando, Marco; Vicari, Stefano

    2014-01-01

    The treatment of postpartum depression with selective serotonin reuptake inhibitors (SSRIs) has been claimed to be both efficacious and well tolerated, but no recent systematic reviews have been conducted. A qualitative systematic review of randomized clinical trials on women with postpartum depression comparing SSRIs to placebo and/or other treatments was performed. A comprehensive literature search of online databases, the bibliographies of published articles and grey literature were conducted. Data on efficacy, acceptability and tolerability were extracted and the quality of the trials was assessed. Six randomised clinical trials, comprising 595 patients, met quality criteria for inclusion in the analysis. Cognitive-behavioural intervention, psychosocial community-based intervention, psychodynamic therapy, cognitive behavioural therapy, a second-generation tricyclic antidepressant and placebo were used as comparisons. All studies demonstrated higher response and remission rates among those treated with SSRIs and greater mean changes on depression scales, although findings were not always statistically significant. Dropout rates were high in three of the trials but similar among treatment and comparison groups. In general, SSRIs were well tolerated and trial quality was good. There are few trials, patients included in the trials were not representative of all patients with postpartum depression, dropout rates in three trials were high, and long-term efficacy and tolerability were assessed in only two trials. SSRIs appear to be efficacious and well tolerated in the treatment of postpartum depression, but the available evidence fails to demonstrate a clear superiority over other treatments. © 2013 Elsevier B.V. All rights reserved.

  16. Antidepressants for depressive disorder in children and adolescents: a database of randomised controlled trials.

    Science.gov (United States)

    Zhang, Yuqing; Zhou, Xinyu; Pu, Juncai; Zhang, Hanping; Yang, Lining; Liu, Lanxiang; Zhou, Chanjuan; Yuan, Shuai; Jiang, Xiaofeng; Xie, Peng

    2018-05-31

    In recent years, whether, when and how to use antidepressants to treat depressive disorder in children and adolescents has been hotly debated. Relevant evidence on this topic has increased rapidly. In this paper, we present the construction and content of a database of randomised controlled trials of antidepressants to treat depressive disorder in children and adolescents. This database can be freely accessed via our website and will be regularly updated. Major bibliographic databases (PubMed, the Cochrane Library, Web of Science, Embase, CINAHL, PsycINFO and LiLACS), international trial registers and regulatory agencies' websites were systematically searched for published and unpublished studies up to April 30, 2017. We included randomised controlled trials in which the efficacy or tolerability of any oral antidepressant was compared with that of a control group or any other treatment. In total, 7377 citations from bibliographical databases and 3289 from international trial registers and regulatory agencies' websites were identified. Of these, 53 trials were eligible for inclusion in the final database. Selected data were extracted from each study, including characteristics of the participants (the study population, setting, diagnostic criteria, type of depression, age, sex, and comorbidity), characteristics of the treatment conditions (the treatment conditions, general information, and detail of pharmacotherapy and psychotherapy) and study characteristics (the sponsor, country, number of sites, blinding method, sample size, treatment duration, depression scales, other scales, and primary outcome measure used, and side-effect monitoring method). Moreover, the risk of bias for each trial were assessed. This database provides information on nearly all randomised controlled trials of antidepressants in children and adolescents. By using this database, researchers can improve research efficiency, avoid inadvertent errors and easily focus on the targeted subgroups in

  17. Depression

    Science.gov (United States)

    ... in the winter. Depression is one part of bipolar disorder. There are effective treatments for depression, including antidepressants, talk therapy, or both. NIH: National Institute of Mental Health

  18. The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression

    DEFF Research Database (Denmark)

    Krogh, Jesper; Saltin, Bengt; Gluud, Christian

    2009-01-01

    OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners or psych......: Our findings do not support a biologically mediated effect of exercise on symptom severity in depressed patients, but they do support a beneficial effect of strength training on work capacity. TRIAL REGISTRATION: (ClinicalTrials.gov) Identifier: NCT00103415.......OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners...... or psychiatrists and were eligible if they fulfilled the International Classification of Diseases, Tenth Revision, criteria for unipolar depression and were aged between 18 and 55 years. Patients (N = 165) were allocated to supervised strength, aerobic, or relaxation training during a 4-month period. The primary...

  19. The Effect of Improving Primary Care Depression Management on Employee Absenteeism and Productivity A Randomized Trial

    Science.gov (United States)

    Rost, Kathryn; Smith, Jeffrey L.; Dickinson, Miriam

    2005-01-01

    Objective: To test whether an intervention to improve primary care depression management significantly improves productivity at work and absenteeism over 2 years. Setting and Subjects: Twelve community primary care practices recruiting depressed primary care patients identified in a previsit screening. Research Design: Practices were stratified by depression treatment patterns before randomization to enhanced or usual care. After delivering brief training, enhanced care clinicians provided improved depression management over 24 months. The research team evaluated productivity and absenteeism at baseline, 6, 12, 18, and 24 months in 326 patients who reported full-or part-time work at one or more completed waves. Results: Employed patients in the enhanced care condition reported 6.1% greater productivity and 22.8% less absenteeism over 2 years. Consistent with its impact on depression severity and emotional role functioning, intervention effects were more observable in consistently employed subjects where the intervention improved productivity by 8.2% over 2 years at an estimated annual value of $1982 per depressed full-time equivalent and reduced absenteeism by 28.4% or 12.3 days over 2 years at an estimated annual value of $619 per depressed full-time equivalent. Conclusions: This trial, which is the first to our knowledge to demonstrate that improving the quality of care for any chronic disease has positive consequences for productivity and absenteeism, encourages formal cost-benefit research to assess the potential return-on-investment employers of stable workforces can realize from using their purchasing power to encourage better depression treatment for their employees. PMID:15550800

  20. The effect of improving primary care depression management on employee absenteeism and productivity. A randomized trial.

    Science.gov (United States)

    Rost, Kathryn; Smith, Jeffrey L; Dickinson, Miriam

    2004-12-01

    To test whether an intervention to improve primary care depression management significantly improves productivity at work and absenteeism over 2 years. Twelve community primary care practices recruiting depressed primary care patients identified in a previsit screening. Practices were stratified by depression treatment patterns before randomization to enhanced or usual care. After delivering brief training, enhanced care clinicians provided improved depression management over 24 months. The research team evaluated productivity and absenteeism at baseline, 6, 12, 18, and 24 months in 326 patients who reported full-or part-time work at one or more completed waves. Employed patients in the enhanced care condition reported 6.1% greater productivity and 22.8% less absenteeism over 2 years. Consistent with its impact on depression severity and emotional role functioning, intervention effects were more observable in consistently employed subjects where the intervention improved productivity by 8.2% over 2 years at an estimated annual value of US 1982 dollars per depressed full-time equivalent and reduced absenteeism by 28.4% or 12.3 days over 2 years at an estimated annual value of US 619 dollars per depressed full-time equivalent. This trial, which is the first to our knowledge to demonstrate that improving the quality of care for any chronic disease has positive consequences for productivity and absenteeism, encourages formal cost-benefit research to assess the potential return-on-investment employers of stable workforces can realize from using their purchasing power to encourage better depression treatment for their employees.

  1. A randomized controlled trial of an HIV/AIDS Symptom Management Manual for depressive symptoms.

    Science.gov (United States)

    Eller, Lucille S; Kirksey, Kenn M; Nicholas, Patrice K; Corless, Inge B; Holzemer, William L; Wantland, Dean J; Willard, Suzanne S; Robinson, Linda; Hamilton, Mary Jane; Sefcik, Elizabeth F; Moezzi, Shahnaz; Mendez, Marta Rivero; Rosa, Maria; Human, Sarie

    2013-01-01

    Abstract Depressive symptoms are highly prevalent, underdiagnosed, and undertreated in people living with HIV/AIDS (PLWH), and are associated with poorer health outcomes. This randomized controlled trial examined the effects of the HIV/AIDS Symptom Management Manual self-care symptom management strategies compared with a nutrition manual on depressive symptoms in an international sample of PLWH. The sample consisted of a sub-group (N=222) of participants in a larger study symptom management study who reported depressive symptoms. Depressive symptoms of the intervention (n=124) and control (n=98) groups were compared over three months: baseline, one-month, and two-months. Use and effectiveness of specific strategies were examined. Depressive symptom frequency at baseline varied significantly by country (χ (2) 12.9; p=0.04). Within the intervention group there were significant differences across time in depressive symptom frequency [F(2, 207) = 3.27, p=0.05], intensity [F(2, 91) = 4.6, p=0.01], and impact [F(2, 252) = 2.92, p= 0.05), and these were significantly lower at one month but not at two months, suggesting that self-care strategies are effective in reducing depressive symptoms, however effects may be short term. Most used and most effective self-care strategies were distraction techniques and prayer. This study suggests that people living with HIV can be taught and will employ self-care strategies for management of depressive symptoms and that these strategies are effective in reducing these symptoms. Self-care strategies are noninvasive, have no side-effects, and can be readily taught as an adjunct to other forms of treatment. Studies are needed to identify the most effective self-care strategies and quantify optimum dose and frequency of use as a basis for evidence-based practice.

  2. Protocol for the ENCODE trial: evaluating a novel online depression intervention for persons with epilepsy.

    Science.gov (United States)

    Meyer, Björn; Weiss, Mario; Holtkamp, Martin; Arnold, Stephan; Brückner, Katja; Schröder, Johanna; Scheibe, Franziska; Nestoriuc, Yvonne

    2017-02-07

    Depression is common among persons with epilepsy (PwE), affecting roughly one in three individuals, and its presence is associated with personal suffering, impaired quality of life, and worse prognosis. Despite the availability of effective treatments, depression is often overlooked and treated inadequately in PwE, in part because of assumed concerns over drug interactions or proconvulsant effects of antidepressants. Internet-administered psychological interventions might complement antidepressant medication or psychotherapy, and preliminary evidence suggests that they can be effective. However, no trial has yet examined whether an Internet intervention designed to meet the needs of PwE can achieve sustained reductions in depression and related symptoms, such as anxiety, when offered as adjunct to treatment as usual. This randomized controlled trial will include 200 participants with epilepsy and a current depressive disorder, along with currently at least moderately elevated depression (Patient Health Questionnaire (PHQ-9) sum score of at least 10). Patients will be recruited via epilepsy treatment centers and other sources, including Internet forums, newspaper articles, flyers, posters, and media articles or advertisements, in German-speaking countries. Main inclusion criteria are: self-reported diagnosis of epilepsy and a depressive disorder, as assessed with a phone-administered structured diagnostic interview, none or stable antidepressant medication, no current psychotherapy, no other major psychiatric disorder, no acute suicidality. Participants will be randomly assigned to either (1) a care-as-usual/waitlist (CAU/WL) control group, in which they receive CAU and are given access to the Internet intervention after 3 months (that is, a CAU/WL control group), or (2) a treatment group that may also use CAU and in addition immediately receives six-month access to the novel, Internet-administered intervention. The primary outcome measure is the PHQ-9, collected

  3. Initial Field Trial of a Coach-Supported Web-Based Depression Treatment.

    Science.gov (United States)

    Schueller, Stephen M; Mohr, David C

    2015-08-01

    Early web-based depression treatments were often self-guided and included few interactive elements, instead focusing mostly on delivering informational content online. Newer programs include many more types of features. As such, trials should analyze the ways in which people use these sites in order to inform the design of subsequent sites and models of support. The current study describes of a field trial consisting of 9 patients with major depressive disorder who completed a 12-week program including weekly coach calls. Patients usage varied widely, however, patients who formed regular patterns tended to persist with the program for the longest. Future sites might be able to facilitate user engagement by designing features to support regular use and to use coaches to help establish patterns to increase long-term use and benefit.

  4. Telephone Cognitive-Behavioral Therapy for Subthreshold Depression and Presenteeism in Workplace: A Randomized Controlled Trial

    Science.gov (United States)

    Furukawa, Toshi A.; Horikoshi, Masaru; Kawakami, Norito; Kadota, Masayo; Sasaki, Megumi; Sekiya, Yuki; Hosogoshi, Hiroki; Kashimura, Masami; Asano, Kenichi; Terashima, Hitomi; Iwasa, Kazunori; Nagasaku, Minoru; Grothaus, Louis C.

    2012-01-01

    Background Subthreshold depression is highly prevalent in the general population and causes great loss to society especially in the form of reduced productivity while at work (presenteeism). We developed a highly-structured manualized eight-session cognitive-behavioral program with a focus on subthreshold depression in the workplace and to be administered via telephone by trained psychotherapists (tCBT). Methods We conducted a parallel-group, non-blinded randomized controlled trial of tCBT in addition to the pre-existing Employee Assistance Program (EAP) versus EAP alone among workers with subthreshold depression at a large manufacturing company in Japan. The primary outcomes were depression severity as measured with Beck Depression Inventory-II (BDI-II) and presenteeism as measured with World Health Organization Health and Work Productivity Questionnaire (HPQ). In the course of the trial the follow-up period was shortened in order to increase acceptability of the study. Results The planned sample size was 108 per arm but the trial was stopped early due to low accrual. Altogether 118 subjects were randomized to tCBT+EAP (n = 58) and to EAP alone (n = 60). The BDI-II scores fell from the mean of 17.3 at baseline to 11.0 in the intervention group and to 15.7 in the control group after 4 months (p<0.001, Effect size = 0.69, 95%CI: 0.32 to 1.05). However, there was no statistically significant decrease in absolute and relative presenteeism (p = 0.44, ES = 0.15, −0.21 to 0.52, and p = 0.50, ES = 0.02, −0.34 to 0.39, respectively). Conclusion Remote CBT, including tCBT, may provide easy access to quality-assured effective psychotherapy for people in the work force who present with subthreshold depression. Further studies are needed to evaluate the effectiveness of this approach in longer terms. The study was funded by Sekisui Chemicals Co. Ltd. Trial Registration ClinicalTrials.gov NCT00885014 PMID:22532849

  5. Community pharmacist intervention in depressed primary care patients (PRODEFAR study: randomized controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Travé Pere

    2009-08-01

    Full Text Available Abstract Background Treatment of depression, the most prevalent and costly mental disorder, needs to be improved. Non-concordance with clinical guidelines and non-adherence can limit the efficacy of pharmacological treatment of depression. Through pharmaceutical care, pharmacists can improve patients' compliance and wellbeing. The aim of this study is to evaluate the effectiveness and cost-effectiveness of a community pharmacist intervention developed to improve adherence and outcomes of primary care patients with depression. Methods/design A randomized controlled trial, with 6-month follow-up, comparing patients receiving a pharmaceutical care support programme in primary care with patients receiving usual care. The total sample comprises 194 patients (aged between 18 and 75 diagnosed with depressive disorder in a primary care health centre in the province of Barcelona (Spain. Subjects will be asked for written informed consent in order to participate in the study. Diagnosis will be confirmed using the SCID-I. The intervention consists of an educational programme focused on improving knowledge about medication, making patients aware of the importance of compliance, reducing stigma, reassuring patients about side-effects and stressing the importance of carrying out general practitioners' advice. Measurements will take place at baseline, and after 3 and 6 months. Main outcome measure is compliance with antidepressants. Secondary outcomes include; clinical severity of depression (PHQ-9, anxiety (STAI-S, health-related quality of life (EuroQol-5D, satisfaction with the treatment received, side-effects, chronic physical conditions and socio-demographics. The use of healthcare and social care services will be assessed with an adapted version of the Client Service Receipt Inventory (CSRI. Discussion This trial will provide valuable information for health professionals and policy makers on the effectiveness and cost-effectiveness of a pharmaceutical

  6. Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance.

    Science.gov (United States)

    Titov, Nickolai; Andrews, Gavin; Davies, Matthew; McIntyre, Karen; Robinson, Emma; Solley, Karen

    2010-06-08

    Internet-based cognitive behavioural therapy (iCBT) for depression is effective when guided by a clinician, less so if unguided. Would guidance from a technician be as effective as guidance from a clinician? Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au) research program, and 141 participants with major depressive disorder were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for depression comprising 6 online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 8 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Beck Depression Inventory (BDI-II) and the Patient Health QUESTIONnaire-9 Item (PHQ-9). Completion rates were high, and at post-treatment, both treatment groups reduced scores on the BDI-II (ptechnician-assisted groups respectively, and on the PHQ-9, were 1.54 and 1.60 respectively. At 4-month follow-up participants in the technician group had made further improvements and had significantly lower scores on the PHQ-9 than those in the clinician group. A total of approximately 60 minutes of clinician or technician time was required per participant during the 8-week treatment program. Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment control group did not improve. These results provide support for large scale trials to determine the clinical effectiveness and acceptability of technician-assisted iCBT programs for depression. This form of treatment has potential to increase the capacity of existing mental health services. Australian New

  7. The effect of exercise in clinically depressed adults: systematic review and meta-analysis of randomized controlled trials

    DEFF Research Database (Denmark)

    Krogh, Jesper; Nordentoft, Merete; Sterne, Jonathan A C

    2011-01-01

    SH) and text word terms depression, depressive disorder and exercise, aerobic, non-aerobic, physical activity, physical fitness, walk*, jog*, run*, bicycling, swim*, strength, and resistance. STUDY SELECTION: Randomized trials including adults with clinical depression according to any diagnostic system were......OBJECTIVE: To assess the effectiveness of exercise in adults with clinical depression. DATA SOURCES: The databases CINAHL, Embase, Cochrane Database of Systematic reviews, Cochrane Controlled Trials Register, MEDLINE, and PsycINFO were searched (1806-2008) using medical subject headings (Me...... with depression (P = .002). No other characteristics were related to between-study heterogeneity. Pooled analysis of 5 trials with long-term follow-up (ie, that examined outcomes beyond the end of the intervention) suggested no long-term benefit (SMD, -0.01; 95% CI, -0.28 to 0.26), with no strong evidence...

  8. Cross-trial prediction of treatment outcome in depression: a machine learning approach.

    Science.gov (United States)

    Chekroud, Adam Mourad; Zotti, Ryan Joseph; Shehzad, Zarrar; Gueorguieva, Ralitza; Johnson, Marcia K; Trivedi, Madhukar H; Cannon, Tyrone D; Krystal, John Harrison; Corlett, Philip Robert

    2016-03-01

    Antidepressant treatment efficacy is low, but might be improved by matching patients to interventions. At present, clinicians have no empirically validated mechanisms to assess whether a patient with depression will respond to a specific antidepressant. We aimed to develop an algorithm to assess whether patients will achieve symptomatic remission from a 12-week course of citalopram. We used patient-reported data from patients with depression (n=4041, with 1949 completers) from level 1 of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D; ClinicalTrials.gov, number NCT00021528) to identify variables that were most predictive of treatment outcome, and used these variables to train a machine-learning model to predict clinical remission. We externally validated the model in the escitalopram treatment group (n=151) of an independent clinical trial (Combining Medications to Enhance Depression Outcomes [COMED]; ClinicalTrials.gov, number NCT00590863). We identified 25 variables that were most predictive of treatment outcome from 164 patient-reportable variables, and used these to train the model. The model was internally cross-validated, and predicted outcomes in the STAR*D cohort with accuracy significantly above chance (64·6% [SD 3·2]; p<0·0001). The model was externally validated in the escitalopram treatment group (N=151) of COMED (accuracy 59·6%, p=0.043). The model also performed significantly above chance in a combined escitalopram-buproprion treatment group in COMED (n=134; accuracy 59·7%, p=0·023), but not in a combined venlafaxine-mirtazapine group (n=140; accuracy 51·4%, p=0·53), suggesting specificity of the model to underlying mechanisms. Building statistical models by mining existing clinical trial data can enable prospective identification of patients who are likely to respond to a specific antidepressant. Yale University. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. Smartphone-Supported versus Full Behavioural Activation for Depression: A Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Kien Hoa Ly

    Full Text Available There is need for more cost and time effective treatments for depression. This is the first randomised controlled trial in which a blended treatment--including four face-to-face sessions and a smartphone application--was compared against a full behavioural treatment. Hence, the aim of the current paper was to examine whether a blended smartphone treatment was non-inferior to a full behavioural activation treatment for depression.This was a randomised controlled non-inferiority trial (NCT01819025 comparing a blended treatment (n=46 against a full ten-session treatment (n=47 for people suffering from major depression. Primary outcome measure was the BDI-II, that was administered at pre- and post-treatment, as well as six months after the treatment.Results showed significant improvements in both groups across time on the primary outcome measure (within-group Cohen's d=1.35; CI [-0.82, 3.52] to d=1.47; CI [-0.41, 3.35]; between group d=-0.13 CI [-2.37, 2.09] and d=-0.10 CI [-2.53, 2.33]. At the same time, the blended treatment reduced the therapist time with an average of 47%.We could not establish whether the blended treatment was non-inferior to a full BA treatment. Nevertheless, this study points to that the blended treatment approach could possibly treat nearly twice as many patients suffering from depression by using a smartphone application as add-on. More studies are needed before we can suggest that the blended treatment method is a promising cost-effective alternative to regular face-to-face treatment for depression.Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support NCT01819025.

  10. A Multicenter, Randomized, Controlled Trial of Electroacupuncture for Perimenopause Women with Mild-Moderate Depression

    Directory of Open Access Journals (Sweden)

    Sheng Li

    2018-01-01

    Full Text Available Objective. Up to 62% of perimenopausal women have depression symptoms. However, there is no efficacy treatment. The aim of this study is to compare the clinical efficacy and safety of EA therapy and escitalopram on perimenopause women with mild-moderate depressive symptom. Method. A multicenter, randomized, positive-controlled clinical trial was conducted at 6 hospitals in China. 242 perimenopause women with mild-moderate depressive symptom were recruited and randomly assigned to receive 36 sessions of EA treatment or escitalopram treatment. The primary outcome measure was the 17-item Hamilton Depression Rating Scale (HAMD-17. The secondary outcome measures include menopause-specific quality of life (MENQOL and serum sexual hormones which include estrogen, follicle-stimulating hormone, and luteinizing hormone. Results. 221 (91.3% completed the study, including 116 in the EA group and 105 in the escitalopram group. The baseline levels of demographic and outcome measurements were similar in the two groups. In the intervention period, there was no difference between two groups. However, in the follow-up, both HAMD-17 and MENQOL were significantly decreased, and at week 24 the mean differences were −2.23 and −8.97, respectively. There were no significant differences in the change of serum sexual hormones between the two groups. No serious adverse events occurred. Conclusion. EA treatment is effective and safe in relieving depression symptom and improving the quality of life in the perimenopausal depression. Further research is needed to understand long-term efficacy and explore the mechanism of this intervention. This study is registered with ClinicalTrials.gov NCT02423694.

  11. Cognitive behavioral therapy for depressed adolescents exposed to interpersonal trauma: an initial effectiveness trial.

    Science.gov (United States)

    Shirk, Stephen R; Deprince, Anne P; Crisostomo, Patrice S; Labus, Jennifer

    2014-03-01

    Four clinical trials have shown that a history of interpersonal trauma is associated with diminished response to cognitive-behavioral therapy (CBT) for adolescent depression. An efficacious CBT protocol for adolescent depression was modified to address cognitive deficits and distortions associated with interpersonal trauma. Initial feasibility, acceptability, and treatment impact of the modified treatment (m-CBT) were evaluated in a randomized effectiveness trial conducted in community clinics. Clients were 43 referred adolescents with a depressive disorder and a history of interpersonal trauma. Adolescents either received m-CBT or usual care (UC) therapy. Results indicated that m-CBT was delivered with good fidelity by community clinicians, but that number of sessions completed was attenuated in both m-CBT and UC. Adolescents reported high levels of treatment satisfaction and acceptability for the new treatment. There were significant reductions in depressive symptoms over time, but no differences in outcomes between groups. Although the new treatment produced promising results, it did not outperform UC. Implications for treatment development are considered. (c) 2014 APA, all rights reserved.

  12. Treatments for acute bipolar depression: meta-analyses of placebo-controlled, monotherapy trials of anticonvulsants, lithium and antipsychotics

    NARCIS (Netherlands)

    Selle, V.; Schalkwijk, S.J.; Vazquez, G.H.; Baldessarini, R.J.

    2014-01-01

    BACKGROUND: Optimal treatments for bipolar depression, and the relative value of specific drugs for that purpose, remain uncertain, including agents other than antidepressants. METHODS: We searched for reports of placebo-controlled, monotherapy trials of mood-stabilizing anticonvulsants,

  13. The effect of exercise in clinically depressed adults: systematic review and meta-analysis of randomized controlled trials

    DEFF Research Database (Denmark)

    Krogh, Jesper; Nordentoft, Merete; Sterne, Jonathan A C

    2011-01-01

    these, the estimated beneficial effect of exercise was more modest (SMD, -0.19; 95% CI, -0.70 to 0.31) than the pooled result for all 13 studies, with no strong evidence of benefit. CONCLUSIONS: Our results suggest a short-term effect of exercise on depression: on average, depression scores 0......OBJECTIVE: To assess the effectiveness of exercise in adults with clinical depression. DATA SOURCES: The databases CINAHL, Embase, Cochrane Database of Systematic reviews, Cochrane Controlled Trials Register, MEDLINE, and PsycINFO were searched (1806-2008) using medical subject headings (Me......SH) and text word terms depression, depressive disorder and exercise, aerobic, non-aerobic, physical activity, physical fitness, walk*, jog*, run*, bicycling, swim*, strength, and resistance. STUDY SELECTION: Randomized trials including adults with clinical depression according to any diagnostic system were...

  14. Depression

    Science.gov (United States)

    ... reasons why a woman may have depression: Family history . Women with a family history of depression may be more at risk. But depression can also happen in women who don’t have a family history of depression. Brain changes. The brains of people ...

  15. A randomized controlled trial of behavioral weight loss treatment versus combined weight loss/depression treatment among women with comorbid obesity and depression.

    Science.gov (United States)

    Linde, Jennifer A; Simon, Gregory E; Ludman, Evette J; Ichikawa, Laura E; Operskalski, Belinda H; Arterburn, David; Rohde, Paul; Finch, Emily A; Jeffery, Robert W

    2011-02-01

    Obesity is associated with clinical depression among women. However, depressed women are often excluded from weight loss trials. This study examined treatment outcomes among women with comorbid obesity and depression. Two hundred three (203) women were randomized to behavioral weight loss (n = 102) or behavioral weight loss combined with cognitive-behavioral depression management (n = 101). Average participant age was 52 years; mean baseline body mass index was 39 kg/m(2). Mean Patient Health Questionnaire and Hopkins Symptom Checklist (SCL-20) scores indicated moderate to severe baseline depression. Weight loss and SCL-20 changes did not differ between groups at 6 or 12 months in intent-to-treat analyses (p = 0.26 and 0.55 for weight, p = 0.70 and 0.25 for depressive symptoms). Depressed obese women lost weight and demonstrated improved mood in both treatment programs. Future weight loss trials are encouraged to enroll depressed women.

  16. Probiotic supplementation can positively affect anxiety and depressive symptoms: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Pirbaglou, Meysam; Katz, Joel; de Souza, Russell J; Stearns, Jennifer C; Motamed, Mehras; Ritvo, Paul

    2016-09-01

    Gastrointestinal microbiota, consisting of microbial communities in the gastrointestinal tract, play an important role in digestive, metabolic, and immune functioning. Preclinical studies on rodents have linked behavioral and neurochemical changes in the central nervous system with deficits or alterations in these bacterial communities. Moreover, probiotic supplementation in rodents has been shown to markedly change behavior, with correlated changes in central neurochemistry. While such studies have documented behavioral and mood-related supplementation effects, the significance of these effects in humans, especially in relation to anxiety and depression symptoms, are relatively unknown. Thus, the purpose of this paper was to systematically evaluate current literature on the impact of probiotic supplementation on anxiety and depression symptoms in humans. To this end, multiple databases, including Medline, PsycINFO, PubMed, Scopus, and Web of Science were searched for randomized controlled trials published between January 1990 and January 2016. Search results led to a total of 10 randomized controlled trials (4 in clinically diagnosed and 6 in non-clinical samples) that provided limited support for the use of some probiotics in reducing human anxiety and depression. Despite methodological limitations of the included trials and the complex nature of gut-brain interactions, results suggest the detection of apparent psychological benefits from probiotic supplementation. Nevertheless a better understanding of developmental, modulatory, and metagenomic influences on the GI microbiota, specifically as they relate to mood and mental health, represent strong priorities for future research in this area. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment in the prevention of depressive relapse/recurrence: the PREVENT trial

    Directory of Open Access Journals (Sweden)

    Hayes Rachel

    2010-10-01

    Full Text Available Abstract Background Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society. Medication and psychological therapies are effective for treating depression and maintenance anti-depressants (m-ADM can prevent relapse. However, individuals with depression often express a wish for psychological help that can help them recover from depression in the long-term. We need to develop psychological therapies that prevent depressive relapse/recurrence. A recently developed treatment, Mindfulness-based Cognitive Therapy (MBCT, see http://www.mbct.co.uk shows potential as a brief group programme for people with recurring depression. In two studies it has been shown to halve the rates of depression recurring compared to usual care. This trial asks the policy research question, is MBCT superior to m-ADM in terms of: a primary outcome of preventing depressive relapse/recurrence over 24 months; and, secondary outcomes of (a depression free days, (b residual depressive symptoms, (c antidepressant (ADM usage, (d psychiatric and medical co-morbidity, (e quality of life, and (f cost effectiveness? An explanatory research question asks is an increase in mindfulness skills the key mechanism of change? Methods/Design The design is a single blind, parallel RCT examining MBCT vs. m-ADM with an embedded process study. To answer the main policy research question the proposed trial compares MBCT plus ADM-tapering with m-ADM for patients with recurrent depression. Four hundred and twenty patients with recurrent major depressive disorder in full or partial remission will be recruited through primary care. Depressive relapse/recurrence over two years is the primary outcome variable. The explanatory question will be addressed in two mutually informative ways: quantitative measurement of potential mediating variables pre/post-treatment and a qualitative study of service users' views and experiences

  18. Brief Cognitive-Behavioral Depression Prevention Program for High-Risk Adolescents Outperforms Two Alternative Interventions: A Randomized Efficacy Trial

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2008-01-01

    In this depression prevention trial, 341 high-risk adolescents (mean age = 15.6 years, SD = 1.2) with elevated depressive symptoms were randomized to a brief group cognitive-behavioral (CB) intervention, group supportive-expressive intervention, bibliotherapy, or assessment-only control condition. CB participants showed significantly greater…

  19. Adjunctive low-dose docosahexaenoic acid (DHA) for major depression: An open-label pilot trial.

    Science.gov (United States)

    Smith, Deidre J; Sarris, Jerome; Dowling, Nathan; O'Connor, Manjula; Ng, Chee H

    2018-04-01

    Whilst the majority of evidence supports the adjunctive use of eicosapentaenoic acid (EPA) in improving mood, to date no study exists using low-dose docosahexaenoic acid (DHA) alone as an adjunctive treatment in patients with mild to moderate major depressive disorder (MDD). A naturalistic 8-week open-label pilot trial of low-dose DHA, (260 mg or 520 mg/day) in 28 patients with MDD who were non-responsive to medication or psychotherapy, with a Hamilton Depression Rating Scale (HAM-D) score of greater than 17, was conducted. Primary outcomes of depression, clinical severity, and daytime sleepiness were measured. After 8 weeks, 54% of patients had a ≥50% reduction on the HAM-D, and 45% were in remission (HAM-D ≤ 7). The eta-squared statistic (0.59) indicated a large effect size for the reduction of depression (equivalent to Cohen's d of 2.4). However confidence in this effect size is tempered due to the lack of a placebo. The mean score for the Clinical Global Impression Severity Scale was significantly improved by 1.28 points (P depression.

  20. Telephone cognitive-behavioral therapy for subthreshold depression and presenteeism in workplace: a randomized controlled trial.

    Science.gov (United States)

    Furukawa, Toshi A; Horikoshi, Masaru; Kawakami, Norito; Kadota, Masayo; Sasaki, Megumi; Sekiya, Yuki; Hosogoshi, Hiroki; Kashimura, Masami; Asano, Kenichi; Terashima, Hitomi; Iwasa, Kazunori; Nagasaku, Minoru; Grothaus, Louis C

    2012-01-01

    Subthreshold depression is highly prevalent in the general population and causes great loss to society especially in the form of reduced productivity while at work (presenteeism). We developed a highly-structured manualized eight-session cognitive-behavioral program with a focus on subthreshold depression in the workplace and to be administered via telephone by trained psychotherapists (tCBT). We conducted a parallel-group, non-blinded randomized controlled trial of tCBT in addition to the pre-existing Employee Assistance Program (EAP) versus EAP alone among workers with subthreshold depression at a large manufacturing company in Japan. The primary outcomes were depression severity as measured with Beck Depression Inventory-II (BDI-II) and presenteeism as measured with World Health Organization Health and Work Productivity Questionnaire (HPQ). In the course of the trial the follow-up period was shortened in order to increase acceptability of the study. The planned sample size was 108 per arm but the trial was stopped early due to low accrual. Altogether 118 subjects were randomized to tCBT+EAP (n = 58) and to EAP alone (n = 60). The BDI-II scores fell from the mean of 17.3 at baseline to 11.0 in the intervention group and to 15.7 in the control group after 4 months (p<0.001, Effect size = 0.69, 95%CI: 0.32 to 1.05). However, there was no statistically significant decrease in absolute and relative presenteeism (p = 0.44, ES = 0.15, -0.21 to 0.52, and p = 0.50, ES = 0.02, -0.34 to 0.39, respectively). Remote CBT, including tCBT, may provide easy access to quality-assured effective psychotherapy for people in the work force who present with subthreshold depression. Further studies are needed to evaluate the effectiveness of this approach in longer terms. The study was funded by Sekisui Chemicals Co. Ltd. ClinicalTrials.gov NCT00885014.

  1. Telephone cognitive-behavioral therapy for subthreshold depression and presenteeism in workplace: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Toshi A Furukawa

    Full Text Available Subthreshold depression is highly prevalent in the general population and causes great loss to society especially in the form of reduced productivity while at work (presenteeism. We developed a highly-structured manualized eight-session cognitive-behavioral program with a focus on subthreshold depression in the workplace and to be administered via telephone by trained psychotherapists (tCBT.We conducted a parallel-group, non-blinded randomized controlled trial of tCBT in addition to the pre-existing Employee Assistance Program (EAP versus EAP alone among workers with subthreshold depression at a large manufacturing company in Japan. The primary outcomes were depression severity as measured with Beck Depression Inventory-II (BDI-II and presenteeism as measured with World Health Organization Health and Work Productivity Questionnaire (HPQ. In the course of the trial the follow-up period was shortened in order to increase acceptability of the study.The planned sample size was 108 per arm but the trial was stopped early due to low accrual. Altogether 118 subjects were randomized to tCBT+EAP (n = 58 and to EAP alone (n = 60. The BDI-II scores fell from the mean of 17.3 at baseline to 11.0 in the intervention group and to 15.7 in the control group after 4 months (p<0.001, Effect size = 0.69, 95%CI: 0.32 to 1.05. However, there was no statistically significant decrease in absolute and relative presenteeism (p = 0.44, ES = 0.15, -0.21 to 0.52, and p = 0.50, ES = 0.02, -0.34 to 0.39, respectively.Remote CBT, including tCBT, may provide easy access to quality-assured effective psychotherapy for people in the work force who present with subthreshold depression. Further studies are needed to evaluate the effectiveness of this approach in longer terms. The study was funded by Sekisui Chemicals Co. Ltd.ClinicalTrials.gov NCT00885014.

  2. Activation and Self-Efficacy in a Randomized Trial of a Depression Self-Care Intervention.

    Science.gov (United States)

    McCusker, Jane; Lambert, Sylvie D; Cole, Martin G; Ciampi, Antonio; Strumpf, Erin; Freeman, Ellen E; Belzile, Eric

    2016-12-01

    In a sample of primary care participants with chronic physical conditions and comorbid depressive symptoms: to describe the cross-sectional and longitudinal associations of activation and self-efficacy with demographic, physical and mental health status, health behaviors, depression self-care, health care utilization, and use of self-care tools; and to examine the effects of a depression self-care coaching intervention on these two outcomes. Design/Study Setting. A secondary analysis of activation and self-efficacy data collected as part of a randomized trial to compare the effects of a telephone-based coached depression self-care intervention with a noncoached intervention. Activation (Patient Activation Measure) was measured at baseline and 6 months. Depression self-care self-efficacy was assessed at baseline, at 3 months, and at 6 months. In multivariable cross-sectional analyses (n = 215), activation and/or self-efficacy were associated with language, birthplace, better physical and mental health, individual exercise, specialist visits, and antidepressant nonuse. In longitudinal analyses (n = 158), an increase in activation was associated with increased medication adherence; an increase in self-efficacy was associated with use of cognitive self-care strategies and increases in social and solitary activities. There were significant improvements from baseline to 6 months in activation and self-efficacy scores both among coached and noncoached groups. The self-care coaching intervention did not affect 6-month activation or self-efficacy but was associated with quicker improvement in self-efficacy. Overall, the results for activation and self-efficacy were similar, although self-efficacy correlated more consistently than activation with depression-specific behaviors and was responsive to a depression self-care coaching intervention. © 2016 Society for Public Health Education.

  3. Benefits of Individualized Feedback in Internet-Based Interventions for Depression: A Randomized Controlled Trial.

    Science.gov (United States)

    Zagorscak, Pavle; Heinrich, Manuel; Sommer, Daniel; Wagner, Birgit; Knaevelsrud, Christine

    2018-01-01

    Even though there is an increasing number of studies on the efficacy of Internet-based interventions (IBI) for depression, experimental trials on the benefits of added guidance by clinicians are scarce and inconsistent. This study compared the efficacy of semistandardized feedback provided by psychologists with fully standardized feedback in IBI. Participants with mild-to-moderate depression (n = 1,089, 66% female) from the client pool of a health insurance company participated in a cognitive-behavioral IBI targeting depression over 6 weeks. Individuals were randomized to weekly semistandardized e-mail feedback from psychologists (individual counseling; IC) or to automated, standardized feedback where a psychologist could be contacted on demand (CoD). The contents and tasks were identical across conditions. The primary outcome was depression; secondary outcomes included anxiety, rumination, and well-being. Outcomes were assessed before and after the intervention and 3, 6, and 12 months later. Changes in outcomes were evaluated using latent change score modeling. Both interventions yielded large pre-post effects on depression (Beck Depression Inventory-II: dIC = 1.53, dCoD = 1.37; Patient Health Questionnaire-9: dIC = 1.20, dCoD = 1.04), as well as significant improvements of all other outcome measures. The effects remained significant after 3, 6, and 12 months. The groups differed with regard to attrition (IC: 17.3%, CoD: 25.8%, p = 0.001). Between-group effects were statistically nonsignificant across outcomes and measurement occasions. Adding semistandardized guidance in IBI for depression did not prove to be more effective than fully standardized feedback on primary and secondary outcomes, but it had positive effects on attrition. © 2018 S. Karger AG, Basel.

  4. Internet-based treatment for adults with depressive symptoms: the protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Cuijpers Pim

    2007-12-01

    Full Text Available Abstract Background Depression is a highly prevalent condition, affecting more than 15% of the adult population at least once in their lives. Guided self-help is effective in the treatment of depression. The purpose of this study is to investigate the effectiveness of two Internet-based guided self-help treatments with adults reporting elevated depressive symptoms. Other research questions concern the identification of potential mediators and the search for subgroups who respond differently to the interventions. Methods This study is a randomized controlled trial with three conditions: two treatment conditions and one waiting list control group. The two treatment conditions are Internet-based cognitive behavior therapy and Internet-based problem-solving therapy. They consist of 8 and 5 weekly lessons respectively. Both interventions are combined with support by e-mail. Participants in the waiting list control group receive the intervention three months later. The study population consists of adults from the general population. They are recruited through advertisements in local and national newspapers and through banners on the Internet. Subjects with symptoms of depression (≥ 16 on the Center for Epidemiological Studies Depression scale are included. Other inclusion criteria are having sufficient knowledge of the Dutch language, access to the Internet and an e-mail address. Primary outcome is depressive symptoms. Secondary outcomes are anxiety, quality of life, dysfunctional cognitions, worrying, problem solving skills, mastery, absence at work and use of healthcare. We will examine the following variables as potential mediators: dysfunctional cognitions, problem solving skills, worrying, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics and symptom severity. Data are collected at baseline and at 5 weeks, 8 weeks, 12 weeks and 9 months after baseline. Analyses will be conducted on the intention

  5. Impact of depressive symptoms, self-esteem and neuroticism on trajectories of overgeneral autobiographical memory over repeated trials.

    Science.gov (United States)

    Kashdan, Todd B; Roberts, John E; Carlos, Erica L

    2006-04-01

    The present study examined trajectories of change in the frequency of overgeneral autobiographical memory (OGM) over the course of repeated trials, and tested whether particular dimensions of depressive symptomatology (somatic and cognitive-affective distress), self-esteem, and neuroticism account for individual differences in these trajectories. Given that depression is associated with impairments in effortful processing, we predicted that over repeated trials depression would be associated with increasingly OGM. Generalised Linear Mixed Models with Penalised Quasi-Likelihood demonstrated significant linear and quadratic trends in OGM over repeated trials, and somatic distress and self-esteem moderated these slopes. The form of these interactions suggested that somatic distress and low self-esteem primarily contribute to OGM during the second half of the trial sequence. The present findings demonstrate the value of a novel analytical approach to OGM that estimates individual trajectories of change over repeated trials.

