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Sample records for psychological treatment trials

  1. Randomised controlled trials of psychological & pharmacological treatments for body dysmorphic disorder: A systematic review.

    Science.gov (United States)

    Phillipou, Andrea; Rossell, Susan L; Wilding, Helen E; Castle, David J

    2016-11-30

    Treatment for body dysmorphic disorder (BDD) often involves a combination of psychological and pharmacological interventions. However, only a small number of randomised controlled trials (RCTs) have been undertaken examining the efficacy of different therapeutic interventions. The aim of this study was to systematically review the RCTs involving psychological and pharmacological interventions for the treatment of BDD. The literature was searched to June 2015, and studies were included if they were written in English, empirical research papers published in peer-review journals, specifically assessed BDD patients, and involved a RCT assessing BDD symptoms pre- and post-intervention. Nine studies were identified: six involving psychological and three involving pharmacological interventions. Cognitive behaviour therapy, metacognitive therapy and selective serotonin reuptake inhibitors were identified as treatments with potential benefit. The small number of RCTs and the heterogeneity of findings emphasises the need for more high quality RCTs assessing both psychological and pharmacological interventions for BDD. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  2. Psychological Treatment

    Science.gov (United States)

    ... cognitive-behavioral therapy ), relaxation therapy , hypnotherapy , and biofeedback therapy . Psychological treatments can also be combined. Review of well- ... Antidepressant Medications Newer IBS Medications Probiotics and Antibiotics ... Cognitive Behavioral Therapy Relaxation Techniques for IBS Take Part in Online ...

  3. Psychological Treatment Trials for Hypoactive Sexual Desire Disorder: A Sexual Medicine Critique and Perspective.

    Science.gov (United States)

    Pyke, Robert E; Clayton, Anita H

    2015-12-01

    Publications claim efficacy for treatment of hypoactive sexual desire disorder (HSDD) in women with cognitive behavior therapy (CBT) and mindfulness meditation training (MMT). However, no review has evaluated the evidence for these therapies from the rigorous perspective of sexual medicine. The aim of this study was to evaluate the published controlled trials of CBT and MMT for disorders of sexual desire from the perspective of sexual medicine standards of control paradigms, risk/benefit ratios, and clinical significance. MEDLINE was reviewed from the last 10 years. Evaluated study quality via 10 metrics and efficacy as mean change, and proportion of responders and remitters. Three controlled trials support CBT and two controlled trials support MMT. The reports of the trials each lacked several scientific requirements: a hierarchy of endpoints with a planned primary endpoint, sufficient information on the intervention to reproduce it, randomization, adequate control, accepted measures of benefits and harms, compliance data, and/or outcomes of clinical relevance. Psychological treatments for HSDD are not yet supported by adequate clinical trials. The current scientific and regulatory standards for drug treatment trials should also be applicable to psychological treatment trials. © 2015 International Society for Sexual Medicine.

  4. Direct-to-consumer marketing of psychological treatments: A randomized controlled trial.

    Science.gov (United States)

    Gallo, Kaitlin P; Comer, Jonathan S; Barlow, David H; Clarke, Roberta N; Antony, Martin M

    2015-10-01

    Although direct-to-consumer (DTC) marketing of pharmacologic interventions is effective and common, similar approaches have yet to be evaluated in the promotion of psychological treatments (PTs). This is the first randomized controlled trial evaluating the potential of DTC marketing of PTs. Participants (N = 344; 75.0% female, mean age = 18.6 years, 48.5% non-Hispanic White) were randomly assigned to consume one of four extended commercial campaigns embedded within unrelated programming across 3 weeks. The four campaign conditions were a PT campaign, a PT informing about medication side effects campaign, a medication campaign, and a neutral campaign. Attitudes about and intention to seek psychological treatment were assessed prior to campaign exposure (T1), 1 week following the final week of campaign exposure (T2), and at a 3-month follow-up evaluation (T3). The percentage of participants who newly intended psychological treatment at T2 or T3 differed by condition, with those assigned to the PT campaign slightly more likely to have intended to receive psychological treatment at T2 or T3 than those in other conditions. Baseline reports of emotional symptoms moderated the effect of condition on attitudes toward PT and perceived likelihood of seeking treatment in the future. Findings support the preliminary utility of DTC marketing of psychological treatments. Increasing consumer knowledge of PTs may be a worthwhile complement to current dissemination and implementation efforts aimed at promoting the uptake of PTs in mental health care. (c) 2015 APA, all rights reserved).

  5. 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.

  6. Effectiveness of the psychological and pharmacological treatment of catastrophization in patients with fibromyalgia: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Magallón Rosa

    2009-04-01

    Full Text Available Abstract Background Fibromyalgia is a prevalent and disabling disorder characterized by widespread pain and other symptoms such as insomnia, fatigue or depression. Catastrophization is considered a key clinical symptom in fibromyalgia; however, there are no studies on the pharmacological or psychological treatment of catastrophizing. The general aim of this study is to assess the effectiveness of cognitive-behaviour therapy and recommended pharmacological treatment for fibromyalgia (pregabalin, with duloxetine added where there is a comorbid depression, compared with usual treatment at primary care level. Method/design Design: A multi-centre, randomized controlled trial involving three groups: the control group, consisting of usual treatment at primary care level, and two intervention groups, one consisting of cognitive-behaviour therapy, and the other consisting of the recommended pharmacological treatment for fibromyalgia. Setting: 29 primary care health centres in the city of Zaragoza, Spain. Sample: 180 patients, aged 18–65 years, able to understand and read Spanish, who fulfil criteria for primary fibromyalgia, with no previous psychological treatment, and no pharmacological treatment or their acceptance to discontinue it two weeks before the onset of the study. Intervention: Psychological treatment is based on the manualized protocol developed by Prof. Escobar et al, from the University of New Jersey, for the treatment of somatoform disorders, which has been adapted by our group for the treatment of fibromyalgia. It includes 10 weekly sessions of cognitive-behaviour therapy. Pharmacological therapy consists of the recommended pharmacological treatment for fibromyalgia: pregabalin (300–600 mg/day, with duloxetine (60–120 mg/day added where there is a comorbid depression. Measurements: The following socio-demographic data will be collected: sex, age, marital status, education, occupation and social class. The diagnosis of psychiatric

  7. Suicide prevention after traumatic brain injury: a randomized controlled trial of a program for the psychological treatment of hopelessness.

    Science.gov (United States)

    Simpson, Grahame K; Tate, Robyn L; Whiting, Diane L; Cotter, Rachel E

    2011-01-01

    To evaluate the efficacy of a psychological treatment to reduce moderate to severe hopelessness after severe traumatic brain injury (TBI). Randomized controlled trial. Participants were aged between 18 and 65 years, experienced posttraumatic amnesia more than 1day and moderate to severe hopelessness (Beck Hopelessness Scale [BHS]) and/or suicide ideation. Intervention comprised a 20-hour manualized group cognitive behavior therapy program. Participants were randomly allocated using concealed allocation (treatment n = 8; wait-list n = 9); all remained in their allocated group. Outcome variables were collected by assessors blind to group allocation. No between-groups differences were observed on demographic, injury, cognitive, and psychosocial variables at baseline (time 1). A significant group-by-time interaction was found for BHS in the treatment group (F1,15 = 13.20, P = .002), reflecting a reduction in mean BHS scores between time 1 and time 2 (posttreatment) with no main effects for group or time. At 3-month follow-up (time 3), the treatment gains were maintained or improved for 75% (6/8) of participants. Secondary outcome variables (suicide ideation, depression, social problem solving, self-esteem, hopefulness) displayed no significant group-by-time interactions or main effects. This trial provides initial evidence for the efficacy of a psychological intervention in reducing hopelessness among long-term survivors with severe TBI.

  8. Psychological effects of the intensified follow-up of the CEAwatch trial after treatment for colorectal cancer

    NARCIS (Netherlands)

    Zhan, Zhuozhao; Verberne, Charlotte J.; van den Heuvel, Edwin R.; Grossmann, Irene; Ranchor, Adelita V.; Wiggers, Theo; de Bock, Geertruida H.

    2017-01-01

    Background: The aim of the study was to evaluate psychological effects of the state-of-art intensified follow-up protocol for colorectal cancer patients in the CEAwatch trial. Method: At two time points during the CEAwatch trial questionnaires regarding patients' attitude towards follow-up,

  9. Rock climbing and acute emotion regulation in patients with major depressive disorder in the context of a psychological inpatient treatment: a controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Kleinstäuber M

    2017-08-01

    Full Text Available Maria Kleinstäuber,1,2 Merle Reuter,3 Norbert Doll,4 Andreas J Fallgatter4 1Division of Clinical Psychology and Psychotherapy, Faculty of Psychology, Philipps University, Marburg, Germany; 2Department of Psychological Medicine, School of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand; 3Department of Educational Psychology, Faculty of Psychology, Eberhard Karls University, Tübingen, Germany, 4Department of General Psychiatry and Psychotherapy, University Hospital for Psychiatry and Psychotherapy, Eberhard Karls University, Tübingen, Germany Background: Major depressive disorder is characterized by deficits in emotion regulation. This study examined associations between rock climbing and acute emotion regulating effects in patients with major depression. Patients and methods: In a nonrandomized, controlled study, 40 major depressive disorder inpatients were assigned to either a climbing session (n=20 or a relaxation session (n=20. Positive and negative affect, depressiveness, and coping emotions were assessed immediately before and after the session. Results: Mixed analyses of variance and covariance revealed significant time × group interaction effects for all assessed outcomes (p≤0.012: positive affect and coping emotions significantly increased and negative affect and depressiveness significantly decreased after the climbing session (1.04≤ Cohen’s d ≤1.30, in contrast to a relaxation session (0.16≤ Cohen’s d ≤0.36. Conclusion: The results show that rock climbing is associated with acute emotion regulatory effects. These findings have to be replicated with a randomized design, and future research should pay attention to possible mechanisms of rock climbing in regard to emotion regulation. Keywords: physical activity, controlled trial, relaxation, inpatient treatment

  10. Implementation of psychological clinical trials in epilepsy: Review and guide.

    Science.gov (United States)

    Modi, Avani C; Wagner, Janelle; Smith, Aimee W; Kellermann, Tanja S; Michaelis, Rosa

    2017-09-01

    The International League Against Epilepsy (ILAE) Neuropsychiatry commission and United States Institute of Medicine report both identified cognitive and psychological comorbidities as a significant issue for individuals with epilepsy, with rates as high as 60%. However, there is a paucity of evidence-based treatments for many psychological conditions (e.g., learning disorders, cognitive disorders, behavioral disorders). Because of inherent challenges in the implementation of psychological therapy trials and specific considerations for the population with epilepsy, the focus of the current review was to provide guidance and recommendations to conduct psychological trials for individuals with epilepsy. Several key areas will be discussed, including selection of patients, trial design, psychological intervention considerations, outcomes and evaluation of results, publication of trial results, and special issues related to pediatric clinical trials. Rigorously designed psychological therapy trials will set the stage for evidence-based practice in the care of individuals with epilepsy, with the goal of improving seizures, side effects, and HRQOL. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. Association between objective and subjective binge eating and psychopathology during a psychological treatment trial for bulimic symptoms.

    Science.gov (United States)

    Goldschmidt, Andrea B; Accurso, Erin C; Crosby, Ross D; Cao, Li; Ellison, Jo; Smith, Tracey L; Klein, Marjorie H; Mitchell, James E; Crow, Scott J; Wonderlich, Stephen A; Peterson, Carol B

    2016-12-01

    Although loss of control (LOC) while eating is a core construct of bulimia nervosa (BN), questions remain regarding its validity and prognostic significance independent of overeating. We examined trajectories of objective and subjective binge eating (OBE and SBE, respectively; i.e., LOC eating episodes involving an objectively or subjectively large amount of food) among adults participating in psychological treatments for BN-spectrum disorders (n = 80). We also explored whether changes in the frequency of these eating episodes differentially predicted changes in eating-related and general psychopathology and, conversely, whether changes in eating-related and general psychopathology predicted differential changes in the frequency of these eating episodes. Linear mixed models with repeated measures revealed that OBE decreased twice as rapidly as SBE throughout treatment and 4-month follow-up. Generalized linear models revealed that baseline to end-of-treatment reductions in SBE frequency predicted baseline to 4-month follow-up changes in eating-related psychopathology, depression, and anxiety, while changes in OBE frequency were not predictive of psychopathology at 4-month follow-up. Zero-inflation models indicated that baseline to end-of-treatment changes in eating-related psychopathology and depression symptoms predicted baseline to 4-month follow-up changes in OBE frequency, while changes in anxiety and self-esteem did not. Baseline to end-of-treatment changes in eating-related psychopathology, self-esteem, and anxiety predicted baseline to 4-month follow-up changes in SBE frequency, while baseline to end-of-treatment changes in depression did not. Based on these findings, LOC accompanied by objective overeating may reflect distress at having consumed an objectively large amount of food, whereas LOC accompanied by subjective overeating may reflect more generalized distress related to one's eating- and mood-related psychopathology. BN treatments should

  12. An online psychological intervention can improve the sexual satisfaction of men following treatment for localized prostate cancer: outcomes of a Randomised Controlled Trial evaluating My Road Ahead.

    Science.gov (United States)

    Wootten, Addie C; Meyer, Denny; Abbott, Jo-Anne M; Chisholm, Katherine; Austin, David W; Klein, Britt; McCabe, Marita; Murphy, Declan G; Costello, Anthony J

    2017-07-01

    Prostate cancer treatment often results in significant psycho-sexual challenges for men following treatment; however, many men report difficulty in accessing appropriate care. A randomized controlled trial was undertaken to assess the efficacy of a 10-week self-guided online psychological intervention called My Road Ahead (MRA) for men with localized prostate cancer in improving sexual satisfaction. Participants were randomized to 1 of 3 conditions MRA alone or MRA plus online forum, or forum access alone. Pre, post, and follow-up assessments of overall sexual satisfaction were conducted. Mixed models and structural equation modeling were used to analyze the data. One hundred forty-two men (mean age 61 y; SD = 7) participated. The majority of participants had undergone radical prostatectomy (88%) and all men had received treatment for localized prostate cancer. Significant differences were obtained for the 3 groups (P = .026) and a significant improvement in total sexual satisfaction was observed only for participants who were allocated to MRA + forum with a large effect size (P = .004, partial η 2  = 0.256). Structural equation modeling indicated that increases in sexual function, masculine self-esteem, and sexual confidence contributed significantly to overall sexual satisfaction for the MRA + forum plus forum condition. This study is the first, to our knowledge, that has evaluated a self-guided online psychological intervention tailored to the specific needs of men with prostate cancer. The findings indicate the potential for MRA to deliver support that men may not otherwise receive and also highlight the importance of psychological intervention to facilitate improved sexual outcomes. Copyright © 2016 John Wiley & Sons, Ltd.

  13. Two-year follow-up of the MOSAIC trial: A multicenter randomized controlled trial comparing two psychological treatments in adult outpatients with broadly defined anorexia nervosa.

    Science.gov (United States)

    Schmidt, Ulrike; Ryan, Elizabeth G; Bartholdy, Savani; Renwick, Bethany; Keyes, Alexandra; O'Hara, Caitlin; McClelland, Jessica; Lose, Anna; Kenyon, Martha; Dejong, Hannah; Broadbent, Hannah; Loomes, Rachel; Serpell, Lucy; Richards, Lorna; Johnson-Sabine, Eric; Boughton, Nicky; Whitehead, Linette; Bonin, Eva; Beecham, Jennifer; Landau, Sabine; Treasure, Janet

    2016-08-01

    This study reports follow-up data from a multicenter randomized controlled trial (n = 142) comparing the Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with broadly defined anorexia nervosa (AN). At 12 months postrandomization, all patients had statistically significant improvements in body mass index (BMI), eating disorder (ED) symptomatology and other outcomes with no differences between groups. MANTRA was more acceptable to patients. The present study assessed whether gains were maintained at 24 months postrandomization. Follow-up data at 24 months were obtained from 73.2% of participants. Outcome measures included BMI, ED symptomatology, distress, impairment, and additional service utilization during the study period. Outcomes were analyzed using linear mixed models. There were few differences between groups. In both treatment groups, improvements in BMI, ED symptomatology, distress levels, and clinical impairment were maintained or increased further. Estimated mean BMI change from baseline to 24 months was 2.16 kg/m(2) for SSCM and 2.25 kg/m(2) for MANTRA (effect sizes of 1.75 and 1.83, respectively). Most participants (83%) did not require any additional intensive treatments (e.g., hospitalization). Two SSCM patients became overweight through binge-eating. Both treatments have value as outpatient interventions for patients with AN. © 2016 Crown copyright. International Journal of Eating Disorders. (Int J Eat Disord 2016; 49:793-800). © 2016 Crown copyright. International Journal of Eating Disorders.

  14. The Healthy Activity Program (HAP), a lay counsellor-delivered brief psychological treatment for severe depression, in primary care in India: a randomised controlled trial.

    Science.gov (United States)

    Patel, Vikram; Weobong, Benedict; Weiss, Helen A; Anand, Arpita; Bhat, Bhargav; Katti, Basavraj; Dimidjian, Sona; Araya, Ricardo; Hollon, Steve D; King, Michael; Vijayakumar, Lakshmi; Park, A-La; McDaid, David; Wilson, Terry; Velleman, Richard; Kirkwood, Betty R; Fairburn, Christopher G

    2017-01-14

    Although structured psychological treatments are recommended as first-line interventions for depression, only a small fraction of people globally receive these treatments because of poor access in routine primary care. We assessed the effectiveness and cost-effectiveness of a brief psychological treatment (Healthy Activity Program [HAP]) for delivery by lay counsellors to patients with moderately severe to severe depression in primary health-care settings. In this randomised controlled trial, we recruited participants aged 18-65 years scoring more than 14 on the Patient Health Questionnaire 9 (PHQ-9) indicating moderately severe to severe depression from ten primary health centres in Goa, India. Pregnant women or patients who needed urgent medical attention or were unable to communicate clearly were not eligible. Participants were randomly allocated (1:1) to enhanced usual care (EUC) alone or EUC combined with HAP in randomly sized blocks (block size four to six [two to four for men]), stratified by primary health centre and sex, and allocation was concealed with use of sequential numbered opaque envelopes. Physicians providing EUC were masked. Primary outcomes were depression symptom severity on the Beck Depression Inventory version II and remission from depression (PHQ-9 score of better results than did EUC alone for the secondary outcomes of disability (adjusted mean difference -2·73 [-4·39 to -1·06]; p=0·001), days out of work (-2·29 [-3·84 to -0·73]; p=0·004), intimate partner physical violence in women (0·53 [0·29-0·96]; p=0·04), behavioural activation (2·17 [1·34-3·00]; pbetter than EUC alone was for patients with moderately severe to severe depression in routine primary care in Goa, India. HAP was readily accepted by this previously untreated population and was cost-effective in this setting. HAP could be a key strategy to reduce the treatment gap for depressive disorders, the leading mental health disorder worldwide. Wellcome Trust

  15. Psychological aspects of male fertility treatment

    DEFF Research Database (Denmark)

    Mikkelsen, Alice Toft; Madsen, Svend Aage Lykke; Humaidan, Peter

    2013-01-01

    To explore and to identify the possible need for psychological communicative support in men undergoing fertility treatment.......To explore and to identify the possible need for psychological communicative support in men undergoing fertility treatment....

  16. Psychological treatments for gambling disorder

    Directory of Open Access Journals (Sweden)

    Rash CJ

    2014-10-01

    Full Text Available Carla J Rash, Nancy M Petry Department of Medicine, University of Connecticut Health Center, Farmington, CT, USA Abstract: This review discusses the research evidence for psychological treatment of gambling disorder. Several treatment options for gamblers have been explored, ranging from self-help and peer support, to brief and motivational interventions, to more intensive therapy approaches. Involvement in peer support programs seems to be optimal when combined with professional treatment; however, engagement and retention in peer support is limited. Self-directed interventions appear to benefit some gamblers; however, the involvement of therapist support, either in person or by telephone, may bolster these effects and such support need not be extensive. These self-directed options reduce the barriers associated with treatment-seeking, and may reach a wider range of gamblers than professionally delivered treatments alone. Brief and motivational approaches similarly may extend treatment options to more gamblers, namely at-risk and problem gamblers and those not seeking treatment. Of more extensive therapies, no consistent benefit of one approach emerges, although cognitive–behavioral interventions have been most often applied. Overall, several treatments have been developed for gambling disorder and results are promising, but variability in findings suggests a need for further systematic evaluation. Keywords: gambling treatment, cognitive behavioral treatment, brief interventions, pathological gambling, problem gambling, behavioral addictions

  17. The InterHerz project--a web-based psychological treatment for cardiac patients with depression: study protocol of a randomized controlled trial

    OpenAIRE

    Messerli-Bürgy, Nadine; Barth, Jürgen; Berger, Thomas

    2012-01-01

    Abstract Background Patients with heart disease often suffer from difficulties in psychological adaptation during cardiac rehabilitation. Mood disorders such as depression are known to be highly prevalent in cardiac patients and to have a negative impact on the progression of coronary heart disease. However, cardiac patients have difficulties to get psychological treatments due to low availability and motivational difficulties. Web-based interventions have been proven to be effective in treat...

  18. An open trial of individualized face-to-face cognitive behavior therapy for psychological distress in parents of children after end of treatment for childhood cancer including a cognitive behavioral conceptualization

    Directory of Open Access Journals (Sweden)

    Lisa Ljungman

    2018-04-01

    Full Text Available Objective A subgroup of parents of children who have been treated for childhood cancer report high levels of psychological distress. To date there is no empirically supported psychological treatment targeting cancer-related psychological distress in this population. The aim of the current study was to test the feasibility and preliminarily evaluate the effect of individualized face-to-face cognitive behavior therapy (CBT for parents of children after the end of treatment for childhood cancer. A secondary aim was to present a cognitive behavioral conceptualization of cancer-related distress for these parents. Methods An open trial was conducted where 15 parents of children who had completed successful treatment for cancer three months to five years earlier and who reported psychological distress related to a child’s previous cancer disease were provided CBT at a maximum of 15 sessions. Participants were assessed at baseline, post-intervention, and three-month follow-up using self-reported psychological distress (including posttraumatic stress symptoms (PTSS, depression, and anxiety and the diagnostic Mini-International Neuropsychiatric Interview. Feasibility outcomes relating to recruitment, data collection, and delivery of the treatment were also examined. Individual case formulations for each participant guided the intervention and these were aggregated and presented in a conceptualization detailing core symptoms and their suggested maintenance mechanisms. Results A total of 93% of the participants completed the treatment and all of them completed the follow-up assessment. From baseline to post-assessment, parents reported significant improvements in PTSS, depression, and anxiety with medium to large effect sizes (Cohen’s d = 0.65–0.92. Results were maintained or improved at a three-month follow-up. At baseline, seven (47% participants fulfilled the diagnostic criteria for major depressive disorder and four (29% fulfilled the criteria for

  19. An open trial of individualized face-to-face cognitive behavior therapy for psychological distress in parents of children after end of treatment for childhood cancer including a cognitive behavioral conceptualization.

    Science.gov (United States)

    Ljungman, Lisa; Cernvall, Martin; Ghaderi, Ata; Ljungman, Gustaf; von Essen, Louise; Ljótsson, Brjánn

    2018-01-01

    A subgroup of parents of children who have been treated for childhood cancer report high levels of psychological distress. To date there is no empirically supported psychological treatment targeting cancer-related psychological distress in this population. The aim of the current study was to test the feasibility and preliminarily evaluate the effect of individualized face-to-face cognitive behavior therapy (CBT) for parents of children after the end of treatment for childhood cancer. A secondary aim was to present a cognitive behavioral conceptualization of cancer-related distress for these parents. An open trial was conducted where 15 parents of children who had completed successful treatment for cancer three months to five years earlier and who reported psychological distress related to a child's previous cancer disease were provided CBT at a maximum of 15 sessions. Participants were assessed at baseline, post-intervention, and three-month follow-up using self-reported psychological distress (including posttraumatic stress symptoms (PTSS), depression, and anxiety) and the diagnostic Mini-International Neuropsychiatric Interview. Feasibility outcomes relating to recruitment, data collection, and delivery of the treatment were also examined. Individual case formulations for each participant guided the intervention and these were aggregated and presented in a conceptualization detailing core symptoms and their suggested maintenance mechanisms. A total of 93% of the participants completed the treatment and all of them completed the follow-up assessment. From baseline to post-assessment, parents reported significant improvements in PTSS, depression, and anxiety with medium to large effect sizes (Cohen's d = 0.65-0.92). Results were maintained or improved at a three-month follow-up. At baseline, seven (47%) participants fulfilled the diagnostic criteria for major depressive disorder and four (29%) fulfilled the criteria for posttraumatic stress disorder, compared to

  20. Specialist group therapy for psychological factors associated with firesetting: Evidence of a treatment effect from a non-randomized trial with male prisoners.

    Science.gov (United States)

    Gannon, Theresa A; Alleyne, Emma; Butler, Helen; Danby, Harriet; Kapoor, Aparna; Lovell, Tamsin; Mozova, Katarina; Spruin, Elizabeth; Tostevin, Tracey; Tyler, Nichola; Ciardha, Caoilte Ó

    2015-10-01

    Despite huge societal costs associated with firesetting, no standardized therapy has been developed to address this hugely damaging behavior. This study reports the evaluation of the first standardized CBT group designed specifically to target deliberate firesetting in male prisoners (the Firesetting Intervention Programme for Prisoners; FIPP). Fifty-four male prisoners who had set a deliberate fire were referred for FIPP treatment by their prison establishment and psychologically assessed at baseline, immediately post treatment, and three-months post treatment. Prisoners who were treatment eligible yet resided at prison establishments not identified for FIPP treatment were recruited as Treatment as Usual controls and tested at equivalent time-points. Results showed that FIPP participants improved on one of three primary outcomes (i.e., problematic fire interest and associations with fire), and made some improvement on secondary outcomes (i.e., attitudes towards violence and antisocial attitudes) post treatment relative to controls. Most notable gains were made on the primary outcome of fire interest and associations with fire and individuals who gained in this area tended to self-report more serious firesetting behavior. FIPP participants maintained all key improvements at three-month follow up. These outcomes suggest that specialist CBT should be targeted at those holding the most serious firesetting history. Copyright © 2015 Elsevier Ltd. All rights reserved.