  6. The DiaS trial: dialectical behavior therapy versus collaborative assessment and management of suicidality on self-harm in patients with a recent suicide attempt and borderline personality disorder traits - study protocol for a randomized controlled trial.

    Science.gov (United States)

    Andreasson, Kate; Krogh, Jesper; Rosenbaum, Bent; Gluud, Christian; Jobes, David A; Nordentoft, Merete

    2014-05-29

    In Denmark 8,000 to 10,000 people will attempt suicide each year. The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior, and a recent survey has shown that 30% of the patients are suffering from borderline personality disorder. The majority of patients (70% to 75%) with borderline personality disorder have a history of deliberate self-harm and 10% have a lifetime risk to die by suicide. The DiaS trial is comparing dialectical behavior therapy with collaborative assessment and management of suicidality-informed supportive psychotherapy, for the risk of repetition of deliberate self-harm in patients with a recent suicide attempt and personality traits within the spectrum of borderline personality disorder. Both treatments have previously shown effects in this group of patients on suicide ideation and self-harm compared with treatment as usual. The trial is designed as a single-center, two-armed, parallel-group observer-blinded randomized clinical superiority trial. We will recruit 160 participants with a recent suicide attempt and at least two traits of the borderline personality disorder from the Centre of Excellence in Suicide Prevention, Capital Region of Denmark. Randomization will be performed though a centralized and computer-generated approach that conceals the randomization sequence. The interventions that are offered are a modified version of a dialectical behavior therapy program lasting 16 weeks versus collaborative assessment and management of suicidality-informed supportive psychotherapy, where the duration treatment will vary in accordance with established methods up to 16 weeks. The primary outcome measure is the ratio of deliberate self-harming acts including suicide attempts measured at week 28. Other exploratory outcomes are included such as severity of symptoms, suicide intention and ideation, depression, hopelessness, self-esteem, impulsivity, anger, and duration of respective

  7. European Collaboration on Low-dose Aspirin in Polycythemia Vera (ECLAP): a randomized trial.

    Science.gov (United States)

    Landolfi, R; Marchioli, R

    1997-01-01

    Thrombotic complications characterize the clinical course of polycythemia vera (PV) and represent the main cause of morbidity and mortality. However, uncertainty still exists as to the benefit/risk ratio of aspirin prophylaxis in this setting. In vivo platelet biosynthesis of thromboxane A2 is enhanced and can be suppressed by low-dose aspirin in PV, thus providing a rationale for assessing the efficacy and safety of a low-dose aspirin regimen in these patients. The Gruppo Italiano Studio Policitemia Vera has recently performed a pilot study on 112 patients randomized to receive aspirin, 40 mg daily, or placebo and followed for 16 +/- 6 months (mean +/- SD). This study showed that low-dose aspirin is well tolerated in PV patients, and that a large-scale efficacy trial is feasible in this setting. In this article we report the protocol of the European Collaboration on Low-dose Aspirin in Polycythemia Vera (ECLAP) study, which is a randomized trial designed to assess the risk/benefit ratio of low-dose aspirin in PV. To estimate the size and the follow-up duration required for the ECLAP trial, a retrospective analysis of the clinical epidemiology of a large PV population has recently been completed by the Gruppo Italiano Studio Policitemia Vera. On this basis, approximately 3500 patients will be enrolled in the ECLAP study with a follow-up of 3 to 4 years. The uncertainty principle will be used as the main eligibility criterion: Polycythemic patients of any age, having no clear indication for or contraindication to aspirin treatment, will be randomized in a double-blind fashion to receive oral aspirin (100 mg daily) or placebo. According to current therapeutic recommendations, the basic treatment of randomized patients should be aimed at maintaining the hematocrit value 50. Randomization will be stratified by participating center. The study is funded by the European Union BIOMED 2 program.

  8. Depression

    DEFF Research Database (Denmark)

    Kessing, Lars Veddel; Bukh, Jens Drachmann

    2014-01-01

    The prevalence of depression is not clearly established, but estimated to 3-4% in a Danish questionnaire study. Lifetime's prevalences of 12-17% are reported in other community samples. In the current diagnostic system depression is defined categorically and operationally. It has been argued......, that these diagnostic criteria represent an oversimplification, which has blurred the concept of depression. We suggest a greater emphasis on the depressed mood as the core symptom of depression, which may increase the specificity of the diagnosis. Furthermore, basic principles for the treatment of depression...

  9. Effects of cognitive therapy versus interpersonal psychotherapy in patients with major depressive disorder: a systematic review of randomized clinical trials with meta-analyses and trial sequential analyses.

    Science.gov (United States)

    Jakobsen, J C; Hansen, J L; Simonsen, S; Simonsen, E; Gluud, C

    2012-07-01

    Major depressive disorder afflicts an estimated 17% of individuals during their lifetime at tremendous suffering and cost. Cognitive therapy and interpersonal psychotherapy are treatment options, but their effects have only been limitedly compared in systematic reviews. Using Cochrane systematic review methodology we compared the benefits and harm of cognitive therapy versus interpersonal psychotherapy for major depressive disorder. Trials were identified by searching the Cochrane Library's CENTRAL, Medline via PubMed, EMBASE, Psychlit, PsycInfo, and Science Citation Index Expanded until February 2010. Continuous outcome measures were assessed by mean difference and dichotomous outcomes by odds ratio. We conducted trial sequential analysis to control for random errors. We included seven trials randomizing 741 participants. All trials had high risk of bias. Meta-analysis of the four trials reporting data at cessation of treatment on the Hamilton Rating Scale for Depression showed no significant difference between the two interventions [mean difference -1.02, 95% confidence interval (CI) -2.35 to 0.32]. Meta-analysis of the five trials reporting data at cessation of treatment on the Beck Depression Inventory showed comparable results (mean difference -1.29, 95% CI -2.73 to 0.14). Trial sequential analysis indicated that more data are needed to definitively settle the question of a differential effect. None of the included trial reported on adverse events. Randomized trials with low risk of bias and low risk of random errors are needed, although the effects of cognitive therapy and interpersonal psychotherapy do not seem to differ significantly regarding depressive symptoms. Future trials should report on adverse events.

  10. Depressants

    Science.gov (United States)

    ... For Teens / Depressants Print en español Depresores del sistema nervioso What They Are: Tranquilizers and other depressants ... of Use Notice of Nondiscrimination Visit the Nemours Web site. Note: All information on TeensHealth® is for ...

  11. Venlafaxine versus nortriptyline in the treatment of elderly depressed inpatients : a randomised, double-blind, controlled trial

    NARCIS (Netherlands)

    Kok, Rob M.; Nolen, Willem A.; Heeren, Thea J.

    2007-01-01

    Background The majority of the trials in the elderly are outpatient trials which excluded psychotic patients and patients with common comorbid physical disorders. Consequently information is lacking about the more complex cases of elderly depressed patients, as found in inpatient wards. Objective To

  12. Effectiveness of adjuvant occupational therapy in employees with depression: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hees Hiske L

    2010-09-01

    Full Text Available Abstract Background Major depressive disorder is among the medical conditions with the highest negative impact on work outcome. However, little is known regarding evidence-based interventions targeting the improvement of work outcomes in depressed employees. In this paper, the design of a randomized controlled trial is presented in order to evaluate the effectiveness of adjuvant occupational therapy in employees with depression. This occupational intervention is based on an earlier intervention, which was designed and proven effective by our research group, and is the only intervention to date that specifically targets work outcome in depressed employees. Methods/Design In a two-arm randomized controlled trial, a total of 117 participants are randomized to either 'care as usual' or ' care as usual' with the addition of occupational therapy. Patients included in the study are employees who are absent from work due to depression for at least 25% of their contract hours, and who have a possibility of returning to their own or a new job. The occupational intervention consists of six individual sessions, eight group sessions and a work-place visit over a 16-week period. By increasing exposure to the working environment, and by stimulating communication between employer and employee, the occupational intervention aims to enhance self-efficacy and the acquisition of more adaptive coping strategies. Assessments take place at baseline, and at 6, 12, and 18-month follow-ups. Primary outcome measure is work participation (hours of absenteeism and time until work resumption. Secondary outcome measures are work functioning, symptomatology, health-related quality of life, and neurocognitive functioning. In addition, cost-effectiveness is evaluated from a societal perspective. Finally, mechanisms of change (intermediate outcomes and potential patient-treatment matching variables are investigated. Discussion This study hopes to provide valuable knowledge

  13. Pragmatic randomised controlled trial of preferred intensity exercise in women living with depression

    Directory of Open Access Journals (Sweden)

    Morres Ioannis

    2011-06-01

    Full Text Available Abstract Background Exercise may be effective in treating depression, but trials testing its effect in depressed women are rare. Aim To compare the effect of exercise of preferred intensity with exercise of prescribed intensity in thirty-eight women living with depression. Methods A Pragmatic RCT of 12 sessions of exercise at preferred intensity compared with 12 sessions at prescribed intensity. Beck Depression Inventory (BDI, Rosenberg Self Esteem Scale (RSES, General Health Questionnaire 12 (GHQ-12, heart rate (HR, Rating of Perceived Exertion Scale (RPE, Quality of Life in Depression Scale (QLDS, Multi-Dimensional Scale of Perceived Social Support (MDSPSS, SF12 Health Survey and exercise participation rates were compared between groups. Results Intervention participants had statistically better BDI (t = 2.638, df = 36, p = 0.006, 95% mean (SD 26.5 (10.7, CI-20.4 to -2.7, d = 0.86, GHQ-12 (t = 3.284, df = 36, p = 0.001, mean (SD 8.3 (3.7 95% CI -6.5 to -1.5, d = 1.08, RSES (t = 2.045, df = 36, p = 0.024, mean (SD 11.3 (5.8, 95% CI 0.3 -6.4, d = 0.25, QLDS (t = 1.902, df = 36, p = 0.0325, mean (SD 15.5 (7.9, 95% CI -12.2 -0.4, d = 0.27 RPE scores (t = 1.755, df = 36, p = 0.0475, mean (SD 9.2 (3.2, 95% CI -.5 - 5.2, d = 0.77 and attended more exercise sessions (t = 1.781, df = 36, p = 0.0415, number of sessions 8 (65%, 95% CI-0.3 -4.8, d = 0.58. SF-12, MSPSS and HR did not differ significantly between groups. Conclusions Exercise of preferred intensity improves psychological, physiological and social outcomes, and exercise participation rates in women living with depression. Trial Registration ClinicalTrials.gov: NCT00546221

  14. Vitamin C as an adjuvant for treating major depressive disorder and suicidal behavior, a randomized placebo-controlled clinical trial.

    Science.gov (United States)

    Sahraian, Ali; Ghanizadeh, Ahmad; Kazemeini, Fereshteh

    2015-03-14

    There are some animal studies suggesting the possible role of vitamin C for treating depression. However, the efficacy of vitamin C for treating adult patients with major depressive disorder (MDD) has never been examined. This 8-week randomized double-blind placebo-controlled clinical trial included adult patients with major depressive disorder according to DSM-IV diagnostic criteria. Twenty-one patients in the treatment group received citalopram plus vitamin C and the 22 patients in the control group received citalopram plus placebo. The Hamilton Depression Rating Scale was used to measure depressive symptoms at baseline, week 2, week 4, and week 8. We also checked for the presence of adverse effects. While depression symptoms decreased in both groups during this trial, there was no statistically significant difference between the 2 groups (P = .5). The rate of remission, partial response, and complete response was not different between the two groups. The rate of adverse effects were not different between the two groups. Adding vitamin C to citalopram did not increase the efficacy of citalopram in MDD patients. Vitamin C plus citalopram is as effective as placebo plus citalopram for treating adult patients with suicidal behavior. No serious adverse effect for this combination was identified during this trial. This trial was registered at http://www.irct.ir . The registration number of this trial was: IRCT201312263930N31 . Date registered: 5 July 2014.

  15. INDIVIDUALIZED YOGA FOR REDUCING DEPRESSION AND ANXIETY, AND IMPROVING WELL-BEING: A RANDOMIZED CONTROLLED TRIAL.

    Science.gov (United States)

    de Manincor, Michael; Bensoussan, Alan; Smith, Caroline A; Barr, Kylie; Schweickle, Monica; Donoghoe, Lee-Lee; Bourchier, Suzannah; Fahey, Paul

    2016-09-01

    Depression and anxiety are leading causes of disability worldwide. Current treatments are primarily pharmaceutical and psychological. Questions remain about effectiveness and suitability for different people. Previous research suggests potential benefits of yoga for reducing depression and anxiety. The aim of this study is to investigate the effects of an individualized yoga intervention. A sample of 101 people with symptoms of depression and/or anxiety participated in a randomized controlled trial comparing a 6-week yoga intervention with waitlist control. Yoga was additional to usual treatment. The control group was offered the yoga following the waitlist period. Measures included Depression Anxiety Stress Scale (DASS-21), Kessler Psychological Distress Scale (K10), Short-Form Health Survey (SF12), Scale of Positive and Negative Experience (SPANE), Flourishing Scale (FS), and Connor-Davidson Resilience Scale (CD-RISC2). There were statistically significant differences between yoga and control groups on reduction of depression scores (-4.30; 95% CI: -7.70, -0.01; P = .01; ES -.44). Differences in reduced anxiety scores were not statistically significant (-1.91; 95% CI: -4.58, 0.76; P = .16). Statistically significant differences in favor of yoga were also found on total DASS (P = .03), K10, SF12 mental health, SPANE, FS, and resilience scores (P stress and SF12 physical health scores were not statistically significant. Benefits were maintained at 6-week follow-up. Yoga plus regular care was effective in reducing symptoms of depression compared with regular care alone. Further investigation is warranted regarding potential benefits in anxiety. Individualized yoga may be particularly beneficial in mental health care in the broader community. © 2016 Wiley Periodicals, Inc.

  16. Role of magnesium supplementation in the treatment of depression: A randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Emily K Tarleton

    Full Text Available Current treatment options for depression are limited by efficacy, cost, availability, side effects, and acceptability to patients. Several studies have looked at the association between magnesium and depression, yet its role in symptom management is unclear. The objective of this trial was to test whether supplementation with over-the-counter magnesium chloride improves symptoms of depression. An open-label, blocked, randomized, cross-over trial was carried out in outpatient primary care clinics on 126 adults (mean age 52; 38% male diagnosed with and currently experiencing mild-to-moderate symptoms with Patient Health Questionnaire-9 (PHQ-9 scores of 5-19. The intervention was 6 weeks of active treatment (248 mg of elemental magnesium per day compared to 6 weeks of control (no treatment. Assessments of depression symptoms were completed at bi-weekly phone calls. The primary outcome was the net difference in the change in depression symptoms from baseline to the end of each treatment period. Secondary outcomes included changes in anxiety symptoms as well as adherence to the supplement regimen, appearance of adverse effects, and intention to use magnesium supplements in the future. Between June 2015 and May 2016, 112 participants provided analyzable data. Consumption of magnesium chloride for 6 weeks resulted in a clinically significant net improvement in PHQ-9 scores of -6.0 points (CI -7.9, -4.2; P<0.001 and net improvement in Generalized Anxiety Disorders-7 scores of -4.5 points (CI -6.6, -2.4; P<0.001. Average adherence was 83% by pill count. The supplements were well tolerated and 61% of participants reported they would use magnesium in the future. Similar effects were observed regardless of age, gender, baseline severity of depression, baseline magnesium level, or use of antidepressant treatments. Effects were observed within two weeks. Magnesium is effective for mild-to-moderate depression in adults. It works quickly and is well tolerated

  17. Treating major depression with yoga: A prospective, randomized, controlled pilot trial.

    Directory of Open Access Journals (Sweden)

    Sudha Prathikanti

    Full Text Available Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression.Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI. At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22-72, and mean BDI score 22.4 (SD = 4.5. Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES and Rosenberg Self-Esteem Scale (RSES at baseline and at 8 weeks.In intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034. In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018. Effect size of yoga in reducing BDI scores was large, per Cohen's d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for either the GSES or

  18. A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT: study protocol and design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kruger Peter

    2011-03-01

    Full Text Available Abstract Background Swine origin influenza A/H1N1 infection (H1N1 emerged in early 2009 and rapidly spread to humans. For most infected individuals, symptoms were mild and self-limited; however, a small number developed a more severe clinical syndrome characterized by profound respiratory failure with hospital mortality ranging from 10 to 30%. While supportive care and neuraminidase inhibitors are the main treatment for influenza, data from observational and interventional studies suggest that the course of influenza can be favorably influenced by agents not classically considered as influenza treatments. Multiple observational studies have suggested that HMGCoA reductase inhibitors (statins can exert a class effect in attenuating inflammation. The Collaborative H1N1 Adjuvant Treatment (CHAT Pilot Trial sought to investigate the feasibility of conducting a trial during a global pandemic in critically ill patients with H1N1 with the goal of informing the design of a larger trial powered to determine impact of statins on important outcomes. Methods/Design A multi-national, pilot randomized controlled trial (RCT of once daily enteral rosuvastatin versus matched placebo administered for 14 days for the treatment of critically ill patients with suspected, probable or confirmed H1N1 infection. We propose to randomize 80 critically ill adults with a moderate to high index of suspicion for H1N1 infection who require mechanical ventilation and have received antiviral therapy for ≤ 72 hours. Site investigators, research coordinators and clinical pharmacists will be blinded to treatment assignment. Only research pharmacy staff will be aware of treatment assignment. We propose several approaches to informed consent including a priori consent from the substitute decision maker (SDM, waived and deferred consent. The primary outcome of the CHAT trial is the proportion of eligible patients enrolled in the study. Secondary outcomes will evaluate adherence to

  19. Problem-solving versus cognitive restructuring of medically ill seniors with depression (PROMISE-D trial: study protocol and design

    Directory of Open Access Journals (Sweden)

    Sharpe Louise

    2012-11-01

    Full Text Available Abstract Background With an ageing population in most Western countries, people are living longer but often with one or more chronic physical health problems. Older people in physically poor health are at greater risk of developing clinical depression. Cognitive Behavioural Therapy (CBT and Problem Solving Therapy (PST have both been found to be efficacious in treating late-life depression, however patients with “multi-morbidity” (i.e. more than one chronic condition are often excluded from these trials. The aim of this study is to compare the efficacy of CBT and PST in treating older adults who have one or more chronic physical health conditions and a diagnosable depressive disorder. This study will be the first to explicitly target the treatment of depression in older people in primary care settings presenting with a range of health problems using behavioural interventions. Methods/design The PROMISE-D study is a randomised controlled trial of two evidence-based treatments for late-life major or minor depression for patients who also have at least one co-morbid chronic health problem. Participants will be randomised to two active interventions (PST or CBT or enhanced treatment-as-usual (E-TAU. Primary outcomes will be depression diagnostic status and severity of depression (according to the Hamilton Depression Rating Scale and the Geriatric Depression Scale. Secondary outcomes will be anxiety severity, quality of life and health care utilisation. Assessments will be conducted by a researcher who remains blind to the patient’s treatment allocation and will be conducted pre and post-treatment and at six and 12 months follow-up. Health care utilisation will be assessed throughout a two year period following entry to the trial. Executive function, rumination and emotion regulation will also be measured to determine the impact of these factors on treatment response in two treatment groups. Discussion Multi-morbidity, the experience of two or

  20. Effect of exercise on depression in university students: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Yan, Shi; Jin, YinZhe; Oh, YongSeok; Choi, YoungJun

    2016-06-01

    The aim of this study was to assess the effect of exercise on depression in university students. A systematic literature search was conducted in PubMed, EMBASE and the Cochrane library from their inception through December 10, 2014 to identify relevant articles. The heterogeneity across studies was examined by Cochran's Q statistic and the I2 statistic. Standardized mean difference (SMD) and 95% confidence interval (CI) were pooled to evaluate the effect of exercise on depression. Then, sensitivity and subgroup analyses were performed. In addition, publication bias was assessed by drawing a funnel plot. A total of 352 participants (154 cases and 182 controls) from eight included trials were included. Our pooled result showed a significant alleviative depression after exercise (SMD=-0.50, 95% CI: -0.97 to -0.03, P=0.04) with significant heterogeneity (P=0.003, I2=67%). Sensitivity analyses showed that the pooled result may be unstable. Subgroup analysis indicated that sample size may be a source of heterogeneity. Moreover, no publication bias was observed in this study. Exercise may be an effective therapy for treating depression in university students. However, further clinical studies with strict design and large samples focused on this specific population should be warranted in the future.

  1. [Wuling Capsule for climacteric patients with depression and anxiety state: a randomized, positive parallel controlled trial].

    Science.gov (United States)

    Wang, Xing-juan; Li, Ji; Zou, Qin-di; Jin, Ling

    2009-11-01

    The incidence of menopausal anxiety and depression is increasing. It can induce and aggravate a variety of somatic symptoms. Despite of the good effects of psychotropic drugs on the disease, patients' compliance is poor. Therefore, it is necessary to find a drug which is practical, effective, and easy for patients to take. To evaluate the efficacy of Wuling Capsule (WC), a Chinese herbal medicine, in treatment of female climacteric syndrome with depression and anxiety state. A total of 96 outpatients of female climacteric syndrome from Department of Gynecology of Integrated Traditional Chinese and Western Medicine, Huashan Hospital, Fudan University, Department of Gynecology of Traditional Chinese Medicine, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, and Department of Traditional Chinese Medicine, Obstetrics and Gynecology Hospital, Fudan University were included. The study was designed as a randomized, positive drug parallel controlled trial. The patients were divided into WC group (64 cases) and control group (32 cases) and were orally administered Wuling Capsule and Gengnianan Tablet, respectively. The efficacy was evaluated with Kupperman menopausal index (KMI), Self-rating Depression Scale (SDS), and Self-rating Anxiety Scale (SAS) before treatment, and after 3-week and 6-week treatment. The total response rate was 89.66% (52/58) in the WC group, which was superior to that in the control group [76.67% (23/30)]. Ridit test showed that there was a significant difference between the two groups (Pstate. Wuling Capsule is more effective to alleviate depression and anxiety as compared with Gengnianan Tablet.

  2. Depression

    DEFF Research Database (Denmark)

    Cizza, G; Ravn, Pernille; Chrousos, G P

    2001-01-01

    Existing studies of the relationship between depression and osteoporosis have been heterogeneous in their design and use of diagnostic instruments for depression, which might have contributed to the different results on the comorbidity of these two conditions. Nevertheless, these studies reveal...... a strong association between depression and osteoporosis. Endocrine factors such as depression-induced hypersecretion of corticotropin-releasing hormone and hypercortisolism, hypogonadism, growth hormone deficiency and increased concentration of circulating interleukin 6, might play a crucial role...... in the bone loss observed in subjects suffering from major depression....

  3. Teens Engaged in Collaborative Health: The Feasibility and Acceptability of an Online Skill-Building Intervention for Adolescents at Risk for Depression.

    Science.gov (United States)

    Lattie, Emily G; Ho, Joyce; Sargent, Elizabeth; Tomasino, Kathryn N; Smith, J D; Brown, C Hendricks; Mohr, David C

    2017-06-01

    There is an ongoing need for effective and accessible preventive interventions for adolescent depression and substance abuse. This paper reports on a field trial of an online indicated preventive intervention, ProjectTECH, which is based on cognitive-behavioral therapy (CBT) techniques. The study aims to gather information about the feasibility and acceptability of this program. Secondary aims of this study were to examine the impact of the program on depression symptoms, perceived stress, positive affect, and substance use and to compare differences between groups that were led by a peer versus those that were led by a licensed clinician. High school students (n = 39) were recruited primarily through social media advertisements, and assigned to four groups of 8-12 individuals to collaboratively participate in an 8 week peer network-based online preventive intervention which were led by a trained peer guide or a licensed clinician. Participants were provided with didactic lessons, CBT-based mood management tools, and peer networking features, and completed quantitative and qualitative feedback at baseline, midpoint, end of intervention, and 1 month follow up. The program attracted and retained users primarily from social media and was used frequently by many of the participants (system login M = 25.62, SD = 16.58). Participants rated the program as usable, and offered several suggestions for improving the program, including allowing for further personalization by the individual user, and including more prompts to engage with the social network. From baseline to end of intervention, significant decreases were observed in depressive symptoms and perceived stress ( p 's power to detect group differences, no consistent differences were observed between participants in a peer-led group and those in a clinician-led group. Results of this study indicates that ProjectTECH, an indicated preventive intervention for high school-aged adolescents, demonstrates both feasibility

  4. Implementation of treat-to-target in rheumatoid arthritis through a Learning Collaborative: Rationale and design of the TRACTION trial.

    Science.gov (United States)

    Solomon, Daniel H; Lee, Sara B; Zak, Agnes; Corrigan, Cassandra; Agosti, Jenifer; Bitton, Asaf; Harrold, Leslie; Losina, Elena; Lu, Bing; Pincus, Ted; Radner, Helga; Smolen, Josef; Katz, Jeffrey N; Fraenkel, Liana

    2016-08-01

    Treat-to-target (TTT) is a recommended strategy in the management of rheumatoid arthritis (RA), but various data sources suggest that its uptake in routine care in the US is suboptimal. Herein, we describe the design of a randomized controlled trial of a Learning Collaborative to facilitate implementation of TTT. We recruited 11 rheumatology sites from across the US and randomized them into the following two groups: one received the Learning Collaborative intervention in Phase 1 (month 1-9) and the second formed a wait-list control group to receive the intervention in Phase 2 (months 10-18). The Learning Collaborative intervention was designed using the Model for Improvement, consisting of a Change Package with corresponding principles and action phases. Phase 1 intervention practices had nine learning sessions, collaborated using a web-based tool, and shared results of plan-do-study-act cycles and monthly improvement metrics collected at each practice. The wait-list control group sites had no intervention during Phase 1. The primary trial outcome is the implementation of TTT as measured by chart review, comparing the differences from baseline to end of Phase 1, between intervention and control sites. All intervention sites remained engaged in the Learning Collaborative throughout Phase 1, with a total of 38 providers participating. The primary trial outcome measures are currently being collected by the study team through medical record review. If the Learning Collaborative is an effective means for improving implementation of TTT, this strategy could serve as a way of implementing disseminating TTT more widely. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Effect of a Collaborative Care Intervention vs Usual Care on Health Status of Patients With Chronic Heart Failure: The CASA Randomized Clinical Trial.

    Science.gov (United States)

    Bekelman, David B; Allen, Larry A; McBryde, Connor F; Hattler, Brack; Fairclough, Diane L; Havranek, Edward P; Turvey, Carolyn; Meek, Paula M

    2018-04-01

    Many patients with chronic heart failure experience reduced health status despite receiving conventional therapy. To determine whether a symptom and psychosocial collaborative care intervention improves heart failure-specific health status, depression, and symptom burden in patients with heart failure. A single-blind, 2-arm, multisite randomized clinical trial was conducted at Veterans Affairs, academic, and safety-net health systems in Colorado among outpatients with symptomatic heart failure and reduced health status recruited between August 2012 and April 2015. Data from all participants were included regardless of level of participation, using an intent-to-treat approach. Patients were randomized 1:1 to receive the Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) intervention or usual care. The CASA intervention included collaborative symptom care provided by a nurse and psychosocial care provided by a social worker, both of whom worked with the patients' primary care clinicians and were supervised by a study primary care clinician, cardiologist, and palliative care physician. The primary outcome was patient-reported heart failure-specific health status, measured by difference in change scores on the Kansas City Cardiomyopathy Questionnaire (range, 0-100) at 6 months. Secondary outcomes included depression (measured by the 9-item Patient Health Questionnaire), anxiety (measured by the 7-item Generalized Anxiety Disorder Questionnaire), overall symptom distress (measured by the General Symptom Distress Scale), specific symptoms (pain, fatigue, and shortness of breath), number of hospitalizations, and mortality. Of 314 patients randomized (157 to intervention arm and 157 to control arm), there were 67 women and 247 men, mean (SD) age was 65.5 (11.4) years, and 178 (56.7%) had reduced ejection fraction. At 6 months, the mean Kansas City Cardiomyopathy Questionnaire score improved 5.5 points in the intervention arm and 2.9 points in the control

  6. Internet-based cognitive behavior therapy for major depressive disorder: A randomized controlled trial.

    Science.gov (United States)

    Rosso, Isabelle M; Killgore, William D S; Olson, Elizabeth A; Webb, Christian A; Fukunaga, Rena; Auerbach, Randy P; Gogel, Hannah; Buchholz, Jennifer L; Rauch, Scott L

    2017-03-01

    Prior research has shown that the Sadness Program, a technician-assisted Internet-based cognitive behavioral therapy (iCBT) intervention developed in Australia, is effective for treating major depressive disorder (MDD). The current study aimed to expand this work by adapting the protocol for an American population and testing the Sadness Program with an attention control group. In this parallel-group, randomized controlled trial, adult MDD participants (18-45 years) were randomized to a 10-week period of iCBT (n = 37) or monitored attention control (MAC; n = 40). Participants in the iCBT group completed six online therapy lessons, which included access to content summaries and homework assignments. During the 10-week trial, iCBT and MAC participants logged into the web-based system six times to complete self-report symptom scales, and a nonclinician technician contacted participants weekly to provide encouragement and support. The primary outcome was the Hamilton Rating Scale for Depression (HRSD), and the secondary outcomes were the Patient Health Questionnaire-9 and Kessler-10. Intent-to-treat analyses revealed significantly greater reductions in depressive symptoms in iCBT compared with MAC participants, using both the self-report measures and the clinician-rated HRSD (d = -0.80). Importantly, iCBT participants also showed significantly higher rates of clinical response and remission. Exploratory analyses did not support illness severity as a moderator of treatment outcome. The Sadness Program led to significant reductions in depression and distress symptoms. With its potential to be delivered in a scalable, cost-efficient manner, iCBT is a promising strategy to enhance access to effective care. © 2016 Wiley Periodicals, Inc.

  7. Low Vision Depression Prevention Trial in Age-Related Macular Degeneration

    Science.gov (United States)

    Rovner, Barry W.; Casten, Robin J.; Hegel, Mark T.; Massof, Robert W.; Leiby, Benjamin E.; Ho, Allen C.; Tasman, William S.

    2014-01-01

    Purpose To compare the efficacy of behavior activation (BA) + low vision rehabilitation (LVR) with supportive therapy (ST) + LVR to prevent depressive disorders in patients with age-related macular degeneration (AMD). Design Single-masked, attention-controlled, randomized, clinical trial with outcome assessment at 4 months. Participants Patients with AMD and subsyndromal depressive symptoms attending retina practices (n = 188). Interventions Before randomization, all subjects had 2 outpatient LVR visits, and were then randomized to in-home BA+LVR or ST+LVR. Behavior activation is a structured behavioral treatment that aims to increase adaptive behaviors and achieve valued goals. Supportive therapy is a nondirective, psychological treatment that provides emotional support and controls for attention. Main Outcome Measures The Diagnostic and Statistical Manual IV defined depressive disorder based on the Patient Health Questionnaire-9 (primary outcome), Activities Inventory, National Eye Institute Vision Function Questionnaire–25 plus Supplement (NEI-VFQ), and NEI-VFQ quality of life (secondary outcomes). Results At 4 months, 11 BA+LVR subjects (12.6%) and 18 ST+LVR subjects (23.4%) developed a depressive disorder (relative risk [RR], 0.54; 95% CI, 0.27–1.06; P = 0.067). In planned adjusted analyses the RR was 0.51 (95% CI, 0.27–0.98; P = 0.04). A mediational analysis suggested that BA+LVR prevented depression to the extent that it enabled subjects to remain socially engaged. In addition, BA+LVR was associated with greater improvements in functional vision than ST+LVR, although there was no significant between-group difference. There was no significant change or between-group difference in quality of life. Conclusions An integrated mental health and low vision intervention halved the incidence of depressive disorders relative to standard outpatient LVR in patients with AMD. As the population ages, the number of persons with AMD and the adverse effects of comorbid

  8. A web-based clinical trial management system for a sham-controlled multicenter clinical trial in depression.

    Science.gov (United States)

    Durkalski, Valerie; Wenle Zhao; Dillon, Catherine; Kim, Jaemyung

    2010-04-01

    Clinical trial investigators and sponsors invest vast amounts of resources and energy into conducting trials and often face daily challenges with data management, project management, and data quality control. Rather than waiting months for study progress reports, investigators need the ability to use real-time data for the coordination and management of study activities across all study team members including site investigators, oversight committees, data and safety monitoring boards, and medical safety monitors. Web-based data management systems are beginning to meet this need but what distinguishes one system from the other are user needs/requirements and cost. To illustrate the development and implementation of a web-based data and project management system for a multicenter clinical trial designed to test the superiority of repeated transcranial magnetic stimulation versus sham for the treatment of patients with major depression. The authors discuss the reasons for not using a commercially available system for this study and describe the approach to developing their own web-based system for the OPT-TMS study. Timelines, effort, system architecture, and lessons learned are shared with the hope that this information will direct clinical trial researchers and software developers towards more efficient, user-friendly systems. The developers use a combination of generic and custom application code to allow for the flexibility to adapt the system to the needs of the study. Features of the system include: central participant registration and randomization; secure data entry at the site; participant progress/study calendar; safety data reporting; device accounting; monitor verification; and user-configurable generic reports and built-in customized reports. Hard coding was more time-efficient to address project-specific issues compared with the effort of creating a generic code application. As a consequence of this strategy, the required maintenance of the system is

  9. Dextromethorphan/quinidine pharmacotherapy in patients with treatment resistant depression: A proof of concept clinical trial.

    Science.gov (United States)

    Murrough, James W; Wade, Elizabeth; Sayed, Sehrish; Ahle, Gabriella; Kiraly, Drew D; Welch, Alison; Collins, Katherine A; Soleimani, Laili; Iosifescu, Dan V; Charney, Dennis S

    2017-08-15

    At least one-third of patients with major depressive disorder (MDD) have treatment-resistant depression (TRD), defined as lack of response to two or more adequate antidepressant trials. For these patients, novel antidepressant treatments are urgently needed. The current study is a phase IIa open label clinical trial examining the efficacy and tolerability of a combination of dextromethorphan (DM) and the CYP2D6 enzyme inhibitor quinidine (Q) in patients with TRD. Dextromethorphan acts as an antagonist at the glutamate N-methyl-d-aspartate (NMDA) receptor, in addition to other pharmacodynamics properties that include activity at sigma-1 receptors. Twenty patients with unipolar TRD who completed informed consent and met all eligibility criteria we enrolled in an open-label study of DM/Q up to 45/10mg by mouth administered every 12h over the course of a 10-week period, and constitute the intention to treat (ITT) sample. Six patients discontinued prior to study completion. There was no treatment-emergent suicidal ideation, psychotomimetic or dissociative symptoms. Montgomery-Asberg Depression Rating Scale (MADRS) score was reduced from baseline to the 10-week primary outcome (mean change: -13.0±11.5, t 19 =5.0, p<0.001), as was QIDS-SR score (mean change: -5.9±6.6, t 19 =4.0, p<0.001). The response and remission rates in the ITT sample were 45% and 35%, respectively. Open-label, proof-of-concept design. Herein we report acceptable tolerability and preliminary efficacy of DM/Q up to 45/10mg administered every 12h in patients with TRD. Future larger placebo controlled randomized trials in this population are warranted. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression.

    Science.gov (United States)

    Brunoni, Andre R; Moffa, Adriano H; Sampaio-Junior, Bernardo; Borrione, Lucas; Moreno, Marina L; Fernandes, Raquel A; Veronezi, Beatriz P; Nogueira, Barbara S; Aparicio, Luana V M; Razza, Lais B; Chamorro, Renan; Tort, Luara C; Fraguas, Renerio; Lotufo, Paulo A; Gattaz, Wagner F; Fregni, Felipe; Benseñor, Isabela M

    2017-06-29

    We compared transcranial direct-current stimulation (tDCS) with a selective serotonin-reuptake inhibitor for the treatment of depression. In a single-center, double-blind, noninferiority trial involving adults with unipolar depression, we randomly assigned patients to receive tDCS plus oral placebo, sham tDCS plus escitalopram, or sham tDCS plus oral placebo. The tDCS was administered in 30-minute, 2-mA prefrontal stimulation sessions for 15 consecutive weekdays, followed by 7 weekly treatments. Escitalopram was given at a dose of 10 mg per day for 3 weeks and 20 mg per day thereafter. The primary outcome measure was the change in the 17-item Hamilton Depression Rating Scale (HDRS-17) score (range, 0 to 52, with higher scores indicating more depression). Noninferiority of tDCS versus escitalopram was defined by a lower boundary of the confidence interval for the difference in the decreased score that was at least 50% of the difference in the scores with placebo versus escitalopram. A total of 245 patients underwent randomization, with 91 being assigned to escitalopram, 94 to tDCS, and 60 to placebo. In the intention-to-treat analysis, the mean (±SD) decrease in the score from baseline was 11.3±6.5 points in the escitalopram group, 9.0±7.1 points in the tDCS group, and 5.8±7.9 points in the placebo group. The lower boundary of the confidence interval for the difference in the decrease for tDCS versus escitalopram (difference, -2.3 points; 95% confidence interval [CI], -4.3 to -0.4; P=0.69) was lower than the noninferiority margin of -2.75 (50% of placebo minus escitalopram), so noninferiority could not be claimed. Escitalopram and tDCS were both superior to placebo (difference vs. placebo, 5.5 points [95% CI, 3.1 to 7.8; Pescitalopram had more frequent sleepiness and obstipation than did those in the other two groups. In a single-center trial, tDCS for the treatment of depression did not show noninferiority to escitalopram over a 10-week period and was

  11. A randomized controlled trial of 6-week Chlorella vulgaris supplementation in patients with major depressive disorder.

    Science.gov (United States)

    Panahi, Yunes; Badeli, Roghayeh; Karami, Gholam-Reza; Badeli, Zeinab; Sahebkar, Amirhossein

    2015-08-01

    Major depressive disorder (MDD) is a widespread psychiatric disorder with incapacitating symptoms. Oxidative stress has been identified to play a role in the pathophysiology of MDD. To evaluate the therapeutic effectiveness of a chemically defined and antioxidant-rich Chlorella vulgaris extract (CVE) as adjunct to standard treatment in patients suffering from MDD. Subjects with MDD diagnosis according to DSM-IV criteria who were receiving standard antidepressant therapy were assigned to add-on therapy with CVE (1800 mg/day; n=42), or continued standard antidepressant therapy alone (n=50) for a period of 6 weeks. Changes in the frequency of depressive symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS) and Beck Depression Inventory II (BDI-II) scale. There were significant reductions in total and subscale BDI-II and HADS scores in both CVE and control groups by the end of trial. The magnitude of reductions in total BDI-II score [-4.14 (-5.30 to -2.97)] as well as physical [-2.34 (-2.84 to -1.84)] and cognitive [-1.12 (-1.62 to -0.61)] subscales were significantly greater in the CVE versus control group, however, reduction of the affective symptoms was greater in the control compared with the CVE group [0.95 (0.18-0.72)]. Total HADS [-3.71 (-4.44 to -2.98)] as well as individual subscales of depression [-1.46 (-2.02 to -0.90)] and anxiety [-2.25 (-2.74 to -1.76)] were reduced to a greater degree in the CVE group. CVE was well tolerated and no serious adverse event was reported. This pilot exploratory trial provides the first clinical evidence on the efficacy and safety of adjunctive therapy with CVE in improving physical and cognitive symptoms of depression as well as anxiety symptoms in patients who are receiving standard antidepressant therapy. Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. The Collaborative Lithium Trials (CoLT: specific aims, methods, and implementation

    Directory of Open Access Journals (Sweden)

    Hooper Stephen R

    2008-08-01

    Full Text Available Abstract Background Lithium is a benchmark treatment for bipolar illness in adults. However, there has been relatively little methodologically stringent research regarding the use of lithium in youth suffering from bipolarity. Methods Under the auspices of the Best Pharmaceuticals for Children Act (BPCA, a Written Request (WR pertaining to the study of lithium in pediatric mania was issued by the United States Food and Drug Administration (FDA to the National Institute of Child Health and Human Development (NICHD in 2004. Accordingly, the NICHD issued a Request for Proposals (RFP soliciting submissions to pursue this research. Subsequently, the NICHD awarded a contract to a group of investigators in order to conduct these studies. Results The Collaborative Lithium Trials (CoLT investigators, the BPCA-Coordinating Center, and the NICHD developed protocols to provide data that will: (1 establish evidence-based dosing strategies for lithium; (2 characterize the pharmacokinetics and biodisposition of lithium; (3 examine the acute efficacy of lithium in pediatric bipolarity; (4 investigate the long-term effectiveness of lithium treatment; and (5 characterize the short- and long-term safety of lithium. By undertaking two multi-phase trials rather than multiple single-phase studies (as was described in the WR, the feasibility of the research to be undertaken was enhanced while ensuring all the data outlined in the WR would be obtained. The first study consists of: (1 an 8-week open-label, randomized, escalating dose Pharmacokinetic Phase; (2 a 16-week Long-Term Effectiveness Phase; (3 a 28-week double-blind Discontinuation Phase; and (4 an 8-week open-label Restabilization Phase. The second study consists of: (1 an 8-week, double-blind, parallel-group, placebo-controlled Efficacy Phase; (2 an open-label Long-Term Effectiveness lasting either 16 or 24 weeks (depending upon blinded treatment assignment during the Efficacy Phase; (3 a 28-week double

  13. Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial.

    Science.gov (United States)

    Kanes, Stephen; Colquhoun, Helen; Gunduz-Bruce, Handan; Raines, Shane; Arnold, Ryan; Schacterle, Amy; Doherty, James; Epperson, C Neill; Deligiannidis, Kristina M; Riesenberg, Robert; Hoffmann, Ethan; Rubinow, David; Jonas, Jeffrey; Paul, Steven; Meltzer-Brody, Samantha

    2017-07-29

    Post-partum depression is a serious mood disorder in women that might be triggered by peripartum fluctuations in reproductive hormones. This phase 2 study investigated brexanolone (USAN; formerly SAGE-547 injection), an intravenous formulation of allopregnanolone, a positive allosteric modulator of γ-aminobutyric acid (GABA A ) receptors, for the treatment of post-partum depression. For this double-blind, randomised, placebo-controlled trial, we enrolled self-referred or physician-referred female inpatients (≤6 months post partum) with severe post-partum depression (Hamilton Rating Scale for Depression [HAM-D] total score ≥26) in four hospitals in the USA. Eligible women were randomly assigned (1:1), via a computer-generated randomisation program, to receive either a single, continuous intravenous dose of brexanolone or placebo for 60 h. Patients and investigators were masked to treatment assignments. The primary efficacy endpoint was the change from baseline in the 17-item HAM-D total score at 60 h, assessed in all randomised patients who started infusion of study drug or placebo and who had a completed baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Patients were followed up until day 30. This trial is registered with ClinicalTrials.gov, number NCT02614547. This trial was done between Dec 15, 2015 (first enrolment), and May 19, 2016 (final visit of the last enrolled patient). 21 women were randomly assigned to the brexanolone (n=10) and placebo (n=11) groups. At 60 h, mean reduction in HAM-D total score from baseline was 21·0 points (SE 2·9) in the brexanolone group compared with 8·8 points (SE 2·8) in the placebo group (difference -12·2, 95% CI -20·77 to -3·67; p=0·0075; effect size 1·2). No deaths, serious adverse events, or discontinuations because of adverse events were reported in either group. Four of ten patients in the brexanolone group had adverse events compared with eight of 11 in the placebo group. The most

  14. Depression

    DEFF Research Database (Denmark)

    Pouwer, Frans

    2017-01-01

    There is ample evidence that depression is000  a common comorbid health issue in people with type 1 or type 2 diabetes. Reviews have also concluded that depression in diabetes is associated with higher HbA1c levels, less optimal self-care behaviours, lower quality of life, incident vascular...... complications and higher mortality rates. However, longitudinal studies into the course of depression in people with type 1 diabetes remain scarce. In this issue of Diabetologia, Kampling and colleagues (doi: 10.1007/s00125-016-4123-0 ) report the 5 year trajectories of depression in adults with newly diagnosed...... type 1 diabetes (mean age, 28 years). Their baseline results showed that shortly after the diagnosis of type 1 diabetes a major depressive episode was diagnosed in approximately 6% of participants, while 8% suffered from an anxiety disorder. The longitudinal depression data showed that, in a 5 year...

  15. Rumination-focused cognitive behaviour therapy vs. cognitive behaviour therapy for depression: study protocol for a randomised controlled superiority trial.

    Science.gov (United States)

    Hvenegaard, Morten; Watkins, Ed R; Poulsen, Stig; Rosenberg, Nicole K; Gondan, Matthias; Grafton, Ben; Austin, Stephen F; Howard, Henriette; Moeller, Stine B

    2015-08-11

    Cognitive behavioural therapy is an effective treatment for depression. However, one third of the patients do not respond satisfactorily, and relapse rates of around 30 % within the first post-treatment year were reported in a recent meta-analysis. In total, 30-50 % of remitted patients present with residual symptoms by the end of treatment. A common residual symptom is rumination, a process of recurrent negative thinking and dwelling on negative affect. Rumination has been demonstrated as a major factor in vulnerability to depression, predicting the onset, severity, and duration of future depression. Rumination-focused cognitive behavioural therapy is a psychotherapeutic treatment targeting rumination. Because rumination plays a major role in the initiation and maintenance of depression, targeting rumination with rumination-focused cognitive behavioural therapy may be more effective in treating depression and reducing relapse than standard cognitive behavioural therapy. This study is a two-arm pragmatic randomised controlled superiority trial comparing the effectiveness of group-based rumination-focused cognitive behaviour therapy with the effectiveness of group-based cognitive behavioural therapy for treatment of depression. One hundred twenty-eight patients with depression will be recruited from and given treatment in an outpatient service at a psychiatric hospital in Denmark. Our primary outcome will be severity of depressive symptoms (Hamilton Rating Scale for Depression) at completion of treatment. Secondary outcomes will be level of rumination, worry, anxiety, quality of life, behavioural activation, experimental measures of cognitive flexibility, and emotional attentional bias. A 6-month follow-up is planned and will include the primary outcome measure and assessment of relapse. The clinical outcome of this trial may guide clinicians to decide on the merits of including rumination-focused cognitive behavioural therapy in the treatment of depression in

  16. An open trial of mindfulness-based cognitive therapy for the prevention of perinatal depressive relapse/recurrence.

    Science.gov (United States)

    Dimidjian, Sona; Goodman, Sherryl H; Felder, Jennifer N; Gallop, Robert; Brown, Amanda P; Beck, Arne

    2015-02-01

    Pregnant women with histories of depression are at high risk of depressive relapse/recurrence during the perinatal period, and options for relapse/recurrence prevention are limited. Mindfulness-based cognitive therapy (MBCT) has strong evidence among general populations but has not been studied among at-risk pregnant women to prevent depression. We examined the feasibility, acceptability, and clinical outcomes of depression symptom severity and relapse/recurrence associated with MBCT adapted for perinatal women (MBCT-PD). Pregnant women with depression histories were recruited from obstetrics clinics in a large health maintenance organization at two sites and enrolled in MBCT-PD (N = 49). Self-reported depressive symptoms and interview-based assessments of depression relapse/recurrence status were measured at baseline, during MBCT-PD, and through 6-months postpartum. Pregnant women reported interest, engagement, and satisfaction with the program. Retention rates were high, as were rates of completion of daily homework practices. Intent to treat analyses indicated a significant improvement in depression symptom levels and an 18 % rate of relapse/recurrence through 6 months postpartum. MBCT-PD shows promise as an acceptable, feasible, and clinically beneficial brief psychosocial prevention option for pregnant women with histories of depression. Randomized controlled trials are needed to examine the efficacy of MBCT-PD for the prevention of depressive relapse/recurrence during pregnancy and postpartum.

  17. Prediction of depressive disorder following myocardial infarction Data from the Myocardial INfarction and Depression-Intervention Trial (MIND-IT)

    NARCIS (Netherlands)

    van Melle, JP; de Jonge, P; Kuyper, AMG; Honig, A; Schene, AH; Crijns, HJGM; van den Berg, MP; van Veldhuisen, DJ; Ormel, J

    2006-01-01

    Background: Depression following myocardial infarction (MI) is associated with complicated cardiac rehabilitation, non-compliance and poor prognosis. Whether depression following MI can be predicted from variables routinely assessed during hospitalization for MI is unknown. Methods: Using data from

  18. Collaborative research between academia and industry using a large clinical trial database: a case study in Alzheimer's disease

    DEFF Research Database (Denmark)

    Jones, Roy; Wilkinson, David; Lopez, Oscar L

    2011-01-01

    Large clinical trials databases, developed over the course of a comprehensive clinical trial programme, represent an invaluable resource for clinical researchers. Data mining projects sponsored by industry that use these databases, however, are often not viewed favourably in the academic medical...... community because of concerns that commercial, rather than scientific, goals are the primary purpose of such endeavours. Thus, there are few examples of sustained collaboration between leading academic clinical researchers and industry professionals in a large-scale data mining project. We present here...

  19. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Randomized Clinical Trial.

    Science.gov (United States)

    Weersing, V Robin; Brent, David A; Rozenman, Michelle S; Gonzalez, Araceli; Jeffreys, Megan; Dickerson, John F; Lynch, Frances L; Porta, Giovanna; Iyengar, Satish

    2017-06-01

    Anxiety and depression affect 30% of youth but are markedly undertreated compared with other mental disorders, especially in Hispanic populations. To examine whether a pediatrics-based behavioral intervention targeting anxiety and depression improves clinical outcome compared with referral to outpatient community mental health care. This 2-center randomized clinical trial with masked outcome assessment conducted between brief behavioral therapy (BBT) and assisted referral to care (ARC) studied 185 youths (aged 8.0-16.9 years) from 9 pediatric clinics in San Diego, California, and Pittsburgh, Pennsylvania, recruited from October 6, 2010, through December 5, 2014. Youths who met DSM-IV criteria for full or probable diagnoses of separation anxiety disorder, generalized anxiety disorder, social phobia, major depression, dysthymic disorder, and/or minor depression; lived with a consenting legal guardian for at least 6 months; and spoke English were included in the study. Exclusions included receipt of alternate treatment for anxiety or depression, presence of a suicidal plan, bipolar disorder, psychosis, posttraumatic stress disorder, substance dependence, current abuse, intellectual disability, or unstable serious physical illness. The BBT consisted of 8 to 12 weekly 45-minute sessions of behavioral therapy delivered in pediatric clinics by master's-level clinicians. The ARC families received personalized referrals to mental health care and check-in calls to support accessing care from master's-level coordinators. The primary outcome was clinically significant improvement on the Clinical Global Impression-Improvement scale (score ≤2). Secondary outcomes included the Pediatric Anxiety Rating Scale, Children's Depression Rating Scale-Revised, and functioning. A total of 185 patients were enrolled in the study (mean [SD] age, 11.3 [2.6] years; 107 [57.8%] female; 144 [77.8%] white; and 38 [20.7%] Hispanic). Youths in the BBT group (n = 95), compared with those in

  20. Memory Flexibility training (MemFlex) to reduce depressive symptomatology in individuals with major depressive disorder: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Hitchcock, Caitlin; Hammond, Emily; Rees, Catrin; Panesar, Inderpal; Watson, Peter; Werner-Seidler, Aliza; Dalgleish, Tim

    2015-11-03

    Major depressive disorder (MDD) is associated with chronic biases in the allocation of attention and recollection of personal memories. Impaired flexibility in attention and autobiographical memory retrieval is seen to both maintain current symptoms and predict future depression. Development of innovative interventions to reduce maladaptive cognitive patterns and improve cognitive flexibility in the domain of memory may therefore advance current treatment approaches for depression. Memory specificity training and cognitive bias modification techniques have both shown some promise in improving cognitive flexibility. Here we outline plans for a trial of an innovative memory flexibility training programme, MemFlex, which advances current training techniques with the aim of improving flexibility of autobiographical memory retrieval. This trial seeks to estimate the efficacy of MemFlex, provide data on feasibility, and begin to explore mechanisms of change. We plan a single-blind, randomised, controlled, patient-level trial in which 50 individuals with MDD will complete either psychoeducation (n = 25) or MemFlex (n = 25). After completing pre-treatment measures and an orientation session, participants complete eight workbook-based sessions at home. Participants will then be assessed at post-treatment and at 3 month follow-up. The co-primary outcomes are depressive symptoms and diagnostic status at 3 month follow-up. The secondary outcomes are memory flexibility at post-treatment and number of depression free days at 3 month follow-up. Other process outcomes and mediators of any treatment effects will also be explored. This trial will establish the efficacy of MemFlex in improving memory flexibility, and reducing depressive symptoms. Any effects on process measures related to relapse may also indicate whether MemFlex may be helpful in reducing vulnerability to future depressive episodes. The low-intensity and workbook-based format of the programme may improve

  1. The effect of technology-based interventions on pain, depression, and quality of life in patients with cancer: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Agboola, Stephen O; Ju, Woong; Elfiky, Aymen; Kvedar, Joseph C; Jethwani, Kamal

    2015-03-13

    The burden of cancer is increasing; projections over the next 2 decades suggest that the annual cases of cancer will rise from 14 million in 2012 to 22 million. However, cancer patients in the 21st century are living longer due to the availability of novel therapeutic regimens, which has prompted a growing focus on maintaining patients' health-related quality of life. Telehealth is increasingly being used to connect with patients outside of traditional clinical settings, and early work has shown its importance in improving quality of life and other clinical outcomes in cancer care. The aim of this study was to systematically assess the literature for the effect of supportive telehealth interventions on pain, depression, and quality of life in cancer patients via a systematic review of clinical trials. We searched PubMed, EMBASE, Google Scholar, CINAHL, and PsycINFO in July 2013 and updated the literature search again in January 2015 for prospective randomized trials evaluating the effect of telehealth interventions in cancer care with pain, depression, and quality of life as main outcomes. Two of the authors independently reviewed and extracted data from eligible randomized controlled trials, based on pre-determined selection criteria. Methodological quality of studies was assessed by the Cochrane Collaboration risk of bias tool. Of the 4929 articles retrieved from databases and relevant bibliographies, a total of 20 RCTs were included in the final review. The studies were largely heterogeneous in the type and duration of the intervention as well as in outcome assessments. A majority of the studies were telephone-based interventions that remotely connected patients with their health care provider or health coach. The intervention times ranged from 1 week to 12 months. In general, most of the studies had low risk of bias across the domains of the Cochrane Collaboration risk of bias tool, but most of the studies had insufficient information about the allocation

  2. Collaborative translational research leading to multicenter clinical trials in Duchenne muscular dystrophy: the Cooperative International Neuromuscular Research Group (CINRG).

    Science.gov (United States)

    Escolar, Diana M; Henricson, Erik K; Pasquali, Livia; Gorni, Ksenija; Hoffman, Eric P

    2002-10-01

    Progress in the development of rationally based therapies for Duchenne muscular dystrophy has been accelerated by encouraging multidisciplinary, multi-institutional collaboration between basic science and clinical investigators in the Cooperative International Research Group. We combined existing research efforts in pathophysiology by a gene expression profiling laboratory with the efforts of animal facilities capable of conducting high-throughput drug screening and toxicity testing to identify safe and effective drug compounds that target different parts of the pathophysiologic cascade in a genome-wide drug discovery approach. Simultaneously, we developed a clinical trial coordinating center and an international network of collaborating physicians and clinics where those drugs could be tested in large-scale clinical trials. We hope that by bringing together investigators at these facilities and providing the infrastructure to support their research, we can rapidly move new bench discoveries through animal model screening and into therapeutic testing in humans in a safe, timely and cost-effective setting.

  3. Benefits and challenges of using the cohort multiple randomised controlled trial design for testing an intervention for depression.

    Science.gov (United States)

    Viksveen, Petter; Relton, Clare; Nicholl, Jon

    2017-07-06

    Trials which test the effectiveness of interventions compared with the status quo frequently encounter challenges. The cohort multiple randomised controlled trial (cmRCT) design is an innovative approach to the design and conduct of pragmatic trials which seeks to address some of these challenges. In this article, we report our experiences with the first completed randomised controlled trial (RCT) using the cmRCT design. This trial-the Depression in South Yorkshire (DEPSY) trial-involved comparison of treatment as usual (TAU) with TAU plus the offer of an intervention for people with self-reported long-term moderate to severe depression. In the trial, we used an existing large population-based cohort: the Yorkshire Health Study. We discuss our experiences with recruitment, attrition, crossover, data analysis, generalisability of results, and cost. The main challenges in using the cmRCT design were the high crossover to the control group and the lower questionnaire response rate among patients who refused the offer of treatment. However, the design did help facilitate efficient and complete recruitment of the trial population as well as analysable data that were generalisable to the population of interest. Attrition rates were also smaller than those reported in other depression trials. This first completed full trial using the cmRCT design testing an intervention for self-reported depression was associated with a number of important benefits. Further research is required to compare the acceptability and cost effectiveness of standard pragmatic RCT design with the cmRCT design. ISRCTN registry: ISRCTN02484593 . Registered on 7 Jan 2013.

  4. Validation of a PCR-based method for detection of food-borne thermotolerant Campylobacters in a multicenter collaborative trial

    DEFF Research Database (Denmark)

    Josefsen, Mathilde Hartmann; Cook, N.; D'Agostino, M.

    2004-01-01

    A PCR-based method for rapid detection of food-borne thermotolerant campylobacters was evaluated through a collaborative trial with 12 laboratories testing spiked carcass rinse samples. The method showed an interlaboratory diagnostic sensitivity of 96.7% and a diagnostic specificity of 100% for c......% for chicken samples, while these values were 94.2 and 83.3%, respectively, for pig samples....

  5. Depression

    DEFF Research Database (Denmark)

    Johansen, Jon O. J.

    2013-01-01

    Nyhederne er fulde af historier om depression. Overskrifter som: ’Danskerne propper sig med lykkepiller’ eller ‘depression er stadigvæk tabu’ går tit igen i dagspressen. Men hvor er nuancerne, og hvorfor gider vi læse de samme historier igen og igen? Måske er det fordi, vores egne forestillinger er...

  6. Bright light treatment as add-on therapy for depression in 28 adolescents: a randomized trial.

    Science.gov (United States)

    Niederhofer, Helmut; von Klitzing, Kai

    2011-01-01

    In the last decade, a significant incidence of depression in the younger population has been observed. Bright light therapy, an effective therapeutic option for depressed adults, could also provide safe, economical, and effective rapid recovery in adolescents. The randomized trial included 28 inpatients (18 females and 10 males) between 14 and 17 years old with depressive complaints. The study was conducted between February and December of 2010 in Rodewisch, Germany. Half of the patients (n = 14) first received placebo (50 lux) 1 hour a day in the morning from 9:00 am to 10:00 am for 1 week and then received bright light therapy (2,500 lux) for 1 week in the morning from 9:00 am to 10:00 am. The other half (n = 14) first received bright light therapy and then received placebo. Patients were encouraged to continue ongoing treatment (fluoxetine 20 mg/day and 2 sessions of psychotherapy/week) because there were no changes in medication/dosage and psychotherapy since 1 month before the 4-week study period. For assessment of depressive symptoms, the Beck Depression Inventory (BDI) was administered 1 week before and 1 day before placebo treatment, on the day between placebo and bright light treatment, and on the day after and 1 week after bright light treatment. Saliva samples of melatonin and cortisol were collected at 8:00 am and 8:00 pm 1 week before and 1 day before placebo treatment, on the day between placebo and bright light treatment, on the day after bright light treatment, and 1 week after bright light treatment and were assayed for melatonin and cortisol to observe any change in circadian timing. The BDI scores improved significantly (P = .015). The assays of saliva showed significant differences between treatment and placebo for evening melatonin (P = .040). No significant adverse reactions were observed. Antidepressant response to bright light treatment in this age group was statistically superior to placebo. World Health Organization International Clinical

  7. The Effect of Debriefing and Brief Cognitive-Behavioral Therapy on Postpartum Depression in Traumatic Childbirth: A Randomized Clinical Trial

    OpenAIRE

    Sedigheh Abdollahpour; Afsaneh Keramat; Seyyed Abbas Mousavi; Ahmad Khosravi; zahra motaghi

    2018-01-01

    Background & aim: Childbirth is a stressful event in women’s lives, and if a mother perceives it as an unpleasant event, it can influence her postpartum mental health. Depression is a common mental disorder, which can has serious consequences depending on its severity. Therefore, this study aimed to investigate the effect of debriefing and brief cognitive-behavioral therapy on postpartum depression in traumatic childbirth. Methods: This clinical trial was performed on 179 mothers who experien...

  8. An evaluation of the effectiveness of recruitment methods: the staying well after depression randomized controlled trial.

    Science.gov (United States)

    Krusche, Adele; Rudolf von Rohr, Isabelle; Muse, Kate; Duggan, Danielle; Crane, Catherine; Williams, J Mark G

    2014-04-01

    Randomized controlled trials (RCTs) are widely accepted as being the most efficient way of investigating the efficacy of psychological therapies. However, researchers conducting RCTs commonly report difficulties in recruiting an adequate sample within planned timescales. In an effort to overcome recruitment difficulties, researchers often are forced to expand their recruitment criteria or extend the recruitment phase, thus increasing costs and delaying publication of results. Research investigating the effectiveness of recruitment strategies is limited, and trials often fail to report sufficient details about the recruitment sources and resources utilized. We examined the efficacy of strategies implemented during the Staying Well after Depression RCT in Oxford to recruit participants with a history of recurrent depression. We describe eight recruitment methods utilized and two further sources not initiated by the research team and examine their efficacy in terms of (1) the return, including the number of potential participants who contacted the trial and the number who were randomized into the trial; (2) cost-effectiveness, comprising direct financial cost and manpower for initial contacts and randomized participants; and (3) comparison of sociodemographic characteristics of individuals recruited from different sources. Poster advertising, web-based advertising, and mental health worker referrals were the cheapest methods per randomized participant; however, the ratio of randomized participants to initial contacts differed markedly per source. Advertising online, via posters, and on a local radio station were the most cost-effective recruitment methods for soliciting participants who subsequently were randomized into the trial. Advertising across many sources (saturation) was found to be important. It may not be feasible to employ all the recruitment methods used in this trial to obtain participation from other populations, such as those currently unwell, or in

  9. Nitrous Oxide for Treatment-Resistant Major Depression: A Proof-of-Concept Trial.

    Science.gov (United States)

    Nagele, Peter; Duma, Andreas; Kopec, Michael; Gebara, Marie Anne; Parsoei, Alireza; Walker, Marie; Janski, Alvin; Panagopoulos, Vassilis N; Cristancho, Pilar; Miller, J Philip; Zorumski, Charles F; Conway, Charles R

    2015-07-01

    N-methyl-D-aspartate receptor antagonists, such as ketamine, have rapid antidepressant effects in patients with treatment-resistant depression (TRD). We hypothesized that nitrous oxide, an inhalational general anesthetic and N-methyl-D-aspartate receptor antagonist, may also be a rapidly acting treatment for TRD. In this blinded, placebo-controlled crossover trial, 20 patients with TRD were randomly assigned to 1-hour inhalation of 50% nitrous oxide/50% oxygen or 50% nitrogen/50% oxygen (placebo control). The primary endpoint was the change on the 21-item Hamilton Depression Rating Scale (HDRS-21) 24 hours after treatment. Mean duration of nitrous oxide treatment was 55.6 ± 2.5 (SD) min at a median inspiratory concentration of 44% (interquartile range, 37%-45%). In two patients, nitrous oxide treatment was briefly interrupted, and the treatment was discontinued in three patients. Depressive symptoms improved significantly at 2 hours and 24 hours after receiving nitrous oxide compared with placebo (mean HDRS-21 difference at 2 hours, -4.8 points, 95% confidence interval [CI], -1.8 to -7.8 points, p = .002; at 24 hours, -5.5 points, 95% CI, -2.5 to -8.5 points, p nitrous oxide and placebo, p nitrous oxide compared with one patient (5%) and none after placebo (odds ratio for response, 4.0, 95% CI, .45-35.79; OR for remission, 3.0, 95% CI, .31-28.8). No serious adverse events occurred; all adverse events were brief and of mild to moderate severity. This proof-of-concept trial demonstrated that nitrous oxide has rapid and marked antidepressant effects in patients with TRD. Copyright © 2015 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

  10. Acupuncture, Counseling, and Usual care for Depression (ACUDep: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MacPherson Hugh

    2012-11-01

    Full Text Available Abstract Background The evidence on the effect of acupuncture or counseling for depression is not conclusive yet is sufficient to warrant further research. Our aim is to conduct a full-scale RCT to determine the clinical and cost effectiveness of acupuncture and counseling compared to usual care alone. We will explore the experiences and perspectives of patients and practitioners. Methods/Design Randomized controlled trial with three parallel arms: acupuncture plus usual care, counseling plus usual care, and usual care alone, in conjunction with a nested qualitative study using in-depth interviews with purposive samples of trial participants. Participants: Patients aged over 18 years diagnosed with depression or mood disorder by their GP and with a score of 20 or above on the Beck Depression Inventory (BDI-II. Randomization: Computer randomization by York Trials Unit to acupuncture, counseling, and usual care alone in proportions of 2:2:1, respectively, with secure allocation concealment. Interventions: Patients allocated to acupuncture and counseling groups receive the offer of up to 12 weekly sessions. Both interventions allow flexibility to address patient variation, yet are constrained within defined protocols. Acupuncture is based on traditional Chinese medicine and counseling is non-directive within the humanistic tradition. Outcome: The PHQ-9 is the primary outcome measure, collected at baseline, 3, 6, 9, and 12 months. Also measured is BDI-II, SF-36 Bodily pain subscale, and EQ-5D. Texted mood scores are collected weekly over the first 15 weeks. Health-related resource use is collected over 12 months. Analysis: The sample size target was for 640 participants, calculated for an effect size of 0.32 on the PHQ-9 when comparing acupuncture with counseling given 90% power, 5% significance, and 20% loss to follow-up. Analysis of covariance will be used on an intention-to-treat basis. Thematic analysis will be used for qualitative data. We will

  11. Universal Prevention for Anxiety and Depressive Symptoms in Children: A Meta-analysis of Randomized and Cluster-Randomized Trials.

    Science.gov (United States)

    Ahlen, Johan; Lenhard, Fabian; Ghaderi, Ata

    2015-12-01

    Although under-diagnosed, anxiety and depression are among the most prevalent psychiatric disorders in children and adolescents, leading to severe impairment, increased risk of future psychiatric problems, and a high economic burden to society. Universal prevention may be a potent way to address these widespread problems. There are several benefits to universal relative to targeted interventions because there is limited knowledge as to how to screen for anxiety and depression in the general population. Earlier meta-analyses of the prevention of depression and anxiety symptoms among children suffer from methodological inadequacies such as combining universal, selective, and indicated interventions in the same analyses, and comparing cluster-randomized trials with randomized trials without any correction for clustering effects. The present meta-analysis attempted to determine the effectiveness of universal interventions to prevent anxiety and depressive symptoms after correcting for clustering effects. A systematic search of randomized studies in PsychINFO, Cochrane Library, and Google Scholar resulted in 30 eligible studies meeting inclusion criteria, namely peer-reviewed, randomized or cluster-randomized trials of universal interventions for anxiety and depressive symptoms in school-aged children. Sixty-three percent of the studies reported outcome data regarding anxiety and 87 % reported outcome data regarding depression. Seventy percent of the studies used randomization at the cluster level. There were small but significant effects regarding anxiety (.13) and depressive (.11) symptoms as measured at immediate posttest. At follow-up, which ranged from 3 to 48 months, effects were significantly larger than zero regarding depressive (.07) but not anxiety (.11) symptoms. There was no significant moderation effect of the following pre-selected variables: the primary aim of the intervention (anxiety or depression), deliverer of the intervention, gender distribution

  12. The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials.

    Science.gov (United States)

    Bloom, Diane; Beetsch, Joel; Harker, Matthew; Hesterlee, Sharon; Moreira, Paulo; Patrick-Lake, Bray; Selig, Wendy; Sherman, Jeffrey; Smith, Sophia K; Valentine, James E; Roberts, Jamie N

    2018-03-01

    To identify the elements necessary for successful collaboration between patient groups and academic and industry sponsors of clinical trials, in order to develop recommendations for best practices for effective patient group engagement. In-depth interviews, informed by a previously reported survey, were conducted to identify the fundamentals of successful patient group engagement. Thirty-two respondents from 3 sectors participated: patient groups, academic researchers, and industry. The findings were presented to a multistakeholder group of experts in January 2015. The expert group came to consensus on a set of actionable recommendations for best practices for patient groups and research sponsors. Interview respondents acknowledged that not all patient groups are created equal in terms of what they can contribute to a clinical trial. The most important elements for effective patient group engagement include establishing meaningful partnerships, demonstrating mutual benefits, and collaborating as partners from the planning stage forward. Although there is a growing appreciation by sponsors about the benefits of patient group engagement, there remains some resistance and some uncertainty about how best to engage. Barriers include mismatched expectations and a perception that patient groups lack scientific sophistication and that "wishful thinking" may cloud their recommendations. Patient groups are developing diverse skillsets and acquiring assets to leverage in order to become collaborators with industry and academia on clinical trials. Growing numbers of research sponsors across the clinical trials enterprise are recognizing the benefits of continuous and meaningful patient group engagement, but there are still mindsets to change, and stakeholders need further guidance on operationalizing a new model of clinical trial conduct.

  13. A Collaborative Paradigm for Improving Management of Sleep Disorders in Primary Care: A Randomized Clinical Trial.

    Science.gov (United States)

    Edinger, Jack D; Grubber, Janet; Ulmer, Christi; Zervakis, Jennifer; Olsen, Maren

    2016-01-01

    To test a collaborative care model for interfacing sleep specialists with primary care providers to enhance patients' sleep disorders management. This study used a randomized, parallel group, clinical intervention trial design. A total of 137 adult (29 women) VA outpatients with sleep complaints were enrolled and randomly assigned to (1) an intervention (INT) consisting of a one-time consultation with a sleep specialist who provided diagnostic feedback and treatment recommendations to the patient and the patient's primary care provider; or (2) a control condition consisting of their usual primary care (UPC). Provider-focused outcomes included rates of adherence to recommended diagnostic procedures and sleep-focused interventions. Patient-focused outcomes included measures taken from sleep diaries and actigraphy; Pittsburgh Sleep Quality Index (PSQI) scores; and self-report measures of sleepiness, fatigue, mood, quality of life, and satisfaction with health care. The proportions of provider-initiated sleep-focused interventions were significantly higher in the INT group than in the UPC group for polysomnography referrals (49% versus 6%; P sleep efficiency (+3.7%; 95% CI: 0.8, 6.5; P = 0.01) than did UPC participants. A greater proportion of the INT group showed ≥ 1 standard deviation decline on the PSQI from baseline to the 10-mo follow-up (41% versus 21%; P = 0.02). Moreover, 69% of the INT group had normal (≤ 10) Epworth Sleepiness Scale scores at the 10-mo follow-up, whereas only 50% of the UPC group fell below this clinical cutoff (P = 0.03). A one-time sleep consultation significantly increased healthcare providers' attention to sleep problems and resulted in benefits to patients' sleep/wake symptoms. This study is registered with clinicaltrials.gov with identifier # NCT00390572. © 2016 Associated Professional Sleep Societies, LLC.

  14. Assessing the Effectiveness of Case-Based Collaborative Learning via Randomized Controlled Trial.

    Science.gov (United States)

    Krupat, Edward; Richards, Jeremy B; Sullivan, Amy M; Fleenor, Thomas J; Schwartzstein, Richard M

    2016-05-01

    Case-based collaborative learning (CBCL) is a novel small-group approach that borrows from team-based learning principles and incorporates elements of problem-based learning (PBL) and case-based learning. CBCL includes a preclass readiness assurance process and case-based in-class activities in which students respond to focused, open-ended questions individually, discuss their answers in groups of 4, and then reach consensus in larger groups of 16. This study introduces CBCL and assesses its effectiveness in one course at Harvard Medical School. In a 2013 randomized controlled trial, 64 medical and dental student volunteers were assigned randomly to one of four 8-person PBL tutorial groups (control; n = 32) or one of two 16-person CBCL tutorial groups (experimental condition; n = 32) as part of a required first-year physiology course. Outcomes for the PBL and CBCL groups were compared using final exam scores, student responses to a postcourse survey, and behavioral coding of portions of video-recorded class sessions. Overall, the course final exam scores for CBCL and PBL students were not significantly different. However, CBCL students whose mean exam performance in prior courses was below the participant median scored significantly higher than their PBL counterparts on the physiology course final exam. The most common adjectives students used to describe CBCL were "engaging," "fun," and "thought-provoking." Coding of observed behaviors indicated that individual affect was significantly higher in the CBCL groups than in the PBL groups. CBCL is a viable, engaging, active learning method. It may particularly benefit students with lower academic performance.

  15. The Clinical Research Center for Depression Study: Baseline Characteristics of a Korean Long-Term Hospital-Based Observational Collaborative Prospective Cohort Study

    Science.gov (United States)

    Kim, Tae-Suk; Jeong, Seung Hee; Kim, Jung-Bum; Lee, Min-Soo; Kim, Jae-Min; Yim, Hyeon-Woo

    2011-01-01

    Objective The Clinical Research Center for Depression (CRESCEND) study is a 9-year observational collaborative prospective cohort study for the clinical outcomes in participants with depressive disorders in Korea. In this study, we examined the baseline characteristics of the depressive participants as the hospital-based cohort. Methods Participants were assessed using various instruments including the Clinical Global Impression scale, 17-item Hamilton Depression Rating Scale (HDRS-17), Hamilton Anxiety Rating Scale, Brief Psychiatric Rating Scale, Social and Occupational Functioning Assessment Scale, Beck Depression Inventory-Second Edition, Scale for Suicide Ideation, and World Health Organization Quality of Life assessment instruments-abbreviated version. Also, personal histories of medical and psychiatric illnesses and the range of socio-epidemiologic and clinical data were collected from each participant. Results One thousand one hundred eighty three participants were recruited from 18 hospitals. The mean age of the participants was 47.9±15.9 year-old, 74.4% were female, 82.9% had been diagnosed of major depressive disorder, 40.9% were experiencing their first depressive episode, and 21.4% had a past history of suicide attempts. The majority (85.3%) of the participants were moderately to severely ill. The average HDRS-17 was 19.8±6.1. Significant gender differences at baseline were shown in age, education, marriage, employment, religion, and first depressive episode. Conclusion The baseline findings in the CRESCEND study showed some different characteristics of depression in Korea, suggesting a possibility of ethnic and cultural factors in depression. PMID:21519530

  16. Assessment of an enhanced program for depression management in primary care: a cluster randomized controlled trial. The INDI project (Interventions for Depression Improvement

    Directory of Open Access Journals (Sweden)

    Hernández Josep M

    2007-09-01

    Full Text Available Abstract Background Most depressed patients are attended at primary care. However, there are significant shortcomings in the diagnosis, management and outcomes of these patients. The aim of this study is to determine whether the implementation of a structured programme for managing depression will provide better health outcomes than usual management. Methods/Design Design: A cluster-randomized controlled trial involving two groups, one of which is the control group consisting of patients who are treated for depression in the usual way and the other is the intervention group consisting of patients on a structured programme for treating depression. Setting: 20 primary care centres in the province of Tarragona (Spain Sample: 400 patients over 18 years of age who have experienced an episode of major depression (DSM-IV and who need to initiate antidepressant treatment Intervention: A multi-component programme with clinical, educational and organisational procedures that includes training for the health care provider and evidence-based clinical guidelines. It also includes primary care nurses working as care-managers who provide educational and emotional support for the patients and who are responsible for active and systematic clinical monitoring. The programme aims to improve the primary care/specialized level interface. Measurements: The patients will be monitored by telephone interviews. The interviewer will not know which group the patient belongs to (blind trial. These interviews will be given at 0, 3, 6 and 12 months. Main variables: Severity of the depressive symptoms, response rate and remission rate. Analysis: Outcomes will be analyzed on an intent-to-treat basis and the unit of analysis will be the individual patient. This analysis will take into account the effect of study design on potential lack of independence between observations within the same cluster. Discussion The effectiveness of caring for depression in primary care can be

  17. Tavistock Adult Depression Study (TADS: a randomised controlled trial of psychoanalytic psychotherapy for treatment-resistant/treatment-refractory forms of depression

    Directory of Open Access Journals (Sweden)

    Taylor David

    2012-07-01

    Full Text Available Abstract Background Long-term forms of depression represent a significant mental health problem for which there is a lack of effective evidence-based treatment. This study aims to produce findings about the effectiveness of psychoanalytic psychotherapy in patients with treatment-resistant/treatment-refractory depression and to deepen the understanding of this complex form of depression. Methods/Design INDEX GROUP: Patients with treatment resistant/treatment refractory depression. DEFINITION & INCLUSION CRITERIA: Current major depressive disorder, 2 years history of depression, a minimum of two failed treatment attempts, ≥14 on the HRSD or ≥21 on the BDI-II, plus complex personality and/or psycho-social difficulties. EXCLUSION CRITERIA: Moderate or severe learning disability, psychotic illness, bipolar disorder, substance dependency or receipt of test intervention in the previous two years. DESIGN: Pragmatic, randomised controlled trial with qualitative and clinical components. TEST INTERVENTION: 18 months of weekly psychoanalytic psychotherapy, manualised and fidelity-assessed using the Psychotherapy Process Q-Sort. CONTROL CONDITION: Treatment as usual, managed by the referring practitioner. RECRUITMENT: GP referrals from primary care. RCT MAIN OUTCOME: HRSD (with ≤14 as remission. SECONDARY OUTCOMES: depression severity (BDI-II, degree of co-morbid disorders Axis-I and Axis-II (SCID-I and SCID-II-PQ, quality of life and functioning (GAF, CORE, Q-les-Q, object relations (PROQ2a, Cost-effectiveness analysis (CSRI and GP medical records. FOLLOW-UP: 2 years. Plus: a. Qualitative study of participants’ and therapists’ problem formulation, experience of treatment and of participation in trial. (b Narrative data from semi-structured pre/post psychodynamic interviews to produce prototypes of responders and non-responders. (c Clinical case-studies of sub-types of TRD and of change. Discussion TRD needs complex, long-term intervention and

  18. A randomized clinical trial of a telephone depression intervention to reduce employee presenteeism and absenteeism.

    Science.gov (United States)

    Lerner, Debra; Adler, David A; Rogers, William H; Chang, Hong; Greenhill, Annabel; Cymerman, Elina; Azocar, Francisca

    2015-06-01

    The study tested an intervention aimed at improving work functioning among middle-aged and older adults with depression and work limitations. A randomized clinical trial allocated an initial sample of 431 eligible employed adults (age ≥45) to a work-focused intervention (WFI) or usual care. Inclusion criteria were depression as measured by the Patient Health Questionnaire-9 (PHQ-9) and at-work limitations indicated by a productivity loss score ≥5% on the Work Limitations Questionnaire (WLQ). Study sites included 19 employers and five related organizations. Telephone-based counseling provided three integrated modalities: care coordination, cognitive-behavioral therapy strategy development, and work coaching and modification. Effectiveness (change in productivity loss scores from preintervention to four months postintervention) was tested with mixed models adjusted for confounders. Secondary outcomes included change in WLQ work performance scales, self-reported absences, and depression. Of 1,227 eligible employees (7% of screened), 431 (35%) enrolled and 380 completed the study (12% attrition). At-work productivity loss improved 44% in the WFI group versus 13% in usual care (difference in change, p<.001). WFI group scores on the four WLQ scales improved 44% to 47%, significantly better than in usual care (p<.001 for each scale). Absence days declined by 53% in the WFI group versus 13% in usual care (difference in change, p<.001). Mean PHQ-9 depression symptom severity scores declined 51% for WFI versus 26% for usual care (difference in change, p<.001). The WFI was more effective than usual care at four-month follow-up. Given increasing efforts to provide more patient-centered, value-based care, the WFI could be an important resource.

  19. Reducing depressive or anxiety symptoms in post-stroke patients: Pilot trial of a constructive integrative psychosocial intervention

    Science.gov (United States)

    Fang, Yihong; Mpofu, Elias; Athanasou, James

    2017-01-01

    Background: About 30% of stroke survivors clinically have depressive symptoms at some point following stroke and anxiety prevalence is around 20-25%. Objective: The purpose of this brief report is to evaluate a pilot trial of a constructive integrative psychosocial intervention (CIPI) over standard care in post-stroke depression or anxiety. Methods: Patients were randomly assigned to either CIPI (n = 23) or standard care (n = 19). Patients were assessed using the Hospital Anxiety and Depression Scale at the 1st, 3rd, and 6th months to monitor changes of mood. Results: A Wilcoxon signed-rank test indicated that compared to admission baseline, patients with the intervention had significantly normal post-stroke depression symptom levels at the 1st, 3rd, and 6th months (P < 0.005). Conclusion: CIPI appears to be of incremental value in treating depression as well as anxiety in subacute care. PMID:29085269

  20. Psychometric analysis of the Melancholia Scale in trials with non-pharmacological augmentation of patients with therapy-resistant depression

    DEFF Research Database (Denmark)

    Bech, Per; Lauritzen, Lise; Lunde, Marianne

    2014-01-01

    . Patients resistant to anti-depressant medication (therapy-resistant depression) have participated in our trials with non-pharmacological augmentation. On the basis of these trials, we have evaluated to what extent the neuropsychiatric subscale of the MES (concentration difficulties, fatigability, emotional...... of transferability, we have tested item ranks across the rating weeks. RESULTS: In the Mokken analysis, the coefficient of homogeneity was above 0.40 for both the HAM-D subscale and the apathia subscale at week 4. The numerical transferability across the weeks was statistically significant (p

  1. The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2): a randomised trial to determine the effectiveness and cost-effectiveness of adding a complex intervention for major depressive disorder to usual care for cancer patients.