  1. Affect school and script analysis versus basic body awareness therapy in the treatment of psychological symptoms in patients with diabetes and high HbA1c concentrations: two study protocols for two randomized controlled trials.

    Science.gov (United States)

    Melin, Eva O; Svensson, Ralph; Gustavsson, Sven-Åke; Winberg, Agneta; Denward-Olah, Ewa; Landin-Olsson, Mona; Thulesius, Hans O

    2016-04-27

    Depression is linked with alexithymia, anxiety, high HbA1c concentrations, disturbances of cortisol secretion, increased prevalence of diabetes complications and all-cause mortality. The psycho-educational method 'affect school with script analysis' and the mind-body therapy 'basic body awareness treatment' will be trialled in patients with diabetes, high HbA1c concentrations and psychological symptoms. The primary outcome measure is change in symptoms of depression. Secondary outcome measures are changes in HbA1c concentrations, midnight salivary cortisol concentration, symptoms of alexithymia, anxiety, self-image measures, use of antidepressants, incidence of diabetes complications and mortality. Two studies will be performed. Study I is an open-labeled parallel-group study with a two-arm randomized controlled trial design. Patients are randomized to either affect school with script analysis or to basic body awareness treatment. According to power calculations, 64 persons are required in each intervention arm at the last follow-up session. Patients with type 1 or type 2 diabetes were recruited from one hospital diabetes outpatient clinic in 2009. The trial will be completed in 2016. Study II is a multicentre open-labeled parallel-group three-arm randomized controlled trial. Patients will be randomized to affect school with script analysis, to basic body awareness treatment, or to treatment as usual. Power calculations show that 70 persons are required in each arm at the last follow-up session. Patients with type 2 diabetes will be recruited from primary care. This study will start in 2016 and finish in 2023. For both studies, the inclusion criteria are: HbA1c concentration ≥62.5 mmol/mol; depression, alexithymia, anxiety or a negative self-image; age 18-59 years; and diabetes duration ≥1 year. The exclusion criteria are pregnancy, severe comorbidities, cognitive deficiencies or inadequate Swedish. Depression, anxiety, alexithymia and self-image are assessed

  2. Mind/Body Psychological Treatments for Irritable Bowel Syndrome

    Directory of Open Access Journals (Sweden)

    Bruce D. Naliboff

    2008-01-01

    Full Text Available Currently, the goal of treatment for those with irritable bowel syndrome (IBS is to improve the quality of life through a reduction in symptoms. While the majority of treatment approaches involve the use of traditional medicine, more and more patients seek out a non-drug approach to managing their symptoms. Current forms of non-drug psychologic or mind/body treatment for IBS include hypnotherapy, cognitive behavioral therapy and brief psychodynamic psychotherapy, all of which have been proven efficacious in clinical trials. We propose that incorporating the constructs of mindfulness and acceptance into a mind/body psychologic treatment of IBS may be of added benefit due to the focus on changing awareness and acceptance of one's own state which is a strong component of traditional and Eastern healing philosophies.

  3. Psychological Neuromodulatory Treatments for Young People with Chronic Pain

    Directory of Open Access Journals (Sweden)

    Jordi Miró

    2016-12-01

    Full Text Available The treatment of young people with chronic pain is a complex endeavor. Many of these youth do not obtain adequate relief from available interventions. Psychological neuromodulatory treatments have been shown to have potential benefit for adults with chronic pain. Here, we review and summarize the available information about the efficacy of three promising psychological neuromodulatory treatments—neurofeedback, meditation and hypnosis—when provided to young people with chronic pain. A total of 16 articles were identified and reviewed. The findings from these studies show that hypnotic treatments are effective in reducing pain intensity for a variety of pediatric chronic pain problems, although research suggests variability in outcomes as a function of the specific pain problem treated. There are too few studies evaluating the efficacy of neurofeedback or meditation training in young people with chronic pain to draw firm conclusions regarding their efficacy. However, preliminary data indicate that these treatments could potentially have positive effects on a variety of outcomes (e.g., pain intensity, frequency of pain episodes, physical and psychological function, at least in the short term. Clinical trials are needed to evaluate the effects of neurofeedback and meditation training, and research is needed to identify the moderators of treatment benefits as well as better understand the mechanisms underlying the efficacy of all three of these treatments. The findings from such research could enhance overall treatment efficacy by: (1 providing an empirical basis for better patient-treatment matching; and (2 identifying specific mechanisms that could be targeted with treatment.

  4. An open trial of individualized face-to-face cognitive behavior therapy for psychological distress in parents of children after end of treatment for childhood cancer including a cognitive behavioral conceptualization

    OpenAIRE

    Lisa Ljungman; Martin Cernvall; Ata Ghaderi; Gustaf Ljungman; Louise von Essen; Brjánn Ljótsson

    2018-01-01

    Objective A subgroup of parents of children who have been treated for childhood cancer report high levels of psychological distress. To date there is no empirically supported psychological treatment targeting cancer-related psychological distress in this population. The aim of the current study was to test the feasibility and preliminarily evaluate the effect of individualized face-to-face cognitive behavior therapy (CBT) for parents of children after the end of treatment for childhood cancer...

  5. The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial

    NARCIS (Netherlands)

    Sitnikova, Kate; Leone, Stephanie S.; Zonneveld, Lyonne N. L.; van Marwijk, Harm W. J.; Bosmans, Judith E.; van der Wouden, Johannes C.; van der Horst, Henriëtte E.

    2017-01-01

    Background: Up to a third of patients presenting medically unexplained physical symptoms in primary care may have a somatoform disorder, of which undifferentiated somatoform disorder (USD) is the most common type. Psychological interventions can reduce symptoms associated with USD and improve

  6. The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care : study protocol for a randomised controlled trial

    NARCIS (Netherlands)

    Sitnikova, Kate; Leone, Stephanie S; Zonneveld, Lyonne N L; van Marwijk, Harm W J; Bosmans, Judith E; van der Wouden, Johannes C; van der Horst, Henriëtte E

    2017-01-01

    BACKGROUND: Up to a third of patients presenting medically unexplained physical symptoms in primary care may have a somatoform disorder, of which undifferentiated somatoform disorder (USD) is the most common type. Psychological interventions can reduce symptoms associated with USD and improve

  7. Use of behavioral economics and social psychology to improve treatment of acute respiratory infections (BEARI): rationale and design of a cluster randomized controlled trial [1RC4AG039115-01] - study protocol and baseline practice and provider characteristics

    Science.gov (United States)

    2013-01-01

    Background Inappropriate antibiotic prescribing for nonbacterial infections leads to increases in the costs of care, antibiotic resistance among bacteria, and adverse drug events. Acute respiratory infections (ARIs) are the most common reason for inappropriate antibiotic use. Most prior efforts to decrease inappropriate antibiotic prescribing for ARIs (e.g., educational or informational interventions) have relied on the implicit assumption that clinicians inappropriately prescribe antibiotics because they are unaware of guideline recommendations for ARIs. If lack of guideline awareness is not the reason for inappropriate prescribing, educational interventions may have limited impact on prescribing rates. Instead, interventions that apply social psychological and behavioral economic principles may be more effective in deterring inappropriate antibiotic prescribing for ARIs by well-informed clinicians. Methods/design The Application of Behavioral Economics to Improve the Treatment of Acute Respiratory Infections (BEARI) Trial is a multisite, cluster-randomized controlled trial with practice as the unit of randomization. The primary aim is to test the ability of three interventions based on behavioral economic principles to reduce the rate of inappropriate antibiotic prescribing for ARIs. We randomized practices in a 2 × 2 × 2 factorial design to receive up to three interventions for non-antibiotic-appropriate diagnoses: 1) Accountable Justifications: When prescribing an antibiotic for an ARI, clinicians are prompted to record an explicit justification that appears in the patient electronic health record; 2) Suggested Alternatives: Through computerized clinical decision support, clinicians prescribing an antibiotic for an ARI receive a list of non-antibiotic treatment choices (including prescription options) prior to completing the antibiotic prescription; and 3) Peer Comparison: Each provider’s rate of inappropriate antibiotic prescribing relative to top

  8. Psychological aspects of male fertility treatment.

    Science.gov (United States)

    Mikkelsen, Alice Toft; Madsen, Svend Aage; Humaidan, Peter

    2013-09-01

    To explore and to identify the possible need for psychological communicative support in men undergoing fertility treatment. Male infertility affects many aspects of a man's life and may cause a life crisis. Although infertility treatment is now commonplace in men, they often feel remote and disconnected from the treatment process. A descriptive survey. A questionnaire with structured and open-ended questions was completed by 210 Danish men undergoing fertility treatment. The questionnaire covered three issues: individual perception of male infertility, gender equality issues, and communication with health professionals in the clinic. Data were collected during 2008. Of the participants, 28% believed that their reduced sperm quality affected their perception of masculinity. 46% stated that equal involvement between partners was a very important element of the treatment; however, 63% said that the health professionals communicated primarily with their female partner. Finally, 62% found that there was a need for a deeper dialogue with the nurses concerning male infertility and 72% lacked information about the psychological consequences of male infertility. In general, participants wanted a more open and balanced dialogue about infertility treatment and the role of the male partner during this process. Infertile men want health professionals to view them on equal terms with their partner. When treating the infertile man, there is a further need to develop more inclusive communication skills. © 2012 Blackwell Publishing Ltd.

  9. Psychological and Educational Intervention to Improve Tuberculosis Treatment Adherence in Ethiopia Based on Health Belief Model: A Cluster Randomized Control Trial

    NARCIS (Netherlands)

    Tola, Habteyes Hailu; Shojaeizadeh, Davoud; Tol, Azar; Garmaroudi, Gholamreza; Yekaninejad, Mir Saeed; Kebede, Abebaw; Ejeta, Luche Tadesse; Kassa, Desta; Klinkenberg, Eveline

    2016-01-01

    Treatment non-adherence results in treatment failure, prolonged transmission of disease and emergence of drug resistance. Although the problem widely investigated, there remains an information gap on the effectiveness of different methods to improve treatment adherence and the predictors of

  10. Psychological Treatments for Binge Eating Disorder

    Science.gov (United States)

    Gredysa, Dana M.; Altman, Myra; Wilfley, Denise E.

    2012-01-01

    Binge eating disorder (BED) is the most prevalent eating disorder in adults, and individuals with BED report greater general and specific psychopathology than non-eating disordered individuals. The current paper reviews research on psychological treatments for BED, including the rationale and empirical support for cognitive behavioral therapy (CBT), interpersonal psychotherapy (IPT), dialectical behavior therapy (DBT), behavioral weight loss (BWL), and other treatments warranting further study. Research supports the effectiveness of CBT and IPT for the treatment of BED, particularly for those with higher eating disorder and general psychopathology. Guided self-help CBT has shown efficacy for BED without additional pathology. DBT has shown some promise as a treatment for BED, but requires further study to determine its long-term efficacy. Predictors and moderators of treatment response, such as weight and shape concerns, are highlighted and a stepped-care model proposed. Future directions include expanding the adoption of efficacious treatments in clinical practice, testing adapted treatments in diverse samples (e.g., minorities and youth), improving treatment outcomes for nonresponders, and developing efficient and cost-effective stepped-care models. PMID:22707016

  11. A meta-analytic review of psychological treatments for tinnitus.

    Science.gov (United States)

    Andersson, G; Lyttkens, L

    1999-08-01

    Meta-analysis is a technique of combining results from different trials in order to obtain estimates of effects across studies. Meta-analysis has, as yet, rarely been used in audiological research. The aim of this paper was to conduct a meta-analysis on psychological treatment of tinnitus. The outcomes of 18 studies, including a total of 24 samples and up to 700 subjects, were included and coded. Included were studies on cognitive/cognitive-behavioural treatment, relaxation, hypnosis, biofeedback, educational sessions and problem-solving. Effect sizes for perceived tinnitus loudness, annoyance, negative affect (e.g. depression) and sleep problems were calculated for randomized controlled studies, pre-post-treatment design studies and follow-up results. Results showed strong to moderate effects on tinnitus annoyance for controlled studies (d = 0.86), pre-post designs (d = 0.5) and at follow-up (d = 0.48). Results on tinnitus loudness were weaker and disappeared at follow-up. Lower effect sizes were also obtained for measures of negative affect and sleep problems. Exploratory analyses revealed that cognitive-behavioural treatments were more effective on ratings of annoyance in the controlled studies. It is concluded that psychological treatment for tinnitus is effective, but that aspects such as depression and sleep problems may need to be targeted in future studies.

  12. The effect of a short message service maintenance treatment on body mass index and psychological well-being in overweight and obese children: a randomized controlled trial

    NARCIS (Netherlands)

    Passchier, J.; de Niet, J.; Timman, R.; Bauer, S.; van den Akker, E.; Buijks, H.; De Klerk, C.; Kordy, H.

    2012-01-01

    Objective: Maintaining weight loss results in childhood obesity treatment is difficult to achieve. Self-management techniques such as self-monitoring are associated with increased weight loss and maintenance. This study analyzes whether self-monitoring of lifestyle behaviours through a short message

  13. Psychological treatments for depression and anxiety disorders in Low- and middle- income countries: a meta-analysis.

    NARCIS (Netherlands)

    van t Hof, E.; Cuijpers, P.; Waheed, W.; Stein, D.J.

    2011-01-01

    Objective: The objective of this meta-analysis was to determine the efficacy of psychological treatments for depression and anxiety disorders in low- and middle- income countries (LAMIC). Method: Meta-analysis of randomized controlled trials on psychological treatment of depression and anxiety

  14. Treatment of Bulimia Nervosa: Psychological and Psychopharmacologic Considerations.

    Science.gov (United States)

    Phillips, Elaine L.; Greydanus, Donald E.; Pratt, Helen D.; Patel, Dilip R.

    2003-01-01

    Reviews the current literature on psychological and psychopharmacologic treatments for bulimia nervosa in the adolescent population. Describes the two most researched psychological treatments--cognitive behavior therapy and interpersonal therapy--in terms of treatment protocols and outcome research. Reviews psychopharmacologic treatment, including…

  15. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. Methods/Design The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. Discussion What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real

  16. Does cognitive flexibility predict treatment gains in Internet-delivered psychological treatment of social anxiety disorder, depression, or tinnitus?

    Directory of Open Access Journals (Sweden)

    Philip Lindner

    2016-04-01

    Full Text Available Little is known about the individual factors that predict outcomes in Internet-administered psychological treatments. We hypothesized that greater cognitive flexibility (i.e. the ability to simultaneously consider several concepts and tasks and switch effortlessly between them in response to changes in environmental contingencies would provide a better foundation for learning and employing the cognitive restructuring techniques taught and exercised in therapy, leading to greater treatment gains. Participants in three trials featuring Internet-administered psychological treatments for depression (n = 36, social anxiety disorder (n = 115 and tinnitus (n = 53 completed the 64-card Wisconsin Card Sorting Test (WCST prior to treatment. We found no significant associations between perseverative errors on the WCST and treatment gains in any group. We also found low accuracy in the classification of treatment responders. We conclude that lower cognitive flexibility, as captured by perseverative errors on the WCST, should not impede successful outcomes in Internet-delivered psychological treatments.

  17. Pilot of a randomised controlled trial of the selective serotonin reuptake inhibitor sertraline versus cognitive behavioural therapy for anxiety symptoms in people with generalised anxiety disorder who have failed to respond to low-intensity psychological treatments as defined by the National Institute for Health and Care Excellence guidelines.

    Science.gov (United States)

    Buszewicz, Marta; Cape, John; Serfaty, Marc; Shafran, Roz; Kabir, Thomas; Tyrer, Peter; Clarke, Caroline S; Nazareth, Irwin

    2017-08-01

    Generalised anxiety disorder (GAD) is common, causing unpleasant symptoms and impaired functioning. The National Institute for Health and Care Excellence (NICE) guidelines have established good evidence for low-intensity psychological interventions, but a significant number of patients will not respond and require more intensive step 3 interventions, recommended as either high-intensity cognitive behavioural therapy (CBT) or a pharmacological treatment such as sertraline. However, there are no head-to-head comparisons evaluating which is more clinically effective and cost-effective, and current guidelines suggest that treatment choice at step 3 is based mainly on patient preference. To assess clinical effectiveness and cost-effectiveness at 12 months of treatment with the selective serotonin reuptake inhibitor (SSRI) sertraline compared with CBT for patients with persistent GAD not improved with NICE-defined low-intensity psychological interventions. Participant randomised trial comparing treatment with sertraline with high-intensity CBT for patients with GAD who had not responded to low-intensity psychological interventions. Community-based recruitment from local Improving Access to Psychological Therapies (IAPT) services. Four pilot services located in urban, suburban and semirural settings. People considered likely to have GAD and not responding to low-intensity psychological interventions identified at review by IAPT psychological well-being practitioners (PWPs). Those scoring ≥ 10 on the Generalised Anxiety Disorder-7 (GAD-7) anxiety measure were asked to consider involvement in the trial. Aged ≥ 18 years, a score of ≥ 10 on the GAD-7, a primary diagnosis of GAD diagnosed on the Mini International Neuropsychiatric Interview questionnaire and failure to respond to NICE-defined low-intensity interventions. Inability to participate because of insufficient English or cognitive impairment, current major depression, comorbid anxiety disorder(s) causing

  18. Supportive Mental Health Self-Monitoring among Smartphone Users with Psychological Distress: Protocol for a Fully Mobile Randomized Controlled Trial

    OpenAIRE

    Till Beiwinkel; Stefan Hey; Olaf Bock; Wulf Rössler; Wulf Rössler; Wulf Rössler

    2017-01-01

    Mobile health (mHealth) could be widely used in the population to improve access to psychological treatment. In this paper, we describe the development of a mHealth intervention on the basis of supportive self-monitoring and describe the protocol for a randomized controlled trial to evaluate its effectiveness among smartphone users with psychological distress. Based on power analysis, a representative quota sample of N = 186 smartphone users will be recruited, with an over-sampling of persons...

  19. Psychological treatments in intellectual disability: the challenges of building a good evidence base.

    Science.gov (United States)

    Bhaumik, Sabyasachi; Gangadharan, Satheesh; Hiremath, Avinash; Russell, Paul Swamidhas Sudhakar

    2011-06-01

    Psychological treatments are widely used for the management of mental health and behavioural problems in people with intellectual disabilities. The evidence base, including the cost-effectiveness of such interventions, is limited. This editorial explores the current evidence base and analyses its strengths and limitations. The editorial also highlights current problems in conducting randomised controlled trials in this area and suggests a way forward.

  20. Psychological treatment for vaginal pain: does etiology matter? A systematic review and meta-analysis.

    Science.gov (United States)

    Flanagan, Esther; Herron, Katherine A; O'Driscoll, Ciarán; Williams, Amanda C de C

    2015-01-01

    Classification of vaginal pain within medical or psychiatric diagnostic systems draws mainly on the presumed presence or absence (respectively) of underlying medical etiology. A focus on the experience of pain, rather than etiology, emphasizes common ground in the aims of treatment to improve pain and sexual, emotional, and cognitive experience. Thus, exploring how vaginal pain conditions with varying etiology respond to psychological treatment could cast light on the extent to which they are the same or distinct. To examine the combined and relative efficacy of psychological treatments for vaginal pain conditions. A systematic search of EMBASE, MEDLINE, PsycINFO, and CINAHL was undertaken. Eleven randomized controlled trials were entered into a meta-analysis, and standardized mean differences and odds ratios were calculated. Effect sizes for individual psychological trial arms were also calculated. Main outcome measures were pain and sexual function. Equivalent effects were found for psychological and medical treatments. Effect sizes for psychological treatment arms were comparable across vaginal pain conditions. Effectiveness was equivalent regardless of presumed medical or psychiatric etiology, indicating that presumed etiology may not be helpful in selecting treatment. Research recommendations and clinical implications are discussed. © 2014 International Society for Sexual Medicine.

  1. Adolescents’ Pain Coping Profiles: Expectations for Treatment, Functional Outcomes and Adherence to Psychological Treatment Recommendations

    Directory of Open Access Journals (Sweden)

    Robyn Lewis Claar

    2011-01-01

    Full Text Available OBJECTIVES: To explore how adolescents’ pain coping profiles relate to their expectations regarding psychological treatment recommendations, and to examine patients’ functioning and engagement in psychological treatment three months following a multidisciplinary pain clinic evaluation.

  2. A randomised controlled trial of time limited CBT informed psychological therapy for anxiety in bipolar disorder.

    Science.gov (United States)

    Jones, Steven; McGrath, Elly; Hampshire, Kay; Owen, Rebecca; Riste, Lisa; Roberts, Chris; Davies, Linda; Mayes, Debbie

    2013-02-15

    Anxiety comorbidity is common in bipolar disorder and is associated with worse treatment outcomes, greater risk of self harm, suicide and substance misuse. To date however there have been no psychological interventions specifically designed to address this problem. The primary objective of this trial is to establish the acceptability and feasibility of a new integrated intervention for anxiety in bipolar disorder designed in collaboration with individuals with personal experience of both problems. Single blind randomised controlled trials to assess the feasibility and acceptability of a time limited CBT informed psychological intervention for anxiety in bipolar disorder (AIBD) compared with treatment as usual. Participants will be recruited from across the North West of England from specialist mental health services and through primary care and self referral. The primary outcome of the study is the feasibility and acceptability of AIBD assessed by recruitment to target and retention to follow-up, as well as absence of untoward incidents associated with AIBD. We will also estimate the effect size of the impact of the intervention on anxiety and mood outcomes, as well as calculate preliminary estimates of cost-effectiveness and investigate potential mechanisms for this (stigma, self appraisal and stability of social rhythms). This is the first trial of an integrated intervention for anxiety in bipolar disorder. It is of interest to researchers involved in the development of new therapies for bipolar disorder as well as indicating the wider potential for evaluating approaches to the treatment of comorbidity in severe mental illness.

  3. Effects of psychological therapies in randomized trials and practice-based studies.

    Science.gov (United States)

    Barkham, Michael; Stiles, William B; Connell, Janice; Twigg, Elspeth; Leach, Chris; Lucock, Mike; Mellor-Clark, John; Bower, Peter; King, Michael; Shapiro, David A; Hardy, Gillian E; Greenberg, Leslie; Angus, Lynne

    2008-11-01

    Randomized trials of the effects of psychological therapies seek internal validity via homogeneous samples and standardized treatment protocols. In contrast, practice-based studies aim for clinical realism and external validity via heterogeneous samples of clients treated under routine practice conditions. We compared indices of treatment effects in these two types of studies. Using published transformation formulas, the Beck Depression Inventory (BDI) scores from five randomized trials of depression (N = 477 clients) were transformed into Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) scores and compared with CORE-OM data collected in four practice-based studies (N = 4,196 clients). Conversely, the practice-based studies' CORE-OM scores were transformed into BDI scores and compared with randomized trial data. Randomized trials showed a modest advantage over practice-based studies in amount of pre-post improvement. This difference was compressed or exaggerated depending on the direction of the transformation but averaged about 12%. There was a similarly sized advantage to randomized trials in rates of reliable and clinically significant improvement (RCSI). The largest difference was yielded by comparisons of effect sizes which suggested an advantage more than twice as large, reflecting narrower pre-treatment distributions in the randomized trials. Outcomes of completed treatments for depression in randomized trials appeared to be modestly greater than those in routine care settings. The size of the difference may be distorted depending on the method for calculating degree of change. Transforming BDI scores into CORE-OM scores and vice versa may be a preferable alternative to effect sizes for comparisons of studies using these measures.

  4. Psychological background of prevention and treatment in geriatrics

    Directory of Open Access Journals (Sweden)

    Nazarov M.l.

    2015-03-01

    Full Text Available Confidentiality as the component of an interpersonal "patient — medical practitioner" contact formation can be considered as a corner stone of geriatric practice. Major psychological pitfalls of geriatric practice have been reviewed. The main issue of the paper is psychological substantiation of treatment and prevention of elderly.

  5. Experiences and psychological distress of fertility treatment and employment.

    Science.gov (United States)

    Payne, Nicola; Seenan, Susan; van den Akker, Olga

    2018-04-16

    This study examined experiences and psychological distress about fertility treatment in people combining work and treatment. Five hundred and sixty-three participants in the UK completed an online survey asking about difficulties in combining work and treatment; workplace disclosure, support, absence and policy; and psychological distress about treatment. Absence from work and perceptions that treatment has an impact on work and career prospects were reported by the majority of participants and this was related to the psychological distress of treatment. Around three quarters of participants disclosed to their employer and colleagues. The key reason for disclosure was needing to ask for absence from work and the main reason for non-disclosure was privacy. Workplace policy relating to managing fertility treatment and support from colleagues and their employer was related to reduced psychological distress but workplace policy was reported by less than one quarter of participants. Difficulties experienced in combining work and treatment suggest that support is needed. Specific workplace policy, guidance for supervisors and flexibility in fertility clinic times should help support employees during treatment and reduce psychological distress, thereby potentially influencing physical health and treatment outcomes.

  6. The Mycotic Ulcer Treatment Trial

    Science.gov (United States)

    Prajna, N. Venkatesh; Krishnan, Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Prajna, Lalitha; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E.; Ray, Kathryn J.; Zegans, Michael E.; McLeod, Stephen D.; Porco, Travis C.; Acharya, Nisha R.; Lietman, Thomas M.