    Science.gov (United States)

    Walker, Jane; Cassidy, Jim; Sharpe, Michael

    2009-03-30

    Depression Care for People with Cancer is a complex intervention delivered by specially trained cancer nurses, under the supervision of a psychiatrist. It is given as a supplement to the usual care for depression, which patients receive from their general practitioner and cancer service. In a 'proof of concept' trial (Symptom Management Research Trials in Oncology-1) Depression Care for People with Cancer improved depression more than usual care alone. The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2 Trial) will test its effectiveness and cost-effectiveness in a 'real world' setting. A two arm parallel group multi-centre randomised controlled trial. TRIAL PROCEDURES: 500 patients will be recruited through established systematic Symptom Monitoring Services, which screen patients for depression. Patients will have: a diagnosis of cancer (of various types); an estimated life expectancy of twelve months or more and a diagnosis of Major Depressive Disorder. Patients will be randomised to usual care or usual care plus Depression Care for People with Cancer. Randomisation will be carried out by telephoning a secure computerised central randomisation system or by using a secure web interface. The primary outcome measure is 'treatment response' measured at 24 week outcome data collection. 'Treatment response' will be defined as a reduction of 50% or more in the patient's baseline depression score, measured using the 20-item Symptom Checklist (SCL-20D). Secondary outcomes include remission of major depressive disorder, depression severity and patients' self-rated improvement of depression. Current controlled trials ISRCTN40568538 TRIAL HYPOTHESES: (1) Depression Care for People with Cancer as a supplement to usual care will be more effective than usual care alone in achieving a 50% reduction in baseline SCL-20D score at 24 weeks. (2) Depression Care for People with Cancer as a supplement to usual care will cost more than usual care alone but will be

  2. The effectiveness of an online support group for members of the community with depression: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Kathleen M Griffiths

    Full Text Available BACKGROUND: Internet support groups (ISGs are popular, particularly among people with depression, but there is little high quality evidence concerning their effectiveness. AIM: The study aimed to evaluate the efficacy of an ISG for reducing depressive symptoms among community members when used alone and in combination with an automated Internet-based psychotherapy training program. METHOD: Volunteers with elevated psychological distress were identified using a community-based screening postal survey. Participants were randomised to one of four 12-week conditions: depression Internet Support Group (ISG, automated depression Internet Training Program (ITP, combination of the two (ITP+ISG, or a control website with delayed access to e-couch at 6 months. Assessments were conducted at baseline, post-intervention, 6 and 12 months. RESULTS: There was no change in depressive symptoms relative to control after 3 months of exposure to the ISG. However, both the ISG alone and the combined ISG+ITP group showed significantly greater reduction in depressive symptoms at 6 and 12 months follow-up than the control group. The ITP program was effective relative to control at post-intervention but not at 6 months. CONCLUSIONS: ISGs for depression are promising and warrant further empirical investigation. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN65657330.

  3. Effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse or recurrence (PREVENT): a randomised controlled trial.

    Science.gov (United States)

    Kuyken, Willem; Hayes, Rachel; Barrett, Barbara; Byng, Richard; Dalgleish, Tim; Kessler, David; Lewis, Glyn; Watkins, Edward; Brejcha, Claire; Cardy, Jessica; Causley, Aaron; Cowderoy, Suzanne; Evans, Alison; Gradinger, Felix; Kaur, Surinder; Lanham, Paul; Morant, Nicola; Richards, Jonathan; Shah, Pooja; Sutton, Harry; Vicary, Rachael; Weaver, Alice; Wilks, Jenny; Williams, Matthew; Taylor, Rod S; Byford, Sarah

    2015-07-04

    ; p=0·43), nor did the number of serious adverse events. Five adverse events were reported, including two deaths, in each of the MBCT-TS and maintenance antidepressants groups. No adverse events were attributable to the interventions or the trial. We found no evidence that MBCT-TS is superior to maintenance antidepressant treatment for the prevention of depressive relapse in individuals at risk for depressive relapse or recurrence. Both treatments were associated with enduring positive outcomes in terms of relapse or recurrence, residual depressive symptoms, and quality of life. National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme, and NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula. Copyright © 2015 Kuyken et al. Open Access article distributed under the terms of CC BY. Published by Elsevier Ltd.. All rights reserved.

  4. Affect-focused psychodynamic psychotherapy for depression and anxiety through the Internet: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Robert Johansson

    2013-07-01

    Full Text Available Background. Psychodynamic psychotherapy is a psychological treatment approach that has a growing empirical base. Research has indicated an association between therapist-facilitated affective experience and outcome in psychodynamic therapy. Affect-phobia therapy (APT, as outlined by McCullough et al., is a psychodynamic treatment that emphasizes a strong focus on expression and experience of affect. This model has neither been evaluated for depression nor anxiety disorders in a randomized controlled trial. While Internet-delivered psychodynamic treatments for depression and generalized anxiety disorder exist, they have not been based on APT. The aim of this randomized controlled trial was to investigate the efficacy of an Internet-based, psychodynamic, guided self-help treatment based on APT for depression and anxiety disorders.Methods. One hundred participants with diagnoses of mood and anxiety disorders participated in a randomized (1:1 ratio controlled trial of an active group versus a control condition. The treatment group received a 10-week, psychodynamic, guided self-help treatment based on APT that was delivered through the Internet. The treatment consisted of eight text-based treatment modules and included therapist contact (9.5 min per client and week, on average in a secure online environment. Participants in the control group also received online therapist support and clinical monitoring of symptoms, but received no treatment modules. Outcome measures were the 9-item Patient Health Questionnaire Depression Scale (PHQ-9 and the 7-item Generalized Anxiety Disorder Scale (GAD-7. Process measures were also included. All measures were administered weekly during the treatment period and at a 7-month follow-up.Results. Mixed models analyses using the full intention-to-treat sample revealed significant interaction effects of group and time on all outcome measures, when comparing treatment to the control group. A large between-group effect size

  5. A Randomized Depression Prevention Trial Comparing Interpersonal Psychotherapy--Adolescent Skills Training to Group Counseling in Schools.

    Science.gov (United States)

    Young, Jami F; Benas, Jessica S; Schueler, Christie M; Gallop, Robert; Gillham, Jane E; Mufson, Laura

    2016-04-01

    Given the rise in depression disorders in adolescence, it is important to develop and study depression prevention programs for this age group. The current study examined the efficacy of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), a group prevention program for adolescent depression, in comparison to group programs that are typically delivered in school settings. In this indicated prevention trial, 186 adolescents with elevated depression symptoms were randomized to receive IPT-AST delivered by research staff or group counseling (GC) delivered by school counselors. Hierarchical linear modeling examined differences in rates of change in depressive symptoms and overall functioning from baseline to the 6-month follow-up assessment. Cox regression compared rates of depression diagnoses. Adolescents in IPT-AST showed significantly greater improvements in self-reported depressive symptoms and evaluator-rated overall functioning than GC adolescents from baseline to the 6-month follow-up. However, there were no significant differences between the two conditions in onset of depression diagnoses. Although both intervention conditions demonstrated significant improvements in depressive symptoms and overall functioning, results indicate that IPT-AST has modest benefits over groups run by school counselors which were matched on frequency and duration of sessions. In particular, IPT-AST outperformed GC in reduction of depressive symptoms and improvements in overall functioning. These findings point to the clinical utility of this depression prevention program, at least in the short-term. Additional follow-up is needed to determine the long-term effects of IPT-AST, relative to GC, particularly in preventing depression onset.

  6. A Randomized Depression Prevention Trial Comparing Interpersonal Psychotherapy—Adolescent Skills Training to Group Counseling in Schools

    Science.gov (United States)

    Benas, Jessica S.; Schueler, Christie M.; Gallop, Robert; Gillham, Jane E.; Mufson, Laura

    2017-01-01

    Given the rise in depression disorders in adolescence, it is important to develop and study depression prevention programs for this age group. The current study examined the efficacy of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), a group prevention program for adolescent depression, in comparison to group programs that are typically delivered in school settings. In this indicated prevention trial, 186 adolescents with elevated depression symptoms were randomized to receive IPT-AST delivered by research staff or group counseling (GC) delivered by school counselors. Hierarchical linear modeling examined differences in rates of change in depressive symptoms and overall functioning from baseline to the 6-month follow-up assessment. Cox regression compared rates of depression diagnoses. Adolescents in IPT-AST showed significantly greater improvements in self-reported depressive symptoms and evaluator-rated overall functioning than GC adolescents from baseline to the 6-month follow-up. However, there were no significant differences between the two conditions in onset of depression diagnoses. Although both intervention conditions demonstrated significant improvements in depressive symptoms and overall functioning, results indicate that IPT-AST has modest benefits over groups run by school counselors which were matched on frequency and duration of sessions. In particular, IPT-AST outperformed GC in reduction of depressive symptoms and improvements in overall functioning. These findings point to the clinical utility of this depression prevention program, at least in the short-term. Additional follow-up is needed to determine the long-term effects of IPT-AST, relative to GC, particularly in preventing depression onset. PMID:26638219

  7. The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Nishi, Daisuke; Su, Kuan-Pin; Usuda, Kentaro; Chiang, Yi-Ju Jill; Guu, Tai-Wei; Hamazaki, Kei; Nakaya, Naoki; Sone, Toshimasa; Sano, Yo; Tachibana, Yoshiyuki; Ito, Hiroe; Isaka, Keiich; Hashimoto, Kenji; Hamazaki, Tomohito; Matsuoka, Yutaka J

    2016-09-15

    Maternal depression can be harmful to both mothers and their children. Omega-3 polyunsaturated fatty acid (PUFA) supplementation has been investigated as an alternative intervention for pregnant women with depressive symptoms because of the supporting evidence from clinical trials in major depression, the safety advantage, and its anti-inflammatory and neuroplasticity effects. This study examines the efficacy of omega-3 PUFA supplementation for pregnant women with depressive symptoms in Taiwan and Japan, to provide evidence available for Asia. The rationale and protocol of this trial are reported here. The Synchronized Trial on Expectant Mothers with Depressive Symptoms by Omega-3 PUFAs (SYNCHRO) is a multicenter, double-blind, parallel group, randomized controlled trial. Participants will be randomized to either the omega-3 PUFAs arm (1,200 mg eicosapentaenoic acid and 600 mg docosahexaenoic acid daily) or placebo arm. Primary outcome is total score on the Hamilton Rating Scale for Depression (HAMD) at 12 weeks after the start of the intervention. We will randomize 56 participants to have 90 % power to detect a 4.7-point difference in mean HAMD scores with omega-3 PUFAs compared with placebo. Because seafood consumption varies across countries and this may have a major effect on the efficacy of omega-3 PUFA supplementation, 56 participants will be recruited at each site in Taiwan and Japan, for a total number of 112 participants. Secondary outcomes include depressive symptoms at 1 month after childbirth, diagnosis of major depressive disorder, changes in omega-3 PUFAs concentrations and levels of biomarkers at baseline and at 12 weeks' follow-up, and standard obstetric outcomes. Data analyses will be by intention to treat. The trial was started in June 2014 and is scheduled to end in February 2018. The trial is expected to provide evidence that can contribute to promoting mental health among mothers and children in Asian populations. Clinicaltrials.gov: NCT

  8. Chinese Herbal Medicine for Postpartum Depression: A Systematic Review of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Yongle Li

    2016-01-01

    Full Text Available Background. Postpartum depression (PPD does great harm to women following childbirth. The aim of this study was to conduct a systematic review of the literature to assess the efficacy and safety of CHM for the treatment of PPD. Methods. Published or ongoing registered trials were searched for from the inception of the various databases to December 31, 2015. Data extraction and methodology assessment were conducted independently by two researchers. RevMan 5.3 software was used to analyze the data. Results. Forty-seven registered clinical trials (RCTs were identified and reviewed. The results showed CHM alone or in combination with routine treatments could reduce HAMD score, EPDS score, incidence of adverse events, TESS, and SERS. CHM combined with routine treatment was more effective in increasing serum estradiol levels and reducing progesterone levels than routine treatment alone. Meanwhile, pooled data revealed that MRLQS combined with routine treatments or MRLQS plus MSHS combined with routine treatments were more effective than other therapeutic methods in TCM. MRLQS plus MSHS alone was found to be an effective alternative when compared to routine treatments. Conclusions. This review suggested that CHM was safe and effective in the treatment of PPD. However, this could not be proven conclusively. To ensure evidence-based clinical practice, more rigorously designed trials are warranted.

  9. Smartphone Cognitive Behavioral Therapy as an Adjunct to Pharmacotherapy for Refractory Depression: Randomized Controlled Trial.

    Science.gov (United States)

    Mantani, Akio; Kato, Tadashi; Furukawa, Toshi A; Horikoshi, Masaru; Imai, Hissei; Hiroe, Takahiro; Chino, Bun; Funayama, Tadashi; Yonemoto, Naohiro; Zhou, Qi; Kawanishi, Nao

    2017-11-03

    In the treatment of major depression, antidepressants are effective but not curative. Cognitive behavioral therapy (CBT) is also effective, alone or in combination with pharmacotherapy, but accessibility is a problem. The aim is to evaluate the effectiveness of a smartphone CBT app as adjunctive therapy among patients with antidepressant-resistant major depression. A multisite, assessor-masked, parallel-group randomized controlled trial was conducted in 20 psychiatric clinics and hospitals in Japan. Participants were eligible if they had a primary diagnosis of major depression and were antidepressant-refractory after taking one or more antidepressants at an adequate dosage for four or more weeks. After a 1-week run-in in which participants started the medication switch and had access to the welcome session of the app, patients were randomized to medication switch alone or to medication switch plus smartphone CBT app via the centralized Web system. The smartphone app, called Kokoro-app ("kokoro" means "mind" in Japanese), included sessions on self-monitoring, behavioral activation, and cognitive restructuring presented by cartoon characters. The primary outcome was depression severity as assessed by masked telephone assessors with the Patient Health Questionnaire-9 (PHQ-9) at week 9. The secondary outcomes included the Beck Depression Inventory-II (BDI-II) and Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER). In the total sample (N=164), 81 participants were allocated to the smartphone CBT in addition to medication change and 83 to medication change alone. In the former group, all but one participant (80/81, 99%) completed at least half, and 71 (88%) completed at least six of eight sessions. In the intention-to-treat analysis, patients allocated the CBT app scored 2.48 points (95% CI 1.23-3.72, Psmartphone app, still symptomatic, and adherent to medication with mild or less side effects after run-in), the intervention group (n=60) scored 1.72 points

  10. Evaluating the efficacy of an integrated motivational interviewing and multi-modal exercise intervention for youth with major depression: Healthy Body, Healthy Mind randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Yasmina Nasstasia

    2018-03-01

    Conclusion: This trial will increase our understanding of the efficacy of multi-modal exercise interventions for depression and the specific effects of exercise on depressive symptom profiles. It also offers a novel contribution by addressing treatment engagement in exercise efficacy trials in youth with MDD.

  11. Social Problem Solving and Depressive Symptoms over Time: A Randomized Clinical Trial of Cognitive-Behavioral Analysis System of Psychotherapy, Brief Supportive Psychotherapy, and Pharmacotherapy

    Science.gov (United States)

    Klein, Daniel N.; Leon, Andrew C.; Li, Chunshan; D'Zurilla, Thomas J.; Black, Sarah R.; Vivian, Dina; Dowling, Frank; Arnow, Bruce A.; Manber, Rachel; Markowitz, John C.; Kocsis, James H.

    2011-01-01

    Objective: Depression is associated with poor social problem solving, and psychotherapies that focus on problem-solving skills are efficacious in treating depression. We examined the associations between treatment, social problem solving, and depression in a randomized clinical trial testing the efficacy of psychotherapy augmentation for…

  12. The study protocol of the Norwegian randomized controlled trial of electroconvulsive therapy in treatment resistant depression in bipolar disorder

    Directory of Open Access Journals (Sweden)

    Oedegaard Ketil J

    2010-02-01

    Full Text Available Abstract Background The treatment of depressive phases of bipolar disorder is challenging. The effects of the commonly used antidepressants in bipolar depression are questionable. Electroconvulsive therapy is generally considered to be the most effective treatment even if there are no randomized controlled trials of electroconvulsive therapy in bipolar depression. The safety of electroconvulsive therapy is well documented, but there are some controversies as to the cognitive side effects. The aim of this study is to compare the effects and side effects of electroconvulsive therapy to pharmacological treatment in treatment resistant bipolar depression. Cognitive changes and quality of life during the treatment will be assessed. Methods/Design A prospective, randomised controlled, multi-centre six- week acute treatment trial with seven clinical assessments. Follow up visit at 26 weeks or until remission (max 52 weeks. A neuropsychological test battery designed to be sensitive to changes in cognitive function will be used. Setting: Nine study centres across Norway, all acute psychiatric departments. Sample: n = 132 patients, aged 18 and over, who fulfil criteria for treatment resistant depression in bipolar disorder, Montgomery Åsberg Depression Rating Scale Score of at least 25 at baseline. Intervention: Intervention group: 3 sessions per week for up to 6 weeks, total up to 18 sessions. Control group: algorithm-based pharmacological treatment as usual. Discussion This study is the first randomized controlled trial that aims to investigate whether electroconvulsive therapy is better than pharmacological treatment as usual in treatment resistant bipolar depression. Possible long lasting cognitive side effects will be evaluated. The study is investigator initiated, without support from industry. Trial registration NCT00664976

  13. A meta-analysis of randomised placebo-controlled treatment trials for depression and anxiety in Parkinson's disease.

    Directory of Open Access Journals (Sweden)

    Lakkhina Troeung

    Full Text Available Psychopharmacotherapy currently constitutes the first-line treatment for depression and anxiety in Parkinson's disease (PD however the efficacy of antidepressant treatments in PD is unclear. Several alternative treatments have been suggested as potentially more viable alternatives including dopamine agonists, repetitive transcranial magnetic stimulation, and cognitive behavioural therapy (CBT.A meta-analysis of randomised placebo-controlled trials for depression and/or anxiety in PD was conducted to systematically examine the efficacy of current treatments for depression and anxiety in PD.Nine trials were included. There was only sufficient data to calculate a pooled effect for antidepressant therapies. The pooled effect of antidepressants for depression in PD was moderate but non-significant (d = .71, 95% CI = -1.33 to 3.08. The secondary effect of antidepressants on anxiety in PD was large but also non-significant (d = 1.13, 95% CI = -.67 to 2.94. Two single-trials of non-pharmacological treatments for depression in PD resulted in significant large effects; Omega-3 supplementation (d = .92, 95% CI = .15 to 1.69 and CBT (d = 1.57, 95% CI = 1.06 to 2.07, and warrant further exploration.There remains a lack of controlled trials for both pharmacological and non-pharmacological treatments for depression and anxiety in PD which limits the conclusions which can be drawn. While the pooled effects of antidepressant therapies in PD were non-significant, the moderate to large magnitude of each pooled effect is promising. Non-pharmacological approaches show potential for depression in PD however more research is required.

  14. Postpartum depression peer support: maternal perceptions from a randomized controlled trial.

    Science.gov (United States)

    Dennis, Cindy-Lee

    2010-05-01

    Peer support in the early postpartum period is effective in the prevention of postpartum depression among women identified as high-risk. To describe maternal perceptions of peer support received while participating in a trial. Cross-sectional survey of women participating in a randomized controlled trial to evaluate the effect of peer support in the prevention of postpartum depression. Seven health regions across Ontario Canada. 701 women were recruited between November 2004 and September 2006. Women eligible for the study were all mothers with an Edinburgh Postnatal Depression Scale score >9 who were within 2 weeks postpartum, at least 18 years of age, able to speak English, had a live birth, and had been discharged home from the hospital. Exclusion criteria included an infant not discharged home with the mother and current use of antidepressant or antipsychotic medication. Two hundred and twenty-one mothers completed the mailed questionnaire. Women were randomly allocated to receive usual postpartum care (control group) or usual postpartum care plus telephone-based peer support (intervention group). Maternal perceptions of peer support were evaluated at 12 weeks postpartum using the validated Peer Support Evaluation Inventory. Interactions provided by the peer volunteer included the provision of emotional (92.7%), informational (72.4%), and appraisal (72.0%) support. Mothers reported high levels of positive relationship qualities such as trust (83.6%) and perceived acceptance (79.1%). Most (80.5%) mothers indicated they were very satisfied with their peer support experience. Maternal satisfaction was associated with the number and duration of peer volunteer contacts. The majority of mothers perceived their peer volunteer experience positively lending further support to telephone-based peer support as a preventative strategy for postpartum depression. The following program modifications were suggested: (a) adapt training to enhance the provision of appraisal

  15. Effect of running therapy on depression (EFFORT-D. Design of a randomised controlled trial in adult patients [ISRCTN 1894

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    Kruisdijk Frank R

    2012-01-01

    Full Text Available Abstract Background The societal and personal burden of depressive illness is considerable. Despite the developments in treatment strategies, the effectiveness of both medication and psychotherapy is not ideal. Physical activity, including exercise, is a relatively cheap and non-harmful lifestyle intervention which lacks the side-effects of medication and does not require the introspective ability necessary for most psychotherapies. Several cohort studies and randomised controlled trials (RCTs have been performed to establish the effect of physical activity on prevention and remission of depressive illness. However, recent meta-analysis's of all RCTs in this area showed conflicting results. The objective of the present article is to describe the design of a RCT examining the effect of exercise on depressive patients. Methods/Design The EFFect Of Running Therapy on Depression in adults (EFFORT-D is a RCT, studying the effectiveness of exercise therapy (running therapy (RT or Nordic walking (NW on depression in adults, in addition to usual care. The study population consists of patients with depressive disorder, Hamilton Rating Scale for Depression (HRSD ≥ 14, recruited from specialised mental health care. The experimental group receives the exercise intervention besides treatment as usual, the control group receives treatment as usual. The intervention program is a group-based, 1 h session, two times a week for 6 months and of increasing intensity. The control group only performs low intensive non-aerobic exercises. Measurements are performed at inclusion and at 3,6 and 12 months. Primary outcome measure is reduction in depressive symptoms measured by the HRSD. Cardio-respiratory fitness is measured using a sub maximal cycling test, biometric information is gathered and blood samples are collected for metabolic parameters. Also, co-morbidity with pain, anxiety and personality traits is studied, as well as quality of life and cost

  16. Using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: Study protocol of an exploratory randomized controlled trial.

    Science.gov (United States)

    Giosan, Cezar; Mogoaşe, Cristina; Cobeanu, Oana; Szentágotai Tătar, Aurora; Mureşan, Vlad; Boian, Rareș

    2016-12-28

    Depression is a major challenge worldwide, with significant increasing personal, economic, and societal costs. Although empirically supported treatments have been developed, they are not always available for patients in routine clinical care. Therefore, we need effective and widely accessible strategies to prevent the onset of the very first depressive symptoms. Mental health apps could prove a valuable solution for this desideratum. Although preliminary research has indicated that such apps can be useful in treating depression, no study has attempted to test their utility in preventing depressive symptoms. The aim of this exploratory study is to contrast the efficacy of a smartphone app in reducing cognitive vulnerability and mild depressive symptoms, as risk factors for the onset of depression, against a wait-list condition. More specifically, we aim to test an app designed to (1) decrease general cognitive vulnerability and (2) promote engagement in protective, adaptive activities, while (3) counteracting (through gamification and customization) the tendency of premature dropout from intervention. Romanian-speaking adults (18 years and older) with access to a computer and the Internet and who own a smartphone are included in the study. Two parallel randomized clinical trials are conducted: in the first one, 50 participants free of depressive symptoms (i.e., who obtain scores ≤4 on the Patient Health Questionnaire, PHQ-9) will be included, while in the second one 50 participants with minimal depressive symptoms (i.e., who obtain PHQ-9 scores between 5 and 9) will be included. Participants undergoing therapy, presenting with substance abuse problems, psychotic symptoms, and organic brain disorders, or serious legal or health issues that would prevent them from using the app, as well as participants reporting suicidal ideation are excluded. Participants randomized to the active intervention will autonomously use the smartphone app for 4 weeks, while the others

  17. Reactivity to smartphone-based ecological momentary assessment of depressive symptoms (MoodMonitor: protocol of a randomised controlled trial

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    Wouter van Ballegooijen

    2016-10-01

    Full Text Available Abstract Background Ecological momentary assessment (EMA of mental health symptoms may influence the symptoms that it measures, i.e. assessment reactivity. In the field of depression, EMA reactivity has received little attention. We aim to investigate whether EMA of depressive symptoms induces assessment reactivity. Reactivity will be operationalised as an effect of EMA on depressive symptoms measured by a retrospective questionnaire, and, secondly, as a change in response rate and variance of the EMA ratings. Methods This study is a 12-week randomised controlled trial comprising three groups: group 1 carries out EMA of mood and completes a retrospective questionnaire, group 2 carries out EMA of how energetic they feel and completes a retrospective questionnaire, group 3 is the control group, which completes only the retrospective questionnaire. The retrospective questionnaire (Centre for Epidemiologic Studies Depression scale; CES-D assesses depressive symptoms and is administered at baseline, 6 weeks after baseline and 12 weeks after baseline. We aim to recruit 160 participants who experience mild to moderate depressive symptoms, defined as a Patient Health Questionnaire (PHQ-9 score of 5 to 15. This study is powered to detect a small between-groups effect, where no clinically relevant effect is defined as the effect size margin −0.25< d <0.25. Discussion To our knowledge, this is the first study to investigate whether self-rated EMA of depressive symptoms could induce assessment reactivity among mildly depressed individuals. Trial registration Netherlands Trial Register NTR5803. Registered 12 April 2016. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5803 .

  18. Guided self-help cognitive behavioural therapy for depression in primary care: a randomised controlled trial.

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    Christopher Williams

    Full Text Available BACKGROUND: Access to Cognitive behavioural therapy (CBT for depression is limited. One solution is CBT self-help books. Trial Objectives: To assess the impact of a guided self-help CBT book (GSH-CBT on mood, compared to treatment as usual (TAU. HYPOTHESES: GSH-CBT will have improved mood and knowledge of the causes and treatment of depression compared to the control receiving TAUGuided self-help will be acceptable to patients and staff. METHODS AND FINDINGS: PARTICIPANTS: Adults attending seven general practices in Glasgow, UK with a BDI-II score of ≥14. 141 randomised to GSH-CBT and 140 to TAU. INTERVENTIONS: RCT comparing 'Overcoming Depression: A Five Areas Approach' book plus 3-4 short face to face support appointments totalling up to 2 hours of guided support, compared with general practitioner TAU. PRIMARY OUTCOME: The BDI (II score at 4 months. Numbers analysed: 281 at baseline, 203 at 4 months (primary outcome, 117 at 12 months. OUTCOME: Mean BDI-II scores were lower in the GSH-CBT group at 4 months by 5.3 points (2.6 to 7.9, p<0.001. At 4 and 12 months there were also significantly higher proportions of participants achieving a 50% reduction in BDI-II in the GSH-CBT arm. The mean support was 2 sessions with 42.7 minutes for session 1, 41.4 minutes for session 2 and 40.2 minutes of support for session 3. Adverse effects/Harms: Significantly less deterioration in mood in GSH-CBT (2.0% compared to 9.8% in the TAU group for BDI-II category change. LIMITATIONS: Weaknesses: Our follow-up rate of 72.2% at 4 months is better than predicted but is poorer at 12 months (41.6%. In the GSH-CBT arm, around 50% of people attended 2 or fewer sessions. 22% failed to take up treatment. CONCLUSIONS: GSH-CBT is substantially more effective than TAU. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN13475030.

  19. Specialist mental health consultation for depression in Australian aged care residents with dementia: a cluster randomized trial.

    Science.gov (United States)

    McSweeney, Kate; Jeffreys, Aimee; Griffith, Joanne; Plakiotis, Chris; Kharsas, Renee; O'Connor, Daniel W

    2012-11-01

    This cluster randomized controlled trial sought to determine whether multidisciplinary specialist mental health consultation was more effective than care as usual in treating the depression of aged care residents with dementia. Three hundred and eighty nine aged care residents were screened for dementia and major depression. Forty four were ultimately included in the intervention sample, selected from 20 aged care facilities located in Melbourne, Australia. Facilities were randomly allocated to an intervention condition involving the provision of multidisciplinary specialist consultation regarding the best-practice management of depression in dementia, or to a care as usual condition. Consultations involved individually tailored medical and psychosocial recommendations provided to care staff and general practitioners. All residents participated in a comprehensive pre-intervention diagnostic assessment, including the administration of the Cornell Scale for Depression in Dementia. This assessment was repeated approximately 15 weeks post-intervention by a rater blind to study condition. Multidisciplinary specialist mental health consultation was significantly more effective than care as usual in treating the clinical depression of aged care residents with dementia (p Depression in Dementia score for the intervention group was 9.47, compared with 14.23 for the control group. In addition, 77% of the intervention group no longer met criteria for major depression. The results of this study suggest that the psychosocial and medical management of depressed aged care residents can be improved by increasing access to specialist mental health consultation. Copyright © 2012 John Wiley & Sons, Ltd.

  20. Minimal contact psychotherapy for sub-threshold depression in primary care: a randomised trial.

    NARCIS (Netherlands)

    Willemse, G.R.W.M.; Smit, F.; Cuijpers, W.J.M.J.; Tiemens, B.G.

    2004-01-01

    Background: Sub-threshold depression is a prognostic variable for major depression. Interventions in sub-threshold depression may prevent the onset of new cases of major depression. Aims: To examine the effects of minimal-contact psychotherapy in primary care patients with sub-threshold depression

  1. Self-Help for Depression via E-mail: A Randomised Controlled Trial of Effects on Depression and Self-Help Behaviour.

    Directory of Open Access Journals (Sweden)

    Amy J Morgan

    Full Text Available Self-help or self-management strategies are commonly used to deal with depression, but not all are thought to be helpful. A previous study found that sub-threshold depression symptoms were improved by an e-mail intervention that encouraged the use of evidence-based self-help strategies.To investigate whether these e-mails were effective for adults with a range of depression symptomatology including major depression.The study was a parallel-group randomised controlled trial. Adult participants with any level of depressive symptoms were recruited over the internet from the United Kingdom, Australia, Canada, Ireland, New Zealand and the United States. Participants were randomised to receive a series of e-mails either promoting the use of evidence-based self-help strategies or containing depression information as a control. E-mails were sent automatically twice a week for six weeks. Depression symptoms were assessed with the self-rated Patient Health Questionnaire depression scale (PHQ-9.1736 participants with a wide range of symptom severity were recruited and assigned to active (n = 862 and control (n = 874 groups. However, there was a significant attrition rate, with 66.9% lost to follow-up at post-intervention. Both groups showed large improvements in depression symptoms overall, with no significant difference in improvement at the end of the study (mean difference in improvement 0.35 points, 95% CI: -0.57 to 1.28, d = 0.11, 95% CI: -0.06 to 0.27, although there was a small effect at the study mid-point. Results were similar for the sub-group of participants with major depression. The active group showed small to moderate improvements in self-help behaviour (d = 0.40, 95% CI: 0.23 to 0.56.These results suggest that the e-mails were able to increase participants' use of evidence-based self-help, but that this did not improve depression more than an attention control.NCT01399502.

  2. Escitalopram and neuroendocrine response in healthy first-degree relatives to depressed patients--a randomized placebo-controlled trial

    DEFF Research Database (Denmark)

    Knorr, Ulla; Vinberg, Maj; Hansen, Allan

    2011-01-01

    Introduction The mechanisms by which selective serotonin re-uptake inhibitors (SSRI) act in depressed patients remain unknown. The serotonergic neurotransmitter system and the hypothalamic-pituitary-adrenal (HPA) system may interact. The aim of the AGENDA trial was to investigate whether long-ter...

  3. Contradictory effects for prevention of depression and anxiety in residents in home for the elderly: a pragmatic randomized controlled trial

    NARCIS (Netherlands)

    Dozeman, Els; van Marwijk, Harm; van Schaik, Digna J.F.; Smit, Filip; Stek, Max; van der Horst, Henriëtte E.; Bohlmeijer, Ernst Thomas; Beekman, Aartjan T.F.

    2012-01-01

    Background: The aim of this study was to evaluate the effectiveness of a stepped-care program to prevent the onset of depression and anxiety disorders in elderly people living in residential homes. Methods: A pragmatic randomized controlled trial was conducted to compare the intervention with usual

  4. Testing sex-specific pathways from peer victimization to anxiety and depression in early adolescents through a randomized intervention trial

    NARCIS (Netherlands)

    Vuijk, P.; Lier, P.A.C. van; Crijnen, A.A.M.; Huizink, A.C.

    2007-01-01

    The aim of this study was to test for sex differences in the role of physical and relational victimization in anxiety and depression development through a randomized prevention trial. 448 seven-year-old boys and girls were randomly assigned to the Good Behavior Game intervention, a two-year

  5. The efficacy of N-acetylcysteine as an adjunctive treatment in bipolar depression: an open label trial.

    Science.gov (United States)

    Berk, Michael; Dean, Olivia; Cotton, Sue M; Gama, Clarissa S; Kapczinski, Flavio; Fernandes, Brisa S; Kohlmann, Kristy; Jeavons, Susan; Hewitt, Karen; Allwang, Christine; Cobb, Heidi; Bush, Ashley I; Schapkaitz, Ian; Dodd, Seetal; Malhi, Gin S

    2011-12-01

    Evidence is accumulating to support the presence of redox dysregulation in a number of psychiatric disorders, including bipolar disorder. This dysregulation may be amenable to therapeutic intervention. Glutathione is the predominant non-enzymatic intracellular free radical scavenger in the brain, and the most generic of all endogenous antioxidants in terms of action. N-acetylcysteine (NAC) is a glutathione precursor that effectively replenishes brain glutathione. Given the failure of almost all modern trials of antidepressants in bipolar disorder to demonstrate efficacy, and the limited efficacy of mood stabilisers in the depressive phase of the disorder, this is a major unmet need. This study reports data on the treatment of 149 individuals with moderate depression during the 2 month open label phase of a randomised placebo controlled clinical trial of the efficacy of 1g BID of NAC that examined the use of NAC as a maintenance treatment for bipolar disorder. In this trial, the estimated mean baseline Bipolar Depression Rating Scale (BDRS) score was 19.7 (SE=0.8), and the mean BDRS score at the end of the 8 week open label treatment phase was 11.1 (SE=0.8). This reduction was statistically significant (pdepression scores with NAC treatment. Large placebo controlled trials of acute bipolar depression are warranted. Copyright © 2011 Elsevier B.V. All rights reserved.

  6. Relative Cost-Effectiveness of Treatments for Adolescent Depression: 36-Week Results from the TADS Randomized Trial

    Science.gov (United States)

    Domino, Marisa Elena; Foster, E. Michael; Vitiello, Benedetto; Kratochvil, Christopher J.; Burns, Barbara J.; Silva, Susan G.; Reinecke, Mark A.; March, John S.

    2009-01-01

    Randomized controlled trials that involve 327 participants aged 12 to 18 who were diagnosed with major depression were given either fluoxetine alone, cognitive-behavioral therapy, or a combination of both. Cost-effectiveness acceptability curves suggest that combination treatment is highly likely to be the most cost-effective treatment than…

  7. Improving depression and enhancing resilience in family dementia caregivers: a pilot randomized placebo-controlled trial of escitalopram.

    Science.gov (United States)

    Lavretsky, Helen; Siddarth, Prabha; Irwin, Michael R

    2010-02-01

    This study examined the potential of an antidepressant drug, escitalopram, to improve depression, resilience to stress, and quality of life in family dementia caregivers in a randomized placebo-controlled double-blinded trial. Forty family caregivers (43-91 years of age, 25 children and 15 spouses; 26 women) who were taking care of their relatives with Alzheimer disease were randomized to receive either escitalopram 10 mg/day or placebo for 12 weeks. Severity of depression, resilience, burden, distress, quality of life, and severity of care-recipient's cognitive and behavioral disturbances were assessed at baseline and over the course of the study. The Hamilton Depression Rating Scale scores at baseline ranged between 10 and 28. The groups were stratified by the diagnosis of major and minor depression. Most outcomes favored escitalopram over placebo. The severity of depression improved, and the remission rate was greater with the drug compared with placebo. Measures of anxiety, resilience, burden, and distress improved on escitalopram compared with placebo. Among caregivers, this small randomized controlled trial found that escitalopram use resulted in improvement in depression, resilience, burden and distress, and quality of life. Our results need to be confirmed in a larger sample.

  8. Conducting a fully mobile and randomised clinical trial for depression: access, engagement and expense.

    Science.gov (United States)

    Anguera, Joaquin A; Jordan, Joshua T; Castaneda, Diego; Gazzaley, Adam; Areán, Patricia A

    2016-01-01

    Advances in mobile technology have resulted in federal and industry-level initiatives to facilitate large-scale clinical research using smart devices. Although the benefits of technology to expand data collection are obvious, assumptions about the reach of mobile research methods ( access ), participant willingness to engage in mobile research protocols ( engagement ), and the cost of this research ( cost ) remain untested. To assess the feasibility of a fully mobile randomised controlled trial using assessments and treatments delivered entirely through mobile devices to depressed individuals. Using a web-based research portal, adult participants with depression who also owned a smart device were screened, consented and randomised to 1 of 3 mental health apps for treatment. Assessments of self-reported mood and cognitive function were conducted at baseline, 4, 8 and 12 weeks. Physical and social activity was monitored daily using passively collected phone use data. All treatment and assessment tools were housed on each participant's smart phone or tablet. A cognitive training application, an application based on problem-solving therapy, and a mobile-sensing application promoting daily activities. Access : We screened 2923 people and enrolled 1098 participants in 5 months. The sample characteristics were comparable to the 2013 US census data. Recruitment via Craigslist.org yielded the largest sample. Engagement : Study engagement was high during the first 2 weeks of treatment, falling to 44% adherence by the 4th week. Cost : The total amount spent on for this project, including staff costs and β testing, was $314 264 over 2 years. These findings suggest that mobile randomised control trials can recruit large numbers of participants in a short period of time and with minimal cost, but study engagement remains challenging. NCT00540865.

  9. Pilot Randomized Controlled Trial of Titrated Subcutaneous Ketamine in Older Patients with Treatment-Resistant Depression.

    Science.gov (United States)

    George, Duncan; Gálvez, Verònica; Martin, Donel; Kumar, Divya; Leyden, John; Hadzi-Pavlovic, Dusan; Harper, Simon; Brodaty, Henry; Glue, Paul; Taylor, Rohan; Mitchell, Philip B; Loo, Colleen K

    2017-11-01

    To assess the efficacy and safety of subcutaneous ketamine for geriatric treatment-resistant depression. Secondary aims were to examine if repeated treatments were safe and more effective in inducing or prolonging remission than a single treatment. In this double-blind, controlled, multiple-crossover study with a 6-month follow-up (randomized controlled trial [RCT] phase), 16 participants (≥60 years) with treatment-resistant depression who relapsed after remission or did not remit in the RCT were administered an open-label phase. Up to five subcutaneous doses of ketamine (0.1, 0.2, 0.3, 0.4, and 0.5 mg/kg) were administered in separate sessions (≥1 week apart), with one active control (midazolam) randomly inserted (RCT phase). Twelve ketamine treatments were given in the open-label phase. Mood, hemodynamic, and psychotomimetic outcomes were assessed by blinded raters. Remitters in each phase were followed for 6 months. Seven of 14 RCT-phase completers remitted with ketamine treatment. Five remitted at doses below 0.5 mg/kg. Doses ≥ 0.2 mg/kg were significantly more effective than midazolam. Ketamine was well tolerated. Repeated treatments resulted in higher likelihood of remission or longer time to relapse. Results provide preliminary evidence for the efficacy and safety of ketamine in treating elderly depressed. Dose titration is recommended for optimizing antidepressant and safety outcomes on an individual basis. Subcutaneous injection is a practical method for giving ketamine. Repeated treatments may improve remission rates (clinicaltrials.gov; NCT01441505). Copyright © 2017 American Association for Geriatric Psychiatry. All rights reserved.

  10. Augmented Cognitive Behavioral Therapy for Poststroke Depressive Symptoms: A Randomized Controlled Trial.

    Science.gov (United States)

    Kootker, Joyce A; Rasquin, Sascha M C; Lem, Frederik C; van Heugten, Caroline M; Fasotti, Luciano; Geurts, Alexander C H

    2017-04-01

    To evaluate the effectiveness of individually tailored cognitive behavioral therapy (CBT) for reducing depressive symptoms with or without anxiety poststroke. Multicenter, assessor-blinded, randomized controlled trial. Ambulatory rehabilitation setting. Patients who had a Hospital Anxiety and Depression Scale-depression subscale (HADS-D) score >7 at least 3 months poststroke (N=61). Participants were randomly allocated to either augmented CBT or computerized cognitive training (CCT). The CBT intervention was based on the principles of recognizing, registering, and altering negative thoughts and cognitions. CBT was augmented with goal-directed real-life activity training given by an occupational or movement therapist. HADS-D was the primary outcome, and measures of participation and quality of life were secondary outcomes. Outcome measurements were performed at baseline, immediately posttreatment, and at 4- and 8-month follow-up. Analysis was performed with linear mixed models using group (CBT vs CCT) as the between-subjects factor and time (4 assessments) as the within-subjects factor. Mixed model analyses showed a significant and persistent time effect for HADS-D (mean difference, -4.6; 95% confidence interval, -5.7 to -3.6; P<.001) and for participation and quality of life in both groups. There was no significant group × time effect for any of the outcome measures. Our augmented CBT intervention was not superior to CCT for the treatment of mood disorders after stroke. Future studies should determine whether both interventions are better than natural history. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  11. A Machine Learning Approach to Identifying Placebo Responders in Late-Life Depression Trials.

    Science.gov (United States)

    Zilcha-Mano, Sigal; Roose, Steven P; Brown, Patrick J; Rutherford, Bret R

    2018-01-11

    Despite efforts to identify characteristics associated with medication-placebo differences in antidepressant trials, few consistent findings have emerged to guide participant selection in drug development settings and differential therapeutics in clinical practice. Limitations in the methodologies used, particularly searching for a single moderator while treating all other variables as noise, may partially explain the failure to generate consistent results. The present study tested whether interactions between pretreatment patient characteristics, rather than a single-variable solution, may better predict who is most likely to benefit from placebo versus medication. Data were analyzed from 174 patients aged 75 years and older with unipolar depression who were randomly assigned to citalopram or placebo. Model-based recursive partitioning analysis was conducted to identify the most robust significant moderators of placebo versus citalopram response. The greatest signal detection between medication and placebo in favor of medication was among patients with fewer years of education (≤12) who suffered from a longer duration of depression since their first episode (>3.47 years) (B = 2.53, t(32) = 3.01, p = 0.004). Compared with medication, placebo had the greatest response for those who were more educated (>12 years), to the point where placebo almost outperformed medication (B = -0.57, t(96) = -1.90, p = 0.06). Machine learning approaches capable of evaluating the contributions of multiple predictor variables may be a promising methodology for identifying placebo versus medication responders. Duration of depression and education should be considered in the efforts to modulate placebo magnitude in drug development settings and in clinical practice. Copyright © 2018 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

  12. Dropout from individual psychotherapy for major depression: A meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Cooper, Andrew A; Conklin, Laren R

    2015-08-01

    Dropout from mental health treatment poses a substantial problem, but rates vary substantially across studies and diagnoses. Focused reviews are needed to provide more detailed estimates for specific areas of research. Randomized clinical trials involving individual psychotherapy for unipolar depression are ubiquitous and important, but empirical data on average dropout rates from these studies is lacking. We conducted a random-effects meta-analysis of 54 such studies (N=5852) including 80 psychotherapy conditions, and evaluated a number of predictors of treatment- and study-level dropout rates. Our overall weighted dropout estimates were 19.9% at the study level, and 17.5% for psychotherapy conditions specifically. Therapy orientation did not significantly account for variance in dropout estimates, but estimates were significantly higher in psychotherapy conditions with more patients of minority racial status or with comorbid personality disorders. Treatment duration was also positively associated with dropout rates at trend level. Studies with an inactive control comparison had higher dropout rates than those without such a condition. Limitations include the inability to test certain potential predictors (e.g., socioeconomic status) due to infrequent reporting. Overall, our findings suggest the need to consider how specific patient and study characteristics may influence dropout rates in clinical research on individual therapy for depression. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. Partnered Evaluation of a Community Engagement Intervention: Use of a “Kickoff” Conference in a Randomized Trial for Depression Care Improvement in Underserved Communities

    Science.gov (United States)

    Mendel, Peter; Ngo, Victoria K.; Dixon, Elizabeth; Stockdale, Susan; Jones, Felica; Chung, Bowen; Jones, Andrea; Masongsong, Zoe; Khodyakov, Dmitry

    2013-01-01

    Community partnered research and engagement strategies are gaining recognition as innovative approaches to improving healthcare systems and reducing health disparities in underserved communities. These strategies may have particular relevance for mental health interventions in low income, minority communities in which there often is great stigma and silence surrounding conditions such as depression and difficulty in implementing improved access and quality of care. At the same time, there is a relative dearth of evidence on the effectiveness of specific community engagement interventions and on the design, process, and context of these interventions necessary for understanding their implementation and generalizability. This paper evaluates one of a number of community engagement strategies employed in the Community Partners in Care (CPIC) study, the first randomized controlled trial of the role of community engagement in adapting and implementing evidence-based depression care. We specifically describe the unique goals and features of a community engagement “kickoff” conference as used in CPIC and provide evidence on the effectiveness of this type of intervention by analyzing its impact on: 1) stimulating a dialogue, sense of collective efficacy, and opportunities for learning and networking to address depression and depression care in the community, 2) activating interest and participation in CPIC’s randomized trial of two different ways to implement evidence-based quality improvement (QI) programs for depression across diverse community agencies, and 3) introducing evidence-based toolkits and collaborative care models to potential participants in both intervention conditions and other community members. We evaluated the effectiveness of the conference through a community-partnered process in which both community and academic project members were involved in study design, data collection and analysis. Data sources include participant conference evaluation

  14. Rationale and study design of a patient-centered intervention to improve health status in chronic heart failure: The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) randomized trial.

    Science.gov (United States)

    Bekelman, David B; Allen, Larry A; Peterson, Jamie; Hattler, Brack; Havranek, Edward P; Fairclough, Diane L; McBryde, Connor F; Meek, Paula M

    2016-11-01

    While contemporary heart failure management has led to some improvements in morbidity and mortality, patients continue to report poor health status (i.e., burdensome symptoms, impaired function, and poor quality of life). The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) trial is a NIH-funded, three-site, randomized clinical trial that examines the effect of the CASA intervention compared to usual care on the primary outcome of patient-reported health status at 6months in patients with heart failure and poor health status. The CASA intervention involves a nurse who works with patients to treat symptoms (e.g., shortness of breath, fatigue, pain) using disease-specific and palliative approaches, and a social worker who provides psychosocial care targeting depression and adjustment to illness. The intervention uses a collaborative care team model of health care delivery and is structured and primarily phone-based to enhance reproducibility and scalability. This article describes the rationale and design of the CASA trial, including several decision points: (1) how to design a patient-centered intervention to improve health status; (2) how to structure the intervention so that it is reproducible and scalable; and (3) how to systematically identify outpatients with heart failure most likely to need and benefit from the intervention. The results should provide valuable information to providers and health systems about the use of team care to manage symptoms and provide psychosocial care in chronic illness. Published by Elsevier Inc.

  15. Effects of Rosmarinus officinalis L. on memory performance, anxiety, depression, and sleep quality in university students: A randomized clinical trial.

    Science.gov (United States)

    Nematolahi, Pouya; Mehrabani, Mitra; Karami-Mohajeri, Somayyeh; Dabaghzadeh, Fatemeh

    2018-02-01

    To evaluate the effects of oral rosemary on memory performance, anxiety, depression, and sleep quality in university students. In this double-blinded randomized controlled trial, the 68 participating students randomly received 500 mg rosemary and placebo twice daily for one month. Prospective and retrospective memory performance, depression, anxiety and sleep quality of the students were measured using Prospective and Retrospective Memory Questionnaire, Hospital Anxiety and Depression Scale, and Pittsburgh Sleep Quality Inventory at baseline and after one month. The scores of all the scales and subscales except the sleep latency and sleep duration components of Pittsburgh Sleep Quality Inventory were significantly decreased in the rosemary group in comparison with the control group after one month. Rosemary as a traditional herb could be used to boost prospective and retrospective memory, reduce anxiety and depression, and improve sleep quality in university students. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. Depression (PDQ)

    Science.gov (United States)

    ... Data Conducting Clinical Trials Statistical Tools and Data Terminology Resources NCI Data Catalog Cryo-EM NCI's Role ... that may also cause depression. There are many medical conditions that can cause depression. Medical conditions that ...

  17. Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Dabholkar Hamid

    2011-01-01

    Full Text Available Abstract Background There is a large treatment gap with few community services for people with schizophrenia in low income countries largely due to the shortage of specialist mental healthcare human resources. Community based rehabilitation (CBR, involving lay health workers, has been shown to be feasible, acceptable and more effective than routine care for people with schizophrenia in observational studies. The aim of this study is to evaluate whether a lay health worker led, Collaborative Community Based Care (CCBC intervention, combined with usual Facility Based Care (FBC, is superior to FBC alone in improving outcomes for people with schizophrenia and their caregivers in India. Methods/Design This trial is a multi-site, parallel group randomised controlled trial design in India. The trial will be conducted concurrently at three sites in India where persons with schizophrenia will be screened for eligibility and recruited after providing informed consent. Trial participants will be randomly allocated in a 2:1 ratio to the CCBC+FBC and FBC arms respectively using an allocation sequence pre-prepared through the use of permuted blocks, stratified within site. The structured CCBC intervention will be delivered by trained lay community health workers (CHWs working together with the treating Psychiatrist. We aim to recruit 282 persons with schizophrenia. The primary outcomes are reduction in severity of symptoms of schizophrenia and disability at 12 months. The study will be conducted according to good ethical practice, data analysis and reporting guidelines. Discussion If the additional CCBC intervention delivered by front line CHWs is demonstrated to be effective and cost-effective in comparison to usually available care, this intervention can be scaled up to expand coverage and improve outcomes for persons with schizophrenia and their caregivers in low income countries. Trial registration The trial is registered with the International Society

  18. Collaborative stepped care for anxiety disorders in primary care: aims and design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Spinhoven Philip

    2009-09-01

    Full Text Available Abstract Background Panic disorder (PD and generalized anxiety disorder (GAD are two of the most disabling and costly anxiety disorders seen in primary care. However, treatment quality of these disorders in primary care generally falls beneath the standard of international guidelines. Collaborative stepped care is recommended for improving treatment of anxiety disorders, but cost-effectiveness of such an intervention has not yet been assessed in primary care. This article describes the aims and design of a study that is currently underway. The aim of this study is to evaluate effects and costs of a collaborative stepped care approach in the primary care setting for patients with PD and GAD compared with care as usual. Methods/design The study is a two armed, cluster randomized controlled trial. Care managers and their primary care practices will be randomized to deliver either collaborative stepped care (CSC or care as usual (CAU. In the CSC group a general practitioner, care manager and psychiatrist work together in a collaborative care framework. Stepped care is provided in three steps: 1 guided self-help, 2 cognitive behavioral therapy and 3 antidepressant medication. Primary care patients with a DSM-IV diagnosis of PD and/or GAD will be included. 134 completers are needed to attain sufficient power to show a clinically significant effect of 1/2 SD on the primary outcome measure, the Beck Anxiety Inventory (BAI. Data on anxiety symptoms, mental and physical health, quality of life, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months. Discussion It is hypothesized that the collaborative stepped care intervention will be more cost-effective than care as usual. The pragmatic design of this study will enable the researchers to evaluate what is possible in real clinical practice, rather than under ideal circumstances. Many requirements for a high quality trial are being met. Results of

  19. Reducing depression during the menopausal transition with health coaching: Results from the healthy menopausal transition randomised controlled trial.

    Science.gov (United States)

    Almeida, Osvaldo P; Marsh, Kylie; Murray, Karen; Hickey, Martha; Sim, Moira; Ford, Andrew; Flicker, Leon

    2016-10-01

    To determine if health coaching (HC) decreases the incidence of depression, reduces the severity of symptoms, and increases quality of life during the menopausal transition (MT). Parallel, single-blinded, randomised controlled trial of 6 sessions of phone-delivered HC compared with usual care. Participants were 351 community-dwelling women free of major depression going through the MT, of whom 180 were assigned the intervention and 171 usual care. The primary outcome of interest was the incidence of clinically significant depressive symptoms over 52 weeks. Other study measures included the Hospital Anxiety and Depression Scale, quality of life (SF-12), the Menopause Rating Scale (MRS), diet, body mass index, alcohol use, smoking and physical activity. We considered that women with Patient Health Questionnaire (PHQ-9) scores between 5 and 14 (inclusive) had sub-threshold depressive symptoms. Nine women developed clinically significant symptoms of depression during the study-2 had been assigned HC (odds ratio, OR=0.26, 95%CI=0.05, 1.29; p=0.099). Intention-to-treat showed that, compared with usual care, the intervention led to a greater decline in depressive scores, most markedly for participants with sub-threshold depressive symptoms. Similar, but less pronounced, benefits were noticed for anxiety scores and the mental component summary of the SF-12. The intervention led to a decline in MRS scores by week 26 and subtle improvements in body mass, consumption of vegetables and smoking. HC addressing relevant risk factors for depression during the MT improves mental health measures. Our findings indicate that women with sub-threshold depressive symptoms may benefit the most from such interventions, and suggest that HC could play a useful role in minimizing mental health disturbance for women going through the MT. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  20. A comparison of patients with major depressive disorder recruited through newspaper advertising versus consultation referrals for clinical drug trials.

    Science.gov (United States)

    Miller, C A; Hooper, C L; Bakish, D

    1997-01-01

    Difficulties in recruiting patients for clinical trials have plagued investigators for many years. One concern is the generalizability of clinical trial results to community practice, that is, whether volunteers recruited through advertising are homogeneous with those seeking treatment in a clinical setting. This article retrospectively compares the baseline characteristics of patients recruited through newspaper advertisements with those recruited through consultation referrals by reviewing the charts of 54 patients enrolled in two clinical trials for major depressive disorder (MDD). We examined demographic data, background information, clinical histories, and baseline status. Results indicated homogeneity for most variables. The consultation group was significantly more likely to have had previous treatment for the current episode of depression. These results suggest that, although the advertisement and consultation groups were very similar, the drug naivety of the advertisement group may make them a preferred source in terms of generalizability to community practice.

  1. Treatment of chronically depressed patients: A multisite randomized controlled trial testing the effectiveness of 'Cognitive Behavioral Analysis System of Psychotherapy' (CBASP for chronic depressions versus usual secondary care

    Directory of Open Access Journals (Sweden)

    Penninx Brenda WJH

    2008-03-01

    Full Text Available Abstract Background 'Cognitive Behavioral Analysis System of Psychotherapy' (CBASP is a form of psychotherapy specifically developed for patients with chronic depression. In a study in the U.S., remarkable favorable effects of CBASP have been demonstrated. However, no other studies have as yet replicated these findings and CBASP has not been tested outside the United States. This protocol describes a randomized controlled trial on the effectiveness of CBASP in the Netherlands. Methods/Design The purpose of the present paper is to report the study protocol of a multisite randomized controlled trial testing the effectiveness of 'Cognitive Behavioral Analysis System of Psychotherapy' (CBASP for chronic depression in the Netherlands. In this study, CBASP in combination with medication, will be tested versus usual secondary care in combination with medication. The aim is to recruit 160 patients from three mental health care organizations. Depressive symptoms will be assessed at baseline, after 8 weeks, 16 weeks, 32 weeks and 52 weeks, using the 28-item Inventory for Depressive Symptomatology (IDS. Effect modification by co morbid anxiety, alcohol consumption, general and social functioning and working alliance will be tested. GEE analyses of covariance, controlling for baseline value and center will be used to estimate the overall treatment effectiveness (difference in IDS score at post-treatment and follow up. The primary analysis will be by 'intention to treat' using double sided tests. An economic analysis will compare the two groups in terms of mean costs and cost-effectiveness from a societal perspective. Discussion The study will provide an answer to the question whether the favorable effects of CBASP can be replicated outside the US. Trial Registration The Dutch Cochrane Center, NTR1090.

  2. Vitamin D Supplementation Affects the Beck Depression Inventory, Insulin Resistance, and Biomarkers of Oxidative Stress in Patients with Major Depressive Disorder: A Randomized, Controlled Clinical Trial.

    Science.gov (United States)

    Sepehrmanesh, Zahra; Kolahdooz, Fariba; Abedi, Fatemeh; Mazroii, Navid; Assarian, Amin; Asemi, Zatollah; Esmaillzadeh, Ahmad

    2016-02-01

    Vitamin D may decrease depression symptoms through its beneficial effects on neurotransmitters, metabolic profiles, biomarkers of inflammation, and oxidative stress. This study was designed to assess whether vitamin D supplementation can reduce symptoms of depression, metabolic profiles, serum high-sensitivity C-reactive protein (hs-CRP), and biomarkers of oxidative stress in patients with major depressive disorder (MDD). This randomized, double-blind, placebo-controlled clinical trial was performed in 40 patients between 18 and 65 y of age with a diagnosis of MDD based on criteria from the Diagnostic and Statistical Manual of Mental Disorders. Patients were randomly assigned to receive either a single capsule of 50 kIU vitamin D/wk (n = 20) or placebo (n = 20) for 8 wk. Fasting blood samples were taken at baseline and postintervention to quantify relevant variables. The primary [Beck Depression Inventory (BDI), which examines depressive symptoms] and secondary (glucose homeostasis variables, lipid profiles, hs-CRP, and biomarkers of oxidative stress) outcomes were assessed. Baseline concentrations of mean serum 25-hydroxyvitamin D were significantly different between the 2 groups (9.2 ± 6.0 and 13.6 ± 7.9 μg/L in the placebo and control groups, respectively, P = 0.02). After 8 wk of intervention, changes in serum 25-hydroxyvitamin D concentrations were significantly greater in the vitamin D group (+20.4 μg/L) than in the placebo group (-0.9 μg/L, P stress. This trial was registered at www.irct.ir as IRCT201412065623N29. © 2016 American Society for Nutrition.

  3. Computerised cognitive behavioural therapy for the treatment of depression in people with multiple sclerosis: external pilot trial

    Directory of Open Access Journals (Sweden)

    Cooper Cindy L

    2011-12-01

    Full Text Available Abstract Background People with multiple sclerosis (MS are at high risk of depression. We undertook a pilot trial of computerised cognitive behavioural therapy (CCBT for the treatment of depression in people with MS to test the feasibility of undertaking a full trial. Methods Participants with a diagnosis of MS and clinical levels of depression were recruited through out-patient clinics and postal screening questionnaires at two UK centres and randomised to CCBT or usual care. Clinical outcomes included the Beck Depression Inventory (BDI-II and Multiple Sclerosis Impact Scale (MSIS-29 at baseline, 8 and 21 weeks. Feasibility outcomes included: recruitment rate; reasons for refusal, withdrawal and dropout; feasibility and acceptability of the proposed outcome measures; sample size estimation and variation in and preferences for service delivery. Results Twenty-four participants were recruited. The recruitment rate, calculated as the proportion of those invited to fill in a screening questionnaire who were consented into the trial, was 4.1%. Recruitment through out-patient clinics was somewhat slower than through screening questionnaire mail-out but the overall recruitment yield was similar. Of the 12 patients in the CCBT arm, 9 (75% completed at least four, and 6 completed all 8 CCBT sessions. For completers, the median time (IQR to complete all eight CCBT sessions was 15 (13 to 20 weeks. Participants expressed concern about the face validity of the Beck Depression Inventory II for the measurement of self-reported depression in people with MS. The MSIS-29 was the patient-reported outcome measure which participants felt best reflected their concerns. The estimated sample size for a full trial is between 180 and 390 participants. NHS partners were not delivering CCBT in community facilities and participants preferred to access CCBT at home, with no one expressing a preference for use of CCBT in an alternative location. Conclusions A definitive

  4. Collaborative multicenter trials in Latin America: challenges and opportunities in orthopedic and trauma surgery.

    Science.gov (United States)

    Moraes, Vinicius Ynoe de; Belloti, Joao Carlos; Faloppa, Flavio; Bhandari, Mohit

    2013-01-01

    CONTEXT AND OBJECTIVE Orthopedic research agendas should be considered from a worldwide perspective. Efforts should be planned as the means for obtaining evidence that is valid for health promotion with global outreach. DESIGN AND SETTING Exploratory study conducted at Universidade Federal de São Paulo (Unifesp), São Paulo, Brazil, and McMaster University, Hamilton, Canada. METHODS We identified and analyzed collaborative and multicenter research in Latin America, taking into account American and Canadian efforts as the reference points. We explored aspects of the data available from official sources and used data from traffic accidents as a model for discussing collaborative research in these countries. RESULTS The evaluation showed that the proportion of collaborative and multicenter studies in our setting is small. A brief analysis showed that the death rate due to traffic accidents is very high. Thus, it seems clear to us that initiatives involving collaborative studies are important for defining and better understanding the patterns of injuries resulting from orthopedic trauma and the forms of treatment. Orthopedic research may be an important tool for bringing together orthopedic surgeons, researchers and medical societies for joint action. CONCLUSIONS We have indicated some practical guidelines for initiatives in collaborative research and have proposed some solutions with a summarized plan of action for conducting evidence-based research involving orthopedic trauma.

  5. Efficacy and Safety of Electroacupuncture on Treating Depression Related Sleep Disorders: Study Protocol of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Xuan Yin

    2016-01-01

    Full Text Available Background. Depression is frequently accompanied by sleep disturbances including insomnia. Insomnia may persist even after mood symptoms have been adequately treated. Acupuncture is considered to be beneficial to adjust the state of body and mind and restore the normal sleep-awake cycle. This trial is aimed at evaluating the efficacy and safety of electroacupuncture on treating insomnia in patients with depression. Methods. We describe a protocol for a randomized, single-blinded, sham controlled trial. Ninety eligible patients will be randomly assigned to one of 3 treatment groups: treatment group (acupuncture, control A group (superficial acupuncture at sham points, and control B group (sham acupuncture. All treatment will be given 3 times per week for 8 weeks. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI. The secondary outcomes are sleep parameters recorded in the Actigraphy, Hamilton Rating Scale for Depression (HAMD, and Self-Rating Depression Scale (SDS. All adverse effects will be accessed by the Treatment Emergent Symptom Scale (TESS. Outcomes will be evaluated at baseline, 4 weeks after treatment, 8 weeks after treatment, and 4 weeks of follow-up. Ethics. This trial has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2015SHL-KY-21 and is registered with ChiCTR-IIR-16008058.

  6. RAndomised controlled trial to imProve depressIon and the quality of life of people with Dementia using cognitive bias modification: RAPID study protocol.

    Science.gov (United States)

    Almeida, Osvaldo P; MacLeod, Colin; Flicker, Leon; Ford, Andrew; Grafton, Ben; Etherton-Beer, Christopher

    2014-07-23

    Depressive symptoms are common and undermine the quality of life of people with Alzheimer's disease (AD). Cholinesterase inhibitors and antidepressants have all but no effect on the mood of patients, and their use increases adverse events. Cognitive bias modification (CBM) targets attentional and interpretative biases associated with anxiety, dysphoria and depression and may be useful to treat depression in AD (DAD). This trial aims to determine the effect of CBM on depression scores and the quality of life of people with DAD. Randomised, double-blind, parallel, controlled trial of CBM (1:1 allocation ratio). Participants will be 80 adults with probable AD living in the Western Australian community who score 8 or more on the Cornell Scale for Depression in Dementia (CSDD). They will have mild to moderate dementia (Mini-Mental State Examination-MMSE score ≥15) and will be free of severe sensory impairment or suicidal intent. The intervention will consist of 10 40 min sessions of CBM delivered over 2 weeks using a high-resolution monitor using a local computer station at the Western Australian Centre for Health and Ageing. The primary outcomes of interest are the 2-week change, from baseline, in the severity of CSDD scores and the Quality of Life AD (QoL-AD) scores. Secondary outcomes include changes in the CSDD, QoL-AD after 12 weeks, and changes in MMSE scores, negative attentional and interpretative bias and the proportion of participants with CSDD principles of the Declaration of Helsinki and participants will provide written informed consent. The Ethics Committee of the Royal Perth Hospital will approve and oversee the study (REG14-036). The results of this trial will provide level 2 evidence of efficacy for CBM as a treatment of DAD. Australian and New Zealand Clinical Trials Registry number ACTRN12614000420640, date registered 06/04/2014. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence

  7. Brief cognitive behavioral therapy compared to general practitioners care for depression in primary care: a randomized trial

    Science.gov (United States)

    2010-01-01

    Background Depressive disorders are highly prevalent in primary care (PC) and are associated with considerable functional impairment and increased health care use. Research has shown that many patients prefer psychological treatments to pharmacotherapy, however, it remains unclear which treatment is most optimal for depressive patients in primary care. Methods/Design A randomized, multi-centre trial involving two intervention groups: one receiving brief cognitive behavioral therapy and the other receiving general practitioner care. General practitioners from 109 General Practices in Nijmegen and Amsterdam (The Netherlands) will be asked to include patients aged between 18-70 years presenting with depressive symptomatology, who do not receive an active treatment for their depressive complaints. Patients will be telephonically assessed with the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) to ascertain study eligibility. Eligible patients will be randomized to one of two treatment conditions: either 8 sessions of cognitive behavioral therapy by a first line psychologist or general practitioner's care according to The Dutch College of General Practitioners Practice Guideline (NHG- standaard). Baseline and follow-up assessments are scheduled at 0, 6, 12 and 52 weeks following the start of the intervention. Primary outcome will be measured with the Hamilton Depression Rating Scale-17 (HDRS-17) and the Patient Health Questionnaire-9 (PHQ-9). Outcomes will be analyzed on an intention to treat basis. Trial Registration ISRCTN65811640 PMID:20939917

  8. Efficacy of psychodynamic short-term psychotherapy for depressed breast cancer patients: study protocol for a randomized controlled trial

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    Zwerenz Rüdiger

    2012-12-01

    Full Text Available Abstract Background There is a lack of psychotherapeutic trials of treatments of comorbid depression in cancer patients. Our study determines the efficacy of a manualized short-term psychodynamic psychotherapy and predictors of outcome by personality and quality of the therapeutic relationship. Methods/design Eligible breast cancer patients with comorbid depression are assigned to short-term psychodynamic psychotherapy (up to 20 + 5 sessions or to treatment as usual (augmented by recommendation for counseling center and physician information. We plan to recruit a total of 180 patients (90 per arm in two centers. Assessments are conducted pretreatment, after 6 (treatment termination and 12 months (follow-up. The primary outcome measures are reduction of the depression score in the Hospital Anxiety and Depression Scale and remission of depression as assessed by means of the Structured Clinical Interview for DSM IV Disorders by independent, blinded assessors at treatment termination. Secondary outcomes refer to quality of life. Discussion We investigate the efficacy of short-term psychodynamic psychotherapy in acute care and we aim to identify predictors for acceptance and success of treatment. Trial registration ISRCTN96793588

  9. Psychological treatment of depression and anxiety in patients with co-morbid personality disorder: A scoping study of trial evidence.

    Science.gov (United States)

    French, L R M; Turner, K M; Dawson, S; Moran, P

    2017-05-01

    It is unclear what the best psychological treatment is for depression and anxiety in people with co-morbid personality disorder. Trials of different psychological treatment options for this patient group have been conducted, but this evidence has not previously been systematically reviewed or critically appraised. We set out to conduct a scoping review in order to describe which psychological therapies appear most effective in treating depression and/or anxiety in patients with co-morbid personality disorder. PsycINFO, Cochrane library trials, Medline and Embase databases were searched for studies involving randomized, controlled, experimental, parallel-arm comparisons, examining any well-defined, psychotherapeutic intervention for adults, in an outpatient setting, with a clearly defined diagnosis of depression and/or anxiety, and co-morbid personality disorder. A total of 1662 papers were identified. Fifteen met criteria for inclusion and were reviewed. There was weak evidence to support the use of cognitive behavioural therapy as a psychological treatment for depression in patients with co-morbid personality disorder. However, the literature is characterized by considerable methodological heterogeneity, and further research is needed before there is sufficient evidence to indicate which psychological treatment would be most effective in treating anxiety and/or depression in this patient group. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  10. A randomised controlled trial of cognitive behaviour therapy in adolescents with major depression treated by selective serotonin reuptake inhibitors. The ADAPT trial.

    Science.gov (United States)

    Goodyer, I M; Dubicka, B; Wilkinson, P; Kelvin, R; Roberts, C; Byford, S; Breen, S; Ford, C; Barrett, B; Leech, A; Rothwell, J; White, L; Harrington, R

    2008-05-01

    To determine if, in the short term, depressed adolescents attending routine NHS Child and Adolescent Mental Health Services (CAMHS), and receiving ongoing active clinical care, treatment with selective serotonin reuptake inhibitors (SSRIs) plus cognitive behaviour therapy (CBT) compared with SSRI alone, results in better healthcare outcomes. A pragmatic randomised controlled trial (RCT) was conducted on depressed adolescents attending CAMHS who had not responded to a psychosocial brief initial intervention (BII) prior to randomisation. Six English CAMHS participated in the study. A total of 208 patients aged between 11 and 17 years were recruited and randomised. All participants received active routine clinical care in a CAMHS outpatient setting and an SSRI and half were offered CBT. The duration of the trial was a 12-week treatment phase, followed by a 16-week maintenance phase. Follow-up assessments were at 6, 12 and 28 weeks. The primary outcome measure was the Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA). Secondary outcome measures were self-report depressive symptoms, interviewer-rated depressive signs and symptoms, interviewer-rated psychosocial impairment and clinical global impression of response to treatment. Information on resource use was collected in interview at baseline and at the 12- and 28-week follow-up assessments using the Child and Adolescent Service Use Schedule (CA-SUS). Of the 208 patients randomised, 200 (96%) completed the trial to the primary end-point at 12 weeks. By the 28-week follow-up, 174 (84%) participants were re-evaluated. Overall, 193 (93%) participants had been assessed at one or more time points. Clinical characteristics indicated that the trial was conducted on a severely depressed group. There was significant recovery at all time points in both arms. The findings demonstrated no difference in treatment effectiveness for SSRI + CBT over SSRI only for the primary or secondary outcome measures at

  11. Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial.

    Science.gov (United States)

    Chatterjee, Sudipto; Leese, Morven; Koschorke, Mirja; McCrone, Paul; Naik, Smita; John, Sujit; Dabholkar, Hamid; Goldsmith, Kimberley; Balaji, Madhumitha; Varghese, Mathew; Thara, Rangaswamy; Patel, Vikram; Thornicroft, Graham

    2011-01-13

    There is a large treatment gap with few community services for people with schizophrenia in low income countries largely due to the shortage of specialist mental healthcare human resources. Community based rehabilitation (CBR), involving lay health workers, has been shown to be feasible, acceptable and more effective than routine care for people with schizophrenia in observational studies. The aim of this study is to evaluate whether a lay health worker led, Collaborative Community Based Care (CCBC) intervention, combined with usual Facility Based Care (FBC), is superior to FBC alone in improving outcomes for people with schizophrenia and their caregivers in India. This trial is a multi-site, parallel group randomised controlled trial design in India.The trial will be conducted concurrently at three sites in India where persons with schizophrenia will be screened for eligibility and recruited after providing informed consent. Trial participants will be randomly allocated in a 2:1 ratio to the CCBC+FBC and FBC arms respectively using an allocation sequence pre-prepared through the use of permuted blocks, stratified within site. The structured CCBC intervention will be delivered by trained lay community health workers (CHWs) working together with the treating Psychiatrist. We aim to recruit 282 persons with schizophrenia. The primary outcomes are reduction in severity of symptoms of schizophrenia and disability at 12 months. The study will be conducted according to good ethical practice, data analysis and reporting guidelines. If the additional CCBC intervention delivered by front line CHWs is demonstrated to be effective and cost-effective in comparison to usually available care, this intervention can be scaled up to expand coverage and improve outcomes for persons with schizophrenia and their caregivers in low income countries. The trial is registered with the International Society for the Registration of Clinical Trials and the allocated unique ID number is ISRCTN

  12. Effects of structured exercise and pharmacotherapy vs. pharmacotherapy for adults with depressive symptoms: A randomized clinical trial.

    Science.gov (United States)

    Carneiro, Lara S F; Fonseca, António Manuel; Vieira-Coelho, Maria Augusta; Mota, Maria Paula; Vasconcelos-Raposo, José

    2015-12-01

    Physical exercise has been consistently documented as a complementary therapy in the treatment of depressive disorders. However, despite a higher prevalence among women compared to men, the trials developed in women are scarce. In addition, the optimal dosage of exercise capable of producing benefits that reduce depressive symptoms remains unclear. This clinical trial is designed to measure the effect of a structured physical exercise program as a complement to antidepressant medication in the treatment of women with depression. From July 2013 to May 2014, we implemented a randomized controlled trial (HAPPY BRAIN study). A total of 26 women (aged 50.16 ± 12.08) diagnosed with clinical depression were randomized either to a supervised aerobic exercise group (45-50 min/week three times a week for four months) plus pharmacotherapy (intervention group), or only antidepressant medication (control group). The exercise group presented a decrease in BDI-II and DASS-21 total score scales. Relatively to DASS-21, it showed a significant decrease in anxiety and stress. The exercise group when compared to a control group showed improvement in relation to physical functioning parameters between baseline and post-intervention. Moreover, anthropometric parameters presented only significant differences between groups in fat mass percentage. Nonetheless, no differences were found between groups in weight, body mass index, waist circumference, and self-esteem. Our results showed that supervised structured aerobic exercise training could be an effective adjuvant therapy for treating women with depression, reducing depressive symptomatology and improving physical fitness. A key factor of this improvement included strict control of exercise workload parameters and adjustment to each subject's capacity. In our study, due to the sample size there is an increase in the probability of type II errors. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. A randomized clinical trial to evaluate the effects of rasagiline on depressive symptoms in non-demented Parkinson's disease patients.

    Science.gov (United States)

    Barone, P; Santangelo, G; Morgante, L; Onofrj, M; Meco, G; Abbruzzese, G; Bonuccelli, U; Cossu, G; Pezzoli, G; Stanzione, P; Lopiano, L; Antonini, A; Tinazzi, M

    2015-08-01

    Depressed mood is a common psychiatric problem associated with Parkinson's disease (PD), and studies have suggested a benefit of rasagiline treatment. ACCORDO (see the ) was a 12-week, double-blind, placebo-controlled trial to evaluate the effects of rasagiline 1 mg/day on depressive symptoms and cognition in non-demented PD patients with depressive symptoms. The primary efficacy variable was the change from baseline to week 12 in depressive symptoms measured by the Beck Depression Inventory (BDI-IA) total score. Secondary outcomes included change from baseline to week 12 in cognitive function as assessed by a comprehensive neuropsychological battery; Parkinson's disease quality of life questionnaire (PDQ-39) scores; Apathy Scale scores; and Unified Parkinson's Disease Rating Scale (UPDRS) subscores. One hundred and twenty-three patients were randomized. At week 12 there was no significant difference between groups for the reduction in total BDI-IA score (primary efficacy variable). However, analysis at week 4 did show a significant difference in favour of rasagiline (marginal means difference ± SE: rasagiline -5.46 ± 0.73 vs. placebo -3.22 ± 0.67; P = 0.026). There were no significant differences between groups on any cognitive test. Rasagiline significantly improved UPDRS Parts I (P = 0.03) and II (P = 0.003) scores versus placebo at week 12. Post hoc analyses showed the statistical superiority of rasagiline versus placebo in the UPDRS Part I depression item (P = 0.04) and PDQ-39 mobility (P = 0.007) and cognition domains (P = 0.026). Treatment with rasagiline did not have significant effects versus placebo on depressive symptoms or cognition in PD patients with moderate depressive symptoms. Although limited by lack of correction for multiple comparisons, post hoc analyses signalled some improvement in patient-rated cognitive and depression outcomes. © 2015 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European

  14. Escitalopram treatment for depressive disorder following acute coronary syndrome: a 24-week double-blind, placebo-controlled trial.

    Science.gov (United States)

    Kim, Jae-Min; Bae, Kyung-Yeol; Stewart, Robert; Jung, Bo-Ok; Kang, Hee-Ju; Kim, Sung-Wan; Shin, Il-Seon; Hong, Young Joon; Kim, Ju Han; Shin, Hee-Young; Kang, Gaeun; Ahn, Youngkeun; Kim, Jong-Keun; Jeong, Myung Ho; Yoon, Jin-Sang

    2015-01-01

    Depression is common after acute coronary syndrome (ACS) and has adverse effects on prognosis. There are few evidence-based interventions for treating depression in ACS. This study investigated the efficacy and safety of escitalopram in treating depressive disorders identified 2-14 weeks after a confirmed ACS episode. A total of 217 patients with DSM-IV depressive disorders (121 major and 96 minor) and ACS were randomly assigned to receive escitalopram in flexible doses of 5-20 mg/d (n = 108) or placebo (n = 109) for 24 weeks. The study was conducted from 2007 to 2013. The primary outcome measure was the Hamilton Depression Rating Scale (HDRS). Secondary outcome measures included the Montgomery-Asberg Depression Rating Scale (MADRS), Beck Depression Inventory (BDI), Clinical Global Impressions-Severity of Illness scale (CGI-S), Social and Occupational Functioning Assessment Scale (SOFAS), and World Health Organization Disability Assessment Schedule-12. Cardiovascular safety outcomes included echocardiography, electrocardiography, laboratory test, body weight, and blood pressure results. Escitalopram was superior to placebo in reducing HDRS scores (mean difference = 2.3, P = .016, effect size = 0.38). Escitalopram was also superior to placebo in decreasing depressive symptoms evaluated by the MADRS, BDI, and CGI-S and in improving SOFAS functioning level. Escitalopram was not associated with any harmful changes in cardiovascular safety measures. Dizziness was significantly more frequently reported in the escitalopram group (P = .018), but there were no significant differences in any other adverse events. These results indicate that escitalopram has clinically meaningful antidepressant effects with no evidence of reduced cardiovascular safety in depressive disorder following ACS. ClinicalTrials.gov identifier: NCT00419471. © Copyright 2015 Physicians Postgraduate Press, Inc.

  15. Effect of peer support on prevention of postnatal depression among high risk women: multisite randomised controlled trial.

    Science.gov (United States)

    Dennis, C-L; Hodnett, E; Kenton, L; Weston, J; Zupancic, J; Stewart, D E; Kiss, A

    2009-01-15

    To evaluate the effectiveness of telephone based peer support in the prevention of postnatal depression. Multisite randomised controlled trial. Seven health regions across Ontario, Canada. 701 women in the first two weeks postpartum identified as high risk for postnatal depression with the Edinburgh postnatal depression scale and randomised with an internet based randomisation service. Proactive individualised telephone based peer (mother to mother) support, initiated within 48-72 hours of randomisation, provided by a volunteer recruited from the community who had previously experienced and recovered from self reported postnatal depression and attended a four hour training session. Edinburgh postnatal depression scale, structured clinical interview-depression, state-trait anxiety inventory, UCLA loneliness scale, and use of health services. After web based screening of 21 470 women, 701 (72%) eligible mothers were recruited. A blinded research nurse followed up more than 85% by telephone, including 613 at 12 weeks and 600 at 24 weeks postpartum. At 12 weeks, 14% (40/297) of women in the intervention group and 25% (78/315) in the control group had an Edinburgh postnatal depression scale score >12 (chi(2)=12.5, P<0.001; number need to treat 8.8, 95% confidence interval 5.9 to 19.6; relative risk reduction 0.46, 95% confidence interval 0.24 to 0.62). There was a positive trend in favour of the intervention group for maternal anxiety but not loneliness or use of health services. For ethical reasons, participants identified with clinical depression at 12 weeks were referred for treatment, resulting in no differences between groups at 24 weeks. Of the 221 women in the intervention group who received and evaluated their experience of peer support, over 80% were satisfied and would recommend this support to a friend. Telephone based peer support can be effective in preventing postnatal depression among women at high risk. ISRCTN 68337727.

  16. Early Improvement in Work Productivity Predicts Future Clinical Course in Depressed Outpatients: Findings from the CO-MED Trial

    Science.gov (United States)

    Jha, Manish K.; Minhajuddin, Abu; Greer, Tracy L.; Carmody, Thomas; Rush, A. John; Trivedi, Madhukar H.

    2018-01-01

    Objective Depression symptom severity, the most commonly studied outcome in antidepressant treatment trials, accounts for only a small portion of burden related to major depression. While lost work productivity is the biggest contributor to depression’s economic burden, few studies have systematically evaluated the independent effect of treatment on work productivity and the relationship between changes in work productivity and longer-term clinical course. Method Work productivity was measured repeatedly by the Work Productivity and Activity Impairment (WPAI) self-report in 331 employed participants with major depression enrolled in the Combining Medications to Enhance Depression Outcomes (CO-MED) trial. Trajectories of change in work productivity during the first 6 weeks of treatment were identified and used to predict remission at 3 and 7 months. Results Participants reported reduced absence from work and increased work productivity with antidepressant treatment even after controlling for changes in depression severity. Three distinct trajectories of changes in work productivity were identified: 1) robust early improvement (24%), 2) minimal change (49%), and 3) high-impairment slight reduction (27%). As compared to other participants, those with robust improvement had 3–5 times higher remission rates at 3 months and 2–5 times higher remission rates at 7 months, even after controlling for select baseline variables and remission status at week 6. Conclusions In this secondary analysis, self-reported work productivity improved in depressed patients with antidepressant treatment even after accounting for depressive symptom reduction. Early improvement in work productivity is associated with much higher remission rates after 3 and 7 months of treatment. PMID:27523501

  17. Internet-based self-help treatment for depression in multiple sclerosis: study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Boeschoten Rosa E

    2012-09-01

    Full Text Available Abstract Background Depression in MS patients is frequent but often not treated adequately. An important underlying factor may be physical limitations that preclude face-to-face contact. Internet-based treatment showed to be effective for depressive symptoms in general and could thus be a promising tool for treatment in MS. Methods/design Here, we present a study protocol to investigate the effectiveness of a 5 week Internet-based self-help problem solving treatment (PST for depressive symptoms in MS patients in a randomized controlled trial. We aim to include 166 MS patients with moderate to severe depressive symptoms who will be randomly assigned to an Internet-based intervention (with or without supportive text-messages or waiting list control group. The primary outcome is the change in depressive symptoms defined by a change in the sum score on the Beck Depression Inventory (BDI-II. Secondary outcomes will include measures of anxiety, fatigue, cognitive functioning, physical and psychological impact of MS, quality of life, problem solving skills, social support, mastery, satisfaction and compliance rate. Assessments will take place at baseline (T0, within a week after the intervention (T1, at four months (T2 and at ten months follow-up (T3: only the intervention group. The control group will be measured at the same moments in time. Analysis will be based on the intention-to-treat principle. Discussion If shown to be effective, Internet-based PST will offer new possibilities to reach and treat MS patients with depressive symptoms and to improve the quality of care. Trial Registration The Dutch Cochrane Center, NTR2772

  18. Systematic review on randomized controlled trials of coronary heart disease complicated with depression treated with Chinese herbal medicines.