    2013-01-01

    Objective To compare topical natamycin vs voriconazole in the treatment of filamentous fungal keratitis. Methods This phase 3, double-masked, multicenter trial was designed to randomize 368 patients to voriconazole (1%) or natamycin (5%), applied topically every hour while awake until reepithelialization, then 4 times daily for at least 3 weeks. Eligibility included smear-positive filamentous fungal ulcer and visual acuity of 20/40 to 20/400. Main Outcome Measures The primary outcome was best spectacle-corrected visual acuity at 3 months; secondary outcomes included corneal perforation and/or therapeutic penetrating keratoplasty. Results A total of 940 patients were screened and 323 were enrolled. Causative organisms included Fusarium (128 patients [40%]), Aspergillus (54 patients [17%]), and other filamentous fungi (141 patients [43%]). Natamycin-treated cases had significantly better 3-month best spectacle-corrected visual acuity than voriconazole-treated cases (regression coefficient=−0.18 logMAR; 95% CI, −0.30 to −0.05; P=.006). Natamycin-treated cases were less likely to have perforation or require therapeutic penetrating keratoplasty (odds ratio=0.42; 95% CI, 0.22 to 0.80; P=.009). Fusarium cases fared better with natamycin than with voriconazole (regression coefficient=−0.41 logMAR; 95% CI, −0.61 to −0.20; P<.001; odds ratio for perforation=0.06; 95% CI, 0.01 to 0.28; P<.001), while non-Fusarium cases fared similarly (regression coefficient=−0.02 logMAR; 95% CI, −0.17 to 0.13; P=.81; odds ratio for perforation=1.08; 95% CI, 0.48 to 2.43; P=.86). Conclusions Natamycin treatment was associated with significantly better clinical and microbiological outcomes than voriconazole treatment for smear-positive filamentous fungal keratitis, with much of the difference attributable to improved results in Fusarium cases. Application to Clinical Practice Voriconazole should not be used as monotherapy in filamentous keratitis. Trial Registration

  7. Designing Psychological Treatments for Scalability: The PREMIUM Approach.

    Directory of Open Access Journals (Sweden)

    Sukumar Vellakkal

    Full Text Available Lack of access to empirically-supported psychological treatments (EPT that are contextually appropriate and feasible to deliver by non-specialist health workers (referred to as 'counsellors' are major barrier for the treatment of mental health problems in resource poor countries. To address this barrier, the 'Program for Effective Mental Health Interventions in Under-resourced Health Systems' (PREMIUM designed a method for the development of EPT for severe depression and harmful drinking. This was implemented over three years in India. This study assessed the relative usefulness and costs of the five 'steps' (Systematic reviews, In-depth interviews, Key informant surveys, Workshops with international experts, and Workshops with local experts in the first phase of identifying the strategies and theoretical model of the treatment and two 'steps' (Case series with specialists, and Case series and pilot trial with counsellors in the second phase of enhancing the acceptability and feasibility of its delivery by counsellors in PREMIUM with the aim of arriving at a parsimonious set of steps for future investigators to use for developing scalable EPT.The study used two sources of data: the usefulness ratings by the investigators and the resource utilization. The usefulness of each of the seven steps was assessed through the ratings by the investigators involved in the development of each of the two EPT, viz. Healthy Activity Program for severe depression and Counselling for Alcohol Problems for harmful drinking. Quantitative responses were elicited to rate the utility (usefulness/influence, followed by open-ended questions for explaining the rankings. The resources used by PREMIUM were computed in terms of time (months and monetary costs.The theoretical core of the new treatments were consistent with those of EPT derived from global evidence, viz. Behavioural Activation and Motivational Enhancement for severe depression and harmful drinking respectively

  8. The Psychological Impact of IVF Treatment

    NARCIS (Netherlands)

    C. de Klerk (Cora)

    2008-01-01

    textabstractIVF treatment requires the woman to undergo several invasive procedures, which are repeated in subsequent treatment cycles. In addition to the physical burden, the threat of treatment failure confronts the couple with the possibility that they have to give up hope to have a child of

  9. Psychological effects of diagnosis and treatment of cervical intraepithelial neoplasia

    DEFF Research Database (Denmark)

    Frederiksen, Maria Eiholm; Njor, Sisse; Lynge, Elsebeth

    2015-01-01

    BACKGROUND: Treatment of cervical intraepithelial neoplasia (CIN) is a common minor surgical procedure to prevent uterine cervical cancer. However, news of an abnormality detected at screening for cancer might cause the woman to worry. OBJECTIVES: To investigate the psychological consequences...... test results, but the impact decreased over time. In several but not all studies, CIN appeared to have similar psychological consequences to abnormal smears. No study showed a difference in psychological outcomes between CIN and cervical cancer diagnosis when these were measured some years after...... psychological outcomes in women with a histological diagnosis or treatment of CIN, and in women having an outcome other than CIN at cervical screening. DATA COLLECTION AND ANALYSIS: We abstracted the data using a pre-specified list of study characteristics and measured outcomes. For studies not reporting...

  10. Barriers to Implementing Treatment Integrity Procedures in School Psychology Research: Survey of Treatment Outcome Researchers

    Science.gov (United States)

    Sanetti, Lisa M. Hagermoser; DiGennaro Reed, Florence D.

    2012-01-01

    Treatment integrity data are essential to drawing valid conclusions in treatment outcome studies. Such data, however, are not always included in peer-reviewed research articles in school psychology or related fields. To gain a better understanding of why treatment integrity data are lacking in the school psychology research, we surveyed the…

  11. Treatment Acceptability of Interventions Published in Six School Psychology Journals

    Science.gov (United States)

    Villarreal, Victor; Ponce, Christopher; Gutierrez, Heveli

    2015-01-01

    Treatment acceptability (TA) is critical when selecting and implementing an intervention, as TA is associated with treatment outcomes. The significance of TA is reflected in school psychology models for services that state that school psychologists should address TA during development, implementation, and evaluation of interventions. However, the…

  12. Mindfulness-based cognitive therapy for psychological distress in pregnancy: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Tomfohr-Madsen, Lianne M; Campbell, Tavis S; Giesbrecht, Gerald F; Letourneau, Nicole L; Carlson, Linda E; Madsen, Joshua W; Dimidjian, Sona

    2016-10-13

    Clinically significant psychological distress in pregnancy is common, with epidemiological research suggesting that between 15 and 25 % of pregnant women experience elevated symptoms of stress, anxiety, and depression. Untreated psychological distress in pregnancy is associated with poor obstetrical outcomes, changes in maternal physiology, elevated incidence of child physical and psychological disorders, and is predictive of maternal postpartum mood disorders. Despite the wide-ranging impact of antenatal psychological distress on mothers and their children, there is a gap in our knowledge about the most effective treatments that are available for psychological distress experienced in pregnancy. Additionally, no trials have focused on potential physiological changes that may occur as a result of receiving mindfulness training in pregnancy. The proposed trial will determine the effectiveness of an 8-week modified Mindfulness-based Cognitive Therapy (MBCT) intervention delivered during pregnancy. A randomized controlled trial (RCT) design with repeated measures will be used to evaluate the effectiveness of MBCT to treat psychological distress in pregnancy. A sample of 60 consenting pregnant women aged 18 years and above will be enrolled and randomized to the experimental (MBCT) or control (treatment as usual) condition. Primary (e.g., symptoms of stress, depression, and anxiety), secondary (cortisol, blood pressure (BP), heart rate variability (HRV), and sleep) and other outcome data (e.g., psychological diagnoses) will be collected via a combination of laboratory visits and at-home assessments from both groups at baseline (T 1 ), immediately following the intervention (T 2 ), and at 3 months postpartum (T 3 ). Descriptive statistics will be used to describe sample characteristics. Data will be analyzed using an intention-to-treat approach. Hierarchical linear models will be used to test intervention effects on primary and secondary outcomes. The trial is expected

  13. Male psychological adaptation to unsuccessful medically assisted reproduction treatments

    DEFF Research Database (Denmark)

    Martins, Mariana Veloso; Basto-Pereira, Miguel; Pedro, Juliana

    2016-01-01

    BACKGROUND: Similarly to women, men suffer from engaging in fertility treatments, both physically and psychologically. Although there is a vast body of evidence on the emotional adjustment of women to infertility, there are no systematic reviews focusing on men's psychological adaptation...... for psychological maladaptation?' SEARCH METHODS: A literature search was conducted from inception to September 2015 on five databases using combinations of MeSH terms and keywords. Eligible studies had to present quantitative prospective designs and samples including men who did not achieve pregnancy or parenthood...... at follow-up. A narrative synthesis approach was used to conduct the review. OUTCOMES: Twelve studies from three continents were eligible from 2534 records identified in the search. The results revealed that psychological symptoms of maladjustment significantly increased in men 1 year after the first...

  14. Psychological determinants of life satisfaction in women undergoing infertility treatment

    OpenAIRE

    Aleksandra Anna Dembińska

    2016-01-01

    Background Infertility treatment is a long-term process, spread out over months, or even years, and carries no guarantee of success. It generates an incessant state of uncertainty which becomes a chronic state of psychological discomfort. Each stage of treatment may become a source of more trouble. Women deciding to undergo infertility treatment are exposed to many negative feelings concerning different aspects of their life. Participants and procedure The present study wa...

  15. The psychology of own versus others’ treatment:

    NARCIS (Netherlands)

    Bos, K. van den; Lind, E. Allan

    2001-01-01

    This article focuses on how people interpret their own versus others’ treatment. Two experiments investigate how perceived procedural justice is affected by procedures that are experienced personally versus those seen to have been experienced by others. The studies show that, at least under some

  16. [Psychology and psychosomatics of the orthodontic treatment].

    Science.gov (United States)

    Fábián, Gábor; Bálint, Mária; Fábían, Tibor Károly

    2005-06-01

    Psychosomatic problems related to orthodontic treatment are a special group of oral psychosomatic disorders. The most frequent complaints are related to aesthetics and occlusion. Most of the patients are children, adolescence or young adults, with special emotional problems. Authors reviewed the most important knowledge related to this specific field, but some general aspects of oral psychosomatics are also discussed.

  17. Comparison of Pharmaceutical, Psychological, and Exercise Treatments for Cancer-Related Fatigue: A Meta-analysis.

    Science.gov (United States)

    Mustian, Karen M; Alfano, Catherine M; Heckler, Charles; Kleckner, Amber S; Kleckner, Ian R; Leach, Corinne R; Mohr, David; Palesh, Oxana G; Peppone, Luke J; Piper, Barbara F; Scarpato, John; Smith, Tenbroeck; Sprod, Lisa K; Miller, Suzanne M

    2017-07-01

    Cancer-related fatigue (CRF) remains one of the most prevalent and troublesome adverse events experienced by patients with cancer during and after therapy. To perform a meta-analysis to establish and compare the mean weighted effect sizes (WESs) of the 4 most commonly recommended treatments for CRF-exercise, psychological, combined exercise and psychological, and pharmaceutical-and to identify independent variables associated with treatment effectiveness. PubMed, PsycINFO, CINAHL, EMBASE, and the Cochrane Library were searched from the inception of each database to May 31, 2016. Randomized clinical trials in adults with cancer were selected. Inclusion criteria consisted of CRF severity as an outcome and testing of exercise, psychological, exercise plus psychological, or pharmaceutical interventions. Studies were independently reviewed by 12 raters in 3 groups using a systematic and blinded process for reconciling disagreement. Effect sizes (Cohen d) were calculated and inversely weighted by SE. Severity of CRF was the primary outcome. Study quality was assessed using a modified 12-item version of the Physiotherapy Evidence-Based Database scale (range, 0-12, with 12 indicating best quality). From 17 033 references, 113 unique studies articles (11 525 unique participants; 78% female; mean age, 54 [range, 35-72] years) published from January 1, 1999, through May 31, 2016, had sufficient data. Studies were of good quality (mean Physiotherapy Evidence-Based Database scale score, 8.2; range, 5-12) with no evidence of publication bias. Exercise (WES, 0.30; 95% CI, 0.25-0.36; P psychological (WES, 0.27; 95% CI, 0.21-0.33; P psychological interventions (WES, 0.26; 95% CI, 0.13-0.38; P psychological mode, type of control condition, use of intention-to-treat analysis, and fatigue measures (WES range, -0.91 to 0.99). Results suggest that the effectiveness of behavioral interventions, specifically exercise and psychological interventions, is not attributable to

  18. Psychological treatments for fibromyalgia: A meta-analysis

    NARCIS (Netherlands)

    Glombiewski, J.A.; Sawyer, A.T.; Gutermann, J.; Koenig, K.; Rief, W.; Hofmann, S.G.

    2010-01-01

    The aims of the present analysis were to investigate the short-and long-term efficacies and treatment moderators of psychological interventions for fibromyalgia. A literature search using PubMed, PsychINFO, the Cochrane Library, and manual searches identified 23 eligible studies including 30

  19. Childhood obesity treatment and prevention. Psychological perspectives of clinical approaches

    OpenAIRE

    Maria Catena Quattropani; Teresa Buccheri

    2013-01-01

    Objective: This work focuses on clinical psychologist’ presence within childhood obesity prevention programmes in several countries. Method: The Authors collected articles considering psychological, biological and social aspects linked to childhood obesity. Results: Studies reveal that childhood obesity prevention programmes are based on biological, medical and educational aspects; clinical psychologists up until now have been engaged almost exclusively in the treatment of obesity. Conclusion...

  20. Meseron Therapy: An African Approach To Psychological Treatment ...

    African Journals Online (AJOL)

    Meseron therapy is a psychological treatment approach of African origin that consists of a direct and holistic counter-attack on undesirable conditions. It derives from an African custom of rejecting the negative while accepting the positive circumstances of life. Based on the philosophy of “I can”, and the concept of man as a ...

  1. Internet-Based Acceptance and Commitment Therapy for Psychological Distress Experienced by People With Hearing Problems: Study Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Molander, Peter; Hesser, Hugo; Weineland, Sandra; Bergwall, Kajsa; Buck, Sonia; Hansson-Malmlöf, Johan; Lantz, Henning; Lunner, Thomas; Andersson, Gerhard

    2015-09-01

    Psychological distress and psychiatric symptoms are prevalent among people with hearing loss or other audiological conditions, but psychological interventions for these groups are rare. This article describes the study protocol for a randomized controlled trial for evaluating the effect of a psychological treatment delivered over the Internet for individuals with hearing problems and concurrent psychological distress. Participants who are significantly distressed will be randomized to either an 8-week Internet-delivered acceptance-based cognitive behavioral therapy (i.e., acceptance and commitment therapy [ACT]), or wa it-list control. We aim to include measures of distress associated with hearing difficulties, anxiety, and depression. In addition, we aim to measure acceptance associated with hearing difficulties as well as quality of life. The results of the trial may further our understanding of how to best treat people who present problems with both psychological distress and hearing in using the Internet.

  2. Protocol for a systematic review of psychological interventions for cancer-related fatigue in post-treatment cancer survivors.

    Science.gov (United States)

    Corbett, Teresa; Devane, Declan; Walsh, Jane C; Groarke, AnnMarie; McGuire, Brian E

    2015-12-04

    Fatigue is a common symptom in cancer patients that can persist beyond the curative treatment phase. Some evidence has been reported for interventions for fatigue during active treatment. However, to date, there is no systematic review on psychological interventions for fatigue after the completion of curative treatment for cancer. This is a protocol for a systematic review that aims to evaluate the effectiveness of psychological interventions for cancer-related fatigue in post-treatment cancer survivors. This systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) database. We will search the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library), PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, and relevant sources of grey literature. Randomised controlled trials (RCTs) which have evaluated psychological interventions in adult cancer patients after the completion of treatment, with fatigue as an outcome measure, will be included. Two review authors will independently extract data from the selected studies and assess the methodological quality using the Cochrane Collaboration Risk of Bias Tool. Most existing evidence on cancer-related fatigue is from those in active cancer treatment. This systematic review and meta-analysis will build upon previous evaluations of psychological interventions in people during and after cancer treatment. With the growing need for stage-specific research in cancer, this review seeks to highlight a gap in current practice and to strengthen the evidence base of randomised controlled trials in the area. PROSPERO CRD42014015219.

  3. Psychological Therapy for People with Tinnitus: A Scoping Review of Treatment Components.

    Science.gov (United States)

    Thompson, Dean M; Hall, Deborah A; Walker, Dawn-Marie; Hoare, Derek J

    , habituation, hypnosis, or relaxation as necessary parts of the treatment. A total of 5043 records were retrieved of which 64 were retained. Twenty-five themes of components that have been included within a psychological therapy were identified, including tinnitus education, psychoeducation, evaluation treatment rationale, treatment planning, problem-solving behavioral intervention, thought identification, thought challenging, worry time, emotions, social comparison, interpersonal skills, self-concept, lifestyle advice, acceptance and defusion, mindfulness, attention, relaxation, sleep, sound enrichment, comorbidity, treatment reflection, relapse prevention, and common therapeutic skills. The most frequently reported psychological therapies were cognitive behavioral therapy, tinnitus education, and internet-delivered cognitive behavioral therapy. No records reported that an audiologist delivered any of these psychological therapies in the context of an empirical trial in which their role was clearly delineated from that of other clinicians. Scoping review methodology does not attempt to appraise the quality of evidence or synthesize the included records. Further research should therefore determine the relative importance of these different components of psychological therapies from the perspective of the patient and the clinician.

  4. Social networking sites: an adjunctive treatment modality for psychological problems.

    Science.gov (United States)

    Menon, Indu S; Sharma, Manoj Kumar; Chandra, Prabha S; Thennarasu, K

    2014-07-01

    Social networking is seen as a way to enhance social support and feeling of well-being. The present work explores the potentials of social networking sites as an adjunctive treatment modality for initiating treatment contact as well as for managing psychological problems. Interview schedule, Facebook intensity questionnaire were administered on 28 subjects with a combination of 18 males and 10 females. They were taken from the in-patient and out-patient psychiatry setting of the hospital. Facebook was the most popular sites and used to seek emotional support on the basis of the frequent updates of emotional content that users put in their profile; reconciliations, escape from the problems or to manage the loneliness; getting information about illness and its treatment and interaction with experts and also manifested as problematic use. It has implications for developing social networking based adjunctive treatment modality for psychological problems.

  5. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Directory of Open Access Journals (Sweden)

    Marleine Azar

    Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is

  6. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Science.gov (United States)

    Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

    2015-01-01

    Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is

  7. [Psychological aspects of immunotherapies in the treatment of malignant melanoma].

    Science.gov (United States)

    Kovács, Péter; Pánczél, Gitta; Melegh, Krisztina; Balatoni, Tímea; Pörneczy, Edit; Lõrincz, Lenke; Czirbesz, Kata; Gorka, Eszter; Liszkay, Gabriella

    2016-03-02

    Psychological problems may arise in connection with oncomedical treatments in three ways: 1. acute and/or 2. chronic ways, as well as 3. co-morbid psychiatric diseases that already exist must also be taken into account. Immunotherapies have the most common and also clinically relevant psychological side effects. Fatigue, anhedonia, social isolation, psychomotor slowness is reported during treatment. Anti-CTLA-4 antibody (ipilimumab) immunotherapy can present one of the most modern opportunities for adequate treatment for patients having distant metastasis or unresectable tumour. In relation to immunotherapies, acute psychological side effects (acute stress) emerging during treatments develop in a way that can mostly be linked to environmental factors, e.g. notification of diagnosis, hospitalisation, progression, deterioration in quality of life, imminent dates of control. Crisis is a temporary and threatening condition that endangers psychological balance. In such conditions, enhanced psychological vulnerability must be taken into account and doctors play a key role in the rapid recognition of the condition. Chronic psychological problems, which may arise from the depressogenic effect of the applied treatment or originated from a pre-melanoma psychiatric condition, may exceed the diagnostic and psychotherapeutic competences of a clinical psychologist. Even in case of a well-defined depressogenic biological mechanism such as the activation of the pro-inflammatory cytokine pathway, positive environmental effects can reduce symptoms and thus increase compliance. Side effects can be treated successfully using psychotherapeutic methods and/or psychiatric medicines. The application of routinely used complex psychosocial screening packages can provide the easiest method to identify worsening psychological condition during immunotherapy and give rapid feedback to the oncologist and the patient. Team work is of particular importance in a situation like this as it requires

  8. Sustained effectiveness and cost-effectiveness of Counselling for Alcohol Problems, a brief psychological treatment for harmful drinking in men, delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial.

    Science.gov (United States)

    Nadkarni, Abhijit; Weiss, Helen A; Weobong, Benedict; McDaid, David; Singla, Daisy R; Park, A-La; Bhat, Bhargav; Katti, Basavaraj; McCambridge, Jim; Murthy, Pratima; King, Michael; Wilson, G Terence; Kirkwood, Betty; Fairburn, Christopher G; Velleman, Richard; Patel, Vikram

    2017-09-01

    Counselling for Alcohol Problems (CAP), a brief intervention delivered by lay counsellors, enhanced remission and abstinence over 3 months among male primary care attendees with harmful drinking in a setting in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of CAP over 12 months, and the effects of the hypothesized mediator 'readiness to change' on clinical outcomes. Male primary care attendees aged 18-65 years screening with harmful drinking on the Alcohol Use Disorders Identification Test (AUDIT) were randomised to either CAP plus enhanced usual care (EUC) (n = 188) or EUC alone (n = 189), of whom 89% completed assessments at 3 months, and 84% at 12 months. Primary outcomes were remission and mean standard ethanol consumed in the past 14 days, and the proposed mediating variable was readiness to change at 3 months. CAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up, with the proportion with remission (AUDIT score costs and better outcomes; uncertainty analysis showed a 99% chance of CAP being cost-effective per remission achieved from a health system perspective, using a willingness to pay threshold equivalent to 1 month's wages for an unskilled manual worker in Goa. Readiness to change level at 3 months mediated the effect of CAP on mean standard ethanol consumption at 12 months (indirect effect -6.014 [95% CI -13.99, -0.046]). Serious adverse events were infrequent, and prevalence was similar by arm. The methodological limitations of this trial are the susceptibility of self-reported drinking to social desirability bias, the modest participation rates of eligible patients, and the examination of mediation effects of only 1 mediator and in only half of our sample. CAP's superiority over EUC at the end of treatment was largely stable over time and was mediated by readiness to change. CAP provides better outcomes at lower costs from a societal

  9. Types of Treatment: Clinical Trials

    Science.gov (United States)

    ... disease type and stage; your age, gender and race; and other treatments you've used. Your doctor ... Drug Listings Radiation Therapy Immunotherapy Chimeric Antigen Receptor (CAR) T-Cell Therapy Vaccine Therapy Stem Cell Transplantation ...

  10. Psychological treatments for adults and children with epilepsy: Evidence-based recommendations by the International League Against Epilepsy Psychology Task Force.

    Science.gov (United States)

    Michaelis, Rosa; Tang, Venus; Goldstein, Laura H; Reuber, Markus; LaFrance, William Curt; Lundgren, Tobias; Modi, Avani C; Wagner, Janelle L

    2018-06-19

    Given the significant impact that psychosocial factors and epilepsy treatments can have on the health-related quality of life (HRQOL) of individuals with epilepsy and their families, there is great clinical interest in the role of psychological evaluation and treatments to improve HRQOL and comorbidities. Therefore, the International League Against Epilepsy (ILAE) charged the Psychology Task Force with the development of recommendations for clinical care based on evaluation of the evidence from their recent Cochrane review of psychological treatments in individuals with epilepsy. The literature search for a recent Cochrane review of randomized controlled trials investigating psychological treatments for individuals with epilepsy constitutes the key source of evidence for this article. To provide practical guidance to service providers, we provide ratings on study research designs based on (1) the American Academy of Neurology's Level of Evidence system and (2) the Grading of Recommendations, Assessment, Development, and Evaluation system. This paper is the culmination of an international collaboration process involving pediatric and adult psychologists, neurologists, psychiatrists, and neuropsychiatrists. The process and conclusions were reviewed and approved by the ILAE Executive Committee. The strongest evidence for psychological interventions was identified for the most common mental health problems, including depression, neurocognitive disturbances, and medication adherence. Psychological interventions targeting the enhancement of HRQOL and adherence and a decrease in comorbidity symptoms (anxiety, depression) should be incorporated into comprehensive epilepsy care. There is a range of psychological strategies (ie, cognitive behavioral therapy and mindfulness-based therapies) that show promise for improving the lives of persons with epilepsy, and clinical recommendations are provided to assist epilepsy health care providers in treating the comorbidities and

  11. Psychological determinants of life satisfaction in women undergoing infertility treatment

    Directory of Open Access Journals (Sweden)

    Aleksandra Anna Dembińska

    2016-01-01

    Full Text Available Background Infertility treatment is a long-term process, spread out over months, or even years, and carries no guarantee of success. It generates an incessant state of uncertainty which becomes a chronic state of psychological discomfort. Each stage of treatment may become a source of more trouble. Women deciding to undergo infertility treatment are exposed to many negative feelings concerning different aspects of their life. Participants and procedure The present study was an attempt to understand psychological determinants of life satisfaction in women undergoing infertility treatment. The study group included 470 women treated for infertility. Results Patients perceiving more social support in general, as well as more of the support types used in the study, i.e. emotional, instrumental, informational and institutional support, and support from family and friends, have better self-esteem, higher acceptance of their infertility, higher satisfaction with life, higher hope as an emotional state, and lower levels of anxiety and depression. Three negative emotional states, i.e. anxiety, depression and irritation, are predictors influencing (lowering life satisfaction of women struggling with infertility. The strongest of these predictors is depression, which is also a factor lowering the acceptance of one’s own infertility. The conducted analyses revealed that predictors influencing the life satisfaction of patients treated for infertility are self-esteem and acceptance of one’s own infertility (apart from the aforementioned emotional state – anxiety, depression, irritation. It was found that the higher the self-esteem and acceptance of one’s own infertility, the higher was the satisfaction with life. Conclusions Knowledge of these determinants is extremely valuable for medical personnel conducting treatments, because, according to many studies, the psychological state of women suffering from procreation problems is connected not only with

  12. The effects of providing periodontal disease risk information on psychological outcomes - a randomized controlled trial.

    Science.gov (United States)

    Asimakopoulou, Koula; Newton, Jonathon Tim; Daly, Blánaid; Kutzer, Yvonne; Ide, Mark

    2015-04-01

    In a two arm randomized controlled trial this study compared the effects of a routine periodontal assessment consultation versus a routine consultation + individualized risk assessment communication intervention on patient thoughts and emotions about periodontal disease. Adults (N = 102) with moderate/advanced chronic periodontitis referred to a Periodontology Department of a large UK dental school, completed psychological measures before a periodontal assessment and again at the end of the visit. Intervention participants received an individualized calculation of their periodontal disease risk using PreViser Risk Calculator in addition to their routine assessment consultation. In routine care, patients' thoughts about periodontal disease seriousness (p periodontal disease. These effects were also seen in intervention participants. Additionally, the individualized risk communication intervention led to patients reporting i) periodontal disease treatment as more effective than they did pre-consultation (p periodontal management (p periodontal disease risk communication influences psychological variables that underpin adherence with periodontal instructions. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  13. Barriers to treatment for older adults seeking psychological therapy.

    Science.gov (United States)

    Wuthrich, Viviana M; Frei, Jacqueline

    2015-07-01

    Older adults with mental health disorders underutilize mental health services more than other adults. While there are well known general barriers to help seeking across the population, specific barriers for older adults include difficulties with transportation, beliefs that it is normal to be anxious and depressed in old age, and beliefs by referrers that psychological therapy is less likely to be effective. This study examined barriers related to identifying the need for help, seeking help and participating in therapy in a clinical population of older adults. Sixty older adults (aged 60-79 years) with comorbid anxiety and unipolar mood disorders completed barriers to treatment questionnaires before and after psychological group treatment, as well as measures of cognitive ability, anxiety, depression, and quality of life at baseline. The greatest barriers to help seeking related to difficulties identifying the need for help, with 50% of the sample reporting their belief that their symptoms were normal as a major barrier. Other major barriers identified were related to: self-reliance, cost of treatment, and fear of medication replicating previous findings. The main barriers reported for difficulties in continuing therapy included not finding therapy helpful, cost of treatment, and thinking that the therapist did not understand their issues. The main barriers identified related to issues with identifying the need to seek help. More attention is needed to educate older adults and professionals about the need for, and effectiveness of, psychological therapies for older adults with anxiety and depression to reduce this barrier to help seeking.

  14. Psychological treatment of social anxiety disorder improves body dysmorphic concerns.

    Science.gov (United States)

    Fang, Angela; Sawyer, Alice T; Aderka, Idan M; Hofmann, Stefan G

    2013-10-01

    Social anxiety disorder and body dysmorphic disorder are considered nosologically distinct disorders. In contrast, some cognitive models suggest that social anxiety disorder and body dysmorphic disorder share similar cognitive maintenance factors. The aim of this study was to examine the effects of psychological treatments for social anxiety disorder on body dysmorphic disorder concerns. In Study 1, we found that 12 weekly group sessions of cognitive-behavioral therapy led to significant decreases in body dysmorphic symptom severity. In Study 2, we found that an attention retraining intervention for social anxiety disorder was associated with a reduction in body dysmorphic concerns, compared to a placebo control condition. These findings support the notion that psychological treatments for individuals with primary social anxiety disorder improve co-occurring body dysmorphic disorder symptoms. Copyright © 2013 Elsevier Ltd. All rights reserved.

  15. The role of psychological correction in discogenic dorsopathies treatment

    Directory of Open Access Journals (Sweden)

    N. Chuhraev

    2017-02-01

      1. LLC «NMZ Мedintech», Kiev, Ukraine. Email: nv11111@mail.ru 2. Kazimierz Wielki University, Bydgoszcz, Poland 3. National Medical Academy of Postgraduate Education named P. L. Shupik, Department of neurology №1, Kiev, Ukraine 4. Private higher education institution «Interregional Academy of Personnel Management», Kiev, Ukraine     Summary   The article dials with the role of psychological correction in the treatment of discogenic dorsopathies based on zonal applicated ultraphonophoresis of analgesic drugs and psychological treatment of anxious depression (F41.2 Mixed anxiety and depressive disorder with the use of binaural rhythms and magnetofotostimulation.     Keywords: discogenic dorsopathy, anxious depression, binaural rhythms, magnetofotostimulation.

  16. Causal explanations affect judgments of the need for psychological treatment

    Directory of Open Access Journals (Sweden)

    Nancy S. Kim

    2009-02-01

    Full Text Available Knowing what event precipitated a client's abnormal behaviors makes the client appear more normal than if the event is not known (Meehl, 1973. Does such knowledge also influence judgments of the need for psychological treatment, and if so, does it matter whether the precipitating event was inside or outside the client's control? We presented undergraduates with cases of hypothetical clients exhibiting abnormal behaviors and manipulated whether they were also told of a precipitating event explaining those behaviors. Knowing the precipitant significantly reduced perceptions of clients' need for treatment, but only when the precipitating event was outside the client's control. These findings call into question the notion that it need always be beneficial for an outside reasoner to uncover the root cause of a client's psychological problems, particularly when the root cause is still unknown to the client. The rationality of the effect and additional implications for decision-making are discussed.

  17. Improving transparency and reproducibility through registration: The status of intervention trials published in clinical psychology journals.

    Science.gov (United States)

    Cybulski, Lukasz; Mayo-Wilson, Evan; Grant, Sean

    2016-09-01

    Prospective registration increases the validity of randomized controlled trials (RCTs). In the United States, registration is a legal requirement for drugs and devices regulated by the Food and Drug Administration (FDA), and many biomedical journals refuse to publish trials that are not registered. Trials in clinical psychology have not been subject to these requirements; it is unknown to what extent they are registered. We searched the 25 highest-impact clinical psychology journals that published at least 1 RCT of a health-related psychological intervention in 2013. For included trials, we evaluated their registration status (prospective, retrospective, not registered) and the completeness of their outcome definitions. We identified 163 articles that reported 165 RCTs; 73 (44%) RCTs were registered, of which only 25 (15%) were registered prospectively. Of registered RCTs, only 42 (58%) indicated their registration status in the publication. Only 2 (1% of all trials) were registered prospectively and defined their primary outcomes completely. For the primary outcome(s), 72 (99%) of all registrations defined the domain, 67 (92%) the time frame, and 48 (66%) the specific measurements. Only 19 (26%) and 5 (7%) defined the specific metric and method of aggregation, respectively, for all primary outcomes. Very few reports of RCTs published in clinical psychology journals were registered prospectively and completely. Clinical psychology journals could improve transparency and reproducibility, as well as reduce bias, by requiring complete prospective trial registration for publication and by including trial registration numbers in all reports of RCTs. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  18. Female Sexual Dysfunction-Medical and Psychological Treatments, Committee 14.

    Science.gov (United States)

    Kingsberg, Sheryl A; Althof, Stanley; Simon, James A; Bradford, Andrea; Bitzer, Johannes; Carvalho, Joana; Flynn, Kathryn E; Nappi, Rossella E; Reese, Jennifer B; Rezaee, Roya L; Schover, Leslie; Shifrin, Jan L

    2017-12-01

    Since the millennium we have witnessed significant strides in the science and treatment of female sexual dysfunction (FSD). This forward progress has included (i) the development of new theoretical models to describe healthy and dysfunctional sexual responses in women; (ii) alternative classification strategies of female sexual disorders; (iii) major advances in brain, hormonal, psychological, and interpersonal research focusing on etiologic factors and treatment approaches; (iv) strong and effective public advocacy for FSD; and (v) greater educational awareness of the impact of FSD on the woman and her partner. To review the literature and describe the best practices for assessing and treating women with hypoactive sexual desire disorder, female sexual arousal disorder, and female orgasmic disorders. The committee undertook a comprehensive review of the literature and discussion among themselves to determine the best assessment and treatment methods. Using a biopsychosocial lens, the committee presents recommendations (with levels of evidence) for assessment and treatment of hypoactive sexual desire disorder, female sexual arousal disorder, and female orgasmic disorders. The numerous significant strides in FSD that have occurred since the previous International Consultation of Sexual Medicine publications are reviewed in this article. Although evidence supports an integrated biopsychosocial approach to assessment and treatment of these disorders, the biological and psychological factors are artificially separated for review purposes. We recognize that best outcomes are achieved when all relevant factors are identified and addressed by the clinician and patient working together in concert (the sum is greater than the whole of its parts). Kingsberg SA, Althof S, Simon JA, et al. Female Sexual Dysfunction-Medical and Psychological Treatments, Committee 14. J Sex Med 2017;14:1463-1491. Copyright © 2017 International Society for Sexual Medicine. Published by

  19. A Randomized Controlled Trial of Tong Len Meditation Practice in Cancer Patients: Evaluation of a Distant Psychological Healing Effect.

    Science.gov (United States)

    Pagliaro, Gioacchino; Pandolfi, Paolo; Collina, Natalina; Frezza, Giovanni; Brandes, Alba; Galli, Margherita; Avventuroso, Federica Marzocchi; De Lisio, Sara; Musti, Muriel Assunta; Franceschi, Enrico; Esposti, Roberta Degli; Lombardo, Laura; Cavallo, Giovanna; Di Battista, Monica; Rimondini, Simonetta; Poggi, Rosalba; Susini, Cinzia; Renzi, Rina; Marconi, Linda

    2016-01-01

    Tong Len meditation is an important therapeutic tool in the Tibetan medicine, and it can be used for self-healing and/or to heal others. Currently, in the West, there is no scientific study concerning the efficacy of a Tong Len distant healing effect on psychological disorders in cancer patients. To evaluate a distant healing effect of Tong Len meditation on stress, anxiety, depression, fatigue, and self-perceived quality of life in cancer patients. These psychological objectives were chosen as a consequence of the limited scientific literature of present day. We performed a double-blind randomized controlled trial on 103 cancer patients with tumors. Overall, 12 meditators used Tong Len in aid of 52 patients randomly selected as experimental group, while the remaining 51 patients constituted the control group. Patients and meditators did not know each other. All patients completed profile of mood states (POMS) and European Quality of Life-5 dimensions (EQ-5D) questionnaires before treatment (T0), after two (T1) and three months of treatment (T2), and one month after treatment cessation (T3). With regard to the parameters related to depression, a statistically significant improvement (P = .003) was observed in the treatment group compared to controls. On the other hand, the vigor/activity parameter saw significant improvements in the control group (P = .009). Both groups exhibited significant improvements in the other factors assessed in the POMS and EQ-5D questionnaires. This study did not provide sufficient evidence supporting an efficacy of Tong Len meditation in distant psychological healing as compared to a control condition. The research highlighted some psychological improvements through Tong Len distant meditation in a group of patients unknown to meditators. Therefore, the enhancement detected in most parameters in both treatment and control groups raises interest on in-depth analysis and evaluation of distant meditation on cancer patients to mitigate

  20. Multiple treatment comparisons in epilepsy monotherapy trials

    Directory of Open Access Journals (Sweden)

    Chadwick David W

    2007-11-01

    Full Text Available Abstract Background The choice of antiepileptic drug for an individual should be based upon the highest quality evidence regarding potential benefits and harms of the available treatments. Systematic reviews and meta-analysis of randomised controlled trials should be a major source of evidence supporting this decision making process. We summarise all available individual patient data evidence from randomised controlled trials that compared at least two out of eight antiepileptic drugs given as monotherapy. Methods Multiple treatment comparisons from epilepsy monotherapy trials were synthesized in a single stratified Cox regression model adjusted for treatment by epilepsy type interactions and making use of direct and indirect evidence. Primary outcomes were time to treatment failure and time to 12 month remission from seizures. A secondary outcome was time to first seizure. Results Individual patient data for 6418 patients from 20 randomised trials comparing eight antiepileptic drugs were synthesized. For partial onset seizures (4628 (72% patients, lamotrigine, carbamazepine and oxcarbazepine provide the best combination of seizure control and treatment failure. Lamotrigine is clinically superior to all other drugs for treatment failure but estimates suggest a disadvantage compared to carbamazepine for time to 12 month remission [Hazard Ratio (95% Confidence Interval = 0.87(0.73 to 1.04] and time to first seizure [1.29(1.13 to 1.48]. Phenobarbitone may delay time to first seizure [0.77(0.61 to 0.96] but at the expense of increased treatment failure [1.60(1.22 to 2.10]. For generalized onset tonic clonic seizures (1790 (28% patients estimates suggest valproate or phenytoin may provide the best combination of seizure control and treatment failure but some uncertainty remains about the relative effectiveness of other drugs. Conclusion For patients with partial onset seizures, results favour carbamazepine, oxcarbazepine and lamotrigine. For

  1. Study protocol of a randomized controlled trial comparing Mindfulness-Based Stress Reduction with treatment as usual in reducing psychological distress in patients with lung cancer and their partners: the MILON study

    NARCIS (Netherlands)

    Schellekens, M.P.J.; Hurk, D.G.M. van den; Prins, J.B.; Molema, J.; Donders, A.R.T.; Woertman, W.H.; Drift, M.A. van der; Speckens, A.E.M.

    2014-01-01

    BACKGROUND: Lung cancer is the leading cause of cancer death worldwide and characterized by a poor prognosis. It has a major impact on the psychological wellbeing of patients and their partners. Recently, it has been shown that Mindfulness-Based Stress Reduction (MBSR) is effective in reducing

  2. The effects of psychological interventions on wound healing: A systematic review of randomized trials.

    Science.gov (United States)

    Robinson, Hayley; Norton, Sam; Jarrett, Paul; Broadbent, Elizabeth

    2017-11-01

    Psychological stress has been shown to delay wound healing. Several trials have investigated whether psychological interventions can improve wound healing, but to date, this evidence base has not been systematically synthesized. The objective was to conduct a systematic review of randomized controlled trials in humans investigating whether psychological interventions can enhance wound healing. A systematic review was performed using PsychINFO, CINAHL, Web of Science, and MEDLINE. The searches included all papers published in English up until September 2016. The reference lists of relevant papers were screened manually to identify further review articles or relevant studies. Nineteen studies met inclusion criteria and were included in the review. Fifteen of nineteen studies were of high methodological quality. Six studies were conducted with acute experimentally created wounds, five studies with surgical patients, two studies with burn wounds, two studies with fracture wounds, and four studies were conducted with ulcer wounds. Post-intervention standardized mean differences (SMD) between groups across all intervention types ranged from 0.13 to 3.21, favouring improved healing, particularly for surgical patients and for relaxation interventions. However, there was some evidence for publication bias suggesting negative studies may not have been reported. Due to the heterogeneity of wound types, population types, and intervention types, it is difficult to pool effect sizes across studies. Current evidence suggests that psychological interventions may aid wound healing. Although promising, more research is needed to assess the efficacy of each intervention on different wound types. Statement of contribution What is already known on this subject? Psychological stress negatively affects wound healing. A number of studies have investigated whether psychological interventions can improve healing. However, no systematic reviews have been conducted. What does this study add

  3. Individual psychological therapy in the outpatient treatment of adults with anorexia nervosa.

    Science.gov (United States)

    Hay, Phillipa J; Claudino, Angélica M; Touyz, Stephen; Abd Elbaky, Ghada

    2015-07-27

    Anorexia nervosa is a disorder with high morbidity and significant mortality. It is most common in young adult women, in whom the incidence may be increasing. The focus of treatment has moved to an outpatient setting, and a number of differing psychological therapies are presently used in treatment. This is an update of a Cochrane review which was last published in 2008. To assess the effects of specific individual psychological therapies for anorexia nervosa in adults or older adolescents treated in an outpatient setting. We searched the Cochrane Depression, Anxiety and Neurosis Review Group Specialised Register (CCDANCTR) (16 July 2014). This register includes relevant randomised controlled trials from: the Cochrane Library (all years), MEDLINE (1950 to date), EMBASE (1974 to date), and PsycINFO (1967 to date). We screened reference lists of all included studies and sent letters to identified, notable researchers requesting information on unpublished or ongoing studies. All randomised controlled trials of one or more individual outpatient psychological therapies for adults with anorexia nervosa, as defined by DSM-5 or similar international criteria. We selected a range of outcome variables, including physical state, severity of eating disorder attitudes and beliefs, interpersonal function, and general psychiatric symptom severity. Continuous outcome data comparisons used the mean or standardised mean difference (MD or SMD), and binary outcome comparisons used the risk ratio (RR). Two review authors (PH and AC or ST) extracted data independently. We identified 10 trials from the search, with a total of 599 anorexia nervosa participants, and included them in the review. Seven had been identified in the previous versions of this review and we now include three new trials. We now deem one previously identified ongoing trial to be ineligible, and six ongoing trials are new for this update. Two of the 10 trials included children. Trials tested diverse psychological

  4. Sustained effectiveness and cost-effectiveness of Counselling for Alcohol Problems, a brief psychological treatment for harmful drinking in men, delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Abhijit Nadkarni

    2017-09-01

    unable to work, or perpetration of intimate partner violence. Economic analyses indicated that CAP plus EUC was dominant over EUC alone, with lower costs and better outcomes; uncertainty analysis showed a 99% chance of CAP being cost-effective per remission achieved from a health system perspective, using a willingness to pay threshold equivalent to 1 month's wages for an unskilled manual worker in Goa. Readiness to change level at 3 months mediated the effect of CAP on mean standard ethanol consumption at 12 months (indirect effect -6.014 [95% CI -13.99, -0.046]. Serious adverse events were infrequent, and prevalence was similar by arm. The methodological limitations of this trial are the susceptibility of self-reported drinking to social desirability bias, the modest participation rates of eligible patients, and the examination of mediation effects of only 1 mediator and in only half of our sample.CAP's superiority over EUC at the end of treatment was largely stable over time and was mediated by readiness to change. CAP provides better outcomes at lower costs from a societal perspective.ISRCTN registry ISRCTN76465238.

  5. Sustained effectiveness and cost-effectiveness of the Healthy Activity Programme, a brief psychological treatment for depression delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial

    Science.gov (United States)

    Weobong, Benedict; Singla, Daisy R.; Hollon, Steven D.; Nadkarni, Abhijit; Park, A-La; Bhat, Bhargav; Anand, Arpita; Dimidjian, Sona; King, Michael; Vijayakumar, Lakshmi; Wilson, G. Terence; Velleman, Richard

    2017-01-01

    per quality-adjusted life year gained. Patient-reported behavioural activation level at 3 months mediated the effect of the HAP intervention on the 12-month depression score (β = −2.62; 95% CI −3.28, −1.97; p behavioural activation. Conclusions HAP’s superiority over EUC at the end of treatment was largely stable over time and was mediated by patient activation. HAP provides better outcomes at lower costs from a perspective covering publicly funded healthcare services and productivity impacts on patients and their families. Trial registration ISRCTN registry ISRCTN95149997 PMID:28898283

  6. Review of the optic neuritis treatment trial

    International Nuclear Information System (INIS)

    Chuman, Hideki

    2007-01-01

    The Optic Neuritis Treatment Trial (ONTT) is a multicenter controlled clinical trial. The primary objective of this trial is to assess the efficacy of corticosteroids in the treatment of optic neuritis. Treatment with intravenous methylprednisolone resulted in a more rapid return of the visual function to normal. Oral prednisone alone was associated with a significantly increased risk of recurrent optic neuritis. The trial also provided invaluable information about the clinical profile of optic neuritis and its relationship to Multiple Sclerosis (MS). At 6 months after the initial optic neuritis attack, a 12-month follow-up of patients was begun and the data collected during this period indicated that visual acuity was more than 20/20 in 69%, 20/40 in 93%, and 20/200 or less in only 3% of the patients. The risk of MS within 10 years after the first episode of optic neuritis was 56% among patients who were found to have had one or more characteristic white-matter lesions at baseline, as compared to only 22% for patients who had no observable lesions at baseline. (author)

  7. Psychological Treatments for the World: Lessons from Low- and Middle-Income Countries.

    Science.gov (United States)

    Singla, Daisy R; Kohrt, Brandon A; Murray, Laura K; Anand, Arpita; Chorpita, Bruce F; Patel, Vikram

    2017-05-08

    Common mental disorders, including depression, anxiety, and posttraumatic stress, are leading causes of disability worldwide. Treatment for these disorders is limited in low- and middle-income countries. This systematic review synthesizes the implementation processes and examines the effectiveness of psychological treatments for common mental disorders in adults delivered by nonspecialist providers in low- and middle-income countries. In total, 27 trials met the eligibility criteria; most treatments targeted depression or posttraumatic stress. Treatments were commonly delivered by community health workers or peers in primary care or community settings; they usually were delivered with fewer than 10 sessions over 2-3 months in an individual, face-to-face format. Treatments included common elements, such as nonspecific engagement and specific domains of behavioral, interpersonal, emotional, and cognitive elements. The pooled effect size was 0.49 (95% confidence interval = 0.36-0.62), favoring intervention conditions. Our review demonstrates that psychological treatments-comprising a parsimonious set of common elements and delivered by a low-cost, widely available human resource-have moderate to strong effects in reducing the burden of common mental disorders.

  8. Socioeconomic and psychological impact of treatment for unilateral intraocular retinoblastoma.

    Science.gov (United States)

    Soliman, S E; Dimaras, H; Souka, A A; Ashry, M H; Gallie, B L

    2015-06-01

    To identify the socioeconomic and psychosocial impacts of clinical treatment decisions for advanced unilateral intraocular retinoblastoma. Retrospective observational case series. institutional study at Alexandria Main University Hospital. records of 66 unilateral retinoblastoma cases treated from May 2005 to May 2013 were retrospectively reviewed. Sixty cases were eligible (International Intraocular Retinoblastoma Classification [IIRC] group C, D or E). two treatment groups were compared: enucleation vs. salvage treatment. Salvage treatment eyes were further subdivided based on IIRC group. Six socioeconomic parameters (financial burden, financial impact, psychological, social, medical and tumor impacts) were scored. Parameter scores ranged from 0 to 3, for overall score range 0 (no adverse impact) to 18 (severe adverse impact). derived Socioeconomic scores were correlated with treatment and outcomes. The enucleation group (28 eyes) had a median overall Socioeconomic score of 4/18, significantly lower than the salvage treatment group (32 eyes), median score 11/18 (PSocioeconomic score varied with IIRC group. Attempted eye salvage failed in 25 children, due to uncontrolled tumor (44%) and socioeconomic impact of cumulative therapies (56%). Treatment duration and Socioeconomic score were higher for the 5 children in the salvage treatment group who developed metastatic disease compared to those without metastasis (Psocioeconomic and psychosocial impacts of attempted ocular salvage for unilateral intraocular retinoblastoma are severe, in comparison to primary enucleation. Primary enucleation is a good treatment for unilateral retinoblastoma. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  9. Psychological rehabilitation after myocardial infarction: multicentre randomised controlled trial.

    OpenAIRE

    Jones, D. A.; West, R. R.

    1996-01-01

    OBJECTIVE: To evaluate rehabilitation after myocardial infarction. DESIGN: Randomised controlled trial of rehabilitation in unselected myocardial infarction patients in six centres, baseline data being collected on admission and by structured interview (of patients and spouses) shortly after discharge and outcome being assessed by structured interview at six months and clinical examination at 12 months. SETTING: Six district general hospitals. SUBJECTS: All 2328 eligible patients admitted ove...

  10. Experiential Virtual Scenarios With Real-Time Monitoring (Interreality) for the Management of Psychological Stress: A Block Randomized Controlled Trial

    Science.gov (United States)

    Pallavicini, Federica; Morganti, Luca; Serino, Silvia; Scaratti, Chiara; Briguglio, Marilena; Crifaci, Giulia; Vetrano, Noemi; Giulintano, Annunziata; Bernava, Giuseppe; Tartarisco, Gennaro; Pioggia, Giovanni; Raspelli, Simona; Cipresso, Pietro; Vigna, Cinzia; Grassi, Alessandra; Baruffi, Margherita; Wiederhold, Brenda; Riva, Giuseppe

    2014-01-01

    Background The recent convergence between technology and medicine is offering innovative methods and tools for behavioral health care. Among these, an emerging approach is the use of virtual reality (VR) within exposure-based protocols for anxiety disorders, and in particular posttraumatic stress disorder. However, no systematically tested VR protocols are available for the management of psychological stress. Objective Our goal was to evaluate the efficacy of a new technological paradigm, Interreality, for the management and prevention of psychological stress. The main feature of Interreality is a twofold link between the virtual and the real world achieved through experiential virtual scenarios (fully controlled by the therapist, used to learn coping skills and improve self-efficacy) with real-time monitoring and support (identifying critical situations and assessing clinical change) using advanced technologies (virtual worlds, wearable biosensors, and smartphones). Methods The study was designed as a block randomized controlled trial involving 121 participants recruited from two different worker populations—teachers and nurses—that are highly exposed to psychological stress. Participants were a sample of teachers recruited in Milan (Block 1: n=61) and a sample of nurses recruited in Messina, Italy (Block 2: n=60). Participants within each block were randomly assigned to the (1) Experimental Group (EG): n=40; B1=20, B2=20, which received a 5-week treatment based on the Interreality paradigm; (2) Control Group (CG): n=42; B1=22, B2=20, which received a 5-week traditional stress management training based on cognitive behavioral therapy (CBT); and (3) the Wait-List group (WL): n=39, B1=19, B2=20, which was reassessed and compared with the two other groups 5 weeks after the initial evaluation. Results Although both treatments were able to significantly reduce perceived stress better than WL, only EG participants reported a significant reduction (EG=12% vs CG=0

  11. Exercise addiction- diagnosis, bio-psychological mechanisms and treatment issues.

    Science.gov (United States)

    Weinstein, Aviv; Weinstein, Yitzhak

    2014-01-01

    Exercise and sports activity are beneficial both physically and psychologically but excessive exercise may have adverse physiological and psychological effects. There are methodological issues in the definition, diagnosis and etiology of exercise addiction. Several questionnaires and diagnostic tools have been developed and validated and they show high validity and reliability. Exercise addiction has been suggested as having an obsessive-compulsive dimension as well as rewarding aspects that may include it among the behavioral addictions. Biological studies show that in rodents, exercise such as wheel running activates the dopamine reward system and thus contributing to stress reduction. Further evidence suggests that running is associated with endorphins and cannabinoids thus explaining the "runners high" or euphoric feelings that may lead to exercise addiction. Genetic studies suggest that genes which control preference for drugs also control the preference for naturally rewarding behaviors such as exercise. Psychological studies also explain exercise addiction in terms of reward, habituation, social support, stress-relief, avoidance of withdrawal and reduction of anxiety. It has been suggested that exercise addiction is a part of a continuum of sportive activity that develops in stages from the recreational exercise to at-risk exercise, problematic exercise and finally into exercise addiction. Assessment and treatment should take into account the various stages of exercise addiction development, its comorbidity with other psychiatric disorders such as eating disorders or substance use and alcohol disorders. Treatment approaches for exercise addiction are based on the cognitive-behavioral approach but little is known about their effectiveness. A single-case study shows promise of pharmacological treatment for exercise addiction and further studies are required. This review summarizes diagnostic and phenomenology of exercise addiction with emphasis on

  12. Treatment of depressed mothers in home visiting: impact on psychological distress and social functioning.

    Science.gov (United States)

    Ammerman, Robert T; Putnam, Frank W; Altaye, Mekibib; Teeters, Angelique R; Stevens, Jack; Van Ginkel, Judith B

    2013-08-01

    Depression is prevalent in mothers receiving home visiting. Little is known about the impact of treatment on associated features of maternal depression in this population. The purpose of this study was to examine the impact of a novel, adapted treatment for depressed mothers in home visiting on psychological distress and social functioning. In-Home Cognitive Behavioral Therapy (IH-CBT) was developed to treat depressed mothers in home visiting. A randomized clinical trial design was used in which subjects were 93 new mothers in a home visiting program. Mothers with major depressive disorder identified at 3 months postpartum were randomized into IH-CBT and ongoing home visiting (n = 47) or standard home visiting (SHV; n = 46) in which they received home visitation alone and could obtain treatment in the community. Measures of psychological distress, social support, and social network were measured at pre-treatment, post-treatment, and three-month follow-up. Clinical features of depression and home visiting parameters were examined as potential moderators. Subjects receiving IH-CBT reported decreased psychological distress at post-treatment (ES = 0.77) and follow-up (ES = 0.73). Examination of types of psychological distress indicated broad improvements at both time points. Those receiving IH-CBT reported increased social support over time relative to those in the SHV condition. Effect sizes were modest at post-treatment (ES = 0.38) but increased at follow-up (ES = 0.65). Improvements were seen in affiliative and belonginess aspects of social support, in contrast to tangible support which was statistically non-significant. Findings were not moderated by clinical features of depression or home visiting parameters. No group differences were found in size of and involvement with social networks. IH-CBT is effective in reducing psychological distress and improving perceived social support in depressed mothers receiving home visiting. To the extent that mothers are better

  13. Psychological treatment and therapeutic change in incarcerated rapists

    Directory of Open Access Journals (Sweden)

    Ana Martínez-Catena

    2017-01-01

    Full Text Available Abstract Most Spanish prisons provide specialised treatment for incarcerated sex offenders, both rapists and child molesters. This treatment is a cognitive-behavioural intervention that has shown relative effectiveness in previous research. With regard to offenders’ rehabilitation, recidivism assessments are necessary as a final measure of treatment effectiveness. However, the evaluation of recidivism by itself does not provide sufficient information on the treatment process and the specific effects that treated subjects could undergo. This paper aims to analyse the therapeutic effectiveness of psychological treatment provided to rapists (in general, males sentenced for committing a sexual offence against women. To this aim, a group of treated rapists (N=153 serving a sentence in prison was analysed. Using a specially designed scale (PASSO, the global therapeutic change and ten specific variables (including assertiveness, readiness to change, cognitive distortions, impulsivity, etc. were assessed. The within-subjects comparison showed that treated sex offenders improved, in therapeutic terms, globally as well as in most of the specific variables assessed (improvements not experimented by the control group. Also, different therapeutic subscales showed relevant associations between them. The findings regarding treatment effectiveness are discussed.