    Science.gov (United States)

    Wang, An-Lu; Chen, Zhuo; Luo, Jing; Shang, Qing-Hua; Xu, Hao

    2016-01-01

    This systemic review evaluated the efficacy and safety of Chinese herbal medicines (CHMs) in patients with coronary heart disease (CHD) complicated with depression. All databases were retrieved till September 30, 2014. Randomized controlled trials (RCTs) comparing CHMs with placebo or conventional Western medicine were retrieved. Data extraction, analyses and quality assessment were performed according to the Cochrane standards. RevMan 5.3 was used to synthesize the results. Thirteen RCTs enrolling 1,095 patients were included. Subgroup analysis was used to assess data. In reducing the degree of depression, CHMs showed no statistic difference in the 4th week [mean difference (MD)=-1.06; 95% confidence interval (CI)-2.38 to 0.26; n=501; I(2)=73%], but it was associated with a statistically significant difference in the 8th week (MD=-1.00; 95% CI-1.64 to-0.36; n=436; I(2)=48%). Meanwhile, the combination therapy (CHMs together with antidepressants) showed significant statistic differences both in the 4th week (MD=-1.99; 95% CI-3.80 to-0.18; n=90) and in the 8th week (MD=-5.61; 95% CI-6.26 to-4.97; n=242; I(2)=87%). In CHD-related clinical evaluation, 3 trials reported the intervention group was superior to the control group. Four trials showed adverse events in the intervention group was less than that in the control group. CHMs showed potentially benefits on patients with CHD complicated with depression. Moreover, the effect of CHMs may be similar to or better than antidepressant in certain fields but with less side effects. However, because of small sample size and potential bias of most trials, this result should be interpreted with caution. More rigorous trials with larger sample size and higher quality are warranted to give high quality of evidence to support the use of CHMs for CHD complicated with depression.

  19. Collaborative research between academia and industry using a large clinical trial database: a case study in Alzheimer's disease

    Directory of Open Access Journals (Sweden)

    Jones Roy

    2011-10-01

    Full Text Available Abstract Background Large clinical trials databases, developed over the course of a comprehensive clinical trial programme, represent an invaluable resource for clinical researchers. Data mining projects sponsored by industry that use these databases, however, are often not viewed favourably in the academic medical community because of concerns that commercial, rather than scientific, goals are the primary purpose of such endeavours. Thus, there are few examples of sustained collaboration between leading academic clinical researchers and industry professionals in a large-scale data mining project. We present here a successful example of this type of collaboration in the field of dementia. Methods The Donepezil Data Repository comprised 18 randomised, controlled trials conducted between 1991 and 2005. The project team at Pfizer determined that the data mining process should be guided by a diverse group of leading Alzheimer's disease clinical researchers called the "Expert Working Group." After development of a list of potential faculty members, invitations were extended and a group of seven members was assembled. The Working Group met regularly with Eisai/Pfizer clinicians and statisticians to discuss the data, identify issues that were currently of interest in the academic and clinical communities that might lend themselves to investigation using these data, and note gaps in understanding or knowledge of Alzheimer's disease that these data could address. Leadership was provided by the Pfizer Clinical Development team leader; Working Group members rotated responsibility for being lead and co-lead for each investigation and resultant publication. Results Six manuscripts, each published in a leading subspecialty journal, resulted from the group's work. Another project resulted in poster presentations at international congresses and two were cancelled due to resource constraints. Conclusions The experience represents a particular approach to

  20. Improving access to geriatric mental health services: a randomized trial comparing treatment engagement with integrated versus enhanced referral care for depression, anxiety, and at-risk alcohol use.

    Science.gov (United States)

    Bartels, Stephen J; Coakley, Eugenie H; Zubritsky, Cynthia; Ware, James H; Miles, Keith M; Areán, Patricia A; Chen, Hongtu; Oslin, David W; Llorente, Maria D; Costantino, Giuseppe; Quijano, Louise; McIntyre, Jack S; Linkins, Karen W; Oxman, Thomas E; Maxwell, James; Levkoff, Sue E

    2004-08-01

    The authors sought to determine whether integrated mental health services or enhanced referral to specialty mental health clinics results in greater engagement in mental health/substance abuse services by older primary care patients. This multisite randomized trial included 10 sites consisting of primary care and specialty mental health/substance abuse clinics. Primary care patients 65 years old or older (N=24,930) were screened. The final study group consisted of 2,022 patients (mean age=73.5 years; 26% female; 48% ethnic minority) with depression (N=1,390), anxiety (N=70), at-risk alcohol use (N=414), or dual diagnosis (N=148) who were randomly assigned to integrated care (mental health and substance abuse providers co-located in primary care; N=999) or enhanced referral to specialty mental health/substance abuse clinics (i.e., facilitated scheduling, transportation, payment; N=1,023). Seventy-one percent of patients engaged in treatment in the integrated model compared with 49% in the enhanced referral model. Integrated care was associated with more mental health and substance abuse visits per patient (mean=3.04) relative to enhanced referral (mean=1.91). Overall, greater engagement was predicted by integrated care and higher mental distress. For depression, greater engagement was predicted by integrated care and more severe depression. For at-risk alcohol users, greater engagement was predicted by integrated care and more severe problem drinking. For all conditions, greater engagement was associated with closer proximity of mental health/substance abuse services to primary care. Older primary care patients are more likely to accept collaborative mental health treatment within primary care than in mental health/substance abuse clinics. These results suggest that integrated service arrangements improve access to mental health and substance abuse services for older adults who underuse these services.

  1. Recruitment to online therapies for depression: pilot cluster randomized controlled trial.

    Science.gov (United States)

    Jones, Ray B; Goldsmith, Lesley; Hewson, Paul; Williams, Christopher J

    2013-03-05

    Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake. To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues. We compared two online interventions with a control without intervention. The pilot RCT had 4 arms, each with 4 British postcode areas: (A) geographically targeted AdWords, (B) adverts placed on local websites by contacting website owners and requesting links be added, (C) both interventions, (D) control. Participants were directed to our research project website linking to two freely available online CBT resource sites (Moodgym and Living Life To The Full (LLTTF)) and two other depression support sites. We used data from (1) AdWords, (2) Google Analytics for our project website and for LLTTF, and (3) research project website. We compared two outcomes: (1) numbers with depression accessing the research project website, and then chose an onward link to one of the two CBT websites, and (2) numbers registering with LLTTF. We documented costs, and explored intervention and assessment methods to make general recommendations to inform researchers aiming to use similar methodologies in future studies. Trying to place local website links appeared much less cost effective than AdWords and although may prove useful for service delivery, was not worth pursuing in the context of the current study design. Our AdWords intervention was effective in recruiting people to the project website but our location targeting "leaked" and was not as geographically specific as claimed. The impact on online CBT was also diluted by offering participants other choices of destinations. Measuring the impact on LLTTF use was

  2. Effectiveness of Aerobic Exercise as an Augmentation Therapy for Inpatients with Major Depressive Disorder: A Preliminary Randomized Controlled Trial.

    Science.gov (United States)

    Shachar-Malach, Tal; Cooper Kazaz, Rena; Constantini, Naama; Lifschytz, Tzuri; Lerer, Bernard

    2015-01-01

    Physical exercise has been shown to reduce depressive symptoms when used in combination with antidepressant medication. We report a randomized controlled trial of aerobic exercise compared to stretching as an augmentation strategy for hospitalized patients with major depression. Male or female patients, 18-80 years, diagnosed with a Major Depressive Episode, were randomly assigned to three weeks of augmentation therapy with aerobic (n=6) or stretching exercise (n=6). Depression was rated, at several time points using the 21-item Hamilton Depression Scale (HAM-D), Beck Depression Inventory (BDI) and other scales. According to the HAM-D, there were four (out of six) responders in the aerobic group, two of whom achieved remission, and none in the stretching group. According to the BDI, there were two responders in the aerobic group who were also remitters and none in the stretching group. The results of this small study suggest that aerobic exercise significantly improves treatment outcome when added to antidepressant medication. However, due to the small sample size the results must be regarded as preliminary and further studies are needed to confirm the findings.

  3. Effectiveness of group music therapy versus recreational group singing for depressive symptoms of elderly nursing home residents: pragmatic trial.

    Science.gov (United States)

    Werner, Jasmin; Wosch, Thomas; Gold, Christian

    2017-02-01

    Several studies have suggested positive effects of music therapy in dementia, but research on age-related depression has been limited and of insufficient quality. The aim of this study was to examine the effect of interactive group music therapy versus recreational group singing on depressive symptoms in elderly nursing home residents. Residents of two German nursing homes with sufficient length of stay who were not bedridden were invited to participate in a pragmatic trial. A total of 117 participants, grouped into four clusters (based on their wards), were randomised to interactive group music therapy (n = 62; 20 units of 40 minutes, 2×/week) or recreational group singing (n = 55; 10 units of 90 minutes, 1×/week). The level of depressive symptoms was assessed using the Montgomery-Åsberg Depression Rating Scale at baseline (47% with at least mild depression) and follow-up in the 6th and 12th weeks. There was no blinding of assessors. The level of depressive symptoms improved significantly more in those assigned to music therapy (n = 60) than in recreational singing (n = 53), both in 6th week (mean difference 3.0 scores, 95% CI 1.21 to 4.79, p = 0.001) and 12th week (mean difference 4.50 scores, 95% CI 2.51 to 6.50, p elderly people in nursing homes more effectively than recreational singing.

  4. The Effect of Debriefing and Brief Cognitive-Behavioral Therapy on Postpartum Depression in Traumatic Childbirth: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Sedigheh Abdollahpour

    2018-01-01

    Full Text Available Background & aim: Childbirth is a stressful event in women’s lives, and if a mother perceives it as an unpleasant event, it can influence her postpartum mental health. Depression is a common mental disorder, which can has serious consequences depending on its severity. Therefore, this study aimed to investigate the effect of debriefing and brief cognitive-behavioral therapy on postpartum depression in traumatic childbirth. Methods: This clinical trial was performed on 179 mothers who experienced a traumatic childbirth and were admitted in postnatal ward of Nohom Dey Hospital in Torbat-e Heydarieh, North East of Iran in 2016. The subjects were randomly allocated into three groups, including two intervention groups of debriefing and brief cognitive-behavioral counseling and a control group. The intervention groups received appropriate counseling for 40-60 minutes in the first 48 postpartum hours and the control group received the routine postpartum care. Edinburgh Postnatal Depression Scale was used to evaluate postpartum depression 4-6 weeks and also three months after the intervention. Post-traumatic stress symptoms in were compared in three groups using t-test, chi-square test, and repeated measures analysis of variance. Results: No significant differences were observed between the mean depression scores of the two intervention groups and that of the control group 4-6 weeks after childbirth. However, three months after delivery, the mean depression scores of the two intervention groups was lower than the control group (P

  5. Treatment of depression after myocardial infarction and the effects on cardiac prognosis and quality of life: Rationale and outline of the Myocardial INfarction and Depression-Intervention Trial (MIND-IT)

    NARCIS (Netherlands)

    van den Brink, Rob H. S.; van Melle, Joost P.; Honig, Adriaan; Schene, Aart H.; Crijns, Harry J. G. M.; Lambert, Frank P. G.; Ormel, Johan

    2002-01-01

    Background Patients with a depressive disorder after myocardial infarction (MI) have a significantly increased risk of major cardiac events. The Myocardial INfarction and Depression-Intervention Trial (MIND-IT) investigates whether antidepressive treatment can improve the cardiac prognosis for these

  6. Treatment of depression after myocardial infarction and the effects on cardiac prognosis and quality of life : Rationale and outline of the Myocardial INfarction and Depression-Intervention Trial (MIND-IT)

    NARCIS (Netherlands)

    van den Brink, Rob H. S.; van Melle, Joost P.; Honig, A; Schene, AH; Crijns, Harry J. G. M.; Lambert, FPG; Ormel, Johan

    Background Patients with a depressive disorder after myocardial infarction (MI) have a significantly increased risk of major cardiac events. The Myocardial INfarction and Depression-Intervention Trial (MIND-IT) investigates whether antidepressive treatment can improve the cardiac prognosis for these

  7. Participation in Training for Depression Care Quality Improvement: A Randomized Trial of Community Engagement or Technical Support.

    Science.gov (United States)

    Chung, Bowen; Ngo, Victoria K; Ong, Michael K; Pulido, Esmeralda; Jones, Felica; Gilmore, James; Stoker-Mtume, Norma; Johnson, Megan; Tang, Lingqi; Wells, Kenneth Brooks; Sherbourne, Cathy; Miranda, Jeanne

    2015-08-01

    Community engagement and planning (CEP) could improve dissemination of depression care quality improvement in underresourced communities, but whether its effects on provider training participation differ from those of standard technical assistance, or resources for services (RS), is unknown. This study compared program- and staff-level participation in depression care quality improvement training among programs enrolled in CEP, which trained networks of health care and social-community agencies jointly, and RS, which provided technical support to individual programs. Matched programs from health care and social-community service sectors in two communities were randomly assigned to RS or CEP. Data were from 1,622 eligible staff members from 95 enrolled programs. Primary outcomes were any staff trained (for programs) and total hours of training (for staff). Secondary staff-level outcomes were hours of training in specific depression collaborative care components. CEP programs were more likely than RS programs to participate in any training (p=.006). Within health care sectors, CEP programs were more likely than RS programs to participate in training (p=.016), but within social-community sectors, there was no difference in training by intervention. Among staff who participated in training, mean training hours were greater among CEP programs versus RS programs for any type of training (ptraining related to each component of depression care (p<.001) except medication management. CEP may be an effective strategy to promote staff participation in depression care improvement efforts in underresourced communities.

  8. Comparison of paroxetine and agomelatine in depressed type 2 diabetes mellitus patients: a double-blind, randomized, clinical trial

    Directory of Open Access Journals (Sweden)

    Kang RY

    2015-05-01

    Full Text Available Ruiying Kang,1 Yan He,1 Yuxiang Yan,1 Zhiwu Li,2 Yeqing Wu,3 Xiaojuan Guo,4 Zhigang Liang,5 Jun Jiang2 1Department of Epidemiology and Biostatics, School of Public Health, Capital Medical University, Beijing, People’s Republic of China; 2Fengtai Nanyuan Hospital of Beijing, Beijing, People’s Republic of China; 3Fengtai District Community Health Center, Beijing, People’s Republic of China; 4Department of Preventive Medicine, School of Environmental and Public Health, Wenzhou Medical University, Wenzhou, People’s Republic of China; 5Xuanwu Hospital, Capital Medical University, Beijing, People’s Republic of China Background: Comorbid depression/anxiety in type 2 diabetes mellitus (DM patients is highly prevalent, affecting both diabetes control and quality of life. However, the best treating method for depression/anxiety in type 2 DM patients is still unclear. This study was conducted to compare the efficacy of paroxetine and agomelatine on depression/anxiety and metabolic control of type 2 DM patients.Methods: A total of 116 depressed, type 2 DM patients were recruited for 12 weeks treatment. Patients were randomly assigned to receive either paroxetine or agomelatine. Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale were used to assess depression and anxiety, respectively. Hemoglobin A1c, fasting plasma glucose, and body mass index were assessed at baseline and at the end of the trial.Results: At the end of the trial, there were 34 (60.7% responders and 22 (39.3% remissions in paroxetine group; and 38 (63.3% responders and 26 (43.3% remissions in agomelatine group. Compared to paroxetine group, lower depression scores were observed in agomelatine group. Fasting plasma glucose and body mass index were not significantly different after 12 weeks treatment between the two groups, but agomelatine group had a significantly lower final hemoglobin A1c level compared to paroxetine group. The two antidepressants had comparable

  9. Implementation of Treat-to-Target in Rheumatoid Arthritis Through a Learning Collaborative: Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Solomon, Daniel H; Losina, Elena; Lu, Bing; Zak, Agnes; Corrigan, Cassandra; Lee, Sara B; Agosti, Jenifer; Bitton, Asaf; Harrold, Leslie R; Pincus, Theodore; Radner, Helga; Yu, Zhi; Smolen, Josef S; Fraenkel, Liana; Katz, Jeffrey N

    2017-07-01

    Treat-to-target (TTT) is an accepted paradigm for the management of rheumatoid arthritis (RA), but some evidence suggests poor adherence. The purpose of this study was to test the effects of a group-based multisite improvement learning collaborative on adherence to TTT. We conducted a cluster-randomized quality-improvement trial with waitlist control across 11 rheumatology sites in the US. The intervention entailed a 9-month group-based learning collaborative that incorporated rapid-cycle improvement methods. A composite TTT implementation score was calculated as the percentage of 4 required items documented in the visit notes for each patient at 2 time points, as evaluated by trained staff. The mean change in the implementation score for TTT across all patients for the intervention sites was compared with that for the control sites after accounting for intracluster correlation using linear mixed models. Five sites with a total of 23 participating rheumatology providers were randomized to intervention and 6 sites with 23 participating rheumatology providers were randomized to the waitlist control. The intervention included 320 patients, and the control included 321 patients. At baseline, the mean TTT implementation score was 11% in both arms; after the 9-month intervention, the mean TTT implementation score was 57% in the intervention group and 25% in the control group (change in score of 46% for intervention and 14% for control; P = 0.004). We did not observe excessive use of resources or excessive occurrence of adverse events in the intervention arm. A learning collaborative resulted in substantial improvements in adherence to TTT for the management of RA. This study supports the use of an educational collaborative to improve quality. © 2017, American College of Rheumatology.

  10. Functional Outcomes of the Low Vision Depression Prevention Trial in Age-Related Macular Degeneration.

    Science.gov (United States)

    Deemer, Ashley D; Massof, Robert W; Rovner, Barry W; Casten, Robin J; Piersol, Catherine V

    2017-03-01

    To compare the efficacy of behavioral activation (BA) plus low vision rehabilitation with an occupational therapist (OT-LVR) with supportive therapy (ST) on visual function in patients with age-related macular degeneration (AMD). Single-masked, attention-controlled, randomized clinical trial with AMD patients with subsyndromal depressive symptoms (n = 188). All subjects had two outpatient low vision rehabilitation optometry visits, then were randomized to in-home BA + OT-LVR or ST. Behavioral activation is a structured behavioral treatment aiming to increase adaptive behaviors and achieve valued goals. Supportive therapy is a nondirective, psychological treatment that provides emotional support and controls for attention. Functional vision was assessed with the activity inventory (AI) in which participants rate the difficulty level of goals and corresponding tasks. Participants were assessed at baseline and 4 months. Improvements in functional vision measures were seen in both the BA + OT-LVR and ST groups at the goal level (d = 0.71; d = 0.56 respectively). At the task level, BA + OT-LVR patients showed more improvement in reading, inside-the-home tasks and outside-the-home tasks, when compared to ST patients. The greatest effects were seen in the BA + OT-LVR group in subjects with a visual acuity ≥20/70 (d = 0.360 reading; d = 0.500 inside the home; d = 0.468 outside the home). Based on the trends of the AI data, we suggest that BA + OT-LVR services, provided by an OT in the patient's home following conventional low vision optometry services, are more effective than conventional optometric low vision services alone for those with mild visual impairment. (ClinicalTrials.gov number, NCT00769015.).

  11. Initial Severity and Differential Treatment Outcome in the National Institute of Mental Health Treatment of Depression Collaborative Research Program.

    Science.gov (United States)

    Elkin, Irene; And Others

    1995-01-01

    Random regression models were used to investigate the role of initial severity in the outcome of four treatments for major depression: cognitive behavioral therapy, interpersonal psychotherapy, imipramine plus clinical management, and placebo plus clinical management. Initial severity of depression and impairment of functioning significantly…

  12. Exploration of the Pathways to Delinquency for Female Adolescents with Depression: Implications for Cross-Systems Collaboration and Counseling

    Science.gov (United States)

    Mellin, Elizabeth A.; Fang, Hong-Ning

    2010-01-01

    This study found that lack of involvement in prosocial institutions, affiliation with other troubled youth, and indifference regarding personal safety partially mediate the relationship between depression and delinquency among justice-involved female adolescents. The results suggest that depression may not be the primary conduit to delinquency.…

  13. Case management for the treatment of patients with major depression in general practices – rationale, design and conduct of a cluster randomized controlled trial – PRoMPT (Primary care Monitoring for depressive Patient's Trial [ISRCTN66386086] – Study protocol

    Directory of Open Access Journals (Sweden)

    Krauth Christian

    2005-10-01

    Full Text Available Abstract Background Depression is a disorder with high prevalence in primary health care and a significant burden of illness. The delivery of health care for depression, as well as other chronic illnesses, has been criticized for several reasons and new strategies to address the needs of these illnesses have been advocated. Case management is a patient-centered approach which has shown efficacy in the treatment of depression in highly organized Health Maintenance Organization (HMO settings and which might also be effective in other, less structured settings. Methods/Design PRoMPT (PRimary care Monitoring for depressive Patients Trial is a cluster randomised controlled trial with General Practice (GP as the unit of randomisation. The aim of the study is to evaluate a GP applied case-management for patients with major depressive disorder. 70 GPs were randomised either to intervention group or to control group with the control group delivering usual care. Each GP will include 10 patients suffering from major depressive disorder according to the DSM-IV criteria. The intervention group will receive treatment based on standardized guidelines and monthly telephone monitoring from a trained practice nurse. The nurse investigates the patient's status concerning the MDD criteria, his adherence to GPs prescriptions, possible side effects of medication, and treatment goal attainment. The control group receives usual care – including recommended guidelines. Main outcome measure is the cumulative score of the section depressive disorders (PHQ-9 from the German version of the Prime MD Patient Health Questionnaire (PHQ-D. Secondary outcome measures are the Beck-Depression-Inventory, self-reported adherence (adapted from Moriskey and the SF-36. In addition, data are collected about patients' satisfaction (EUROPEP-tool, medication, health care utilization, comorbidity, suicide attempts and days out of work. The study comprises three assessment times: baseline

  14. DEMO-II trial. Aerobic exercise versus stretching exercise in patients with major depression-a randomised clinical trial

    DEFF Research Database (Denmark)

    Krogh, Jesper; Videbech, Poul; Thomsen, Carsten

    2012-01-01

    The effect of referring patients from a clinical setting to a pragmatic exercise intervention for depressive symptoms, cognitive function, and metabolic variables has yet to be determined.......The effect of referring patients from a clinical setting to a pragmatic exercise intervention for depressive symptoms, cognitive function, and metabolic variables has yet to be determined....

  15. Trial for the Prevention of Depression (TriPoD) in final-year secondary students: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Perry, Yael; Calear, Alison L; Mackinnon, Andrew; Batterham, Philip J; Licinio, Julio; King, Catherine; Thomsen, Noel; Scott, Jan; Donker, Tara; Merry, Sally; Fleming, Theresa; Stasiak, Karolina; Werner-Seidler, Aliza; Christensen, Helen

    2015-10-12

    Evidence suggests that current treatments cannot fully alleviate the burden of disease associated with depression but that prevention approaches offer a promising opportunity to further reduce this burden. Adolescence is a critical period in the development of mental illness, and final school examinations are a significant and nearly universal stressor that may act as a trigger for mental health difficulties such as depression. The aim of the present trial is to investigate the impact of SPARX-R, an online, gamified intervention based on cognitive behavioural principles, on the prevention of depression in secondary school students before their final examinations. Government, independent and Catholic secondary schools in New South Wales, Australia, will be recruited to participate in the trial. All students enrolled in their final year of high school (year 12) in participating schools will be invited to participate. To account for possible attrition, the target sample size was set at 1600 participants across 30 schools. Participating schools will be cluster randomised at the school level to receive either SPARX-R or lifeSTYLE, an attention-controlled placebo comparator. The control intervention is an online program aimed at maintaining a healthy lifestyle. The primary outcome will be symptoms of depression, and secondary outcomes will include symptoms of anxiety, suicidal ideation and behaviours, stigma and academic performance. Additional measures of cost-effectiveness, as well as process variables (e.g., adherence, acceptability) and potential predictors of response to treatment, will be collected. Consenting parents will be invited to complete measures regarding their own mental health and expectations for their child. Assessments will be conducted pre- and post-intervention and at 6- and 18-month follow-up. Primary analyses will compare changes in levels of depressive symptomatology for the intervention group relative to the attention control condition using

  16. No association between anxiety and depression and adverse clinical outcome among patients with cardiovascular disease: findings from the DANREHAB trial.

    Science.gov (United States)

    Kornerup, Henriette; Zwisler, Ann-Dorthe Olsen; Prescott, Eva

    2011-10-01

    Anxiety and depression have been linked to adverse prognostic outcome in patients with cardiovascular disease (CVD) with mixed results. The timing of anxiety and depression measurement has received little attention so far. The study sample consisted of 536 patients admitted to hospital for CVD and followed in a rehabilitation trial. Symptoms were assessed using the Hospital Anxiety and Depression Scale at baseline and after 1 year. Cox proportional hazards model was used to describe the association between anxiety and depression and adverse outcome (myocardial infarction (MI), heart failure (HF), stroke, death and a combined endpoint) after 5 years. Prevalence of anxiety and depression at baseline was 32% and 13%, respectively. There were 303 combined events; 140 deaths, 60 patients had MI, 177 patients were admitted to hospital with HF and 60 patients had a stroke. Neither anxiety nor depression at any time was associated with mortality or the combined endpoint. Anxiety in IHD patients at baseline and at 1 year was associated with increased risk of MI (HR 2.74; 95% CI: 1.10-6.83) but was attenuated after adjusting for other risk factors (HR 1.18; 95% CI: 0.39-3.55). Both anxiety and depression at 1 year were associated with increased risk of stroke: HR 2.25 (95% CI: 1.05-4.82) and 2.34 (95% CI: 0.99-5.50), respectively, but risk associated with anxiety was attenuated after adjustment. There were no gender differences. Contrary to conclusions from recent meta-analyses, anxiety and depression measured at baseline and after 1 year were not associated with adverse outcome in CVD patients after multivariable adjustment. Copyright © 2011 Elsevier Inc. All rights reserved.

  17. Dropout from exercise randomized controlled trials among people with depression: A meta-analysis and meta regression.

    Science.gov (United States)

    Stubbs, Brendon; Vancampfort, Davy; Rosenbaum, Simon; Ward, Philip B; Richards, Justin; Soundy, Andrew; Veronese, Nicola; Solmi, Marco; Schuch, Felipe B

    2016-01-15

    Exercise has established efficacy in improving depressive symptoms. Dropouts from randomized controlled trials (RCT's) pose a threat to the validity of this evidence base, with dropout rates varying across studies. We conducted a systematic review and meta-analysis to investigate the prevalence and predictors of dropout rates among adults with depression participating in exercise RCT's. Three authors identified RCT's from a recent Cochrane review and conducted updated searches of major electronic databases from 01/2013 to 08/2015. We included RCT's of exercise interventions in people with depression (including major depressive disorder (MDD) and depressive symptoms) that reported dropout rates. A random effects meta-analysis and meta regression were conducted. Overall, 40 RCT's were included reporting dropout rates across 52 exercise interventions including 1720 people with depression (49.1 years (range=19-76 years), 72% female (range=0-100)). The trim and fill adjusted prevalence of dropout across all studies was 18.1% (95%CI=15.0-21.8%) and 17.2% (95%CI=13.5-21.7, N=31) in MDD only. In MDD participants, higher baseline depressive symptoms (β=0.0409, 95%CI=0.0809-0.0009, P=0.04) predicted greater dropout, whilst supervised interventions delivered by physiotherapists (β=-1.2029, 95%CI=-2.0967 to -0.3091, p=0.008) and exercise physiologists (β=-1.3396, 95%CI=-2.4478 to -0.2313, p=0.01) predicted lower dropout. A comparative meta-analysis (N=29) established dropout was lower in exercise than control conditions (OR=0.642, 95%CI=0.43-0.95, p=0.02). Exercise is well tolerated by people with depression and drop out in RCT's is lower than control conditions. Thus, exercise is a feasible treatment, in particular when delivered by healthcare professionals with specific training in exercise prescription. Copyright © 2015 Elsevier B.V. All rights reserved.

  18. Effect of Talbinah food consumption on depressive symptoms among elderly individuals in long term care facilities, randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Badrasawi MM

    2013-03-01

    Full Text Available Manal M Badrasawi, Suzana Shahar, Zahara Abd Manaf, Hasnah HaronDietetics program, School of Health Care Sciences, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, MalaysiaAbstract: Talbinah is a barley syrup cooked with milk and sweetened by honey. In his famous Hadith on Talbinah, the Prophet Mohammad (SAW recommended it when sad events happen for its effect on soothing hearts and relieving sadness. This 3-week crossover designed, randomized clinical trial was conducted to determine the effect of Talbinah on mood and depression among institutionalized elderly people in Seremban. A sample of 30 depressed elderly subjects (21 men and 9 women was selected from the long term care facility. Three different interview-based validated scales (Geriatric Depression Scale, Depression Anxiety Stress Scales, and Profile of Mood States were used to determine mood, depression, stress, and anxiety at week 0, 3, 4, and 7. The nutritional value of Talbinah was examined using proximate food analysis, minerals content analysis, and differential amino acid analysis. The results indicated that Talbinah is a high carbohydrate food (86.4% and has a high tryptophan: branch chain amino acids ratio (1:2. A Wilcoxon nonparametric test showed that there was a statistically significant decrease on depression, stress, and mood disturbances scores among the intervention group (P < 0.05 for all parameters. In conclusion, Talbinah has the potential to reduce depression and enhance mood among the subjects. Ingestion of functional foods such as Talbinah may provide a mental health benefit to elderly people.Keywords: Talbinah, food and depression, cross over study, elderly

  19. Comparison of Eye Movement Desensitization Reprocessing and Cognitive Behavioral Therapy as Adjunctive Treatments for Recurrent Depression: The European Depression EMDR Network (EDEN Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Luca Ostacoli

    2018-02-01

    Full Text Available Background: Treatment of recurrent depressive disorders is currently only moderately successful. Increasing evidence suggests a significant relationship between adverse childhood experiences and recurrent depressive disorders, suggesting that trauma-based interventions could be useful for these patients.Objectives: To investigate the efficacy of Eye Movement Desensitization and Reprocessing therapy (EMDR in addition to antidepressant medication (ADM in treating recurrent depression.Design: A non-inferiority, single-blind, randomized clinical controlled trial comparing EMDR or CBT as adjunctive treatments to ADM. Randomization was carried out by a central computer system. Allocation was carried out by a study coordinator in each center.Setting: Two psychiatric services, one in Italy and one in Spain.Participants: Eighty-two patients were randomized with a 1:1 ratio to the EMDR group (n = 40 or CBT group (n = 42. Sixty-six patients, 31 in the EMDR group and 35 in the CBT group, were included in the completers analysis. Intervention: 15 ± 3 individual sessions of EMDR or CBT, both in addition to ADM. Participants were followed up at 6-months.Main outcome measure: Rate of depressive symptoms remission in both groups, as measured by a BDI-II score <13.Results: Sixty-six patients were analyzed as completers (31 EMDR vs. 35 CBT. No significant difference between the two groups was found either at the end of the interventions (71% EMDR vs. 48.7% CBT or at the 6-month follow-up (54.8% EMDR vs. 42.9% CBT. A RM-ANOVA on BDI-II scores showed similar reductions over time in both groups [F(6,59 = 22.501, p < 0.001] and a significant interaction effect between time and group [F(6,59 = 3.357, p = 0.006], with lower BDI-II scores in the EMDR group at T1 [mean difference = –7.309 (95% CI [–12.811, –1.806], p = 0.010]. The RM-ANOVA on secondary outcome measures showed similar improvement over time in both groups [F(14,51 = 8.202, p < 0.001], with no

  20. Disrupting the rhythm of depression using Mobile Cognitive Therapy for recurrent depression: randomized controlled trial design and protocol

    NARCIS (Netherlands)

    Bockting, Claudi L. H.; Kok, Gemma D.; van der Kamp, Lillian; Smit, Filip; van Valen, Evelien; Schoevers, Robert; van Marwijk, Harm; Cuijpers, Pim; Riper, Heleen; Dekker, Jack; Beck, Aaron T.

    2011-01-01

    Major depressive disorder (MDD) is projected to rank second on a list of 15 major diseases in terms of burden in 2030. The major contribution of MDD to disability and health care costs is largely due to its highly recurrent nature. Accordingly, efforts to reduce the disabling effects of this chronic

  1. Association Between Chronic Physical Conditions and the Effectiveness of Collaborative Care for Depression : An Individual Participant Data Meta-analysis

    NARCIS (Netherlands)

    Panagioti, Maria; Bower, Peter; Kontopantelis, Evangelos; Lovell, Karina; Gilbody, Simon; Waheed, Waquas; Dickens, Chris; Archer, Janine; Simon, Gregory; Ell, Kathleen; Huffman, Jeff C.; Richards, David A.; van der Feltz-Cornelis, Christina; Adler, David A.; Bruce, Martha; Buszewicz, Marta; Cole, Martin G.; Davidson, Karina W.; de Jonge, Peter; Gensichen, Jochen; Huijbregts, Klaas; Menchetti, Marco; Patel, Vikram; Rollman, Bruce; Shaffer, Jonathan; Zijlstra-Vlasveld, Moniek C.; Coventry, Peter A.

    IMPORTANCE Collaborative care is an intensive care model involving several health care professionals working together, typically a physician, a case manager, and a mental health professional. Meta-analyses of aggregate data have shown that collaborative care is particularly effective in people with

  2. [The effectiveness of therapeutic touch on pain, depression and sleep in patients with chronic pain: clinical trial].

    Science.gov (United States)

    Marta, Ilda Estefani Ribeiro; Baldan, Sueli Santiago; Berton, Ani Fabiana; Pavam, Michele; da Silva, Maria Júlia Paes

    2010-12-01

    This research aimed to check the effectiveness of Therapeutic Touch on decreased pain intensity, depression self-assessment scores and improved sleep quality. A clinical before-after trial is presented. The study was carried out at a Basic Health Unit in Fernandópolis, SP-Brazil, involving 30 elderly patients with chronic non-oncologic pain who received 8 sessions of Therapeutic Touch in accordance with the Krieger-Kunz method. The Visual Analogue Scale for pain was applied before and after each session, and Beck Depression Inventory and the Pittsburgh Sleep Quality Index before the first and after the last session. Data analysis showed a significant decrease (p Touch was effective to decrease pain intensity and depressive attitudes and symptoms, as well as to improve sleep quality.

  3. Internet-delivered cognitive behaviour therapy for depression in people with diabetes: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Robins, Lisa; Newby, Jill; Wilhelm, Kay; Smith, Jessica; Fletcher, Therese; Ma, Trevor; Finch, Adam; Campbell, Lesley; Andrews, Gavin

    2015-01-01

    Depression substantially contributes to the personal burden and healthcare costs of living with diabetes mellitus (DM). Comorbid depression and DM are associated with poorer quality of life, poorer self-management and glycemic control, increased risk for DM complications and higher mortality rates, and higher health service utilization. Depression remains under-recognized and undertreated in people with DM, which may, in part, result from barriers associated with accessing face-to-face treatment. This study will examine the efficacy of an internet-based cognitive behaviour therapy programme for major depressive disorder (iCBT-MDD) in people with DM. A CONSORT 2010 compliant, registered randomised controlled trial of the intervention (iCBT-MDD) versus a treatment as usual control group will be conducted. The study will include 100 adults aged 18 years and over with a diagnosis of type 1 or type 2 DM and self-reported symptoms that satisfy MDD which will enable us to detect a statistically significant difference with a group effect size of 0.6 at a power of 80% and significance level of p=0.05. Participants will be randomised to receive the iCBT-MDD programme immediately, or to wait 10 weeks before accessing the programme. Primary outcomes will be self-reported depression severity, DM-related distress, and glycemic control (glycosylated hemoglobin). Secondary outcomes will be general distress and disability, generalized anxiety, lifestyle behaviours, somatization, eating habits, alcohol use, and acceptability of the iCBT programme to participants, and practicality for clinicians. Data will be analyzed with linear mixed models for each outcome measure. The Human Research Ethics Committee of St Vincent's Hospital Australia have given ethics approval (HREC/13/SVH/291). Results will be disseminated via peer-reviewed publication and social media channels of Australian Diabetes Consumer Representative Bodies. The trial is registered with the Australian and New Zealand

  4. Integrating Depression Care Management into Medicare Home Health Reduces Risk of 30 and 60 Day Hospitalization: The Depression CAREPATH Cluster-Randomized Trial

    Science.gov (United States)

    Bruce, Martha L.; Lohman, Matthew C.; Greenberg, Rebecca L.; Bao, Yuhua; Raue, Patrick J.

    2016-01-01

    OBJECTIVES To determine whether a depression care management intervention among Medicare home health recipients decreases risks of hospitalization. DESIGN Cluster-randomized trial. Nurse teams were randomized to Intervention (12 teams) or Enhanced Usual Care (EUC; 9 teams). SETTING Six home health agencies from distinct geographic regions. Patients were interviewed at home and by telephone. PARTICIPANTS Patients age>65 who screened positive for depression on nurse assessments (N=755), and a subset who consented to interviews (N=306). INTERVENTION The Depression CAREPATH (CARE for PATients at Home) guides nurses in managing depression during routine home visits. Clinical functions include weekly symptom assessment, medication management, care coordination, patient education, and goal setting. Researchers conducted biweekly telephone conferences with team supervisors. MEASUREMENTS The study examined acute-care hospitalization and days to hospitalization. H1 used data from the home health record to examine hospitalization over 30-day and 60-day periods while a home health patient. H2 used data from both home care record and research assessments to examine 30-day hospitalization from any setting. RESULTS The adjusted hazard ratio (HR) of being admitted to hospital directly from home health within 30 days of start of home health care was 0.65 (p=.013) for CAREPATH compared to EUC patients, and 0.72 (p=.027) within 60 days. In patients referred to home health directly from hospital, the relative hazard of being rehospitalized was approximately 55% lower (HR = 0.45, p=.001) among CAREPATH patients. CONCLUSION Integrating CAREPATH depression care management into routine nursing practice reduces hospitalization and rehospitalization risk among older adults receiving Medicare home health nursing services. PMID:27739067

  5. Integrating Depression Care Management into Medicare Home Health Reduces Risk of 30- and 60-Day Hospitalization: The Depression Care for Patients at Home Cluster-Randomized Trial.

    Science.gov (United States)

    Bruce, Martha L; Lohman, Matthew C; Greenberg, Rebecca L; Bao, Yuhua; Raue, Patrick J

    2016-11-01

    To determine whether a depression care management intervention in Medicare home health recipients decreases risk of hospitalization. Cluster-randomized trial. Nurse teams were randomized to intervention (12 teams) or enhanced usual care (EUC; 9 teams). Six home health agencies from distinct geographic regions. Home health recipients were interviewed at home and over the telephone. Individuals aged 65 and older who screened positive for depression on nurse assessments (N = 755) and a subset who consented to interviews (n = 306). The Depression CARE for PATients at Home (CAREPATH) guides nurses in managing depression during routine home visits. Clinical functions include weekly symptom assessment, medication management, care coordination, patient education, and goal setting. Researchers conducted telephone conferences with team supervisors every 2 weeks. Hospitalization while receiving home health services was assessed using data from the home health record. Hospitalization within 30 days of starting home health, regardless of how long recipients received home health services, was assessed using data from the home care record and research assessments. The relative hazard of being admitted to the hospital directly from home health was 35% lower within 30 days of starting home health care (hazard ratio (HR) = 0.65, P = .01) and 28% lower within 60 days (HR = 0.72, P = .03) for CAREPATH participants than for participants receiving EUC. In participants referred to home health directly from the hospital, the relative hazard of being rehospitalized was approximately 55% lower (HR = 0.45, P = .001) for CAREPATH participants. Integrating CAREPATH depression care management into routine nursing practice reduces hospitalization and rehospitalization risk in older adults receiving Medicare home health nursing services. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

  6. New analyses of the National Institute of Mental Health Treatment of Depression Collaborative Research Program: do different treatments reflect different processes?

    Science.gov (United States)

    Herbert, Gregory L; Callahan, Jennifer; Ruggero, Camilo J; Murrell, Amy R

    2013-01-01

    To determine whether or not different therapies have distinct patterns of change, it is useful to investigate not only the end result of psychotherapy (outcome) but also the processes by which outcomes are attained. The present study subjected data from the National Institute of Mental Health Treatment of Depression Collaborative Research Program to survival analyses to examine whether the process of psychotherapy, as conceptualized by the phase model, differed between psychotherapy treatment approaches. Few differences in terms of progression through phases of psychotherapy were identified between cognitive behavior therapy and interpersonal therapy. Additionally, results indicate that phases of psychotherapy may not represent discrete, sequentially invariant processes.

  7. Efficacy of a dilemma-focused intervention for unipolar depression: study protocol for a multicenter randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Depression is one of the more severe and serious health problems because of its morbidity, disabling effects and for its societal and economic burden. Despite the variety of existing pharmacological and psychological treatments, most of the cases evolve with only partial remission, relapse and recurrence. Cognitive models have contributed significantly to the understanding of unipolar depression and its psychological treatment. However, success is only partial and many authors affirm the need to improve those models and also the treatment programs derived from them. One of the issues that requires further elaboration is the difficulty these patients experience in responding to treatment and in maintaining therapeutic gains across time without relapse or recurrence. Our research group has been working on the notion of cognitive conflict viewed as personal dilemmas according to personal construct theory. We use a novel method for identifying those conflicts using the repertory grid technique (RGT). Preliminary results with depressive patients show that about 90% of them have one or more of those conflicts. This fact might explain the blockage and the difficult progress of these patients, especially the more severe and/or chronic. These results justify the need for specific interventions focused on the resolution of these internal conflicts. This study aims to empirically test the hypothesis that an intervention focused on the dilemma(s) specifically detected for each patient will enhance the efficacy of cognitive behavioral therapy (CBT) for depression. Design A therapy manual for a dilemma-focused intervention will be tested using a randomized clinical trial by comparing the outcome of two treatment conditions: combined group CBT (eight, 2-hour weekly sessions) plus individual dilemma-focused therapy (eight, 1-hour weekly sessions) and CBT alone (eight, 2-hour group weekly sessions plus eight, 1-hour individual weekly sessions). Method Participants are

  8. The effect of adding psychodynamic therapy to antidepressants in patients with major depressive disorder. A systematic review of randomized clinical trials with meta-analyses and trial sequential analyses.