  14. How many individuals achieve symptom abstinence following psychological treatments for bulimia nervosa? A meta-analytic review.

    Science.gov (United States)

    Linardon, Jake; Wade, Tracey D

    2018-04-01

    It is unclear how many patients with bulimia nervosa (BN) completely abstain from the core behavioral symptoms after receiving psychological treatment. The present meta-analysis of randomized controlled trials (RCTs) aimed to (a) estimate the prevalence of patients who abstain from binge eating and/or purging following all psychological treatments for BN, and (b) test whether these abstinence estimates are moderated by the type of treatment modality delivered, the definition of abstinence applied, and trial quality. Forty-five RCTs were included, with 78 psychotherapy conditions. Pooled event rates were calculated using random effects models. At post-treatment, the total weighted percentage of treatment-completers who achieved abstinence was 35.4% (95% CI = 29.6, 41.7), while the total weighted percentage of abstinence for all randomized patients (intention-to-treat) was 29.9% (95% CI = 25.7, 33.2). Abstinence estimates were highest in trials that used behavioral-based treatments (e.g., cognitive-behavioral therapy, behavior therapy). There was also evidence that guided self-help interventions produced the lowest post-treatment abstinence rates, but with no difference at follow-up from clinician-led treatments, and studies that used a shorter timeframe for defining abstinence (i.e., 14 days symptom-free compared to 28-days symptom-free) produced the highest abstinence rates. Abstinence estimates at follow-up for both the completer (34.6%; 95% CI = 29.3, 40.2) and intention-to-treat (28.6%; 95% CI = 25.1, 32.3) analyses were essentially the same as the post-treatment estimates. Over 60% of patients fail to fully abstain from core BN symptoms even after receiving our most empirically-supported treatments. The present findings highlight the urgency toward improving the effectiveness of psychological treatments for BN. © 2018 Wiley Periodicals, Inc.

  15. [Analysis of psychological conditions of parents of children with cleft lip and palate by using psychological scales before and after psychological treatment].

    Science.gov (United States)

    Gong, Cai-xia; Zheng, Qian; Shi, Bing

    2011-02-01

    To evaluate the psychological conditions of parents of children with cleft lip and palate, and to discuss the clinical psychological treatment methods of these parents. 100 parents of children with cleft lip and palate were selected as the parents of children with cleft lip and palate group, and 34 normal adults were selected as the control group. Two groups were tested by the life event scale (LES) and self-rating anxiety scale (SAS) to analyze their psychological states. After the study group was treated by psychological counseling, two groups were tested by the LES and SAS again. The LES total scores of the patients of children with cleft lip and palate had significant differences compared with the normal adults (P palate had no significant differences compared with the normal adults before and after psychological counseling (P > 0.05). Analyzing the psychological conditions of parents of children with cleft lip and palate by using psychological scales and then treating them by counseling, is an effective psychological treatment method.

  16. Experiential virtual scenarios with real-time monitoring (interreality) for the management of psychological stress: a block randomized controlled trial.

    Science.gov (United States)

    Gaggioli, Andrea; Pallavicini, Federica; Morganti, Luca; Serino, Silvia; Scaratti, Chiara; Briguglio, Marilena; Crifaci, Giulia; Vetrano, Noemi; Giulintano, Annunziata; Bernava, Giuseppe; Tartarisco, Gennaro; Pioggia, Giovanni; Raspelli, Simona; Cipresso, Pietro; Vigna, Cinzia; Grassi, Alessandra; Baruffi, Margherita; Wiederhold, Brenda; Riva, Giuseppe

    2014-07-08

    The recent convergence between technology and medicine is offering innovative methods and tools for behavioral health care. Among these, an emerging approach is the use of virtual reality (VR) within exposure-based protocols for anxiety disorders, and in particular posttraumatic stress disorder. However, no systematically tested VR protocols are available for the management of psychological stress. Our goal was to evaluate the efficacy of a new technological paradigm, Interreality, for the management and prevention of psychological stress. The main feature of Interreality is a twofold link between the virtual and the real world achieved through experiential virtual scenarios (fully controlled by the therapist, used to learn coping skills and improve self-efficacy) with real-time monitoring and support (identifying critical situations and assessing clinical change) using advanced technologies (virtual worlds, wearable biosensors, and smartphones). The study was designed as a block randomized controlled trial involving 121 participants recruited from two different worker populations-teachers and nurses-that are highly exposed to psychological stress. Participants were a sample of teachers recruited in Milan (Block 1: n=61) and a sample of nurses recruited in Messina, Italy (Block 2: n=60). Participants within each block were randomly assigned to the (1) Experimental Group (EG): n=40; B1=20, B2=20, which received a 5-week treatment based on the Interreality paradigm; (2) Control Group (CG): n=42; B1=22, B2=20, which received a 5-week traditional stress management training based on cognitive behavioral therapy (CBT); and (3) the Wait-List group (WL): n=39, B1=19, B2=20, which was reassessed and compared with the two other groups 5 weeks after the initial evaluation. Although both treatments were able to significantly reduce perceived stress better than WL, only EG participants reported a significant reduction (EG=12% vs. CG=0.5%) in chronic "trait" anxiety. A similar

  17. The effects of centralised and specialised combined pharmacological and psychological intervention compared with decentralised and non-specialised treatment in the early course of severe unipolar and bipolar affective disorders--design of two randomised clinical trials

    DEFF Research Database (Denmark)

    Kessing, Lars Vedel; Hansen, Hanne Vibe; Christensen, Ellen Margrethe

    2011-01-01

    In unipolar, and bipolar affective disorders, there is a high risk of relapse that increases as the number of episodes increases. Naturalistic follow-up studies suggest that the progressive development of the diseases is not prevented with the present treatment modalities. It is not known whether...

  18. Seeking psychological help: a comparison of individual and group treatment.

    Science.gov (United States)

    Shechtman, Zipora; Vogel, David; Maman, Neta

    2010-01-01

    The study examined public and self-stigma and their association with attitudes and intentions to seek psychological help in regard to both individual and group treatment as well as to various subgroups, including gender, ethnicity, educational orientation, level of religion, and age. Undergraduate students (N=307) in three universities in Israel participated in the study. Results partly confirmed the model for both individual and group therapy: Self-stigma was related to attitudes and intentions to seek help. However, public stigma was not related to self-stigma. Importantly, some differences were also found among the various subgroups, and the model, which takes into account the different subgroups, looks somewhat different for individual and group therapy.

  19. A Randomised Controlled Trial to Determine the Effectiveness of an Early Psychological Intervention with Children Involved in Road Traffic Accidents

    Science.gov (United States)

    Stallard, Paul; Velleman, Richard; Salter, Emma; Howse, Imogen; Yule, William; Taylor, Gordon

    2006-01-01

    Objective: To determine whether an early intervention using a psychological debriefing format is effective in preventing psychological distress in child road traffic accident survivors. Design: Randomised controlled trial. Setting: Accident and Emergency Department, Royal United Hospital, Bath. Subjects: 158 children aged 7-18. Follow-up…

  20. A Randomized Controlled Trial of a Brief Intervention for Delayed Psychological Effects in Snakebite Victims.

    Directory of Open Access Journals (Sweden)

    Chamara A Wijesinghe

    Full Text Available Snakebite results in delayed psychological morbidity and negative psycho-social impact. However, psychological support is rarely provided to victims.To assess the effectiveness of a brief intervention which can be provided by non-specialist doctors aimed at reducing psychological morbidity following snakebite envenoming.In a single blind, randomized controlled trial, snakebite victims with systemic envenoming [n = 225, 168 males, mean age 42.1 (SD 12.4 years] were randomized into three arms. One arm received no intervention (n = 68, Group A, the second received psychological first aid and psychoeducation (dispelling prevalent cultural beliefs related to snakebite which promote development of a sick role at discharge from hospital (n = 65, Group B, while the third received psychological first aid and psychoeducation at discharge and a second intervention one month later based on cognitive behavioural principles (n = 69, Group C. All patients were assessed six months after hospital discharge for the presence of psychological symptoms and level of functioning using standardized tools.At six months, there was a decreasing trend in the proportion of patients who were positive for psychiatric symptoms of depression and anxiety from Group A through Group B to Group C (Chi square test for trend = 7.901, p = 0.005. This was mainly due to a decreasing trend for symptoms of anxiety (chi-square for trend = 11.256, p = 0.001. There was also decreasing trend in the overall prevalence of disability from Group A through Group B to Group C (chi square for trend = 7.551, p = 0.006, predominantly in relation to disability in family life (p = 0.006 and social life (p = 0.005. However, there was no difference in the proportion of patients diagnosed with depression between the three groups (chi square for trend = 0.391, p = 0.532, and the intervention also had no effect on post-traumatic stress disorder.A brief psychological intervention, which included psychological

  1. A Randomized Controlled Trial of a Brief Intervention for Delayed Psychological Effects in Snakebite Victims.

    Science.gov (United States)

    Wijesinghe, Chamara A; Williams, Shehan S; Kasturiratne, Anuradhani; Dolawaththa, Nishantha; Wimalaratne, Piyal; Wijewickrema, Buddhika; Jayamanne, Shaluka F; Isbister, Geoffrey K; Dawson, Andrew H; Lalloo, David G; de Silva, H Janaka

    2015-01-01

    Snakebite results in delayed psychological morbidity and negative psycho-social impact. However, psychological support is rarely provided to victims. To assess the effectiveness of a brief intervention which can be provided by non-specialist doctors aimed at reducing psychological morbidity following snakebite envenoming. In a single blind, randomized controlled trial, snakebite victims with systemic envenoming [n = 225, 168 males, mean age 42.1 (SD 12.4) years] were randomized into three arms. One arm received no intervention (n = 68, Group A), the second received psychological first aid and psychoeducation (dispelling prevalent cultural beliefs related to snakebite which promote development of a sick role) at discharge from hospital (n = 65, Group B), while the third received psychological first aid and psychoeducation at discharge and a second intervention one month later based on cognitive behavioural principles (n = 69, Group C). All patients were assessed six months after hospital discharge for the presence of psychological symptoms and level of functioning using standardized tools. At six months, there was a decreasing trend in the proportion of patients who were positive for psychiatric symptoms of depression and anxiety from Group A through Group B to Group C (Chi square test for trend = 7.901, p = 0.005). This was mainly due to a decreasing trend for symptoms of anxiety (chi-square for trend = 11.256, p = 0.001). There was also decreasing trend in the overall prevalence of disability from Group A through Group B to Group C (chi square for trend = 7.551, p = 0.006), predominantly in relation to disability in family life (p = 0.006) and social life (p = 0.005). However, there was no difference in the proportion of patients diagnosed with depression between the three groups (chi square for trend = 0.391, p = 0.532), and the intervention also had no effect on post-traumatic stress disorder. A brief psychological intervention, which included psychological

  2. Sustained effectiveness and cost-effectiveness of the Healthy Activity Programme, a brief psychological treatment for depression delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Benedict Weobong

    2017-09-01

    Full Text Available The Healthy Activity Programme (HAP, a brief behavioural intervention delivered by lay counsellors, enhanced remission over 3 months among primary care attendees with depression in peri-urban and rural settings in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of HAP over 12 months, and the effects of the hypothesized mediator of activation on clinical outcomes.Primary care attendees aged 18-65 years screened with moderately severe to severe depression on the Patient Health Questionnaire 9 (PHQ-9 were randomised to either HAP plus enhanced usual care (EUC (n = 247 or EUC alone (n = 248, of whom 95% completed assessments at 3 months, and 91% at 12 months. Primary outcomes were severity on the Beck Depression Inventory-II (BDI-II and remission on the PHQ-9. HAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up (difference in mean BDI-II score between 3 and 12 months = -0.34; 95% CI -2.37, 1.69; p = 0.74, with lower symptom severity scores than participants who received EUC alone (adjusted mean difference in BDI-II score = -4.45; 95% CI -7.26, -1.63; p = 0.002 and higher rates of remission (adjusted prevalence ratio [aPR] = 1.36; 95% CI 1.15, 1.61; p < 0.009. They also fared better on most secondary outcomes, including recovery (aPR = 1.98; 95% CI 1.29, 3.03; p = 0.002, any response over time (aPR = 1.45; 95% CI 1.27, 1.66; p < 0.001, higher likelihood of reporting a minimal clinically important difference (aPR = 1.42; 95% CI 1.17, 1.71; p < 0.001, and lower likelihood of reporting suicidal behaviour (aPR = 0.71; 95% CI 0.51, 1.01; p = 0.06. HAP plus EUC also had a marginal effect on WHO Disability Assessment Schedule score at 12 months (aPR = -1.58; 95% CI -3.33, 0.17; p = 0.08; other outcomes (days unable to work, intimate partner violence toward females did not statistically significantly differ between the two arms. Economic analyses

  3. Vaginismus Treatment: Clinical Trials Follow Up 241 Patients.

    Science.gov (United States)

    Pacik, Peter T; Geletta, Simon

    2017-06-01

    Vaginismus is mostly unknown among clinicians and women. Vaginismus causes women to have fear, anxiety, and pain with penetration attempts. To present a large cohort of patients based on prior published studies approved by an institutional review board and the Food and Drug Administration using a comprehensive multimodal vaginismus treatment program to treat the physical and psychologic manifestations of women with vaginismus and to record successes, failures, and untoward effects of this treatment approach. Assessment of vaginismus included a comprehensive pretreatment questionnaire, the Female Sexual Function Index (FSFI), and consultation. All patients signed a detailed informed consent. Treatment consisted of a multimodal approach including intravaginal injections of onabotulinumtoxinA (Botox) and bupivacaine, progressive dilation under conscious sedation, indwelling dilator, follow-up and support with office visits, phone calls, e-mails, dilation logs, and FSFI reports. Logs noting dilation progression, pain and anxiety scores, time to achieve intercourse, setbacks, and untoward effects. Post-treatment FSFI scores were compared with preprocedure scores. One hundred seventy-one patients (71%) reported having pain-free intercourse at a mean of 5.1 weeks (median = 2.5). Six patients (2.5%) were unable to achieve intercourse within a 1-year period after treatment and 64 patients (26.6%) were lost to follow-up. The change in the overall FSFI score measured at baseline, 3 months, 6 months, and 1 year was statistically significant at the 0.05 level. Three patients developed mild temporary stress incontinence, two patients developed a short period of temporary blurred vision, and one patient developed temporary excessive vaginal dryness. All adverse events resolved by approximately 4 months. One patient required retreatment followed by successful coitus. A multimodal program that treated the physical and psychologic aspects of vaginismus enabled women to achieve

  4. [Psychological Treatments for Borderline Personality Disorder: A Review of Cognitive-Behavioral Oriented Therapies].

    Science.gov (United States)

    Marques, Sofia; Barrocas, Daniel; Rijo, Daniel

    2017-04-28

    Borderline personality disorder is the most common personality disorder, with a global prevalence rate between 1.6% and 6%. It is characterized by affective disturbance and impulsivity, which lead to a high number of self-harm behaviors and great amount of health services use. International guidelines recommend psychotherapy as the primary treatment for borderline personality disorder. This paper reviews evidence about the effects and efficacy of cognitive-behavioral oriented psychological treatments for borderline personality disorder. A literature review was conducted in Medline and PubMed databases, using the following keywords: borderline personality disorder, cognitive-behavioral psychotherapy and efficacy. Sixteen randomized clinical trials were evaluate in this review, which analyzed the effects of several cognitive-behavioral oriented psychotherapeutic interventions, namely dialectical behavioral therapy, cognitive behavioral therapy, schema-focused therapy and manual-assisted cognitive therapy. All above stated treatments showed clinical beneficial effects, by reducing borderline personality disorder core pathology and associated general psychopathology, as well as by reducing the severity and frequency of self-harm behaviors, and by improving the overall social, interpersonal and global adjustment. Dialectical behavioral therapy and schema-focused therapy also caused a soaring remission rate of diagnostic borderline personality disorder criteria of 57% and 94%, respectively. Although there were differences between the psychotherapeutic interventions analysed in this review, all showed clinical benefits in the treatment of borderline personality disorder. Dialectical behavioral therapy and schema-focused therapy presented the strongest scientific data documenting their efficacy, but both interventions are integrative cognitive-behavioral therapies which deviate from the traditional cognitive-behavioral model. In summary, the available studies support

  5. Mindfulness-Based Cognitive Therapy as a Treatment for Chronic Tinnitus: A Randomized Controlled Trial

    OpenAIRE

    McKenna, L.; Marks, E. M.; Hallsworth, C. A.; Schaette, R.

    2017-01-01

    BACKGROUND: Tinnitus is experienced by up to 15% of the population and can lead to significant disability and distress. There is rarely a medical or surgical target and psychological therapies are recommended. We investigated whether mindfulness-based cognitive therapy (MBCT) could offer an effective new therapy for tinnitus. METHODS: This single-site randomized controlled trial compared MBCT to intensive relaxation training (RT) for chronic, distressing tinnitus in adults. Both treatments in...

  6. Effects of a Psychological Intervention in a Primary Health Care Center for Caregivers of Dependent Relatives: A Randomized Trial

    Science.gov (United States)

    Rodriguez-Sanchez, Emiliano; Patino-Alonso, Maria C.; Mora-Simon, Sara; Gomez-Marcos, Manuel A.; Perez-Penaranda, Anibal; Losada-Baltar, Andres; Garcia-Ortiz, Luis

    2013-01-01

    Purpose: To assess, in the context of Primary Health Care (PHC), the effect of a psychological intervention in mental health among caregivers (CGs) of dependent relatives. Design and Methods: Randomized multicenter, controlled clinical trial. The 125 CGs included in the trial were receiving health care in PHC. Inclusion criteria: Identifying…

  7. Psychological issues in the evaluation and treatment of tension-type headache.

    Science.gov (United States)

    Rosen, Noah L

    2012-12-01

    Tension-type headache is the most common headache disorder, affecting approximately 40 % of Americans within a one-year span. Although the most common form, episodic tension-type headache, is rarely impairing, more frequent tension-type headache can occur with significant disability and psychological comorbidity. Appreciating the psychological impact, assessing the associated biopsychosocial issues, and understanding patients' coping styles are important in forming an appropriate treatment plan and maximizing treatment outcomes. A range of psychological therapies including relaxation training, cognitive behavioral therapy, biofeedback and mindfulness have demonstrated utility in treating chronic pain conditions and reducing the associated disability. This may be particularly applicable to special populations, including pediatric patients, pregnant patients and geriatric. Psychological assessment and treatment may be done conjointly with medication management and expands treatment options. There is great need to continue researching the effects of psychological treatments, standardizing interventions and making them available to the wider population.

  8. Phase 2 Neoadjuvant Treatment Intensification Trials in Rectal Cancer

    DEFF Research Database (Denmark)

    Teo, Mark T W; McParland, Lucy; Appelt, Ane L

    2018-01-01

    PURPOSE: Multiple phase 2 trials of neoadjuvant treatment intensification in locally advanced rectal cancer have reported promising efficacy signals, but these have not translated into improved cancer outcomes in phase 3 trials. Improvements in phase 2 trial design are needed to reduce these fals...

  9. An open trial of Acceptance-based Separated Family Treatment (ASFT) for adolescents with anorexia nervosa.

    Science.gov (United States)

    Timko, C Alix; Zucker, Nancy L; Herbert, James D; Rodriguez, Daniel; Merwin, Rhonda M

    2015-06-01

    Family based-treatments have the most empirical support in the treatment of adolescent anorexia nervosa; yet, a significant percentage of adolescents and their families do not respond to manualized family based treatment (FBT). The aim of this open trial was to conduct a preliminary evaluation of an innovative family-based approach to the treatment of anorexia: Acceptance-based Separated Family Treatment (ASFT). Treatment was grounded in Acceptance and Commitment Therapy (ACT), delivered in a separated format, and included an ACT-informed skills program. Adolescents (ages 12-18) with anorexia or sub-threshold anorexia and their families received 20 treatment sessions over 24 weeks. Outcome indices included eating disorder symptomatology reported by the parent and adolescent, percentage of expected body weight achieved, and changes in psychological acceptance/avoidance. Half of the adolescents (48.0%) met criteria for full remission at the end of treatment, 29.8% met criteria for partial remission, and 21.3% did not improve. Overall, adolescents had a significant reduction in eating disorder symptoms and reached expected body weight. Treatment resulted in changes in psychological acceptance in the expected direction for both parents and adolescents. This open trial provides preliminary evidence for the feasibility, acceptability, and efficacy of ASFT for adolescents with anorexia. Directions for future research are discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

  10. Practitioner Review: Psychological treatments for children and adolescents with conduct disorder problems - a systematic review and meta-analysis.

    Science.gov (United States)

    Bakker, M J; Greven, C U; Buitelaar, J K; Glennon, J C

    2017-01-01

    This meta-analysis evaluates the efficacy of nonpharmacological treatments for conduct disorder (CD) problems in children and adolescents, based on child, parent and teacher report. PubMed, PsycINFO and EMBASE were searched for peer-reviewed articles published between January 1970 and March 2015. Main inclusion criteria were nonpharmacological treatment, participants younger than 18 years, clinical CD problems/diagnosis, randomized controlled trials and inclusion of at least one CD problem-related outcome. Treatment efficacy is expressed in effect sizes (ESs) calculated for each rater (parent, teacher, self and blinded observer). Of 1,549 articles retrieved, 17 (published between June 2004 and January 2014) describing 19 interventions met the inclusion criteria. All studies used psychological treatments; only three studies included a blinded observer to rate CD problems. Most studies were of very poor to fair quality. ESs were significant but small for parent-reported outcomes (0.36, 95% CI = 0.27-0.47), teacher-reported outcomes (0.26, 95% CI = 0.12-0.49) and blinded observer outcomes (0.26, 95% CI = 0.06-0.47), and they were nonsignificant for self-reported outcomes (-0.01, 95% CI = -0.25 to 0.23). Comorbidity, gender, age, number of sessions, duration, intervention type, setting, medication use or dropout percentage did not influence the effect of treatment. Psychological treatments have a small effect in reducing parent-, teacher- and observer-rated CD problems in children and adolescents with clinical CD problems/diagnosis. There is not enough evidence to support one specific psychological treatment over another. Future studies should investigate the influence of participant characteristics (e.g. age of CD onset), use more homogeneous outcome measures and allow better evaluation of study quality. Many reports failed to provide detailed information to allow optimization of psychological treatment strategies. © 2016 Association for Child and Adolescent

  11. 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

  12. Sequential psychological and pharmacological therapies for comorbid and primary insomnia: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Morin, Charles M; Edinger, Jack D; Krystal, Andrew D; Buysse, Daniel J; Beaulieu-Bonneau, Simon; Ivers, Hans

    2016-03-03

    Chronic insomnia is a prevalent disorder associated with significant psychosocial, health, and economic impacts. Cognitive behavioral therapies (CBTs) and benzodiazepine receptor agonist (BzRA) medications are the most widely supported therapeutic approaches for insomnia management. However, few investigations have directly compared their relative and combined benefits, and even fewer have tested the benefits of sequential treatment for those who do not respond to initial insomnia therapy. Moreover, insomnia treatment studies have been limited by small, highly screened study samples, fixed-dose, and fixed-agent pharmacotherapy strategies that do not represent usual clinical practices. This study will address these limitations. This is a two-site randomized controlled trial, which will enroll 224 adults who meet the criteria for a chronic insomnia disorder with or without comorbid psychiatric disorders. Prospective participants will complete clinical assessments and polysomnography and then will be randomly assigned to first-stage therapy involving either behavioral therapy (BT) or zolpidem. Treatment outcomes will be assessed after 6 weeks, and treatment remitters will be followed for the next 12 months on maintenance therapy. Those not achieving remission will be offered randomization to a second, 6-week treatment, again involving either pharmacotherapy (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy (CT)). All participants will be re-evaluated 12 weeks after the protocol initiation and at 3-, 6-, 9-, and 12-month follow-ups. Insomnia remission, defined categorically as a score Insomnia Severity Index, a patient-reported outcome, will serve as the primary endpoint for treatment comparisons. Secondary outcomes will include sleep parameters derived from daily sleep diaries and from polysomnography, subjective measures of fatigue, mood, quality of life, and functional impairments; and measures of adverse events; dropout rates; and treatment

  13. Do all psychological treatments really work the same in posttraumatic stress disorder?

    OpenAIRE

    Ehlers, Anke; Bisson, Jonathan; Clark, David M.; Creamer, Mark; Pilling, Steven; Richards, David; Schnurr, Paula P.; Turner, Stuart; Yule, William

    2010-01-01

    A recent meta-analysis by Benish, Imel, and Wampold (2008, Clinical Psychology Review, 28, 746–758) concluded that all bona fide treatments are equally effective in posttraumatic stress disorder (PTSD). In contrast, seven other meta-analyses or systematic reviews concluded that there is good evidence that trauma-focused psychological treatments (trauma-focused cognitive behavior therapy and eye movement desensitization and reprocessing) are effective in PTSD; but that treatments that do not f...

  14. Psychological therapy for inpatients receiving acute mental health care: A systematic review and meta-analysis of controlled trials.

    Science.gov (United States)

    Paterson, Charlotte; Karatzias, Thanos; Dickson, Adele; Harper, Sean; Dougall, Nadine; Hutton, Paul

    2018-04-16

    The effectiveness of psychological therapies for those receiving acute adult mental health inpatient care remains unclear, partly because of the difficulty in conducting randomized controlled trials (RCTs) in this setting. The aim of this meta-analysis was to synthesize evidence from all controlled trials of psychological therapy carried out with this group, to estimate its effects on a number of important outcomes and examine whether the presence of randomization and rater blinding moderated these estimates. A systematic review and meta-analysis of all controlled trials of psychological therapy delivered in acute inpatient settings was conducted, with a focus on psychotic symptoms, readmissions or emotional distress (anxiety and depression). Studies were identified through ASSIA, EMBASE, CINAHL, Cochrane, MEDLINE, and PsycINFO using a combination of the key terms 'inpatient', 'psychological therapy', and 'acute'. No restriction was placed on diagnosis. The moderating effect of the use of assessor-blind RCT methodology was examined via subgroup and sensitivity analyses. Overall, psychological therapy was associated with small-to-moderate improvements in psychotic symptoms at end of therapy but the effect was smaller and not significant at follow-up. Psychological therapy was also associated with reduced readmissions, depression, and anxiety. The use of single-blind randomized controlled trial methodology was associated with significantly reduced benefits on psychotic symptoms and was also associated with reduced benefits on readmission and depression; however, these reductions were not statistically significant. The provision of psychological therapy to acute psychiatric inpatients is associated with improvements; however, the use of single-blind RCT methodology was associated with reduced therapy-attributable improvements. Whether this is a consequence of increased internal validity or reduced external validity is unclear. Trials with both high internal and

  15. Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study.

    Science.gov (United States)

    Carhart-Harris, Robin L; Bolstridge, Mark; Rucker, James; Day, Camilla M J; Erritzoe, David; Kaelen, Mendel; Bloomfield, Michael; Rickard, James A; Forbes, Ben; Feilding, Amanda; Taylor, David; Pilling, Steve; Curran, Valerie H; Nutt, David J

    2016-07-01

    Psilocybin is a serotonin receptor agonist that occurs naturally in some mushroom species. Recent studies have assessed the therapeutic potential of psilocybin for various conditions, including end-of-life anxiety, obsessive-compulsive disorder, and smoking and alcohol dependence, with promising preliminary results. Here, we aimed to investigate the feasibility, safety, and efficacy of psilocybin in patients with unipolar treatment-resistant depression. In this open-label feasibility trial, 12 patients (six men, six women) with moderate-to-severe, unipolar, treatment-resistant major depression received two oral doses of psilocybin (10 mg and 25 mg, 7 days apart) in a supportive setting. There was no control group. Psychological support was provided before, during, and after each session. The primary outcome measure for feasibility was patient-reported intensity of psilocybin's effects. Patients were monitored for adverse reactions during the dosing sessions and subsequent clinic and remote follow-up. Depressive symptoms were assessed with standard assessments from 1 week to 3 months after treatment, with the 16-item Quick Inventory of Depressive Symptoms (QIDS) serving as the primary efficacy outcome. This trial is registered with ISRCTN, number ISRCTN14426797. Psilocybin's acute psychedelic effects typically became detectable 30-60 min after dosing, peaked 2-3 h after dosing, and subsided to negligible levels at least 6 h after dosing. Mean self-rated intensity (on a 0-1 scale) was 0·51 (SD 0·36) for the low-dose session and 0·75 (SD 0·27) for the high-dose session. Psilocybin was well tolerated by all of the patients, and no serious or unexpected adverse events occurred. The adverse reactions we noted were transient anxiety during drug onset (all patients), transient confusion or thought disorder (nine patients), mild and transient nausea (four patients), and transient headache (four patients). Relative to baseline, depressive symptoms were markedly reduced 1

  16. Psychological approaches in the treatment of specific phobias: A meta-analysis

    NARCIS (Netherlands)

    Wolitzky-Taylor, K.B.; Horowitz, J.D.; Powers, M.B.; Telch, M.J.

    2008-01-01

    Data from 33 randomized treatment studies were subjected to a meta-analysis to address questions surrounding the efficacy of psychological approaches in the treatment of specific phobia. As expected, exposure-based treatment produced large effects sizes relative to no treatment. They also

  17. Psychological distress and treatment adherence among children on dialysis.

    Science.gov (United States)

    Simoni, J M; Asarnow, J R; Munford, P R; Koprowski, C M; Belin, T R; Salusky, I B

    1997-10-01

    Among 23 pediatric renal dialysis patients, we obtained self-reported assessments of psychological adjustment and biochemical and subjective ratings of adherence. Findings indicate elevated levels of depressive symptoms and substantial nonadherence. Depressive symptoms were associated with higher levels of hopelessness, more negative self-perceptions, and more depressogenic attributional style. The psychological adjustment measures did not significantly correlate with adherence. Nonsignificant associations among different measures of adherence underscore its multifaceted nature. Implications for monitoring the adjustment of children on dialysis, assessing adherence, and future research are discussed.

  18. Family Therapy of Terroristic Trauma: Psychological Syndromes and Treatment Strategies.

    Science.gov (United States)

    Miller, Laurence

    2003-01-01

    Reviews pertinent literature on terroristic trauma and combines this information with the author's experience in treating adults, children, and family victims and survivors of recent terrorist attacks. Describes the psychological syndromes resulting from terrorism and discusses the relevant individual and family therapy modalities for treating…

  19. Are patients at risk for psychological maladjustment during fertility treatment less willing to comply with treatment? Results from the Portuguese validation of the SCREENIVF

    NARCIS (Netherlands)

    Lopes, V.; Canavarro, M.C.; Verhaak, C.M.; Boivin, J.; Gameiro, S.

    2014-01-01

    STUDY QUESTION: Do patients at risk for psychological maladjustment during fertility treatment present lower intentions to comply with recommended treatment than patients not at risk? SUMMARY ANSWER: Patients at risk of psychological maladjustment present similar high intentions to comply with

  20. Effects of adjunctive exercise on physiological and psychological parameters in depression: a randomized pilot trial.

    Science.gov (United States)

    Kerling, Arno; Tegtbur, Uwe; Gützlaff, Elke; Kück, Momme; Borchert, Luise; Ates, Zeynep; von Bohlen, Anne; Frieling, Helge; Hüper, Katja; Hartung, Dagmar; Schweiger, Ulrich; Kahl, Kai G

    2015-05-15

    Major depressive disorder (MDD) is associated with decreased physical activity and increased rates of the metabolic syndrome (MetS), a risk factor for the development of type 2 diabetes and cardiovascular disorders. Exercise training has been shown to improve cardiorespiratory fitness and metabolic syndrome factors. Therefore, our study aimed at examining whether patients receiving an exercise program as an adjunct to inpatient treatment will benefit in terms of physiological and psychological factors. Fourty-two inpatients with moderate to severe depression were included. Twenty-two patients were randomized to additional 3x weekly exercise training (EXERCISE) and compared to treatment as usual (TAU). Exercise capacity was assessed as peak oxygen uptake (VO2peak), ventilatory anaerobic threshold (VAT) and workload expressed as Watts (W). Metabolic syndrome was defined according to NCEP ATPIII panel criteria. After 6 weeks of treatment, cardiorespiratory fitness (VO2peak, VAT, Watt), waist circumference and HDL cholesterol were significantly improved in EXERCISE participants. Treatment response expressed as ≥50% MADRS reduction was more frequent in the EXERCISE group. Adjunctive exercise training in depressed inpatients improves physical fitness, MetS factors, and psychological outcome. Given the association of depression with cardiometablic disorders, exercise training is recommended as an adjunct to standard antidepressant treatment. Copyright © 2015 Elsevier B.V. All rights reserved.

  1. Early psychological intervention in accidentally injured children ages 2–16: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Didier N. Kramer

    2014-06-01

    Full Text Available Background: Road traffic accidents (RTA and burns are frequent events in children. Although many children recover spontaneously, a considerable number develop long-term psychological sequelae. Evidence on early psychological interventions to prevent such long-term problems is still scarce for school-age children and completely lacking for pre-school children. Objectives: To evaluate the efficacy of an early two-session cognitive-behavioral intervention in 108 children ages 2–16 after RTAs and burns. Methods: Children assessed at risk for the development of posttraumatic stress disorder (PTSD were randomly assigned to either a control group offered treatment as usual or an intervention group. Primary outcomes were PTSD, behavioral problems, and depression symptoms. Baseline and blinded 3- and 6-month follow-up assessments were conducted. Results: In pre-school children, no intervention effects were found. School-age children in the intervention group exhibited significantly fewer internalizing problems at 3-month follow-up relative to controls and a borderline significant time-by-group effect for PTSD intrusion symptoms was found (p=0.06. Conclusions: This is the first study examining the efficacy of an indicated, early psychological intervention among both school-age and pre-school-age children. Because the intervention was ineffective for young children, no evidence-based practice can currently be suggested. Given that parents of pre-school children perceived the intervention as helpful, brief counseling of parents in terms of psychoeducation and training in coping skills still should be provided by clinicians, despite the current lack of evidence. To prevent trauma-related disorders in school-age children, the intervention might be used in a step-wise manner, where only children at risk for long-term psychological maladjustment are provided with psychological support.

  2. [Role of physical, psychological and sexual abuse in functional digestive disorders. A case-controls trial.].

    Science.gov (United States)

    Remes-Troche, J M; Cid-Juárez, S; Campos-Ramos, I; Ramos-de la Medina, A; Galmiche, A; Schmulson-Wasserman, M; Roesch-Dietlen, F

    2008-01-01

    Abuse has been considered a significant factor on the development of functional gastrointestinal disorders (FGID), especially for severe and treatment-refractory patients. The aim of our study was to evaluate the presence of all FGID according to Rome II criteria, in a group of women with history of physical, psychological and/or sexual abuse. A cross sectional study was performed in 96 women (37 +/- 12 years of age) with history of physical, psychological and/or sexual abuse (cases); and 96 open population women (36 +/- 14 years of age) (controls). The following evaluations were administered: Rome II questionnaire, a self-administered instrument to evaluate history of physical (beating), psychological(insults, public humiliation) and/or sexual abuse (rape, coercion), and HAD questionnaire. Among 96 women with history of abuse,91 (95%) reported to have suffered psychological abuse, 72 (75%) physical abuse, and 24 (25%)sexual abuse. Women with history of abuse had a higher prevalence of rumination (6% vs. 0%, p= 0.02), functional heartburn (26% vs. 13%, p =0.04), aerofagia (17% vs. 5%, p = 0.019), irritable bowel syndrome (38% vs. 18%, p = 0.002), fecalin continence (16% vs. 4%, p = 0.01), elevator anisyndrome (5% vs. 0%, p = 0.05), and proctalgia fugax (29% vs. 15%, p = 0.02) compared to controls. There was a positive correlation between anxiety (r = 0.5, p = 0.001) and depression scores(r = 0.45, p = 0.001), and the number of FGID. We demonstrated a high prevalence of FGID among women with history of physical,psychological, and/or sexual abuse. In this association,concomitant anxiety and depression play a significant role.

  3. An integrated intervention to reduce intimate partner violence and psychological distress with refugees in low-resource settings: study protocol for the Nguvu cluster randomized trial.

    Science.gov (United States)

    Tol, Wietse A; Greene, M Claire; Likindikoki, Samuel; Misinzo, Lusia; Ventevogel, Peter; Bonz, Ann G; Bass, Judith K; Mbwambo, Jessie K K

    2017-05-18

    Intimate partner violence (IPV) is a critical public health and human rights concern globally, including for refugee women in low-resource settings. Little is known about effective interventions for this population. IPV and psychological distress have a bi-directional relationship, indicating the potential benefit of a structured psychological component as part of efforts to reduce IPV for women currently in violent relationships. This protocol describes a cluster randomized controlled trial aimed at evaluating an 8-session integrated psychological and advocacy intervention (Nguvu) with female adult survivors of past-year IPV displaying moderate to severe psychological distress. Outcomes are reductions in: recurrence of IPV; symptoms of anxiety, depression and post-traumatic stress (primary); and functional impairment (secondary). Hypothesized mediators of the intervention are improvements in social support, coping skills and support seeking. We will recruit 400 participants from existing women's support groups operating within villages in Nyarugusu refugee camp, Tanzania. Women's groups will be randomized to receive the intervention (Nguvu and usual care) or usual care alone. All eligible women will complete a baseline assessment (week 0) followed by a post-treatment (week 9) and a 3-month post-treatment assessment (week 20). The efficacy of the intervention will be determined by between-group differences in the longitudinal trajectories of primary outcomes evaluated using mixed-effects models. Study procedures have been approved by Institutional Review Boards in the United States and Tanzania. This trial will provide evidence on the efficacy of a novel integrated group intervention aimed at secondary prevention of IPV that includes a structured psychological component to address psychological distress. The psychological and advocacy components of the proposed intervention have been shown to be efficacious for their respective outcomes when delivered in

  4. Physical and psychologic effects of aromatherapy inhalation on pregnant women: a randomized controlled trial.

    Science.gov (United States)

    Igarashi, Toshiko

    2013-10-01

    Stress reduction care is important for pregnant women to decrease obstetric complications and children's health problems after birth. The aim of this study is to clarify the physical and psychologic effects of inhalation aromatherapy on pregnant women. Essential oils with high linalool and linalyl acetate content that may be used during pregnancy were selected and among these, and the one preferred by the participant was used. This was a prospective, randomized, controlled trial. This trial was performed at a gynecology outpatient department in a hospital in Kyoto, Japan. The study included pregnant women in week 28 of a single pregnancy with a normal course. Participants were randomly assigned into an aromatherapy group and a control group. They were seated in the resting, seated position for 10 minutes. During the latter 5 minutes of each 10-minute session, aromatherapy inhalation was performed for the aromatherapy group. Before and after the intervention, the Profile of Mood States (POMS) was measured. During the trial, the heart-rate fluctuations were measured for the autonomic nervous system regulation. A total of 13 pregnant women participated in the trial. Seven (7) participants were assigned to the aromatherapy group and 6 participants to the control group. The results of the POMS were such that based on an intragroup comparison, significant differences were observed in the Tension-Anxiety score (paromatherapy. The results of the autonomic nervous system regulation were such that based on an intragroup comparison within the aromatherapy group, the parasympathetic nerve activity increased significantly (pAromatherapy inhalation using essential oils containing linalyl acetate and linalool was found to be effective for the POMS and parasympathetic nerve activity, based on an intragroup comparison. However, based on a comparison between the groups, no substantial difference was observed; hence, further study is necessary in the future.

  5. Insomnia: psychological and neurobiological aspects and non-pharmacological treatments

    Directory of Open Access Journals (Sweden)

    Yara Fleury Molen

    2014-01-01

    Full Text Available Insomnia involves difficulty in falling asleep, maintaining sleep or having refreshing sleep. This review gathers the existing informations seeking to explain insomnia, including those that focus on psychological aspects and those considered neurobiological. Insomnia has been defined in psychological (cognitive components, such as worries and rumination, and behavioral aspects, such as classic conditioning and physiological terms (increased metabolic rate, with increased muscle tone, heart rate and temperature. From the neurobiological point of view, there are two perspectives: one which proposes that insomnia occurs in association with a failure to inhibit wakefulness and another that considers hyperarousal as having an important role in the physiology of sleep. The non-pharmacological interventions developed to face different aspects of insomnia are presented.

  6. Insomnia: psychological and neurobiological aspects and non-pharmacological treatments.

    Science.gov (United States)

    Molen, Yara Fleury; Carvalho, Luciane Bizari Coin; Prado, Lucila Bizari Fernandes do; Prado, Gilmar Fernandes do

    2014-01-01

    Insomnia involves difficulty in falling asleep, maintaining sleep or having refreshing sleep. This review gathers the existing informations seeking to explain insomnia, including those that focus on psychological aspects and those considered neurobiological. Insomnia has been defined in psychological (cognitive components, such as worries and rumination, and behavioral aspects, such as classic conditioning) and physiological terms (increased metabolic rate, with increased muscle tone, heart rate and temperature). From the neurobiological point of view, there are two perspectives: one which proposes that insomnia occurs in association with a failure to inhibit wakefulness and another that considers hyperarousal as having an important role in the physiology of sleep. The non-pharmacological interventions developed to face different aspects of insomnia are presented.

  7. Obesity and psychological wellbeing in patients undergoing fertility treatment.

    Science.gov (United States)

    Rodino, Iolanda S; Byrne, Susan; Sanders, Katherine A

    2016-01-01

    Obesity negatively affects reproductive functioning and psychological wellbeing. Distress experienced by infertile women with elevated body mass index (BMI) was investigated. Infertile women (n = 403) were stratified according to World Health Organization (2000) BMI categories (normal, overweight and obese) and infertility category (polycystic ovary syndrome [PCOS] or non-PCOS). Participants anonymously completed a Demographics Questionnaire, International Physical Activity Questionnaire, Depression, Anxiety and Stress Scale, Positive and Negative Affect Schedule, Rosenberg Self Esteem Scale, Fertility Problem Inventory, Clinical Perfectionism Questionnaire and the Eating Disorder Examination Questionnaire. Women in the obese BMI group were no more psychologically vulnerable to general mood (depression, anxiety and stress) or fertility-specific distress than normal or overweight BMI women. Independent of their PCOS status, obese women reported more frequent episodes of binge eating, shape concerns and low self-esteem symptoms associated with disordered eating. Women with PCOS had elevated shape concerns and anxiety independent of their BMI category compared with women who did not have PCOS. Obese infertile women presenting with the characteristics of binge eating, low self-esteem and body shape concerns may represent a vulnerable subgroup that could benefit from accessing targeted psychological interventions as do women with PCOS who have body shape concerns. Copyright © 2015 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

  8. Influence of Baseline Psychological Health on Muscle Pain During Atorvastatin Treatment.

    Science.gov (United States)

    Zaleski, Amanda L; Taylor, Beth A; Pescatello, Linda S; Dornelas, Ellen A; White, Charles Michael; Thompson, Paul D

    3-hydroxy-3-methylglutaryl coenzyme A reductase reductase inhibitors (statins) are generally well tolerated, with statin-associated muscle symptoms (SAMS) the most common side effect (~10%) seen in statin users. However, studies and clinical observations indicate that many of the self-reported SAMS appear to be nonspecific (ie, potentially not attributable to statins). Mental health and well-being influence self-perception of pain, so we sought to assess the effect of baseline well-being and depression on the development of muscle pain with 6 months of atorvastatin 80 mg/d (ATORVA) or placebo in healthy, statin-naive adults. The Psychological General Well-being Index (n = 83) and Beck Depression Inventory (n = 55) questionnaires were administered at baseline in participants (aged 59.5 ± 1.2 years) from the effect of Statins on Skeletal Muscle Function and Performance (STOMP) trial (NCT00609063). Muscle pain (Short-Form McGill Pain Questionnaire [SF-MPQ]), pain that interferes with daily life (Brief Pain Inventory [BPI]), and pain severity (BPI) were then measured before, throughout, and after treatment. At baseline, there were no differences in well-being (Psychological General Well-being Index), depression (Beck Depression Inventory), or pain measures (SF-MPQ and BPI) (P values ≥ .05) between the placebo and ATORVA groups. Baseline well-being correlated negatively with baseline BPI pain severity (r = -0.290, P = .008). Baseline depression correlated with baseline pain (SF-MPQ; r = 0.314, P = .020). Baseline well-being and depression did not predict the change in pain severity or interference after 6 months among the total sample or between groups (P values ≥ .05). Baseline well-being and depression were not significant predictors of pain after 6 months of ATORVA (P values ≥ .05). Thus, they do not appear to increase the risk of SAMS in otherwise healthy adults.

  9. Psychological Characteristics of Chronic Pain: a Review of Current Evidence and Assessment Tools to Enhance Treatment.

    Science.gov (United States)

    Miller, Rhondene M; Kaiser, Ronald S

    2018-03-14

    The complicated nature of chronic pain involves an interplay between psychological and physical factors, often resulting in increased emotional distress and reduced quality of life. This review is designed to help the medical practitioner who is working with chronic pain patients to be aware of psychological assessment techniques that can add to comprehensive patient understanding and more effectively guide treatment. Enhanced ability to assess and understand the emotional life of the chronic pain patient provides a basis for intervening and treating more successfully. There are a broad range of assessment techniques, some of which require a background in psychology and some that do not, that can identify psychological differences in chronic pain patients and serve to guide intervention strategies. Chronic pain is often comorbid with depression, anxiety, catastrophizing, and various ineffective coping strategies. Some patients, however, have demonstrated more adaptive and effective strategies for cognitively and behaviorally coping with pain and normalizing their lives. Proper assessment enables the individualization of treatment to overcome and/or build upon each patient's psychological frame of mind to maximize the potential for effective functioning. The use of standardized and documented psychological assessment techniques can lead to a better understanding of chronic pain patients and contribute in ways that can enhance response to medical treatment and improve quality of life. It is recommended that certain psychological tools be included to supplement the medical assessment of patients who have chronic pain. A basic assessment can include a short psychological-based clinical interview along with brief measures of depression, anxiety, and coping strategies. It is also recommended that the pain physician have access to professional psychological practitioners as a resource for more complicated assessments and psychological intervention services.

  10. 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.

  11. Mobilization versus manipulations versus sustain apophyseal natural glide techniques and interaction with psychological factors for patients with chronic neck pain: randomized controlled trial.

    Science.gov (United States)

    Lopez-Lopez, A; Alonso Perez, J L; González Gutierez, J L; La Touche, R; Lerma Lara, S; Izquierdo, H; Fernández-Carnero, J

    2015-04-01

    Three different types of manual therapy techniques for patients with neck pain and relationship with psychological factors has not been evaluated. To compare the effectiveness high velocity and low amplitude (HVLA) manipulation vs. posteroanterior mobilization (PA mob) vs. sustain appophyseal natural glide (SNAG) in the management of patients with neck pain and to evaluate the interaction with psychological factors. Randomized clinical trial. Primary Health Care Center. Patients with history of chronic neck pain over the last 3 months were recruited. Patients were randomly assigned to receive treatment with HVLA (N.=15), with PA mob (N.=16) or with SNAG (N.=17). One session was applied. Pain intensity of neck pain, pressure pain threshold over processus spinosus of C2 (PPT_C2) and cervical range of motion (CROM) were measured pre- and post-intervention. Pain catastrophizing, depression, anxiety and kinesiophobia were assessed in baseline. ANOVAs were performed, with main effects, two-way (treatment x time) and three-way interactions (treatment x psychological variable x time) were examined. Fourthy-eight patients (mean±SD age, 36.5±8.7 years; 87.5% female). A significant interaction treatment x time was observed for VAS-rest in HVLA and AP mob groups (Ptechniques have similar immediate effects over neck pain and while under high anxiety levels a better outcome is expected after mobilization intervention, under low anxiety levels a better prognosis is expected after manipulation and SNAG intervention.

  12. Online psycho-education to the treatment of bipolar disorder: protocol of a randomized controlled trial.

    Science.gov (United States)

    González-Ortega, Itxaso; Ugarte, Amaia; Ruiz de Azúa, Sonia; Núñez, Nuria; Zubia, Marta; Ponce, Sara; Casla, Patricia; Llano, Josu Xabier; Faria, Ángel; González-Pinto, Ana

    2016-12-22

    Bipolar disorder patients frequently present recurrent episodes and often experience subsyndromal symptoms, cognitive impairment and difficulties in functioning, with a low quality of life, illness relapses and recurrent hospitalization. Early diagnosis and appropriate intervention may play a role in preventing neuroprogression in this disorder. New technologies represent an opportunity to develop standardized psychological treatments using internet-based tools that overcome some of the limitations of face-to-face treatments, in that they are readily accessible and the timing of therapy can be tailored to user needs and availability. However, although many psychological programs are offered through the web and mobile devices for bipolar disorder, there is a lack of high quality evidence concerning their efficacy and effectiveness due to the great variability in measures and methodology used. This clinical trial is a simple-blind randomized trial within a European project to compare an internet-based intervention with treatment as usual. Bipolar disorder patients are to be included and randomly assigned to one of two groups: 1) the experimental group (tele-care support) and 2) the control group. Participants in both groups will be evaluated at baseline (pre-treatment) and post-treatment. This study describes the design of a clinical trial based on psychoeducation intervention that may have a significant impact on both prognosis and treatment in bipolar disorder. Specifically, bringing different services together (service aggregation), it is hoped that the approach proposed will significantly increase the impact of information and communication technologies on access and adherence to treatment, quality of the service, patient safety, patient and professional satisfaction, and quality of life of patients. NCT02924415 . Retrospectively registered 27 September 2016.

  13. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  14. Family-related opinions and stressful situations associated with psychological distress in women undergoing infertility treatment.