    Science.gov (United States)

    Jakobsen, Janus Christian; Hansen, Jane Lindschou; Simonsen, Erik; Gluud, Christian

    2012-03-01

    Major depressive disorder afflicts an estimated 17% of individuals during their lifetimes at tremendous suffering and costs. Psychodynamic therapy may be a treatment option for depression, but the effects have only been limitedly assessed in systematic reviews. Using Cochrane systematic review methodology, we compared the benefits and harms of psychodynamic therapy versus 'no intervention' or sham for major depressive disorder. We accepted any co-intervention, including antidepressants, as long as it was delivered similarly in both intervention groups. Trials were identified by searching the Cochrane Library's CENTRAL, MEDLINE via PubMed, EMBASE, Psychlit, Psyc Info, and Science Citation Index Expanded until February 2010. Two authors independently extracted data. We evaluated risk of bias to control for systematic errors. We conducted trial sequential analysis to control for random errors. We included five trials randomizing a total of 365 participants who all received antidepressants as co-intervention. All trials had high risk of bias. Four trials assessed 'interpersonal psychotherapy' and one trial 'short psychodynamic supportive psychotherapy'. Meta-analysis showed that psychodynamic therapy significantly reduced depressive symptoms on the 17-item Hamilton Rating Scale for Depression (mean difference -3.01 (95% confidence interval -3.98 to -2.03; Ptherapy to antidepressants might benefit depressed patients, but the possible treatment effect measured on the Hamilton Rating Scale for Depression is small. Copyright © 2011 Elsevier B.V. All rights reserved.

  9. A Randomised Controlled Trial of Therapist-Assisted, Internet-Delivered Cognitive Behavior Therapy for Women with Maternal Depression.

    Directory of Open Access Journals (Sweden)

    Nicole E Pugh

    Full Text Available Postpartum depression impacts up to 15% of Canadian women following childbirth. Remarkably, many women suffering from this disorder do not receive appropriate treatment. The aim of this study was to conduct a parallel-group randomized controlled trial to determine the efficacy of Therapist-Assisted Internet-delivered Cognitive Behavior Therapy (TA-ICBT for the treatment of postpartum depression. This study was registered with the International Standard Randomized Controlled Trials (85456371 and received funding from Canadian Institutes of Health Research (#101526 and the Saskatchewan Health Research Foundation. Fifty women who gave birth to an infant in the past year, who scored above 10 on the Edinburgh Postnatal Depression Scale (EPDS, and who resided in Saskatchewan, Canada were eligible to participate. Participants were randomly assigned to receive either TA-ICBT (n = 25 or waitlist control (n = 25. The efficacy of the treatment was investigated at baseline and at seven- to 10-week follow-up. TA-ICBT participants were also contacted four-weeks following treatment completion. Symptoms of postpartum depression decreased more for participants in the TA-ICBT group (average reduction of 6.24 points on the EPDS; n = 21 included in analyses compared to those participants in the waitlist control group (average reduction of 2.42 points on the EPDS; n = 20 included in analyses, and these results were clinically significant and maintained at four-week follow-up. TA-ICBT participants demonstrated a reduction in postnatal anxiety, general stress, and parental distress, and an increase in psychological and environmental quality of life when compared to the waitlist control participants. Study implications, limitations, and future research directions are discussed. Trial registration: Controlled-Trials.com ISRCTN85456371.

  10. Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Science.gov (United States)

    Sehatzadeh, Shayan; Tu, Hong Anh; Palimaka, Stefan; Yap, Belinda; O'Reilly, Daria; Bowen, Jim; Higgins, Caroline; Holubowich, Corinne

    2016-01-01

    Background To date, several randomized controlled trials (RCTs) have shown the efficacy of repetitive transcranial magnetic stimulation (rTMS) in the treatment of major depression. Objective This analysis examined the antidepressant efficacy of rTMS in patients with treatment-resistant unipolar depression. Methods A literature search was performed for RCTs published from January 1, 1994, to November 20, 2014. The search was updated on March 1, 2015. Two independent reviewers evaluated the abstracts for inclusion, reviewed full texts of eligible studies, and abstracted data. Meta-analyses were conducted to obtain summary estimates. The primary outcome was changes in depression scores measured by the Hamilton Rating Scale for Depression (HRSD), and we considered, a priori, the mean difference of 3.5 points to be a clinically important treatment effect. Remission and response to the treatment were secondary outcomes, and we calculated number needed to treat on the basis of these outcomes. We examined the possibility of publication bias by constructing funnel plots and by Begg's and Egger's tests. A meta-regression was undertaken to examine the effect of specific rTMS technical parameters on the treatment effects. Results Twenty-three RCTs compared rTMS with sham, and six RCTs compared rTMS with electroconvulsive therapy (ECT). Trials of rTMS versus sham showed a statistically significant improvement in depression scores with rTMS (weighted mean difference [WMD] 2.31, 95% CI 1.19–3.43; P transcranial magnetic stimulation had a small short-term effect for improving depression in comparison with sham, but follow-up studies did not show that the small effect will continue for longer periods. PMID:27099642

  11. Minocycline as an adjunct for treatment-resistant depressive symptoms: A pilot randomised placebo-controlled trial.

    Science.gov (United States)

    Husain, Muhammad I; Chaudhry, Imran B; Husain, Nusrat; Khoso, Ameer B; Rahman, Raza R; Hamirani, Munir M; Hodsoll, John; Qurashi, Inti; Deakin, John Fw; Young, Allan H

    2017-09-01

    Evidence suggests that anti-inflammatory medication may be effective in the treatment of depressive symptoms. In this study, we aimed to investigate whether minocycline added to treatment as usual (TAU) for 3 months in patients with treatment-resistant depression will lead to an improvement in depressive symptoms. Multi-site, 12-week, double-blind, placebo-controlled, pilot trial of minocycline added to TAU for patients suffering from DSM-5 major depressive disorder, whose current episode has failed to respond to at least two antidepressants. The primary outcome measure was mean change in Hamilton Depression Rating Scale (HAMD-17) scores from baseline to week 12. Secondary measures were the Clinical Global Impression scale (CGI), Patient Health Questionnaire-9 (PHQ-9), the Generalised Anxiety Disorder scale (GAD-7) and EuroQoL (EQ-5D) quality-of-life questionnaire. Side-effect checklists were also used. Minocycline was started at 100 mg once daily (OD) and increased to 200 mg after 2 weeks. A total of 41 participants were randomised, with 21 in the minocycline group and 20 in the placebo group. A large decrease in HAMD scores was observed in the minocycline group compared to the placebo group (standardised effect size (ES) -1.21, p minocycline group also showed a large improvement compared with placebo (odds ratio (OR): 17.6, p minocycline leads to improvement in symptoms of treatment-resistant depression. However, our findings require replication in a larger sample. ClinicalTrials.gov identifier: NCT02263872, registered October 2014.

  12. Internet-based CBT for depression with and without telephone tracking in a national helpline: randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Louise Farrer

    Full Text Available BACKGROUND: Telephone helplines are frequently and repeatedly used by individuals with chronic mental health problems and web interventions may be an effective tool for reducing depression in this population. AIM: To evaluate the effectiveness of a 6 week, web-based cognitive behaviour therapy (CBT intervention with and without proactive weekly telephone tracking in the reduction of depression in callers to a helpline service. METHOD: 155 callers to a national helpline service with moderate to high psychological distress were recruited and randomised to receive either Internet CBT plus weekly telephone follow-up; Internet CBT only; weekly telephone follow-up only; or treatment as usual. RESULTS: Depression was lower in participants in the web intervention conditions both with and without telephone tracking compared to the treatment as usual condition both at post intervention and at 6 month follow-up. Telephone tracking provided by a lay telephone counsellor did not confer any additional advantage in terms of symptom reduction or adherence. CONCLUSIONS: A web-based CBT program is effective both with and without telephone tracking for reducing depression in callers to a national helpline. TRIAL REGISTRATION: Controlled-Trials.comISRCTN93903959.

  13. A Randomized Clinical Trial of a Brief, Problem-Focused Couple Therapy for Depression

    OpenAIRE

    Cohen, Shiri; O’Leary, K. Daniel; Foran, Heather

    2010-01-01

    The aim of this study was to evaluate a brief couple therapy for depression targeted for mildly discordant or nondiscordant couples struggling with the negative impact of depression. Subjects included women with major depression or dysthymia who had husbands without clinical depression. Thirty-five couples were randomly assigned to the 5-week intervention (n = 18) or a waitlist control group (n = 17), and followed up 1 and 3 months later. Results showed a significant effect of treatment in re...

  14. Preventing Adolescent Social Anxiety and Depression and Reducing Peer Victimization: Intervention Development and Open Trial

    Science.gov (United States)

    La Greca, Annette M.; Ehrenreich-May, Jill; Mufson, Laura; Chan, Sherilynn

    2016-01-01

    Background: Social anxiety disorder (SAD) and depression are common among adolescents, frequently comorbid, and resistant to change. Prevention programs for adolescent SAD are scant, and depression prevention programs do not fully address peer-risk factors. One critical peer-risk factor for SAD and depression is peer victimization. We describe the…

  15. Care staff training in detection of depression in residential homes for the elderly - Randomised trial

    NARCIS (Netherlands)

    Eisses, AMH; Kluiter, H; Jongenelis, K; Beekman, ATF; Ormel, J

    Background. Many people with depression in residential care homes for the elderly do not receive treatment because their depression remains undetected. Aims. To determine the effects of staff training on the detection, treatment and outcome of depression in residents often homes. Method. We

  16. Care staff training in detection of depression in residential homes for the elderly: randomised trial

    NARCIS (Netherlands)

    Eisses, A.M.H.; Kluiter, H.; Jongenelis, K.; Pot, A.M.; Beekman, A.T.F.; Ormel, J.

    2005-01-01

    Background: Many people with depression in residential care homes for the elderly do not receive treatment because their depression remains undetected. Aims: To determine the effects of staff training on the detection, treatment and outcome of depression in residents of ten homes. Method: We

  17. Treatment of depression with Chai Hu Shu Gan San: a systematic review and meta-analysis of 42 randomized controlled trials.

    Science.gov (United States)

    Sun, Yan; Xu, Xia; Zhang, Jinping; Chen, Yuanyuan

    2018-02-17

    Depression is a common mental disorder. Chai Hu Shu Gan San, a traditional Chinese medicine, is used to treat depression empirically. We present a systematic review and meta-analysis of the therapeutic efficacy and safety of Chai Hu Shu Gan San in treating depression. Several databases, including PubMed, China National Knowledge Internet, Wanfang, Chongqing VIP, and the Cochrane library, were systematically searched from their date of foundation to January 1, 2017. In this review, wehave included randomized control trials that compared Chai Hu Shu Gan San (or its combination with a regular Western medicine) with a regular Western medicine alone for the treatment of depression. Two investigators independently extracted and analyzed the data using RevMan 5.2.0 software. Mean difference (with a 95% confidence interval) was used as efficacy indices for outcomes. We included 42 studies involving 3234 patients with depression in 15 different types of diseases. Meta analyses showed better effect of Chai Hu Shu Gan San than fluoxetine for pure depression (MD = - 1.59, from - 2.82 to - 0.37, 4 trials, I 2  = 26%), for post-stroke depression (MD = - 4.20, from - 6.20 to - 2.19, 7 trials, I 2  = 96%), and for postpartum depression (MD = - 4.10, from - 7.48 to - 0.72 7 trials, I 2  = 86%). None of the articles reported severe adverse events of oral administration of Chai Hu Shu Gan San. Furthermore, any adverse effects of using Chai Hu Shu Gan San alone were fewer than those of regular Western medicines. This review found that Chai Hu Shu Gan San has some advantages in treating depression, especially post-stroke depression and post-partum depression. A meticulously designed and conducted randomized control trial is needed for further evaluation.

  18. Cognitive effects of transcranial direct current stimulation in depression: Results from the SELECT-TDCS trial and insights for further clinical trials.

    Science.gov (United States)

    Brunoni, André Russowsky; Tortella, Gabriel; Benseñor, Isabela Martins; Lotufo, Paulo Andrade; Carvalho, André Ferrer; Fregni, Felipe

    2016-09-15

    Cognitive dysfunction treatment remains an unmet clinical need in major depressive disorder (MDD). Transcranial direct current stimulation (tDCS) may improve cognitive symptoms in MDD. Our aim was to investigate the cognitive effects of tDCS in the Sertraline vs. Electric Current Therapy for Treating Depression Clinical Study (SELECT-TDCS). We also explored whether tDCS could have mood-independent cognitive effects. One hundred twenty MDD patients aged from 18 to 65 years received 12 sessions of active/sham tDCS (2mA for 30min) and real/placebo 50mg/d sertraline over 6 weeks in a factorial trial. We analyzed whether changes in performance of neuropsychological tests (Trail Making, Digit Span, Stroop Task, Mini-Mental Status Exam and Montreal Cognitive Assessment) occurred over time, according to treatment group and depression improvement. Exploratory analyses were carried out to verify the influence of clinical and demographic variables on the outcomes. Cognitive improvement was showed in most tests used, although they occurred regardless of intervention type and depression improvement. Further exploratory analyses revealed that clinical response and education level could have mediated pro-cognitive tDCS effects on some of the tests used. The neuropsychological battery used might not have been sensitive to detect tDCS-induced effects on cognition. Lack of simultaneous cognitive training during application may have also limited its cognitive effects. We found no evidence of beneficial or deleterious cognitive effects of tDCS as a treatment for depression. We discussed clinical trial design considerations for further tDCS studies assessing cognitive effects, including sample and outcomes considerations. Copyright © 2016 Elsevier B.V. All rights reserved.

  19. Omega-3 supplementation effects on body weight and depression among dieter women with co-morbidity of depression and obesity compared with the placebo: A randomized clinical trial.

    Science.gov (United States)

    Keshavarz, Seyed Ali; Mostafavi, Seyed-Ali; Akhondzadeh, Shahin; Mohammadi, Mohammad Reza; Hosseini, Saeed; Eshraghian, Mohammad Reza; Chamari, Maryam

    2018-06-01

    We aimed to evaluate the effects of the omega-3 supplementation on body weight and depression among women with co-morbidity of depression and obesity seeking weight reduction compared with the placebo. Sixty five patients with co-morbidity of depression and overweight/obesity (BMI ≥ 25) signed the informed consent form and enrolled into this 12-week double-blind, placebo-controlled randomized clinical Trial. Subsequently, participants randomly assigned into one of the two groups receiving daily 6 capsules of omega-3 (each capsule containing 180 mg EPA, and 120 mg DHA) or 6 capsules of placebo (two with each meal). We performed body composition assessments and Beck depression inventory at the baseline, and weeks 2, 4, 8, and 12 after the start of the study. One month after stopping the capsules at the follow-up visit, weight was measured to compare weight relapse between the two groups. Forty five patients finished the study. No significant differences were seen between groups regarding demographic and clinical variables at baseline. Using repeated measures ANOVA, omega-3 significantly reduced depression compared with the placebo (P = 0.05). Mean ± SD weight reduction in omega-3 group 3.07 ± 3.4 kg and in the placebo group was 1.16 ± 2.7 kg and the difference between groups was significant using independent sample t-test (p = 0.049). Patients in the omega-3 group did not show significantly more side effects compared to the placebo but they were not successful in preventing weight regain one month after the end of the study. Based on our findings omega-3 capsule as a safe over-the-counter supplement might be helpful in reducing the signs of depression and also body weight in patients with co-morbidity of depression and obesity. Copyright © 2018 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

  20. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials.

    LENUS (Irish Health Repository)

    Sattar, Naveed

    2010-02-27

    Trials of statin therapy have had conflicting findings on the risk of development of diabetes mellitus in patients given statins. We aimed to establish by a meta-analysis of published and unpublished data whether any relation exists between statin use and development of diabetes.

  1. Broad-spectrum antibiotics for spontaneous preterm labour: the ORACLE II randomised trial. ORACLE Collaborative Group.

    Science.gov (United States)

    Kenyon, S L; Taylor, D J; Tarnow-Mordi, W

    2001-03-31

    Preterm birth after spontaneous preterm labour is associated with death, neonatal disease, and long-term disability. Previous small trials of antibiotics for spontaneous preterm labour have reported inconclusive results. We did a randomised multicentre trial to resolve this issue. 6295 women in spontaneous preterm labour with intact membranes and without evidence of clinical infection were randomly assigned 250 mg erythromycin (n=1611), 325 mg co-amoxiclav (250 mg amoxicillin and 125 mg clavulanic acid; n=1550), both (n=1565), or placebo (n=1569) four times daily for 10 days or until delivery, whichever occurred earlier. The primary outcome measure was a composite of neonatal death, chronic lung disease, or major cerebral abnormality on ultrasonography before discharge from hospital. Analysis was by intention to treat. None of the trial antibiotics was associated with a lower rate of the composite primary outcome than placebo (erythromycin 90 [5.6%], co-amoxiclav 76 [5.0%], both antibiotics 91 [5.9%], vs placebo 78 [5.0%]). However, antibiotic prescription was associated with a lower occurrence of maternal infection. This trial provides evidence that antibiotics should not be routinely prescribed for women in spontaneous preterm labour without evidence of clinical infection.

  2. Effectiveness of a mood management component as an adjunct to a telephone counselling smoking cessation intervention for smokers with a past major depression: a pragmatic randomized controlled trial

    NARCIS (Netherlands)

    van der Meer, Regina M.; Willemsen, Marc C.; Smit, Filip; Cuijpers, Pim; Schippers, Gerard M.

    2010-01-01

    Aims To assess whether the addition of a mood management component to telephone counselling produces higher abstinence rates in smokers with past major depression and helps to prevent recurrence of depressive symptoms. Design Pragmatic randomized controlled trial with two conditions, with follow-up

  3. Effectiveness of a mood management component as an adjunct to a telephone counselling smoking cessation intervention for smokers with a past major depression: A pragmatic randomized controlled trial

    NARCIS (Netherlands)

    van der Meer, R.; Willemsen, M.C.; Smit, H.F.E.; Cuijpers, P.; Schippers, G.M.

    2010-01-01

    Aims To assess whether the addition of a mood management component to telephone counselling produces higher abstinence rates in smokers with past major depression and helps to prevent recurrence of depressive symptoms. Design Pragmatic randomized controlled trial with two conditions, with follow-up

  4. Efficacy Trial of a Brief Cognitive-Behavioral Depression Prevention Program for High-Risk Adolescents: Effects at 1- and 2-Year Follow-Up

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Gau, Jeff M.; Wade, Emily

    2010-01-01

    Objective: To evaluate the effects of a brief group cognitive-behavioral (CB) depression prevention program for high-risk adolescents with elevated depressive symptoms at 1- and 2-year follow-up. Method: In this indicated prevention trial, 341 at-risk youths were randomized to a group CB intervention, group supportive expressive intervention, CB…

  5. Screening for and subsequent participation in a trial for depression and anxiety in people with type 2 diabetes treated in primary care: Who do we reach?

    NARCIS (Netherlands)

    Stoop, C.H.; Nefs, G.M.; Pop, V.J.M.; Pouwer, F.

    2017-01-01

    AIMS: This study investigated (factors related to) (a) the response to a screening procedure for depression and anxiety in people with type 2 diabetes in primary care, and (b) participation in a subsequent randomised controlled trial targeting depressive or anxiety symptoms. METHODS: People with

  6. Screening for and subsequent participation in a trial for depression and anxiety in people with type 2 diabetes treated in primary care : Who do we reach?

    NARCIS (Netherlands)

    Stoop, C.H.; Nefs, G.M.; Pop, V.J.M.; Pouwer, François

    2017-01-01

    Aims: This study investigated (factors related to) (a) the response to a screening procedure for depression and anxiety in people with type 2 diabetes in primary care, and (b) participation in a subsequent randomised controlled trial targeting depressive or anxiety symptoms. Methods: People with

  7. Dropout Prevalence and Associated Factors in Randomized Clinical Trials of Adolescents Treated for Depression: Systematic Review and Meta-analysis.

    Science.gov (United States)

    Rohden, Adriane Isabel; Benchaya, Mariana Canellas; Camargo, Roger Santos; Moreira, Taís de Campos; Barros, Helena M T; Ferigolo, Maristela

    2017-05-01

    Depression currently affects 350 million people, and its prevalence among adolescents is 4% to 8%. Adolescents who abandon antidepressant treatment or drop out of clinical trials are less likely to recover or experience a remission of symptoms because they are not being followed up by a medical team. The objective of this study was to analyze the dropout rates of randomized clinical trials of depressed adolescents receiving treatment with antidepressant drugs and the factors associated with nonadherence by summarizing this information in a systematic review and meta-analysis. Articles were retrieved from MEDLINE, EMBASE, Cochrane, Clinical Trial, PsycINFO, and Web of Science using the MeSH terms "depressive disorder," "randomized trials," and "adolescents." The evaluation of study quality was performed by using the Cochrane Handbook for Systematic Reviews of Interventions and the Jadad scale. The final sample included 50 articles, of which 44 presented dropout rates. The overall dropout prevalence was 23% (95% CI, 20-27; P dropout prevalence, respectively (33% [95% CI, 27-39], 45% [95% CI, 31-64], and 15% [95% CI, 13-17]). The adverse effects most associated with dropout were attempted suicide followed by mania, skin rash, and headache. Problems relating to clinical trials and family arbitration were also related with dropout. Serotonin/norepinephrine reuptake inhibitor treatment, adolescent age >16 years, and receiving medication were the only factors demonstrating a higher association with dropout rates. Selective serotonin reuptake inhibitors were linked to the lowest prevalence, probably due to fewer perceived problems with related adverse effects and higher efficacy in adolescents. Cognitive-behavioral therapy combined with pharmacotherapy produced a lower nonadherence prevalence; this approach can be an alternative to avoid dropouts and relapse. Prospero identifier: CRD42014013475. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

  8. A pilot randomised controlled trial of personalised care for depressed patients with symptomatic coronary heart disease in South London general practices: the UPBEAT-UK RCT protocol and recruitment

    Directory of Open Access Journals (Sweden)

    Tylee André

    2012-06-01

    Full Text Available Abstract Background Community studies reveal people with coronary heart disease (CHD are twice as likely to be depressed as the general population and that this co-morbidity negatively affects the course and outcome of both conditions. There is evidence for the efficacy of collaborative care and case management for depression treatment, and whilst NICE guidelines recommend these approaches only where depression has not responded to psychological, pharmacological, or combined treatments, these care approaches may be particularly relevant to the needs of people with CHD and depression in the earlier stages of stepped care in primary care settings. Methods This pilot randomised controlled trial will evaluate whether a simple intervention involving a personalised care plan, elements of case management and regular telephone review is a feasible and acceptable intervention that leads to better mental and physical health outcomes for these patients. The comparator group will be usual general practitioner (GP care. 81 participants have been recruited from CHD registers of 15 South London general practices. Eligible participants have probable major depression identified by a score of ≥8 on the Hospital Anxiety and Depression Scale depression subscale (HADS-D together with symptomatic CHD identified using the Modified Rose Angina Questionnaire. Consenting participants are randomly allocated to usual care or the personalised care intervention which involves a comprehensive assessment of each participant’s physical and mental health needs which are documented in a care plan, followed by regular telephone reviews by the case manager over a 6-month period. At each review, the intervention participant’s mood, function and identified problems are reviewed and the case manager uses evidence based behaviour change techniques to facilitate achievement of goals specified by the patient with the aim of increasing the patient’s self efficacy to solve their

  9. A 6 week randomized double-blind placebo-controlled trial of ziprasidone for the acute depressive mixed state.

    Directory of Open Access Journals (Sweden)

    Ashwin Patkar

    Full Text Available OBJECTIVE: To examine the efficacy of ziprasidone vs. placebo for the depressive mixed state in patients with bipolar disorder type II or major depressive disorder (MDD. METHODS: 73 patients were randomized in a double-blinded, placebo-controlled study to ziprasidone (40-160 mg/d or placebo for 6 weeks. They met DSM-IV criteria for a major depressive episode (MDE, while also meeting 2 or 3 (but not more nor less DSM-IV manic criteria. They did not meet DSM-IV criteria for a mixed or manic episode. Baseline psychotropic drugs were continued unchanged. The primary endpoint measured was Montgomery-Åsberg Depression Rating Scale (MADRS scores over time. The mean dose of ziprasidone was 129.7±45.3 mg/day and 126.1±47.1 mg/day for placebo. RESULTS: The primary outcome analysis indicated efficacy of ziprasidone versus placebo (p = 0.0038. Efficacy was more pronounced in type II bipolar disorder than in MDD (p = 0.036. Overall ziprasidone was well tolerated, without notable worsening of weight or extrapyramidal symptoms. CONCLUSIONS: There was a statistically significant benefit with ziprasidone versus placebo in this first RCT of any medication for the provisional diagnostic concept of the depressive mixed state. TRIAL REGISTRATION: Clinicaltrials.gov NCT00490542.

  10. Design and rationale of a prospective, collaborative meta-analysis of all randomized controlled trials of angiotensin receptor antagonists in Marfan syndrome, based on individual patient data: A report from the Marfan Treatment Trialists' Collaboration

    Science.gov (United States)

    Pitcher, Alex; Emberson, Jonathan; Lacro, Ronald V.; Sleeper, Lynn A.; Stylianou, Mario; Mahony, Lynn; Pearson, Gail D.; Groenink, Maarten; Mulder, Barbara J.; Zwinderman, Aeilko H.; De Backer, Julie; De Paepe, Anne M.; Arbustini, Eloisa; Erdem, Guliz; Jin, Xu Yu; Flather, Marcus D.; Mullen, Michael J.; Child, Anne H.; Forteza, Alberto; Evangelista, Arturo; Chiu, Hsin-Hui; Wu, Mei-Hwan; Sandor, George; Bhatt, Ami B.; Creager, Mark A.; Devereux, Richard B.; Loeys, Bart; Forfar, J. Colin; Neubauer, Stefan; Watkins, Hugh; Boileau, Catherine; Jondeau, Guillaume; Dietz, Harry C.; Baigent, Colin

    2015-01-01

    Rationale A number of randomized trials are underway, which will address the effects of angiotensin receptor blockers (ARBs) on aortic root enlargement and a range of other end points in patients with Marfan syndrome. If individual participant data from these trials were to be combined, a meta-analysis of the resulting data, totaling approximately 2,300 patients, would allow estimation across a number of trials of the treatment effects both of ARB therapy and of β-blockade. Such an analysis would also allow estimation of treatment effects in particular subgroups of patients on a range of end points of interest and would allow a more powerful estimate of the effects of these treatments on a composite end point of several clinical outcomes than would be available from any individual trial. Design A prospective, collaborative meta-analysis based on individual patient data from all randomized trials in Marfan syndrome of (i) ARBs versus placebo (or open-label control) and (ii) ARBs versus β-blockers will be performed. A prospective study design, in which the principal hypotheses, trial eligibility criteria, analyses, and methods are specified in advance of the unblinding of the component trials, will help to limit bias owing to data-dependent emphasis on the results of particular trials. The use of individual patient data will allow for analysis of the effects of ARBs in particular patient subgroups and for time-to-event analysis for clinical outcomes. The meta-analysis protocol summarized in this report was written on behalf of the Marfan Treatment Trialists' Collaboration and finalized in late 2012, without foreknowledge of the results of any component trial, and will be made available online (http://www.ctsu.ox.ac.uk/research/meta-trials). PMID:25965707

  11. The Validity of the Different Versions of the Hamilton Depression Scale in Separating Remission Rates of Placebo and Antidepressants in Clinical Trials of Major Depression

    DEFF Research Database (Denmark)

    Kyle, Phillip Raphael; Lemming, Ole Michael; Timmerby, Nina

    2016-01-01

    . The traditional HAM-D17 version was compared with the shorter HAM-D6 and the longer HAM-D21 or HAM-D24 in a fixed-dose placebo-controlled vortioxetine study. Clinical Global Impression of Severity scores were used to establish standardized cutoff scores for remission across each scale. Using these cutoff scores......Our objective was to validate the different versions of the Hamilton Depression Scale (HAM-D) both psychometrically (scalability) and clinically in discriminating antidepressants from placebo in terms of remission rates in an 8-week clinical trial in the acute treatment of major depression...... in the longer HAM-D versions indicated smaller discriminating validity over placebo. The HAM-D6 indicated a dose effect on remission for vortioxetine in both moderate and severe major depression. The brief HAM-D6 was thus found superior to HAM-D17, HAM-D21, and HAM-D24 both in terms of scalability...

  12. Clinical and cost-effectiveness of computerised cognitive behavioural therapy for depression in primary care: Design of a randomised trial

    Directory of Open Access Journals (Sweden)

    Severens Johan L

    2008-06-01

    Full Text Available Abstract Background Major depression is a common mental health problem in the general population, associated with a substantial impact on quality of life and societal costs. However, many depressed patients in primary care do not receive the care they need. Reason for this is that pharmacotherapy is only effective in severely depressed patients and psychological treatments in primary care are scarce and costly. A more feasible treatment in primary care might be computerised cognitive behavioural therapy. This can be a self-help computer program based on the principles of cognitive behavioural therapy. Although previous studies suggest that computerised cognitive behavioural therapy is effective, more research is necessary. Therefore, the objective of the current study is to evaluate the (cost- effectiveness of online computerised cognitive behavioural therapy for depression in primary care. Methods/Design In a randomised trial we will compare (a computerised cognitive behavioural therapy with (b treatment as usual by a GP, and (c computerised cognitive behavioural therapy in combination with usual GP care. Three hundred mild to moderately depressed patients (aged 18–65 will be recruited in the general population by means of a large-scale Internet-based screening (N = 200,000. Patients will be randomly allocated to one of the three treatment groups. Primary outcome measure of the clinical evaluation is the severity of depression. Other outcomes include psychological distress, social functioning, and dysfunctional beliefs. The economic evaluation will be performed from a societal perspective, in which all costs will be related to clinical effectiveness and health-related quality of life. All outcome assessments will take place on the Internet at baseline, two, three, six, nine, and twelve months. Costs are measured on a monthly basis. A time horizon of one year will be used without long-term extrapolation of either costs or quality of life

  13. Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial

    Science.gov (United States)

    Jacobs, Ian J; Menon, Usha; Ryan, Andy; Gentry-Maharaj, Aleksandra; Burnell, Matthew; Kalsi, Jatinderpal K; Amso, Nazar N; Apostolidou, Sophia; Benjamin, Elizabeth; Cruickshank, Derek; Crump, Danielle N; Davies, Susan K; Dawnay, Anne; Dobbs, Stephen; Fletcher, Gwendolen; Ford, Jeremy; Godfrey, Keith; Gunu, Richard; Habib, Mariam; Hallett, Rachel; Herod, Jonathan; Jenkins, Howard; Karpinskyj, Chloe; Leeson, Simon; Lewis, Sara J; Liston, William R; Lopes, Alberto; Mould, Tim; Murdoch, John; Oram, David; Rabideau, Dustin J; Reynolds, Karina; Scott, Ian; Seif, Mourad W; Sharma, Aarti; Singh, Naveena; Taylor, Julie; Warburton, Fiona; Widschwendter, Martin; Williamson, Karin; Woolas, Robert; Fallowfield, Lesley; McGuire, Alistair J; Campbell, Stuart; Parmar, Mahesh; Skates, Steven J

    2016-01-01

    Summary Background Ovarian cancer has a poor prognosis, with just 40% of patients surviving 5 years. We designed this trial to establish the effect of early detection by screening on ovarian cancer mortality. Methods In this randomised controlled trial, we recruited postmenopausal women aged 50–74 years from 13 centres in National Health Service Trusts in England, Wales, and Northern Ireland. Exclusion criteria were previous bilateral oophorectomy or ovarian malignancy, increased risk of familial ovarian cancer, and active non-ovarian malignancy. The trial management system confirmed eligibility and randomly allocated participants in blocks of 32 using computer-generated random numbers to annual multimodal screening (MMS) with serum CA125 interpreted with use of the risk of ovarian cancer algorithm, annual transvaginal ultrasound screening (USS), or no screening, in a 1:1:2 ratio. The primary outcome was death due to ovarian cancer by Dec 31, 2014, comparing MMS and USS separately with no screening, ascertained by an outcomes committee masked to randomisation group. All analyses were by modified intention to screen, excluding the small number of women we discovered after randomisation to have a bilateral oophorectomy, have ovarian cancer, or had exited the registry before recruitment. Investigators and participants were aware of screening type. This trial is registered with ClinicalTrials.gov, number NCT00058032. Findings Between June 1, 2001, and Oct 21, 2005, we randomly allocated 202 638 women: 50 640 (25·0%) to MMS, 50 639 (25·0%) to USS, and 101 359 (50·0%) to no screening. 202 546 (>99·9%) women were eligible for analysis: 50 624 (>99·9%) women in the MMS group, 50 623 (>99·9%) in the USS group, and 101 299 (>99·9%) in the no screening group. Screening ended on Dec 31, 2011, and included 345 570 MMS and 327 775 USS annual screening episodes. At a median follow-up of 11·1 years (IQR 10·0–12·0), we diagnosed ovarian cancer in

  14. Specific collaborative group intervention for patients with medically unexplained symptoms in general practice: a cluster randomized controlled trial.

    Science.gov (United States)

    Schaefert, R; Kaufmann, C; Wild, B; Schellberg, D; Boelter, R; Faber, R; Szecsenyi, J; Sauer, N; Guthrie, E; Herzog, W

    2013-01-01

    Patients with medically unexplained symptoms (MUS) are frequent in primary care and substantially impaired in their quality of life (QoL). Specific training of general practitioners (GPs) alone did not demonstrate sustained improvement at later follow-up in current reviews. We evaluated a collaborative group intervention. We conducted a cluster randomized controlled trial. Thirty-five GPs recruited 304 MUS patients (intervention group: 170; control group: 134). All GPs were trained in diagnosis and management of MUS (control condition). Eighteen randomly selected intervention GPs participated in training for a specific collaborative group intervention. They conducted 10 weekly group sessions and 2 booster meetings in their practices, together with a psychosomatic specialist. Six and 12 months after baseline, QoL was assessed with the Short-Form 36. The primary outcome was the physical composite score (PCS), and the secondary outcome was the mental composite score (MCS). At 12 months, intention-to-treat analyses showed a significant between-group effect for the MCS (p = 0.023) but not for the PCS (p = 0.674). This effect was preceded by a significant reduction of somatic symptom severity (15-item somatic symptom severity scale of the Patient Health Questionnaire, PHQ-15) at 6 months (p = 0.008) that lacked significance at 12 months (p = 0.078). As additional between-group effects at 12 months, per-protocol analyses showed less health anxiety (Whiteley-7; p = 0.038) and less psychosocial distress (PHQ; p = 0.024); GP visits were significantly (p = 0.042) reduced in the intervention group. Compared to pure GP training, collaborative group intervention achieved a progressive, clinically meaningful improvement in mental but not physical QoL. It could bridge gaps between general practice and mental health care. Copyright © 2012 S. Karger AG, Basel.

  15. Internet Cognitive Behavioral Therapy for Women With Postnatal Depression: A Randomized Controlled Trial of MumMoodBooster.

    Science.gov (United States)

    Milgrom, Jeannette; Danaher, Brian G; Gemmill, Alan W; Holt, Charlene; Holt, Christopher J; Seeley, John R; Tyler, Milagra S; Ross, Jessica; Ericksen, Jennifer

    2016-03-07

    There are few published controlled trials examining the efficacy of Internet-based treatment for postnatal depression (PND) and none that assess diagnostic status (clinical remission) as the primary outcome. This is despite the need to improve treatment uptake and accessibility because fewer than 50% of postnatally depressed women seek help, even when identified as depressed. In a randomized controlled trial (RCT), we aimed to test the efficacy of a 6-session Internet intervention (the MumMoodBooster program, previously evaluated in a feasibility trial) in a sample of postnatal women with a clinical diagnosis of depression. The MumMoodBooster program is a cognitive behavioral therapy (CBT) intervention, is highly interactive, includes a partner website, and was supported by low-intensity telephone coaching. This was a parallel 2-group RCT (N=43) comparing the Internet CBT treatment (n=21) to treatment as usual (n=22). At baseline and at 12 weeks after enrollment, women's diagnostic status was assessed by telephone with the Standardized Clinical Interview for DSM-IV (SCID-IV) and symptom severity with the Beck Depression Inventory (BDI-II). Depression symptoms were measured repeatedly throughout the study period with the Patient Health Questionnaire (PHQ-9). At the end of the study, 79% (15/19) of women who received the Internet CBT treatment no longer met diagnostic criteria for depression on the SCID-IV (these outcome data were missing for 2 intervention participants). This contrasted with only 18% (4/22) remission in the treatment as usual condition. Depression scores on the BDI-II showed a large effect favoring the intervention group (d=.83, 95% CI 0.20-1.45). Small to medium effects were found on the PHQ-9 and on measures of anxiety and stress. Adherence to the program was very good with 86% (18/21) of users completing all sessions; satisfaction with the program was rated 3.1 out of 4 on average. Our results suggest that our Internet CBT program, Mum

  16. Improving help-seeking for postnatal depression and anxiety: a cluster randomised controlled trial of motivational interviewing.

    Science.gov (United States)

    Holt, Charlene; Milgrom, Jeannette; Gemmill, Alan W

    2017-12-01

    Low uptake of treatment by women with symptoms of postnatal depression and anxiety is consistently reported. This study examined whether a brief motivational interviewing (MI) intervention delivered by Maternal and Child Health Nurses (MCHNs) during routine emotional health assessments improves help-seeking following childbirth. In this parallel two-group cluster randomised controlled trial, MCHNs delivered a MI intervention ('PRIMER', n = 20) or Routine Care (n = 20) at women's (n = 541) postnatal consultations. The primary outcome was help-seeking over the 12 months post-birth. Other outcomes were emotional distress measured by the Edinburgh Postnatal Depression Scale, Beck Depression Inventory-Revised and Depression Anxiety Stress Scales, and barriers to help-seeking obtained by self-report via a checklist of potential barriers that was presented to women to select from if applicable. 27.4% of the sample experienced emotional distress over the 12 months post-birth. When comparing women who experienced emotional distress with those who did not, odds of seeking help were 4.0 times higher for the MI condition than Routine Care (p = .004). Of the women who sought help from a psychologist, 47.6% in the MI condition attended 6 + sessions versus 20.0% in Routine Care (numbers too small for reliable significance test). There was a non-significant trend of lower depression, anxiety and stress in the MI condition. Three risk factors for postnatal depression predicted help-seeking: antenatal anxiety (OR = 2.8, p = .002), depression history (OR = 2.5, p = .002) and self-esteem (OR = 0.7, p = .04). Common barriers to seeking help were thinking that one would or should be able to manage without help (endorsed by 11.1%). Treatment uptake for postnatal distress can be increased with MI. Training MCHNs in MI was feasible and valued. Given the devastating effects of depression, further research is needed to ascertain whether MI can improve mental health

  17. Does a family meetings intervention prevent depression and anxiety in family caregivers of dementia patients? A randomized trial.

    Directory of Open Access Journals (Sweden)

    Karlijn J Joling

    Full Text Available Family caregivers of dementia patients are at increased risk of developing depression or anxiety. A multi-component program designed to mobilize support of family networks demonstrated effectiveness in decreasing depressive symptoms in caregivers. However, the impact of an intervention consisting solely of family meetings on depression and anxiety has not yet been evaluated. This study examines the preventive effects of family meetings for primary caregivers of community-dwelling dementia patients.A randomized multicenter trial was conducted among 192 primary caregivers of community dwelling dementia patients. Caregivers did not meet the diagnostic criteria for depressive or anxiety disorder at baseline. Participants were randomized to the family meetings intervention (n = 96 or usual care (n = 96 condition. The intervention consisted of two individual sessions and four family meetings which occurred once every 2 to 3 months for a year. Outcome measures after 12 months were the incidence of a clinical depressive or anxiety disorder and change in depressive and anxiety symptoms (primary outcomes, caregiver burden and quality of life (secondary outcomes. Intention-to-treat as well as per protocol analyses were performed.A substantial number of caregivers (72/192 developed a depressive or anxiety disorder within 12 months. The intervention was not superior to usual care either in reducing the risk of disorder onset (adjusted IRR 0.98; 95% CI 0.69 to 1.38 or in reducing depressive (randomization-by-time interaction coefficient = -1.40; 95% CI -3.91 to 1.10 or anxiety symptoms (randomization-by-time interaction coefficient = -0.55; 95% CI -1.59 to 0.49. The intervention did not reduce caregiver burden or their health related quality of life.This study did not demonstrate preventive effects of family meetings on the mental health of family caregivers. Further research should determine whether this intervention might be more beneficial

  18. Comparison of Eye Movement Desensitization Reprocessing and Cognitive Behavioral Therapy as Adjunctive Treatments for Recurrent Depression: The European Depression EMDR Network (EDEN) Randomized Controlled Trial.