    Science.gov (United States)

    Takaki, Jiro; Hibino, Yuri

    2014-09-02

    The purpose of this study is to investigate how family-related opinions and stressful situations are related to psychological distress in women undergoing infertility treatment. The subjects in this cross-sectional study were recruited from female patients undergoing infertility treatment (n = 2540) at 70 infertility treatment institutions in Japan. Because of non-participation or missing data, the number of subjects included in the analysis was 635 (response rate, 25.0%). The family-related opinions and stressful situations were evaluated using the original questions. Psychological distress was assessed using a self-report measure, the Kessler Six-question Psychological Distress Scale (K6). The K6 scores of the following participants were significantly (p women should devote themselves to their household duties" those who had considered stopping treatment, those without the opinion that "married life without children is favorable" and those who had experienced stressful situations such as inadequate explanation by doctors, frustration of multiple failed attempts, differences of opinion with the partner, and lack of knowledge regarding when to stop treatment. Family-related opinions and stressful situations associated with psychological distress in women undergoing infertility treatment are outlined. The results of this study may contribute to the prevention of and care for psychological distress in female patients undergoing infertility treatment.

  15. Psychological Treatment of Depression in People Aged 65 Years and Over: A Systematic Review of Efficacy, Safety, and Cost-Effectiveness.

    Directory of Open Access Journals (Sweden)

    Ulf Jonsson

    Full Text Available Depression in elderly people is a major public health concern. As response to antidepressants is often unsatisfactory in this age group, there is a need for evidence-based non-pharmacological treatment options. Our objectives were twofold: firstly, to synthesize published trials evaluating efficacy, safety and cost-effectiveness of psychological treatment of depression in the elderly and secondly, to assess the quality of evidence.The electronic databases PubMed, EMBASE, Cochrane Library, CINAL, Scopus, and PsycINFO were searched up to 23 May 2016 for randomized controlled trials (RCTs of psychological treatment for depressive disorders or depressive symptoms in people aged 65 years and over. Two reviewers independently assessed relevant studies for risk of bias. Where appropriate, the results were synthesized in meta-analyses. The quality of the evidence was graded according to GRADE (Grading of Recommendations Assessment, Development and Evaluation.Twenty-two relevant RCTs were identified, eight of which were excluded from the synthesis due to a high risk of bias. Of the remaining trials, six evaluated problem-solving therapy (PST, five evaluated other forms of cognitive behavioural therapy (CBT, and three evaluated life review/reminiscence therapy. In frail elderly with depressive symptoms, the evidence supported the efficacy of PST, with large but heterogeneous effect sizes compared with treatment as usual. The results for life-review/reminiscence therapy and CBT were also promising, but because of the limited number of trials the quality of evidence was rated as very low. Safety data were not reported in any included trial. The only identified cost-effectiveness study estimated an incremental cost per additional point reduction in Beck Depression Inventory II score for CBT compared with talking control and treatment as usual.Psychological treatment is a feasible option for frail elderly with depressive symptoms. However, important questions

  16. Hypoalgesic effects of three different manual therapy techniques on cervical spine and psychological interaction: A randomized clinical trial.

    Science.gov (United States)

    Alonso-Perez, Jose Luis; Lopez-Lopez, Almudena; La Touche, Roy; Lerma-Lara, Sergio; Suarez, Emilio; Rojas, Javier; Bishop, Mark D; Villafañe, Jorge Hugo; Fernández-Carnero, Josué

    2017-10-01

    The purpose of this study was to evaluate the extent to which psychological factors interact with a particular manual therapy (MT) technique to induce hypoalgesia in healthy subjects. Seventy-five healthy volunteers (36 female, 39 males), were recruited in this double-blind, controlled and parallel study. Subjects were randomly assigned to receive: High velocity low amplitude technique (HVLA), joint mobilization, or Cervical Lateral glide mobilization (CLGM). Pressure pain threshold (PPT) over C7 unilaterally, trapezius muscle and lateral epicondyle bilaterally, were measured prior to single technique MT was applied and immediately after to applied MT. Pain catastrophizing, depression, anxiety and kinesiophobia were evaluated before treatment. The results indicate that hypoalgesia was observed in all groups after treatment in the neck and elbow region (P < 0.05), but mobilization induces more hypoalgesic effects. Catastrophizing interacted with change over time in PPT, for changes in C7 and in manipulation group. All the MT techniques studied produced local and segmental hypoalgesic effects, supporting the results of previous studies studying the individual interventions. Interaction between catastrophizing and HVLA technique suggest that whether catastrophizing level is low or medium, the chance of success is high, but high levels of catastrophizing may result in poor outcome after HVLA intervention. ClinicalTrials.gov Registration Number: NCT02782585. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. Mediation and moderation of treatment effects in randomised controlled trials of complex interventions.

    Science.gov (United States)

    Emsley, Richard; Dunn, Graham; White, Ian R

    2010-06-01

    Complex intervention trials should be able to answer both pragmatic and explanatory questions in order to test the theories motivating the intervention and help understand the underlying nature of the clinical problem being tested. Key to this is the estimation of direct effects of treatment and indirect effects acting through intermediate variables which are measured post-randomisation. Using psychological treatment trials as an example of complex interventions, we review statistical methods which crucially evaluate both direct and indirect effects in the presence of hidden confounding between mediator and outcome. We review the historical literature on mediation and moderation of treatment effects. We introduce two methods from within the existing causal inference literature, principal stratification and structural mean models, and demonstrate how these can be applied in a mediation context before discussing approaches and assumptions necessary for attaining identifiability of key parameters of the basic causal model. Assuming that there is modification by baseline covariates of the effect of treatment (i.e. randomisation) on the mediator (i.e. covariate by treatment interactions), but no direct effect on the outcome of these treatment by covariate interactions leads to the use of instrumental variable methods. We describe how moderation can occur through post-randomisation variables, and extend the principal stratification approach to multiple group methods with explanatory models nested within the principal strata. We illustrate the new methodology with motivating examples of randomised trials from the mental health literature.

  18. Internet treatment for social anxiety disorder in Romania: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tulbure Bogdan Tudor

    2012-10-01

    Full Text Available Abstract Background Social anxiety disorder (SAD is one of the most common anxiety disorders and is associated with marked impairments. However, a small proportion of individuals with SAD seek and receive treatment. Internet-administrated cognitive behavior therapy (iCBT has been found to be an effective treatment for SAD. This trial will be the first Internet-delivered guided self-help intervention for SAD in Romania. Methods Participants with social anxiety disorder (N = 96 will be recruited via newspapers, online banners and Facebook. Participants will be randomized to either: a an active treatment, or b a waiting list control group. The treatment will have a guided iCBT format and will last for nine weeks. Self-report questionnaires on social phobia, anxiety, depression, treatment credibility and irrational thinking will be used. All assessments will be collected pre, post and at follow-up (six months after intervention. Liebowitz Social Anxiety Scale – Self-Report version (LSAS-SR will be the primary outcome measure and will be administrated on a weekly basis in both conditions. Discussion The present randomized controlled trial investigates the efficacy of an Internet-administered intervention in reducing social anxiety symptoms in a culture where this form of treatment has not been tested. This trial will add to the body of knowledge on the efficacy of iCBT, and the results might lead to an increase of the accessibility of evidence-based psychological treatment in Romania. Trial registration ClinicalTrials.gov: NCT01557894

  19. Psychological distress, quality of life, symptoms and unmet needs of colorectal cancer survivors near the end of treatment.

    Science.gov (United States)

    Russell, Lahiru; Gough, Karla; Drosdowsky, Allison; Schofield, Penelope; Aranda, Sanchia; Butow, Phyllis N; Westwood, Jennifer A; Krishnasamy, Mei; Young, Jane M; Phipps-Nelson, Jo; King, Dorothy; Jefford, Michael

    2015-09-01

    This study investigated psychological morbidity, quality of life (QoL), colorectal cancer (CRC)-specific symptoms and supportive care needs in a CRC population at the end of treatment (EOT). CRC survivors (n = 152) completed a post-treatment baseline questionnaire as part of a multisite supportive care randomised controlled trial (SurvivorCare). CRC survivors had completed treatment with curative intent within 0 to 6 months. Measures are as follows: Brief Symptom Inventory 18 (BSI-18) (psychological morbidity), EORTC QLQ-C30 and QLQ-CR29 (QoL and CRC-specific symptoms and problems) and Cancer Survivors' Unmet Needs (CaSUN) measure with a simplified response format (unmet needs). Linear regression models were used to compare participants' QoL with a general population sample. Correlation analysis examined associations between psychological morbidity, QoL and CRC-specific symptoms and problems. Average participant age was 64 years, and 51% were male. The majority (68%) had stage 3 disease. In comparison to population norms, CRC survivors had lower depression and anxiety scores (47.4 and 45.6, respectively) but higher somatisation, and lower role, cognitive and social functioning (p < 0.001). CRC survivors had higher fatigue, nausea/vomiting, appetite loss, diarrhoea and financial problems (all p < 0.001), as well as pain (p = 0.002) and constipation (p = 0.019). CRC-specific psychological scores were positively correlated with all three BSI domain scores, and pain and fatigue symptom scores on the QLQ-C30 while negatively correlated with all five functional scales of the QLQ-C30. CRC survivors reported good mental health at EOT. Role and social functioning were impaired compared to population norms, possibly related to physical symptoms. Findings may help guide consultations with patients and inform the design of more tailored supportive care interventions. ACTRN12610000207011.

  20. Psychological therapies for thalassaemia.

    Science.gov (United States)

    Anie, Kofi A; Massaglia, Pia

    2014-03-06

    Thalassaemia is a group of genetic blood disorders characterised by the absence or reduction in the production of haemoglobin. Severity is variable from less severe anaemia, through thalassaemia intermedia, to profound severe anaemia (thalassaemia major). In thalassaemia major other complications include growth retardation, bone deformation, and enlarged spleen. Blood transfusion is required to treat severe forms of thalassaemia, but this results in excessive accumulation of iron in the body (iron overload), removed mostly by a drug called desferrioxamine through 'chelation therapy'. Non-routine treatments are bone marrow transplantation (which is age restricted), and possibly hydroxyurea, designed to raise foetal haemoglobin level, thus reducing anaemia. In addition, psychological therapies seem appropriate to improving outcome and adherence to medical treatment. To examine the evidence that in people with thalassaemia, psychological treatments improve the ability to cope with the condition, and improve both medical and psychosocial outcomes. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register which comprises of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Searches on the Internet were also performed.Date of the most recent search of the Group's Haemoglobinopathies Trials Register: 11 November 2013. All randomised or quasi-randomised controlled trials comparing the use of psychological intervention to no (psychological) intervention in people with thalassaemia. No trials of psychological therapies have been found in the literature for inclusion in this review. There are currently no results to be reported. As a chronic disease with a considerable role for self-management, psychological support seems appropriate for managing thalassaemia. However, from the information currently available, no conclusions

  1. Trial-Based Functional Analysis Informs Treatment for Vocal Scripting.

    Science.gov (United States)

    Rispoli, Mandy; Brodhead, Matthew; Wolfe, Katie; Gregori, Emily

    2018-05-01

    Research on trial-based functional analysis has primarily focused on socially maintained challenging behaviors. However, procedural modifications may be necessary to clarify ambiguous assessment results. The purposes of this study were to evaluate the utility of iterative modifications to trial-based functional analysis on the identification of putative reinforcement and subsequent treatment for vocal scripting. For all participants, modifications to the trial-based functional analysis identified a primary function of automatic reinforcement. The structure of the trial-based format led to identification of social attention as an abolishing operation for vocal scripting. A noncontingent attention treatment was evaluated using withdrawal designs for each participant. This noncontingent attention treatment resulted in near zero levels of vocal scripting for all participants. Implications for research and practice are presented.

  2. Empirical Comparison of Two Psychological Therapies: Self Psychology and Cognitive Orientation in the Treatment of Anorexia and Bulimia

    Science.gov (United States)

    Bachar, Eytan; Latzer, Yael; Kreitler, Shulamit; Berry, Elliot M.

    1999-01-01

    The authors investigated the applicability of self psychological treatment (SPT) and cognitive orientation treatment (COT) to the treatment of anorexia and bulimia. Thirty-three patients participated in this study. The bulimic patients (n = 25) were randomly assigned either to SPT, COT, or control/nutritional counseling only (C/NC). The anorexic patients (n = 8) were randomly assigned to either SPT or COT. Patients were administered a battery of outcome measures assessing eating disorders symptomatology, attitudes toward food, self structure, and general psychiatric symptoms. After SPT, significant improvement was observed. After COT, slight but nonsignificant improvement was observed. After C/NC, almost no changes could be detected.(The Journal of Psychotherapy Practice and Research 1999; 8:115–128) PMID:10079459

  3. Effects of a Tailored Positive Psychology Intervention on Well-Being and Pain in Individuals With Chronic Pain and a Physical Disability: A Feasibility Trial.

    Science.gov (United States)

    Müller, Rachel; Gertz, Kevin J; Molton, Ivan R; Terrill, Alexandra L; Bombardier, Charles H; Ehde, Dawn M; Jensen, Mark P

    2016-01-01

    To determine the feasibility, acceptability, and efficacy of a computer-based positive psychology intervention in individuals with a physical disability and chronic pain. Individuals with spinal cord injury, multiple sclerosis, neuromuscular disease, or postpolio syndrome and chronic pain were randomly assigned to a positive psychology or a control condition. Participants in the intervention group were instructed to practice 4 personalized positive psychology exercises. Participants in the control group were instructed to write about life details for 8 weeks. Participants completed online well-being and pain-related questionnaires at baseline, posttreatment, and at the 2.5-month follow-up, and rated treatment satisfaction at posttreatment. Ninety-six participants were randomized and 68 (70%) completed follow-up assessments. Participants in the positive psychology intervention group reported significant pretreatment to posttreatment improvements in pain intensity, pain control, pain catastrophizing, pain interference, life satisfaction, positive affect, and depression. Improvements in life satisfaction, depression, pain intensity, pain interference, and pain control were maintained to the 2.5-month follow-up. Participants in the control group reported significant pretreatment to posttreatment improvements in life satisfaction, and pretreatment to follow-up improvements in pain intensity and pain control. Significant between-group differences, favoring the treatment group, emerged for pretreatment to posttreatment improvements in pain intensity and pain control. Participants were similarly satisfied with both treatments. The results support the feasibility, acceptability, and potential efficacy of a computer-based positive psychology intervention for improving well-being and pain-related outcomes in individuals with physical disabilities and chronic pain, and indicate that a full trial of the intervention is warranted.

  4. Psychological therapy for psychogenic amnesia: Successful treatment in a single case study.

    Science.gov (United States)

    Cassel, Anneli; Humphreys, Kate

    2016-01-01

    Psychogenic amnesia is widely understood to be a memory impairment of psychological origin that occurs as a response to severe stress. However, there is a paucity of evidence regarding the effectiveness of psychological therapy approaches in the treatment of this disorder. The current article describes a single case, "Ben", who was treated with formulation-driven psychological therapy using techniques drawn from cognitive behavioural therapy (CBT) and acceptance and commitment therapy (ACT) for psychogenic amnesia. Before treatment, Ben exhibited isolated retrograde and anterograde memory impairments. He received 12 therapy sessions that targeted experiential avoidance followed by two review sessions, six weeks and five months later. Ben's retrograde and anterograde memory impairments improved following therapy to return to within the "average" to "superior" ranges, which were maintained at follow-up. Further experimental single case study designs and larger group studies are required to advance the understanding of the effectiveness and efficacy of psychological therapy for psychogenic amnesia.

  5. Procedures for identifying evidence-based psychological treatments for older adults.

    Science.gov (United States)

    Yon, Adriana; Scogin, Forrest

    2007-03-01

    The authors describe the methods used to identify evidence-based psychological treatments for older adults in this contribution to the special section. Coding teams were assembled to review the literature on several problems relevant to mental health and aging. These teams used the manual developed by the Committee on Science and Practice of the Society for Clinical Psychology (Division 12) of the American Psychological Association that provided definitions of key constructs used in coding. The authors provide an overview of the process followed by the review teams and of some of the issues that emerged to illustrate the steps involved in the coding procedure. Identifying evidence-based treatments is a fundamental aspect of promoting evidence-based practice with older adults; such practice is advocated by most health care disciplines, including psychology. ((c) 2007 APA, all rights reserved).

  6. Psychological distress and its effect on tuberculosis treatment outcomes in Ethiopia

    Directory of Open Access Journals (Sweden)

    Habteyes Hailu Tola

    2015-11-01

    Full Text Available Background: Psychological distress is the major comorbidity among tuberculosis (TB patients. However, its magnitude, associated factors, and effect on treatment outcome have not been adequately studied in low-income countries. Objective: This study aimed to determine the magnitude of psychological distress and its effect on treatment outcome among TB patients on treatment. Design: A follow-up study was conducted in Addis Ababa, Ethiopia, from May to December 2014. Patients (N=330 diagnosed with all types of TB who had been on treatment for 1–2 months were enrolled consecutively from 15 randomly selected health centers and one TB specialized hospital. Data on sociodemographic variables and economic status were collected using a structured questionnaire. The presence of psychological distress was assessed at baseline (within 1–2 months after treatment initiation and end point (6 months after treatment initiation using the 10-item Kessler (K-10 scale. Alcohol use and tobacco smoking history were assessed using WHO Alcohol Use Disorder Identification Test and Australian Smoking Assessment Checklist, respectively. The current WHO TB treatment outcome definition was used to differentiate the end result of each patient at completion of the treatment. Results: The overall psychological distress was 67.6% at 1–2 months and 48.5% at 6 months after treatment initiation. Multiple logistic regression analysis revealed that past TB treatment history [adjusted odds ratio (AOR: 3.76; 95% confidence interval (CI: 1.67–8.45], being on anti-TB and anti-HIV treatments (AOR: 5.35; 95% CI: 1.83–15.65, being unmarried (AOR: 4.29; 95% CI: 2.45–7.53, having alcohol use disorder (AOR: 2.95; 95% CI: 1.25–6.99, and having low economic status (AOR: 4.41; 95% CI: 2.44–7.97 were significantly associated with psychological distress at baseline. However, at 6 months after treatment initiation, only being a multidrug-resistant tuberculosis (MDR-TB patient (AOR: 3

  7. Supportive Mental Health Self-Monitoring among Smartphone Users with Psychological Distress: Protocol for a Fully Mobile Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Till Beiwinkel

    2017-09-01

    Full Text Available Mobile health (mHealth could be widely used in the population to improve access to psychological treatment. In this paper, we describe the development of a mHealth intervention on the basis of supportive self-monitoring and describe the protocol for a randomized controlled trial to evaluate its effectiveness among smartphone users with psychological distress. Based on power analysis, a representative quota sample of N = 186 smartphone users will be recruited, with an over-sampling of persons with moderate to high distress. Over a 4-week period, the intervention will be compared to a self-monitoring without intervention group and a passive control group. Telephone interviews will be conducted at baseline, post-intervention (4 weeks, and 12-week follow-up to assess study outcomes. The primary outcome will be improvement of mental health. Secondary outcomes will include well-being, intentions toward help-seeking and help-seeking behavior, user activation, attitudes toward mental-health services, perceived stigmatization, smartphone app quality, user satisfaction, engagement, and adherence with the intervention. Additionally, data from the user’s daily life as collected during self-monitoring will be used to investigate risk and protective factors of mental health in real-world settings. Therefore, this study will allow us to demonstrate the effectiveness of a smartphone application as a widely accessible and low-cost intervention to improve mental health on a population level. It also allows to identify new assessment approaches in the field of psychiatric epidemiology.

  8. Supportive Mental Health Self-Monitoring among Smartphone Users with Psychological Distress: Protocol for a Fully Mobile Randomized Controlled Trial

    Science.gov (United States)

    Beiwinkel, Till; Hey, Stefan; Bock, Olaf; Rössler, Wulf

    2017-01-01

    Mobile health (mHealth) could be widely used in the population to improve access to psychological treatment. In this paper, we describe the development of a mHealth intervention on the basis of supportive self-monitoring and describe the protocol for a randomized controlled trial to evaluate its effectiveness among smartphone users with psychological distress. Based on power analysis, a representative quota sample of N = 186 smartphone users will be recruited, with an over-sampling of persons with moderate to high distress. Over a 4-week period, the intervention will be compared to a self-monitoring without intervention group and a passive control group. Telephone interviews will be conducted at baseline, post-intervention (4 weeks), and 12-week follow-up to assess study outcomes. The primary outcome will be improvement of mental health. Secondary outcomes will include well-being, intentions toward help-seeking and help-seeking behavior, user activation, attitudes toward mental-health services, perceived stigmatization, smartphone app quality, user satisfaction, engagement, and adherence with the intervention. Additionally, data from the user’s daily life as collected during self-monitoring will be used to investigate risk and protective factors of mental health in real-world settings. Therefore, this study will allow us to demonstrate the effectiveness of a smartphone application as a widely accessible and low-cost intervention to improve mental health on a population level. It also allows to identify new assessment approaches in the field of psychiatric epidemiology. PMID:28983477

  9. Supportive Mental Health Self-Monitoring among Smartphone Users with Psychological Distress: Protocol for a Fully Mobile Randomized Controlled Trial.

    Science.gov (United States)

    Beiwinkel, Till; Hey, Stefan; Bock, Olaf; Rössler, Wulf

    2017-01-01

    Mobile health (mHealth) could be widely used in the population to improve access to psychological treatment. In this paper, we describe the development of a mHealth intervention on the basis of supportive self-monitoring and describe the protocol for a randomized controlled trial to evaluate its effectiveness among smartphone users with psychological distress. Based on power analysis, a representative quota sample of N  = 186 smartphone users will be recruited, with an over-sampling of persons with moderate to high distress. Over a 4-week period, the intervention will be compared to a self-monitoring without intervention group and a passive control group. Telephone interviews will be conducted at baseline, post-intervention (4 weeks), and 12-week follow-up to assess study outcomes. The primary outcome will be improvement of mental health. Secondary outcomes will include well-being, intentions toward help-seeking and help-seeking behavior, user activation, attitudes toward mental-health services, perceived stigmatization, smartphone app quality, user satisfaction, engagement, and adherence with the intervention. Additionally, data from the user's daily life as collected during self-monitoring will be used to investigate risk and protective factors of mental health in real-world settings. Therefore, this study will allow us to demonstrate the effectiveness of a smartphone application as a widely accessible and low-cost intervention to improve mental health on a population level. It also allows to identify new assessment approaches in the field of psychiatric epidemiology.

  10. A Couple-Based Psychological Treatment for Chronic Pain and Relationship Distress.

    Science.gov (United States)

    Cano, Annmarie; Corley, Angelia M; Clark, Shannon M; Martinez, Sarah C

    2018-02-01

    Chronic pain impacts individuals with pain as well as their loved ones. Yet, there has been little attention to the social context in individual psychological treatment approaches to chronic pain management. With this need in mind, we developed a couple-based treatment, "Mindful Living and Relating," aimed at alleviating pain and suffering by promoting couples' psychological and relational flexibility skills. Currently, there is no integrative treatment that fully harnesses the power of the couple, treating both the individual with chronic pain and the spouse as two individuals who are each in need of developing greater psychological and relational flexibility to improve their own and their partners' health. Mindfulness, acceptance, and values-based action exercises were used to promote psychological flexibility. The intervention also targets relational flexibility, which we define as the ability to interact with one's partner, fully attending to the present moment, and responding empathically in a way that serves one's own and one's partner's values. To this end, the intervention also included exercises aimed at applying psychological flexibility skills to social interactions as well as emotional disclosure and empathic responding exercises to enhance relational flexibility. The case presented demonstrates that healthy coping with pain and stress may be most successful and sustainable when one is involved in a supportive relationship with someone who also practices psychological flexibility skills and when both partners use relational flexibility skills during their interactions.

  11. Psychological treatment of patients with chronic toxic encephalopathy: lessons from studies of chronic fatigue and whiplash

    NARCIS (Netherlands)

    van Hout, Moniek S. E.; Wekking, Ellie M.; Berg, Ina J.; Deelman, Betto G.

    2003-01-01

    Chronic toxic encephalopathy (CTE), which can result from long-term exposure to organic solvents, is characterized by problems of attention and memory, fatigue and affective symptoms. There is little experience with (neuro)psychological treatment in this patient group. We reviewed treatment outcome

  12. History of the treatment of persons with psychological difficulties and the abuse of their civil rights

    Directory of Open Access Journals (Sweden)

    Petrović Nikola M.

    2013-01-01

    Full Text Available Treatment of persons with psychological difficulties varied in different historical periods, but in its essence remained similar until today. It included an inhumane relationship towards these persons, involuntary treatment through torture, and isolation from society as a kind of punishment for their diversity. It was not until the late 19th century that the relationship of society towards these individuals started to improve gradually, but in the 21st century isolation of these individuals still remained the dominant form of acceptable social solution for the “problem”, with a somewhat more humane attitude towards them and less cruel treatment. Serbia has followed the trends of treatment of the persons with psychological difficulties from the rest of Europe for centuries, but is still lagging behind the world in the introduction of new methods of treatment. Indeed the first legal solution to regulate the human rights of these people is currently in the process of implementation. The subject of this paper is the treatment of persons with psychological difficulties and the violation of their civil rights. In a subject specific context the goal of the analysis was the historical review of the treatment towards persons with psychological difficulties by doctors, other practicioners and the community in general, with reference to the current situation regarding their treatment within the psychiatric institutions, as well as the legal regulations and the protection of their civil rights.

  13. Psychological treatments for mental disorders in adults: A review of the evidence of leading international organizations.

    Science.gov (United States)

    Moriana, Juan Antonio; Gálvez-Lara, Mario; Corpas, Jorge

    2017-06-01

    Most mental health services throughout the world currently regard evidence-based psychological treatments as best practice for the treatment of mental disorders. The aim of this study was to analyze evidence-based treatments drawn from RCTs, reviews, meta-analyses, guides, and lists provided by the National Institute for Health and Care Excellence (NICE), Division 12 (Clinical Psychology) of the American Psychological Association (APA), Cochrane and the Australian Psychological Society (APS) in relation to mental disorders in adults. A total of 135 treatments were analyzed for 23 mental disorders and compared to determine the level of agreement among the organizations. The results indicate that, in most cases, there is little agreement among organizations and that there are several discrepancies within certain disorders. These results require reflection on the meaning attributed to evidence-based practice with regard to psychological treatments. The possible reasons for these differences are discussed. Based on these findings, proposals to unify the criteria that reconcile the realities of clinical practice with a scientific perspective were analyzed. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Interpreting treatment x environment interaction in agronomy trials

    NARCIS (Netherlands)

    Vargas, M.; Crossa, J.; Eeuwijk, van F.A.; Sayre, K.; Reynolds, M.P.