    Science.gov (United States)

    Ostacoli, Luca; Carletto, Sara; Cavallo, Marco; Baldomir-Gago, Paula; Di Lorenzo, Giorgio; Fernandez, Isabel; Hase, Michael; Justo-Alonso, Ania; Lehnung, Maria; Migliaretti, Giuseppe; Oliva, Francesco; Pagani, Marco; Recarey-Eiris, Susana; Torta, Riccardo; Tumani, Visal; Gonzalez-Vazquez, Ana I; Hofmann, Arne

    2018-01-01

    Background: Treatment of recurrent depressive disorders is currently only moderately successful. Increasing evidence suggests a significant relationship between adverse childhood experiences and recurrent depressive disorders, suggesting that trauma-based interventions could be useful for these patients. Objectives: To investigate the efficacy of Eye Movement Desensitization and Reprocessing therapy (EMDR) in addition to antidepressant medication (ADM) in treating recurrent depression. Design: A non-inferiority, single-blind, randomized clinical controlled trial comparing EMDR or CBT as adjunctive treatments to ADM. Randomization was carried out by a central computer system. Allocation was carried out by a study coordinator in each center. Setting: Two psychiatric services, one in Italy and one in Spain. Participants: Eighty-two patients were randomized with a 1:1 ratio to the EMDR group ( n = 40) or CBT group ( n = 42). Sixty-six patients, 31 in the EMDR group and 35 in the CBT group, were included in the completers analysis. Intervention: 15 ± 3 individual sessions of EMDR or CBT, both in addition to ADM. Participants were followed up at 6-months. Main outcome measure : Rate of depressive symptoms remission in both groups, as measured by a BDI-II score <13. Results: Sixty-six patients were analyzed as completers (31 EMDR vs. 35 CBT). No significant difference between the two groups was found either at the end of the interventions (71% EMDR vs. 48.7% CBT) or at the 6-month follow-up (54.8% EMDR vs. 42.9% CBT). A RM-ANOVA on BDI-II scores showed similar reductions over time in both groups [ F (6,59) = 22.501, p < 0.001] and a significant interaction effect between time and group [ F (6,59) = 3.357, p = 0.006], with lower BDI-II scores in the EMDR group at T1 [mean difference = -7.309 (95% CI [-12.811, -1.806]), p = 0.010]. The RM-ANOVA on secondary outcome measures showed similar improvement over time in both groups [ F (14,51) = 8.202, p < 0.001], with no

  19. Depression

    DEFF Research Database (Denmark)

    Eriksen, Stine Aistrup

    2017-01-01

    function, muscle pain, mobility, and balance) among patients taking antidepressants, and study the effect of vitamin D3 treatment over placebo. The thesis is based on a clinical cross-sectional study and a randomised double-blind placebo-controlled trial of women treated with antidepressants and healthy...... controls. Certain balance measures were poorer among the patients compared to the controls and was associated with the dose of the antidepressant. Patients randomised to vitamin D3 increased more in vitamin D and decreased more in PTH levels compared to vitamin D3 treated controls. Moreover, vitamin D3......Use of antidepressants is associated with an increased risk of fractures, and may be a result of both negative effects on the skeleton as well as increased risk of falling; however, the specific mechanisms are not yet known. Vitamin D play important roles for bone and muscle, and has previously...

  20. Collaborative ring trial of the papaya endogenous reference gene and its polymerase chain reaction assays for genetically modified organism analysis.

    Science.gov (United States)

    Wei, Jiaojun; Li, Feiwu; Guo, Jinchao; Li, Xiang; Xu, Junfeng; Wu, Gang; Zhang, Dabing; Yang, Litao

    2013-11-27

    The papaya (Carica papaya L.) Chymopapain (CHY) gene has been reported as a suitable endogenous reference gene for genetically modified (GM) papaya detection in previous studies. Herein, we further validated the use of the CHY gene and its qualitative and quantitative polymerase chain reaction (PCR) assays through an interlaboratory collaborative ring trial. A total of 12 laboratories working on detection of genetically modified organisms participated in the ring trial and returned test results. Statistical analysis of the returned results confirmed the species specificity, low heterogeneity, and single-copy number of the CHY gene among different papaya varieties. The limit of detection of the CHY qualitative PCR assay was 0.1%, while the limit of quantification of the quantitative PCR assay was ∼25 copies of haploid papaya genome with acceptable PCR efficiency and linearity. The differences between the tested and true values of papaya content in 10 blind samples ranged from 0.84 to 6.58%. These results indicated that the CHY gene was suitable as an endogenous reference gene for the identification and quantification of GM papaya.

  1. Implementation of a collaborative care model for the treatment of depression and anxiety in a community health center: results from a qualitative case study

    Directory of Open Access Journals (Sweden)

    Eghaneyan BH

    2014-11-01

    Full Text Available Brittany H Eghaneyan,1 Katherine Sanchez,2 Diane B Mitschke2 1Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX, USA; 2School of Social Work, The University of Texas at Arlington, Arlington, TX, USA Background: The collaborative care model is a systematic approach to the treatment of depression and anxiety in primary care settings that involves the integration of care managers and consultant psychiatrists, with primary care physician oversight, to more proactively manage mental disorders as chronic diseases, rather than treating acute symptoms. While collaborative care has been shown to be more effective than usual primary care in improving depression outcomes in a number of studies, less is known about the factors that support the translation of this evidence-based intervention to real-world program implementation. The purpose of this case study was to examine the implementation of a collaborative care model in a community based primary care clinic that primarily serves a low-income, uninsured Latino population, in order to better understand the interdisciplinary relationships and the specific elements that might facilitate broader implementation. Methods: An embedded single-case study design was chosen in order to thoroughly examine the components of one of several programs within a single organization. The main unit of analysis was semi-structured interviews that were conducted with seven clinical and administrative staff members. A grounded theory approach was used to analyze the interviews. Line-by-line initial coding resulted in over 150 initial codes, which were clustered together to rebuild the data into preliminary categories and then divided into four final categories, or main themes. Results: Four unique themes about how the implementation of a collaborative care model worked in this setting emerged from the interviews: organizational change, communication, processes and outcomes of the program, and barriers to

  2. Selective serotonin reuptake inhibitors versus placebo in patients with major depressive disorder. A systematic review with meta-analysis and Trial Sequential Analysis

    DEFF Research Database (Denmark)

    Jakobsen, Janus Christian; Katakam, Kiran Kumar; Schou, Anne

    2017-01-01

    depressive disorder. We searched for eligible randomised clinical trials in The Cochrane Library's CENTRAL, PubMed, EMBASE, PsycLIT, PsycINFO, Science Citation Index Expanded, clinical trial registers of Europe and USA, websites of pharmaceutical companies, the U.S. Food and Drug Administration (FDA...

  3. Banned antibacterial growth promoters in animal feed: Collaborative trial on the liquid chromatography-tandem mass spectrometry method developed in the feedstuffs-radius project

    NARCIS (Netherlands)

    Poucke, C.V.; Dumoulin, F.; Yakkundi, S.; Situ, C.; Elliott, C.T.; Grutters, E.M.; Verheijen, R.; Schilt, R.; Eriksson, S.; Peteghem, C.V.

    2006-01-01

    A chemical confirmation method for the identification and quantification of five banned antibacterial growth promoters (AGPs) in animal feed was developed and in-house validated as part of the European Feedstuffs-RADIUS project [1]. To complete the validation process a collaborative trial was

  4. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients

    NARCIS (Netherlands)

    Baigent, C; Sudlow, C; Collins, R; Peto, R

    2002-01-01

    Objective To determine the effects of antiplatelet therapy among patients at high risk of occlusive vascular events. Design Collaborative meta-analyses (systematic overviews). Inclusion criteria Randomised trials of an antiplatelet regimen versus control or of one antiplatelet regimen versus another

  5. International Study to Predict Optimized Treatment for Depression (iSPOT-D, a randomized clinical trial: rationale and protocol

    Directory of Open Access Journals (Sweden)

    Cooper Nicholas J

    2011-01-01

    Full Text Available Abstract Background Clinically useful treatment moderators of Major Depressive Disorder (MDD have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators. Methods/Design The International Study to Predict Optimized Treatment - in Depression (iSPOT-D is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65 from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls. Study-eligible patients are antidepressant medication (ADM naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary. Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm. Discussion First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide. Trial registration International Study to Predict Optimised Treatment - in Depression (iSPOT-D ClinicalTrials.gov Identifier

  6. Placebo response of non-pharmacological and pharmacological trials in major depression: a systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    André Russowsky Brunoni

    Full Text Available BACKGROUND: Although meta-analyses have shown that placebo responses are large in Major Depressive Disorder (MDD trials; the placebo response of devices such as repetitive transcranial magnetic stimulation (rTMS has not been systematically assessed. We proposed to assess placebo responses in two categories of MDD trials: pharmacological (antidepressant drugs and non-pharmacological (device- rTMS trials. METHODOLOGY/PRINCIPAL FINDINGS: We performed a systematic review and meta-analysis of the literature from April 2002 to April 2008, searching MEDLINE, Cochrane, Scielo and CRISP electronic databases and reference lists from retrieved studies and conference abstracts. We used the keywords placebo and depression and escitalopram for pharmacological studies; and transcranial magnetic stimulation and depression and sham for non-pharmacological studies. All randomized, double-blinded, placebo-controlled, parallel articles on major depressive disorder were included. Forty-one studies met our inclusion criteria - 29 in the rTMS arm and 12 in the escitalopram arm. We extracted the mean and standard values of depression scores in the placebo group of each study. Then, we calculated the pooled effect size for escitalopram and rTMS arm separately, using Cohen's d as the measure of effect size. We found that placebo response are large for both escitalopram (Cohen's d - random-effects model - 1.48; 95%C.I. 1.26 to 1.6 and rTMS studies (0.82; 95%C.I. 0.63 to 1. Exploratory analyses show that sham response is associated with refractoriness and with the use of rTMS as an add-on therapy, but not with age, gender and sham method utilized. CONCLUSIONS/SIGNIFICANCE: We confirmed that placebo response in MDD is large regardless of the intervention and is associated with depression refractoriness and treatment combination (add-on rTMS studies. The magnitude of the placebo response seems to be related with study population and study design rather than the intervention

  7. Quetiapine monotherapy in acute phase for major depressive disorder: a meta-analysis of randomized, placebo-controlled trials

    Directory of Open Access Journals (Sweden)

    Maneeton Narong

    2012-09-01

    Full Text Available Abstract Background Schizophrenia and bipolar depression trials suggest that quetiapine may have an antidepressant effect. Objectives This meta-analysis aimed to determine the efficacy, acceptability and tolerability of quetiapine treatment for major depressive disorder (MDD. Only the randomized controlled trials (RCTs comparison between quetiapine and placebo were included. The authors searched such clinical trials carried out between 1991 and February 2012. Data sources MEDLINE, EMBASE, CINHL, PsycINFO and Cochrane Controlled Trials Register were searched in February 2012. Study populations comprised adults with MDD or major depression. Study eligible criteria, participants and interventions Eligible studies were randomized, placebo-controlled trials of quetiapine monotherapy carried out in adults with MDD and presenting endpoint outcomes relevant to: i depression severity, ii response rate, iii overall discontinuation rate, or iv discontinuation rate due to adverse events. No language restriction was applied. Study appraisal and synthesis methods All abstracts identified by the electronic searches were examined. The full reports of relevant studies were assessed, and the data of interest were extracted. Based on the Cochrane methods of bias assessment, risks of bias were determined. The studies with two risks or less were included. The efficacy outcomes were the mean change scores of depression rating scales, the overall response rate, and the overall remission rates. The overall discontinuation rate was considered as a measure of acceptability. The discontinuation rate due to adverse events was a measure of tolerability. Relative risks (RRs and weighted mean differences (WMDs with 95% confidence intervals (CIs were computed by using a random effect model. Results A total of 1,497 participants in three RCTs were included. All trials examined the quetiapine extended-release (XR. The pooled mean change scores of the Montgomery-Asberg Depression

  8. ‘Third wave’ cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Jakobsen Janus Christian

    2012-12-01

    Full Text Available Abstract Background Most interventions for depression have shown small or no effects. ‘Third wave‘ cognitive therapy and mentalization-based therapy have both gained some ground as treatments of psychological problems. No randomised trial has compared the effects of these two interventions for patients with major depression. Methods/ design We plan a randomised, parallel group, assessor-blinded superiority clinical trial. During two years we will include 84 consecutive adult participants diagnosed with major depressive disorder. The participants will be randomised to either ‘third wave‘ cognitive therapy versus mentalization-based therapy. The primary outcome will be the Hamilton Rating Scale for Depression at cessation of treatment at 18 weeks. Secondary outcomes will be the proportion of patients with remission, Symptom Checklist 90 Revised, Beck’s Depression Inventory, and The World Health Organisation-Five Well-being Index 1999. Discussion Interventions for depression have until now shown relatively small effects. Our trial results will provide knowledge about the effects of two modern psychotherapeutic interventions. Trial registration ClinicalTrials: NCT01070134

  9. The effect of MELatOnin on Depression, anxietY, cognitive function and sleep disturbances in patients with breast cancer. The MELODY trial

    DEFF Research Database (Denmark)

    Hansen, Melissa Voigt; Madsen, Michael Tvilling; Hageman, Ida

    2012-01-01

    Introduction Breast cancer represents about one-third of all cancer diagnoses and accounts for about 15% of cancer deaths in women. Many of these patients experience depression, anxiety, sleep disturbances and cognitive dysfunction. This may adversely affect quality of life and also contribute......-blind, randomised, placebo-controlled trial is to investigate whether treatment with oral melatonin has a prophylactic or ameliorating effect on depressive symptoms, anxiety, sleep disturbances and cognitive dysfunction in women with breast cancer. Furthermore, the authors will examine whether a specific clock......-gene, PER3, is correlated with an increased risk of depressive symptoms, sleep disturbances or cognitive dysfunction. The MELODY trial is a prospective double-blinded, randomised, placebo-controlled trial in which the authors intend to include 260 patients. The primary outcome is depressive symptoms...

  10. Collaborative care management effectively promotes self-management: patient evaluation of care management for depression in primary care.

    Science.gov (United States)

    DeJesus, Ramona S; Howell, Lisa; Williams, Mark; Hathaway, Julie; Vickers, Kristin S

    2014-03-01

    Chronic disease management in the primary care setting increasingly involves self-management support from a nurse care manager. Prior research had shown patient acceptance and willingness to work with care managers. This survey study evaluated patient-perceived satisfaction with care management and patient opinions on the effectiveness of care management in promoting self-management. Qualitative and quantitative survey responses were collected from 125 patients (79% female; average age 46; 94% Caucasian) enrolled in care management for depression. Qualitative responses were coded with methods of content analysis by 2 independent analysts. Patients were satisfied with depression care management. Patients felt that care management improved their treatment above and beyond other aspects of their depression treatment (mean score, 6.7 [SD, 2]; 10 = Very much), increased their understanding of depression self-management (mean score, 7.2 [SD, 2]; 10 = Very much), and increased the frequency of self-management goal setting (mean score, 6.9 [SD, 3]; 10 = Very much). Predominant qualitative themes emphasized that patients value emotional, motivational, and relational aspects of the care manager relationship. Patients viewed care managers as caring and supportive, helpful in creating accountability for patients and knowledgeable in the area of depression care. Care managers empower patients to take on an active role in depression self-management. Some logistical challenges associated with a telephonic intervention are described. Care manager training should include communication and motivation strategies, specifically self-management education, as these strategies are valued by patients. Barriers to care management, such as scheduling telephone calls, should be addressed in future care management implementation and study.

  11. The effect of individual enabling and support on empowerment and depression severity in persons with affective disorders: outcome of a randomized control trial.

    Science.gov (United States)

    Porter, Susann; Bejerholm, Ulrika

    2018-01-30

    To evaluate the effect of Individual Enabling and Support (IES) on empowerment and depression severity as compared to Traditional Vocational Rehabilitation (TVR) in people with affective disorders at 12 months follow-up. Additionally, longitudinal changes within the intervention groups and the correlation over time between empowerment and depression severity were evaluated. A single-blind randomized controlled trial of two intervention groups, IES (n = 33) and TVR (n = 28), was performed with measurement points at baseline, 6, and 12 months. Individuals with affective disorders, including depression and bipolar disorder diagnoses were included. The Empowerment Scale and Montgomery-Åsberg Depression Self-Rating Scale were administered, and Intention-To-Treat analysis was applied. The study was registered with the trial number ISRCTN93470551. There was a statistically significant difference between the intervention groups on empowerment and depression severity at 12 months. Within-group analysis showed that IES-participants increased their perceived empowerment and decreased their depression severity between measurement points, this was not seen among TVR-participants. A moderate, inverse relationship was detected between empowerment and depression. IES is more effective in increasing empowerment and decreasing depression severity after a 12-month intervention than is TVR. This study was limited by a small sample size and larger trials in different contexts are needed.

  12. The effect of improvisational music therapy on the treatment of depression: protocol for a randomised controlled trial

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    Punkanen Marko

    2008-06-01

    Full Text Available Abstract Background Music therapy is frequently offered to individuals suffering from depression. Despite the lack of research into the effects of music therapy on this population, anecdotal evidence suggests that the results are rather promising. The aim of this study is to examine whether improvisational, psychodynamically orientated music therapy in an individual setting helps reduce symptoms of depression and improve other health-related outcomes. In particular, attention will be given to mediator agents, such as musical expression and interaction in the sessions, as well as to the explanatory potential of EEG recordings in investigating emotion related music perception of individuals with depression. Methods 85 adults (18–50 years of age with depression (ICD-10: F 32 or F33 will be randomly assigned to an experimental or a control condition. All participants will receive standard care, but the experimental group will be offered biweekly sessions of improvisational music therapy over a period of 3 months. A blind assessor will measure outcomes before testing, after 3 months, and after 6 months. Discussion This study aims to fill a gap in knowledge as to whether active (improvisational music therapy applied to people with depression improves their condition. For the first time in this context, the mediating processes, such as changes in musical expression and interaction during the course of therapy, will be objectively investigated, and it is expected that the results will provide new insights into these processes. Furthermore, the findings are expected to reveal whether music related emotional experiences, as measured by EEG, can be utilized in assessing a depressive client's improvement in the therapy. The size and the comprehensiveness of the study are sufficient for generalizing its findings to clinical practice as well as to further music therapy research. Trial registration ISRCTN84185937

  13. Exercise may reduce depression but not anxiety in self-referred cancer patients undergoing chemotherapy. Post-hoc analysis of data from the 'Body & Cancer' trial

    DEFF Research Database (Denmark)

    Midtgaard, Julie; Stage, Maria; Møller, Tom

    2011-01-01

    Abstract Background. The diagnosis and treatment of cancer may cause clinically significant and persistent psychological morbidity. The objective of this study was to determine the short-term effect of a six week exercise intervention on anxiety and depression in cancer patients undergoing.......021). Conclusion. Anti-depressant effects could be caused by exercise in self-referred cancer patients undergoing chemotherapy. Dedicated trials and follow-up studies are needed to clarify the optimal duration and content of exercise interventions to meet the needs of clinically depressive or anxious patients....... chemotherapy (The 'Body & Cancer' trial). Methods. Two hundred and nine self-referred patients (52 males, 157 females, mean age 47 years) were randomised into an intervention group and a waiting-list control group. Anxiety and depression was measured by the Hospital Anxiety and Depression Scale. Results...

  14. Effectiveness of a Guided Self-help Manual in Strengthening Resilience in People Diagnosed with Moderate Depression and Their Family Caregivers in Thailand: A Randomised Controlled Trial.

    Science.gov (United States)

    McCann, Terence V; Songprakun, Wallapa; Stephenson, John

    2017-08-01

    The growing incidence of depression in developing countries, such as Thailand, is placing increasing pressure on public mental health services, and those living in rural areas have limited access to these services. Resilience is integral to the recovery of people with depression and to caregivers. This parallel-group randomised controlled trial evaluated the effectiveness of a guided self-help manual in improving resilience in adults diagnosed with moderate depression and their primary caregivers in Thailand. Our findings provide preliminary evidence that the approach is an effective way of increasing resilience in adults with depression and their caregivers.

  15. Change in Parental Depressive Symptoms in Trauma-Focused Cognitive-Behavioral Therapy: Results from a Randomized Controlled Trial.

    Science.gov (United States)

    Tutus, Dunja; Keller, Ferdinand; Sachser, Cedric; Pfeiffer, Elisa; Goldbeck, Lutz

    2017-03-01

    Depressive symptoms are frequently described in parents whose children have been exposed to traumatic events. Hence, including nonoffending parents in trauma-focused cognitive-behavioral therapy (TF-CBT) for children and adolescents may help both children and their parents to cope with the trauma. Up to now, three randomized controlled trials have investigated parental depressive symptoms after TF-CBT. Given the ambiguous results, further effectiveness trials are needed to investigate parental benefit from TF-CBT. The aim of this study is to determine whether TF-CBT is superior to waitlist (WL) regarding change in parental depressive symptoms. Parents, N = 84, whose children (age 6-17 years) were randomly assigned to either 12 sessions of TF-CBT (n = 40) or to WL condition (n = 44) completed the Beck Depression Inventory-Second Edition (BDI-II) for pre-post comparison. The group difference was tested through repeated-measures analyses of variance (ANOVA). The change in parental depressive symptoms was additionally categorized using the reliable change index. Repeated-measures ANOVA indicated a significant time effect F(1, 82) = 2.55, p = 0.02, and no significant time-group interaction F(1, 82) = 1.09, p = 0.30, suggesting a similar reduction in parental depressive symptoms in both groups. Across both conditions, most of the parents remained unchanged (n = 62), some of them improved (n = 17), and a few deteriorated (n = 5). There was no significant difference between the conditions (χ 2 (2) = 1.74; p = 0.42). Contrary to findings of several previous studies, our results suggest no superiority of TF-CBT in comparison with WL regarding change in depressive symptoms in parents. This might be due to different types of the child's trauma. Parental benefit from TF-CBT was found in samples of sexually abused, but not in children and adolescents exposed to diverse trauma types.

  16. Homeopathic Individualized Q-Potencies versus Fluoxetine for Moderate to Severe Depression: Double-Blind, Randomized Non-Inferiority Trial

    Directory of Open Access Journals (Sweden)

    U. C. Adler

    2011-01-01

    Full Text Available Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies] in acute depression, using fluoxetine as active control. Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day−1 (up to 40 mg day−1 in a prospective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Åsberg Depression Rating Scale (MADRS depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = .654 and 8th weeks (P = .965 of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy-fluoxetine were −3.04 (95% CI −6.95, 0.86 and −2.4 (95% CI −6.05, 0.77 at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of

  17. Homeopathic Individualized Q-Potencies versus Fluoxetine for Moderate to Severe Depression: Double-Blind, Randomized Non-Inferiority Trial

    Science.gov (United States)

    Adler, U. C.; Paiva, N. M. P.; Cesar, A. T.; Adler, M. S.; Molina, A.; Padula, A. E.; Calil, H. M.

    2011-01-01

    Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies)] in acute depression, using fluoxetine as active control. Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day−1 (up to 40 mg day−1) in a prospective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Åsberg Depression Rating Scale (MADRS) depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = .654) and 8th weeks (P = .965) of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI) for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy-fluoxetine) were −3.04 (95% CI −6.95, 0.86) and −2.4 (95% CI −6.05, 0.77) at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of outpatients

  18. The effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse/recurrence: results of a randomised controlled trial (the PREVENT study).

    Science.gov (United States)

    Kuyken, Willem; Hayes, Rachel; Barrett, Barbara; Byng, Richard; Dalgleish, Tim; Kessler, David; Lewis, Glyn; Watkins, Edward; Morant, Nicola; Taylor, Rod S; Byford, Sarah

    2015-09-01

    of the secondary outcomes. Cost-effectiveness analysis did not support the hypothesis that MBCT-TS is more cost-effective than m-ADM in terms of either relapse/recurrence or quality-adjusted life-years. In planned subgroup analyses, a significant interaction was found between treatment group and reported childhood abuse (HR 1.89, 95% CI 1.06 to 3.38), with delayed time to relapse/recurrence for MBCT-TS participants with a more abusive childhood compared with those with a less abusive history. Although changes in mindfulness were specific to MBCT (and not m-ADM), they did not predict outcome in terms of relapse/recurrence at 24 months. In terms of acceptability, the qualitative analyses suggest that many people have views about (dis)/continuing their ADM, which can serve as a facilitator or a barrier to taking part in a trial that requires either continuation for 2 years or discontinuation. There is no support for the hypothesis that MBCT-TS is superior to m-ADM in preventing depressive relapse/recurrence among individuals at risk for depressive relapse/recurrence. Both treatments appear to confer protection against relapse/recurrence. There is an indication that MBCT may be most indicated for individuals at greatest risk of relapse/recurrence. It is important to characterise those most at risk and carefully establish if and why MBCT may be most indicated for this group. Current Controlled Trials ISRCTN26666654. This project was funded by the NIHR Health Technology Assessment programme and the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care South West Peninsula and will be published in full in Health Technology Assessment; Vol. 19, No. 73. See the NIHR Journals Library website for further project information.

  19. Rationale and design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND).

    Science.gov (United States)

    Hedayati, S Susan; Daniel, Divya M; Cohen, Scott; Comstock, Bryan; Cukor, Daniel; Diaz-Linhart, Yaminette; Dember, Laura M; Dubovsky, Amelia; Greene, Tom; Grote, Nancy; Heagerty, Patrick; Katon, Wayne; Kimmel, Paul L; Kutner, Nancy; Linke, Lori; Quinn, Davin; Rue, Tessa; Trivedi, Madhukar H; Unruh, Mark; Weisbord, Steven; Young, Bessie A; Mehrotra, Rajnish

    2016-03-01

    Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes. Published by Elsevier Inc.

  20. Rationale and Design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND)

    Science.gov (United States)

    Hedayati, S. Susan; Daniel, Divya M.; Cohen, Scott; Comstock, Bryan; Cukor, Daniel; Diaz-Linhart, Yaminette; Dember, Laura M.; Dubovsky, Amelia; Greene, Tom; Grote, Nancy; Heagerty, Patrick; Katon, Wayne; Kimmel, Paul L.; Kutner, Nancy; Linke, Lori; Quinn, Davin; Rue, Tessa; Trivedi, Madhukar H.; Unruh, Mark; Weisbord, Steven; Young, Bessie A.; Mehrotra, Rajnish

    2015-01-01

    Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes. PMID:26621218

  1. An analysis of correlations among four outcome scales employed in clinical trials of patients with major depressive disorder

    Directory of Open Access Journals (Sweden)

    Ahmed Saeeduddin

    2009-01-01

    Full Text Available Abstract Background The 17-item Hamilton Depression Rating Scale (HAM-D17 remains the 'gold standard' for measuring treatment outcomes in clinical trials of depressed patients. The Montgomery Ǻsberg Depression Rating Scale (MADRS, Clinical Global Impressions-Severity (CGI-S and -Improvement (CGI-I scales are also widely used. Objective This analysis of data from 22 double-blind, placebo-controlled clinical studies of venlafaxine in adult patients with major depressive disorder was aimed at assessing correlations among these 4 scales. Methods Changes from baseline for MADRS, HAM-D17 and CGI-S, and end point CGI-I scores and response (≥50% decrease from baseline HAM-D17 or MADRS, or CGI-S or CGI-I score ≤2 were analysed. Pearson correlation coefficients were calculated for all pairs of the four scales (HAM-D17/MADRS, HAM-D17/CGI-S, HAM-D17/CGI-I, MADRS/CGI-S, MADRS/CGI-I, CGI-S/CGI-I at different time points. Effect sizes were calculated using the Cohen d. Results Correlations were significant at all time points (p 17 or CGI-S for continuous measures and response. Conclusion Although MADRS and CGI-I were more sensitive to treatment effects, HAM-D17, MADRS, CGI-S and CGI-I scores present a consistent picture of response to venlafaxine treatment.

  2. Coenzyme Q10 as a treatment for fatigue and depression in multiple sclerosis patients: A double blind randomized clinical trial.

    Science.gov (United States)

    Sanoobar, Meisam; Dehghan, Parvin; Khalili, Mohammad; Azimi, Amirreza; Seifar, Fatemeh

    2016-01-01

    Multiple sclerosis (MS) is the chronic inflammatory and demyelinating disorder of central nervous system which is accompanied with disability and negative life style changes such as fatigue and depression. The aim of this study is to investigate the effect of coenzyme Q10 (CoQ10) supplementation on fatigue and depression in patients with MS. We performed a randomized, double-blinded, placebo-controlled trial to determine the effect of CoQ10 supplement (500 mg/day) vs. placebo for 12 weeks. Fatigue symptoms were quantified by means of fatigue severity scale (FSS) and the Beck depression inventory (BDI) was used to assess depressive symptoms. A significant decrease of FSS was observed in CoQ10 group during the intervention (P = 0.001) and significant increase of FSS change was observed within placebo group (P = 0.001). Repeated measure analysis of variance showed a significant time-by-treatment interaction for FSS (baseline 41.5 ± 15.6 vs. endpoint 45 ± 13.6; F1,45 = 55.23, P multiple sclerosis.

  3. Pilot trial evaluating maternal docosahexaenoic acid consumption during pregnancy: Decreased postpartum depressive symptomatology

    Directory of Open Access Journals (Sweden)

    Michelle P. Judge

    2014-12-01

    Conclusions: Women in the DHA intervention group had fewer symptoms of postpartum depression compared to the placebo group. These results support the notion that the consumption of DHA by pregnant women can be efficacious in preventing depressive symptoms and highlight a need for further larger-scale investigations using the PDSS in tandem with a diagnostic evaluation.

  4. A Novel Early Intervention for Preschool Depression: Findings from a Pilot Randomized Controlled Trial

    Science.gov (United States)

    Luby, Joan; Lenze, Shannon; Tillman, Rebecca

    2012-01-01

    Background: Validation for depression in preschool children has been established; however, to date no empirical investigations of interventions for the early onset disorder have been conducted. Based on this and the modest efficacy of available treatments for childhood depression, the need for novel early interventions has been emphasized. Large…

  5. Internet cognitive behaviour therapy for depression in older adults with knee osteoarthritis : A randomized controlled trial

    NARCIS (Netherlands)

    O'Moore, K.A.; Newby, J.M.; Andrews, G.; Hunter, D.J.; Bennell, K.; Smith, J.; Williams, A.D.

    2018-01-01

    Objective To determine the efficacy of an internet-based cognitive behavioural therapy (iCBT) program for depression in older adults with osteoarthritis of the knee and comorbid major depressive disorder (MDD). We conducted a RCT in sixty-nine adults (≥ 50 years) meeting criteria for MDD and

  6. Comparison of Effect of Lavandula officinalis and Venlafaxine in Treating Depression: A Double Blind Clinical Trial

    Science.gov (United States)

    Nikfarjam, Masoud; Rakhshan, Reza

    2017-01-01

    Introduction Major depressive disorder is a chronic disease which may be associated with other mental illnesses. Lavandula officinalis and venlafaxine, herbal and chemical drugs respectively, are used to treat depression. Despite pharmacotherapy, major depressive disorder has a complicated pattern of resistance and recurrence. Aim The aim of this study was to determine the effect of L. officinalis and venlafaxine in treating depression. Materials and Methods For this study, 120 patients referred to the psychiatry clinic of the Shahrekord University of Medical Sciences, Shahrekord, Iran, were randomly selected. The participants were randomly assigned to three groups: venlafaxine (Control Group), venlafaxine + L. officinalis (L. officinalis Group), and venlafaxine + placebo (Placebo Group). All the patients underwent treatment for six weeks. Depression test was administered to the three groups at different time intervals before the treatment, four weeks after the treatment and at completion of the treatment. The data were analysed by SPSS version17.0. Results Depression scores of all the groups decreased over time (p=0.001). The depression scores were significantly different between the control and L. officinalis groups (p=0.004), and the control and placebo groups (p=0.002), but were not significantly different between the L. officinalis and placebo groups (p=0.95). Conclusion Adding L. officinalis or a placebo is equally effective in decreasing mean depression score and venlafaxine obviously decreased this score. PMID:28892932

  7. Adjuvant occupational therapy for work-related major depression works: randomized trial including economic evaluation

    NARCIS (Netherlands)

    Schene, Aart H.; Koeter, Maarten W. J.; Kikkert, Martijn J.; Swinkels, Jan A.; McCrone, Paul

    2007-01-01

    BACKGROUND: Major depression has far-reaching consequences for work functioning and absenteeism. In most cases depression is treated by medication and clinical management. The addition of occupational therapy (OT) might improve outcome. We determined the cost-effectiveness of the addition of OT to

  8. Effectiveness of adjuvant occupational therapy in employees with depression: design of a randomized controlled trial

    NARCIS (Netherlands)

    Hees, Hiske L.; Koeter, Maarten W. J.; de Vries, Gabe; Ooteman, Wendy; Schene, Aart H.

    2010-01-01

    ABSTRACT: BACKGROUND: Major depressive disorder is among the medical conditions with the highest negative impact on work outcome. However, little is known regarding evidence-based interventions targeting the improvement of work outcomes in depressed employees. In this paper, the design of a

  9. Postpartum Depression Prevention for Reservation-Based American Indians: Results from a Pilot Randomized Controlled Trial

    Science.gov (United States)

    Ginsburg, Golda S.; Barlow, Allison; Goklish, Novalene; Hastings, Ranelda; Baker, Elena Varipatis; Mullany, Britta; Tein, Jenn-Yun; Walkup, John

    2012-01-01

    Background: Postpartum depression is a devastating condition that affects a significant number of women and their offspring. Few preventive interventions have targeted high risk youth, such as American Indians (AIs). Objective: To evaluate the feasibility of a depression prevention program for AI adolescents and young adults. Methods: Expectant AI…

  10. Positive Psychology Intervention to Alleviate Child Depression and Increase Life Satisfaction: A Randomized Clinical Trial

    Science.gov (United States)

    Kwok, Sylvia Y. C. L.; Gu, Minmin; Kit, Katrina Tong Kai

    2016-01-01

    Purpose: The study aims to examine the effectiveness of a positive psychology group-based intervention program, incorporating elements of hope and gratitude, in decreasing depression and increasing life satisfaction among primary school students in Hong Kong. Method: A total of 68 children, with the Depression score of Chinese Hospital Anxiety and…

  11. Predicting Outcome in Computerized Cognitive Behavioral Therapy for Depression in Primary Care: A Randomized Trial

    Science.gov (United States)

    de Graaf, L. Esther; Hollon, Steven D.; Huibers, Marcus J. H.

    2010-01-01

    Objective: To explore pretreatment and short-term improvement variables as potential moderators and predictors of 12-month follow-up outcome of unsupported online computerized cognitive behavioral therapy (CCBT), usual care, and CCBT combined with usual care for depression. Method: Three hundred and three depressed patients were randomly allocated…

  12. Activation and Self-Efficacy in a Randomized Trial of a Depression Self-Care Intervention

    Science.gov (United States)

    McCusker, Jane; Lambert, Sylvie D.; Cole, Martin G.; Ciampi, Antonio; Strumpf, Erin; Freeman, Ellen E.; Belzile, Eric

    2016-01-01

    Objectives: In a sample of primary care participants with chronic physical conditions and comorbid depressive symptoms: to describe the cross-sectional and longitudinal associations of activation and self-efficacy with demographic, physical and mental health status, health behaviors, depression self-care, health care utilization, and use of…

  13. Stepped care for depression and anxiety in visually impaired older adults: multicentre randomised controlled trial

    NARCIS (Netherlands)

    van der Aa, H.P.A.; van Rens, G.H.M.B.; Comijs, H.C.; Margrain, T.H.; Galindo Garre, F.; Twisk, J.W.R.; van Nispen, R.M.A.

    2015-01-01

    Study question Is stepped care compared with usual care effective in preventing the onset of major depressive, dysthymic, and anxiety disorders in older people with visual impairment (caused mainly by age related eye disease) and subthreshold depression and/or anxiety? Methods 265 people aged ?50

  14. The third Symptom Management Research Trial in Oncology (SMaRT Oncology-3: a randomised trial to determine the efficacy of adding a complex intervention for major depressive disorder (Depression Care for People with Lung Cancer to usual care, compared to usual care alone in patients with lung cancer

    Directory of Open Access Journals (Sweden)

    Sharpe Michael

    2009-09-01

    Full Text Available Abstract Background Depression Care for People with Lung Cancer is a complex intervention delivered by specially trained cancer nurses, under the supervision of a psychiatrist. It is given as a supplement to the usual care for depression, which patients receive from their general practitioner and cancer service. The third Symptom Management Research Trial in Oncology (SMaRT Oncology-3 Trial will test its efficacy when compared to usual care alone. Design A two arm parallel group multi-centre randomised controlled trial. 200 patients will be recruited through established systematic Symptom Monitoring Services, which screen patients for depression. Patients will have: a diagnosis of lung cancer; an estimated life expectancy of three months or more and a diagnosis of Major Depressive Disorder. Patients will be randomised to usual care or usual care plus Depression Care for People with Lung Cancer. Randomisation will be carried out by telephoning a secure computerised central randomisation system or by using a secure web interface. The primary outcome measure is average depression severity. This will be assessed using scores on the 20-item Symptom Hopkins Checklist (SCL-20D, collected every four weeks over 32 weeks. Secondary outcomes include severity of anxiety, pain and fatigue; self-rated improvement of depression; quality of life and satisfaction with depression care. Trial Registration Current controlled trials ISRCTN75905964

  15. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial.

    Science.gov (United States)

    Ross, Stephen; Bossis, Anthony; Guss, Jeffrey; Agin-Liebes, Gabrielle; Malone, Tara; Cohen, Barry; Mennenga, Sarah E; Belser, Alexander; Kalliontzi, Krystallia; Babb, James; Su, Zhe; Corby, Patricia; Schmidt, Brian L

    2016-12-01

    Clinically significant anxiety and depression are common in patients with cancer, and are associated with poor psychiatric and medical outcomes. Historical and recent research suggests a role for psilocybin to treat cancer-related anxiety and depression. In this double-blind, placebo-controlled, crossover trial, 29 patients with cancer-related anxiety and depression were randomly assigned and received treatment with single-dose psilocybin (0.3 mg/kg) or niacin, both in conjunction with psychotherapy. The primary outcomes were anxiety and depression assessed between groups prior to the crossover at 7 weeks. Prior to the crossover, psilocybin produced immediate, substantial, and sustained improvements in anxiety and depression and led to decreases in cancer-related demoralization and hopelessness, improved spiritual wellbeing, and increased quality of life. At the 6.5-month follow-up, psilocybin was associated with enduring anxiolytic and anti-depressant effects (approximately 60-80% of participants continued with clinically significant reductions in depression or anxiety), sustained benefits in existential distress and quality of life, as well as improved attitudes towards death. The psilocybin-induced mystical experience mediated the therapeutic effect of psilocybin on anxiety and depression. In conjunction with psychotherapy, single moderate-dose psilocybin produced rapid, robust and enduring anxiolytic and anti-depressant effects in patients with cancer-related psychological distress. ClinicalTrials.gov Identifier: NCT00957359. © The Author(s) 2016.

  16. The Health Informatics Trial Enhancement Project (HITE: Using routinely collected primary care data to identify potential participants for a depression trial

    Directory of Open Access Journals (Sweden)

    Lyons Ronan A

    2010-04-01

    Full Text Available Abstract Background Recruitment to clinical trials can be challenging. We identified anonymous potential participants to an existing pragmatic randomised controlled depression trial to assess the feasibility of using routinely collected data to identify potential trial participants. We discuss the strengths and limitations of this approach, assess its potential value, report challenges and ethical issues encountered. Methods Swansea University's Health Information Research Unit's Secure Anonymised Information Linkage (SAIL database of routinely collected health records was interrogated, using Structured Query Language (SQL. Read codes were used to create an algorithm of inclusion/exclusion criteria with which to identify suitable anonymous participants. Two independent clinicians rated the eligibility of the potential participants' identified. Inter-rater reliability was assessed using the kappa statistic and inter-class correlation. Results The study population (N = 37263 comprised all adults registered at five general practices in Swansea UK. Using the algorithm 867 anonymous potential participants were identified. The sensitivity and specificity results > 0.9 suggested a high degree of accuracy from the algorithm. The inter-rater reliability results indicated strong agreement between the confirming raters. The Intra Class Correlation Coefficient (Cronbach's Alpha > 0.9, suggested excellent agreement and Kappa coefficient > 0.8; almost perfect agreement. Conclusions This proof of concept study showed that routinely collected primary care data can be used to identify potential participants for a pragmatic randomised controlled trial of folate augmentation of antidepressant therapy for the treatment of depression. Further work will be needed to assess generalisability to other conditions and settings and the inclusion of this approach to support Electronic Enhanced Recruitment (EER.

  17. A randomized controlled trial of yoga for pregnant women with symptoms of depression and anxiety.

    Science.gov (United States)

    Davis, Kyle; Goodman, Sherryl H; Leiferman, Jenn; Taylor, Mary; Dimidjian, Sona

    2015-08-01

    Yoga may be well suited for depressed and anxious pregnant women, given reported benefits of meditation and physical activity and pregnant women's preference for nonpharmacological treatments. We randomly assigned 46 pregnant women with symptom