    2001-01-01

    Multienvironment trials are important in agronomy because the effects of agronomic treatments can change differentially in relation to environmental changes, producing a treatment × environment interaction (T × E). The aim of this study was to find a parsimonious description of the T × E existing in

  15. Community Trial of a Comprehensive Psychosocial Treatment for HFASDs

    Science.gov (United States)

    Lopata, Christopher; Toomey, Jennifer A.; Thomeer, Marcus L.; McDonald, Christin A.; Fox, Jeffery D.; Smith, Rachael A.; Meichenbaum, David L.; Volker, Martin A.; Lee, Gloria K.; Lipinski, Alanna M.

    2015-01-01

    This community effectiveness trial examined the feasibility and efficacy of a comprehensive psychosocial treatment for 28 children, aged 7 to 10 years with high-functioning autism spectrum disorders (HFASDs). Treatment included instruction and therapeutic activities targeting social skills, face-emotion recognition skills, interest expansion, and…

  16. A two-session psychological intervention for siblings of pediatric cancer patients: a randomized controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Prchal Alice

    2012-01-01

    Full Text Available Abstract Background Since siblings of pediatric cancer patients are at risk for emotional, behavioral, and social problems, there is considerable interest in development of early psychological interventions. This paper aimed at evaluating the effectiveness of a two-session psychological intervention for siblings of newly diagnosed pediatric cancer patients. Methods Thirty siblings age 6-17 years were randomly assigned to an intervention group or an active control group with standard psychosocial care. The manualized intervention provided to siblings in the first 2 months after the cancer diagnosis of the ill child included medical information, promotion of coping skills, and a psychoeducational booklet for parents. At 4 to 6 weeks, 4 months, and 7 months after the diagnosis, all siblings and their parents completed measures (from standardized instruments of social support, quality of life, medical knowledge, posttraumatic stress symptoms, and anxiety. Results At follow-up siblings in the intervention group showed better psychological well-being, had better medical knowledge, and reported receiving social support from more people. However, the intervention had no effects on posttraumatic stress symptoms and anxiety. Conclusions The results of this pilot trial suggest that a two-session sibling intervention can improve siblings' adjustment, particularly psychological well-being, in the early stage after a cancer diagnosis. Trial Registration ClinicalTrials.gov NCT00296907

  17. Treatment of Deaf Clients: Ethical Considerations for Professionals in Psychology

    Science.gov (United States)

    Boness, Cassandra L.

    2016-01-01

    Providing therapy to deaf clients raises important ethical considerations for psychologists related to competence; multiple relationships and boundary issues; confidentiality; assessment, diagnosis, and evaluation; and communication and using interpreters. In evaluating and addressing these, psychologists must consider the APA’s Ethics Code and other relevant issues (e.g., ADA) necessary to provide ethical treatment. The current article provides background, ethical considerations, principles and standards relevant to the treatment of deaf clients, and recommendations to support psychologists, training programs, and the field. Psychologists have the responsibility to guarantee that the benefits of mental health treatment are fairly and justly provided to this traditionally underserved population. PMID:27917030

  18. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  19. Rapid Response in Psychological Treatments for Binge-Eating Disorder

    Science.gov (United States)

    Hilbert, Anja; Hildebrandt, Thomas; Agras, W. Stewart; Wilfley, Denise E.; Wilson, G. Terence

    2015-01-01

    Objective Analysis of short- and long-term effects of rapid response across three different treatments for binge-eating disorder (BED). Method In a randomized clinical study comparing interpersonal psychotherapy (IPT), cognitive-behavioral guided self-help (CBTgsh), and behavioral weight loss (BWL) treatment in 205 adults meeting DSM-IV criteria for BED, the predictive value of rapid response, defined as ≥ 70% reduction in binge-eating by week four, was determined for remission from binge-eating and global eating disorder psychopathology at posttreatment, 6-, 12-, 18-, and 24-month follow-up. Results Rapid responders in CBTgsh, but not in IPT or BWL, showed significantly greater rates of remission from binge-eating than non-rapid responders, which was sustained over the long term. Rapid and non-rapid responders in IPT and rapid responders in CBTgsh showed a greater remission from binge-eating than non-rapid responders in CBTgsh and BWL. Rapid responders in CBTgsh showed greater remission from binge-eating than rapid responders in BWL. Although rapid responders in all treatments had lower global eating disorder psychopathology than non-rapid responders in the short term, rapid responders in CBTgsh and IPT were more improved than those in BWL and non-rapid responders in each treatment. Rapid responders in BWL did not differ from non-rapid responders in CBTgsh and IPT. Conclusions Rapid response is a treatment-specific positive prognostic indicator of sustained remission from binge-eating in CBTgsh. Regarding an evidence-based stepped care model, IPT, equally efficacious for rapid and non-rapid responders, could be investigated as a second-line treatment in case of non-rapid response to first-line CBTgsh. PMID:25867446

  20. Rapid response in psychological treatments for binge eating disorder.

    Science.gov (United States)

    Hilbert, Anja; Hildebrandt, Thomas; Agras, W Stewart; Wilfley, Denise E; Wilson, G Terence

    2015-06-01

    Analysis of short- and long-term effects of rapid response across 3 different treatments for binge eating disorder (BED). In a randomized clinical study comparing interpersonal psychotherapy (IPT), cognitive-behavioral therapy guided self-help (CBTgsh), and behavioral weight loss (BWL) treatment in 205 adults meeting Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV; APA, 1994) criteria for BED, the predictive value of rapid response, defined as ≥70% reduction in binge eating by Week 4, was determined for remission from binge eating and global eating disorder psychopathology at posttreatment, 6-, 12-, 18-, and 24-month follow-ups. Rapid responders in CBTgsh, but not in IPT or BWL, showed significantly greater rates of remission from binge eating than nonrapid responders, which was sustained over the long term. Rapid and nonrapid responders in IPT and rapid responders in CBTgsh showed a greater remission from binge eating than nonrapid responders in CBTgsh and BWL. Rapid responders in CBTgsh showed greater remission from binge eating than rapid responders in BWL. Although rapid responders in all treatments had lower global eating disorder psychopathology than nonrapid responders in the short term, rapid responders in CBTgsh and IPT were more improved than those in BWL and nonrapid responders in each treatment. Rapid responders in BWL did not differ from nonrapid responders in CBTgsh and IPT. Rapid response is a treatment-specific positive prognostic indicator of sustained remission from binge eating in CBTgsh. Regarding an evidence-based, stepped-care model, IPT, equally efficacious for rapid and nonrapid responders, could be investigated as a second-line treatment in case of nonrapid response to first-line CBTgsh. (c) 2015 APA, all rights reserved).

  1. Is weight gain really a catalyst for broader recovery?: The impact of weight gain on psychological symptoms in the treatment of adolescent anorexia nervosa.

    Science.gov (United States)

    Accurso, Erin C; Ciao, Anna C; Fitzsimmons-Craft, Ellen E; Lock, James D; Le Grange, Daniel

    2014-05-01

    The main aims of this study were to describe change in psychological outcomes for adolescents with anorexia nervosa across two treatments, and to explore predictors of change, including baseline demographic and clinical characteristics, as well as weight gain over time. Participants were 121 adolescents with anorexia nervosa from a two-site (Chicago and Stanford) randomized controlled trial who received either family-based treatment or individual adolescent supportive psychotherapy. Psychological symptoms (i.e., eating disorder psychopathology, depressive symptoms, and self-esteem) were assessed at baseline, end of treatment, 6-month, and 12-month follow-up. Conditional multilevel growth models were used to test for predictors of slope for each outcome. Most psychological symptoms improved significantly from baseline to 12 month follow-up, regardless of treatment type. Depressive symptoms and dietary restraint were most improved, weight and shape concerns were least improved, and self-esteem was not at all improved. Weight gain emerged as a significant predictor of improved eating disorder pathology, with earlier weight gain having a greater impact on symptom improvement than later weight gain. Adolescents who presented with more severe, complex, and enduring clinical presentations (i.e., longer duration of illness, greater eating disorder pathology, binge-eating/purging subtype) also appeared to benefit more psychologically from treatment. Copyright © 2014 Elsevier Ltd. All rights reserved.

  2. The effects of psychological treatments for adult depression on physical activity: A systematic review.

    NARCIS (Netherlands)

    Cuijpers, P.; de Wit, L.M.; Taylor, A.

    2014-01-01

    Objectives Physical activity and depression have been consistently shown to be inversely associated in epidemiological surveys. It is not clear, however, whether successful treatment of depression results in increases in physical activity. Method Systematic review of randomized trials examining

  3. [Anorexia nervosa and bulimia nervosa. Psychological considerations for its treatment].

    Science.gov (United States)

    Barriguete Meléndez, J Armando; Rojo, Luis; Emmelhainz, Marisa

    2004-11-01

    It is presented the current perspectives in the study and treatment of the eating disorders, in specific: anorexia nervosa and bulimia nervosa, epidemiology, and the interface among the different medical specialties, nutrition and sciences of the behavior, the diagnostic approaches, instruments and current therapeutic models.

  4. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments.

    Directory of Open Access Journals (Sweden)

    Isabelle Boutron

    2007-02-01

    Full Text Available BACKGROUND: Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on "creative" (nonstandard methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment. METHODS AND FINDINGS: We systematically searched in Medline and the Cochrane Methodology Register for randomized controlled trials (RCTs assessing nonpharmacological treatment with blinding, published during 2004 in high-impact-factor journals. Data were extracted using a standardized extraction form. We identified 145 articles, with the method of blinding described in 123 of the reports. Methods of blinding of participants and/or health care providers and/or other caregivers concerned mainly use of sham procedures such as simulation of surgical procedures, similar attention-control interventions, or a placebo with a different mode of administration for rehabilitation or psychotherapy. Trials assessing devices reported various placebo interventions such as use of sham prosthesis, identical apparatus (e.g., identical but inactivated machine or use of activated machine with a barrier to block the treatment, or simulation of using a device. Blinding participants to the study hypothesis was also an important method of blinding. The methods reported for blinding outcome assessors relied mainly on centralized assessment of paraclinical examinations, clinical examinations (i.e., use of video, audiotape, photography, or adjudications of clinical events. CONCLUSIONS: This study classifies blinding methods and provides a detailed description of methods that could overcome some barriers of blinding in clinical trials assessing nonpharmacological treatment, and provides information for readers assessing the quality of results of such trials.

  5. Augmented Reality: A Brand New Challenge for the Assessment and Treatment of Psychological Disorders.

    Science.gov (United States)

    Chicchi Giglioli, Irene Alice; Pallavicini, Federica; Pedroli, Elisa; Serino, Silvia; Riva, Giuseppe

    2015-01-01

    Augmented Reality is a new technological system that allows introducing virtual contents in the real world in order to run in the same representation and, in real time, enhancing the user's sensory perception of reality. From another point of view, Augmented Reality can be defined as a set of techniques and tools that add information to the physical reality. To date, Augmented Reality has been used in many fields, such as medicine, entertainment, maintenance, architecture, education, and cognitive and motor rehabilitation but very few studies and applications of AR exist in clinical psychology. In the treatment of psychological disorders, Augmented Reality has given preliminary evidence to be a useful tool due to its adaptability to the patient needs and therapeutic purposes and interactivity. Another relevant factor is the quality of the user's experience in the Augmented Reality system determined from emotional engagement and sense of presence. This experience could increase the AR ecological validity in the treatment of psychological disorders. This paper reviews the recent studies on the use of Augmented Reality in the evaluation and treatment of psychological disorders, focusing on current uses of this technology and on the specific features that delineate Augmented Reality a new technique useful for psychology.

  6. Augmented Reality: A Brand New Challenge for the Assessment and Treatment of Psychological Disorders

    Science.gov (United States)

    Chicchi Giglioli, Irene Alice; Pedroli, Elisa

    2015-01-01

    Augmented Reality is a new technological system that allows introducing virtual contents in the real world in order to run in the same representation and, in real time, enhancing the user's sensory perception of reality. From another point of view, Augmented Reality can be defined as a set of techniques and tools that add information to the physical reality. To date, Augmented Reality has been used in many fields, such as medicine, entertainment, maintenance, architecture, education, and cognitive and motor rehabilitation but very few studies and applications of AR exist in clinical psychology. In the treatment of psychological disorders, Augmented Reality has given preliminary evidence to be a useful tool due to its adaptability to the patient needs and therapeutic purposes and interactivity. Another relevant factor is the quality of the user's experience in the Augmented Reality system determined from emotional engagement and sense of presence. This experience could increase the AR ecological validity in the treatment of psychological disorders. This paper reviews the recent studies on the use of Augmented Reality in the evaluation and treatment of psychological disorders, focusing on current uses of this technology and on the specific features that delineate Augmented Reality a new technique useful for psychology. PMID:26339283

  7. Augmented Reality: A Brand New Challenge for the Assessment and Treatment of Psychological Disorders

    Directory of Open Access Journals (Sweden)

    Irene Alice Chicchi Giglioli

    2015-01-01

    Full Text Available Augmented Reality is a new technological system that allows introducing virtual contents in the real world in order to run in the same representation and, in real time, enhancing the user’s sensory perception of reality. From another point of view, Augmented Reality can be defined as a set of techniques and tools that add information to the physical reality. To date, Augmented Reality has been used in many fields, such as medicine, entertainment, maintenance, architecture, education, and cognitive and motor rehabilitation but very few studies and applications of AR exist in clinical psychology. In the treatment of psychological disorders, Augmented Reality has given preliminary evidence to be a useful tool due to its adaptability to the patient needs and therapeutic purposes and interactivity. Another relevant factor is the quality of the user’s experience in the Augmented Reality system determined from emotional engagement and sense of presence. This experience could increase the AR ecological validity in the treatment of psychological disorders. This paper reviews the recent studies on the use of Augmented Reality in the evaluation and treatment of psychological disorders, focusing on current uses of this technology and on the specific features that delineate Augmented Reality a new technique useful for psychology.

  8. Psychological comorbidities and compliance to interventional treatment of patients with cutaneous vascular malformations.

    Science.gov (United States)

    Kenny, Stephanie A; Majeed, Nevin; Zhand, Naista; Glikstein, Rafael; Agid, Ronit; Dos Santos, Marlise P

    2016-08-01

    The aim of this study was to assess qualitatively the psychological stressors affecting patients with cutaneous vascular malformations and hemangiomas (CVM-H) and their impact on compliance to interventional treatment. A retrospective chart review was conducted of all patients with CVM-H treated by interventional neuroradiology at a single academic institution during a five-year period (2009-2014). Psychological complaints were documented during each clinic visit by a neuroradiologist. Compliance to interventional treatment was defined by adherence to the scheduled treatment sessions. Fisher's exact test was used to assess for associations between psychological complaints and compliance. Seventy-five patients were assessed, of whom 49 (65.3%) were female, with an age range of 2-78 years (mean age 30.2 years). All except one patient older than seven years of age (n = 71; 94.6%) had a psychological complaint, including fear of negative appearance (n = 53; 70.6%), dissatisfaction with appearance (n = 46; 61.3%), low self-esteem (n = 35; 46.6%), anxiety (n = 16; 21.3%), stress (n = 13; 17.3%), bullying (n = 5; 6.6%), and low mood (n = 4; 5.3%). Twenty-three (31%) patients were non-compliant. Low self-esteem was significantly associated with non-compliance (p = 0.0381). There is a high prevalence of psychological comorbidities among patients treated for CVM-H. This has potential implications for interventional treatment, as it was found that low self-esteem is significantly associated with non-compliance. These results suggest the need for early psychological support in these patients in order to maximize compliance to interventional treatment. © The Author(s) 2016.

  9. Functional network architecture predicts psychologically mediated analgesia related to treatment in chronic knee pain patients.

    Science.gov (United States)

    Hashmi, Javeria Ali; Kong, Jian; Spaeth, Rosa; Khan, Sheraz; Kaptchuk, Ted J; Gollub, Randy L

    2014-03-12

    Placebo analgesia is an indicator of how efficiently the brain translates psychological signals conveyed by a treatment procedure into pain relief. It has been demonstrated that functional connectivity between distributed brain regions predicts placebo analgesia in chronic back pain patients. Greater network efficiency in baseline brain networks may allow better information transfer and facilitate adaptive physiological responses to psychological aspects of treatment. Here, we theorized that topological network alignments in resting state scans predict psychologically conditioned analgesic responses to acupuncture treatment in chronic knee osteoarthritis pain patients (n = 45). Analgesia was induced by building positive expectations toward acupuncture treatment with verbal suggestion and heat pain conditioning on a test site of the arm. This procedure induced significantly more analgesia after sham or real acupuncture on the test site than in a control site. The psychologically conditioned analgesia was invariant to sham versus real treatment. Efficiency of information transfer within local networks calculated with graph-theoretic measures (local efficiency and clustering coefficients) significantly predicted conditioned analgesia. Clustering coefficients in regions associated with memory, motivation, and pain modulation were closely involved in predicting analgesia. Moreover, women showed higher clustering coefficients and marginally greater pain reduction than men. Overall, analgesic response to placebo cues can be predicted from a priori resting state data by observing local network topology. Such low-cost synchronizations may represent preparatory resources that facilitate subsequent performance of brain circuits in responding to adaptive environmental cues. This suggests a potential utility of network measures in predicting placebo response for clinical use.

  10. Efficacy and safety of pharmacological and psychological interventions for the treatment of psychosis and schizophrenia in children, adolescents and young adults: a systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Megan R Stafford

    Full Text Available Studies report contrasting results regarding the efficacy and safety of pharmacological, psychological, and combined interventions in psychosis and schizophrenia in children, adolescents and young adults.Systematic review and meta-analysis. Embase, Medline, PreMedline, PsycINFO, and CENTRAL were searched to July 2013 without restriction to publication status. Randomised trials comparing any pharmacological, psychological, or combined intervention for psychosis and schizophrenia in children, adolescents and young adults were included. Studies were assessed for bias, and GRADE criteria were used to describe the quality of the results.Twenty-seven trials including 3067 participants were identified. Meta-analyses were performed for 12 comparisons: symptoms, relapse, global state, psychosocial functioning, depression, weight and discontinuation. Low quality evidence demonstrated that antipsychotics have small beneficial effects on psychotic symptoms (SMD = -0.42, 95% CI -0.58 to -0.26, and a medium adverse effect on weight gain (WMD = 1.61, 95% CI 0.61 to 2.60 and discontinuation due to side effects (RR = 2.44, 95% CI, 1.12 to 5.31. There were no trials of psychological treatments in under-18 year olds. There was no evidence of an effect of psychological interventions on psychotic symptoms in an acute episode, or relapse rate, but low quality evidence of a large effect for family plus individual CBT on the number of days to relapse (WMD = 32.25, 95% CI -36.52 to -27.98.For children, adolescents and young adults, the balance of risk and benefit of antipsychotics appears less favourable than in adults. Research is needed to establish the potential for psychological treatments, alone and in combination with antipsychotics, in this population.

  11. Family-Related Opinions and Stressful Situations Associated with Psychological Distress in Women Undergoing Infertility Treatment

    Directory of Open Access Journals (Sweden)

    Jiro Takaki

    2014-09-01

    Full Text Available The purpose of this study is to investigate how family-related opinions and stressful situations are related to psychological distress in women undergoing infertility treatment. The subjects in this cross-sectional study were recruited from female patients undergoing infertility treatment (n = 2540 at 70 infertility treatment institutions in Japan. Because of non-participation or missing data, the number of subjects included in the analysis was 635 (response rate, 25.0%. The family-related opinions and stressful situations were evaluated using the original questions. Psychological distress was assessed using a self-report measure, the Kessler Six-question Psychological Distress Scale (K6. The K6 scores of the following participants were significantly (p < 0.05 and independently high: those with more frequent miscarriage/stillbirth/abortions, those with repeated miscarriages as the cause of infertility, those with infertility of unknown causes, those living with no child, those having a low joint income with their partner, those with the opinion that “women should devote themselves to their household duties” those who had considered stopping treatment, those without the opinion that “married life without children is favorable” and those who had experienced stressful situations such as inadequate explanation by doctors, frustration of multiple failed attempts, differences of opinion with the partner, and lack of knowledge regarding when to stop treatment. Family-related opinions and stressful situations associated with psychological distress in women undergoing infertility treatment are outlined. The results of this study may contribute to the prevention of and care for psychological distress in female patients undergoing infertility treatment.

  12. Can Written Disclosure Reduce Psychological Distress and Increase Objectively Measured Injury Mobility of Student-Athletes? A Randomized Controlled Trial

    OpenAIRE

    Duncan, Elaine; Gidron, Yori; Lavallee, David

    2013-01-01

    Injured students-athletes took part in a randomized controlled trial to test whether written disclosure could reduce psychological distress and improve injury mobility. Writing took place alongside prescribed physical rehabilitation and consisted of three 20-minute writing sessions, once a week for three consecutive weeks. Participants in the experimental injury-writing group followed a structured form of written disclosure, called the guided disclosure protocol (GDP). They firstly, wrote abo...

  13. Weight Change over the Course of Binge Eating Disorder Treatment: Relationship to Binge Episodes and Psychological Factors.

    Science.gov (United States)

    Pacanowski, Carly R; Mason, Tyler B; Crosby, Ross D; Mitchell, James E; Crow, Scott J; Wonderlich, Stephen A; Peterson, Carol B

    2018-05-01

    Treatment for binge eating disorder (BED), a condition associated with both excess adiposity and psychological distress, has not typically produced significant weight loss despite reducing binge eating. Characterizing factors that promote or inhibit weight loss in individuals with co-occurring BED and obesity may help explain overall nonsignificant weight changes during treatment. In this study, 189 adults with BED participated in a randomized clinical trial evaluating the efficacy of 5 months of cognitive behavioral therapy. Assessments included measured height and weight at baseline, midtreatment, end of treatment (EOT), and 6-month follow-up, the Eating Disorder Examination interview, and questionnaires. During treatment, there was a mean weight gain of 1.3 ± 12.0 lb. Twenty-two percent of the sample lost ≥ 5 lb, and 25% of the sample gained ≥ 8 lb. Results showed that baseline objective binge eating episodes predicted weight over treatment. Changes in weight were significantly positively related to concurrent changes in shape concern, weight concern, and disinhibition, but not binge eating episodes. Changes in objective binge eating episodes from baseline to EOT were associated with changes in weight from EOT to follow-up. Further investigation of eating behavior during BED treatment to understand the energy balance contributions to weight change or stability is warranted. © 2018 The Obesity Society.

  14. Right on Post-trial Access to Investigational Treatment

    Directory of Open Access Journals (Sweden)

    Dmytro Lurye

    2018-03-01

    On this base, the author offered to provide in the legislation of Ukraine requirements to inform in advance subjects about the presence or absence of post-trial access and to evaluate these provisions by ethics committees before and at the end of all trials in order to determine its real need in each individual case. The scope of the right on post-trial access to investigational treatment must be reasonably weighed in order to avoid, on the one hand, becoming an excessive stimulus for the subjects, and, on the other hand, not leading to a situation where on such regulation conducting of clinical trials in the country will no longer be appropriate.

  15. Mindfulness-Based Cognitive Therapy as a Treatment for Chronic Tinnitus: A Randomized Controlled Trial.

    Science.gov (United States)

    McKenna, Laurence; Marks, Elizabeth M; Hallsworth, Christopher A; Schaette, Roland

    2017-01-01

    Tinnitus is experienced by up to 15% of the population and can lead to significant disability and distress. There is rarely a medical or surgical target and psychological therapies are recommended. We investigated whether mindfulness-based cognitive therapy (MBCT) could offer an effective new therapy for tinnitus. This single-site randomized controlled trial compared MBCT to intensive relaxation training (RT) for chronic, distressing tinnitus in adults. Both treatments involved 8 weekly, 120-min sessions focused on either relaxation (RT) or mindfulness meditation (MBCT). Assessments were completed at baseline and at treatment commencement 8 weeks later. The primary outcomes were tinnitus severity (Tinnitus Questionnaire) and psychological distress (Clinical Outcomes in Routine Evaluation - Non-Risk, CORE-NR), 16 weeks after baseline. The analysis utilized a modified intention-to-treat approach. A total of 75 patients were randomly allocated to MBCT (n = 39) or RT (n = 36). Both groups showed significant reductions in tinnitus severity and loudness, psychological distress, anxiety, depression, and disability. MBCT led to a significantly greater reduction in tinnitus severity than RT, with a mean difference of 6.3 (95% CI 1.3-11.4, p = 0.016). Effects persisted 6 months later, with a mean difference of 7.2 (95% CI 2.1-2.3, p = 0.006) and a standardized effect size of 0.56 (95% CI 0.16-0.96). Treatment was effective regardless of initial tinnitus severity, duration, or hearing loss. MBCT is effective in reducing tinnitus severity in chronic tinnitus patients compared to intensive RT. It also reduces psychological distress and disability. Future studies should explore the generalizability of this approach and how outcome relates to different aspects of the intervention. © 2017 The Author(s) Published by S. Karger AG, Basel.

  16. A psychological treatment programme for traumatised ex military personnel in the UK

    Directory of Open Access Journals (Sweden)

    Beatriz Sánchez España

    2008-12-01

    Full Text Available A large proportion of homeless people in the UK are former members of the armed services and suffer from a mental illness. In fact, homelessness itself can be considered a symptom or manifestation of other underlying psychological difficulties. For these reasons Community Housing and Therapy (CHT considers that providing psychological therapies to treat the homeless population is a more effective way of tackling the problem of homelessness, as it addresses the roots of the problem. This approach is one which is beginning to be recognised by leading agencies in the field. At the same time, the provision of psychological therapies for symptoms such as depression and anxiety has become accepted through the Department of Health’s (DoH Increased Access to Psychological Therapies ( IAPT initiative. Depression is the most common psychiatric disorder that homeless people suffer and it is well documented that psychological treatments for depression can be extremely effective. As well as approaching homelessness from the angle of psychological therapies, CHT in its work with the ex-service community has become increasingly aware that there are a large number of non statutory homeless that do not get the same attention as rough sleepers.

  17. Weight-based stigmatization, psychological distress, & binge eating behavior among obese treatment-seeking adults.

    Science.gov (United States)

    Ashmore, Jamile A; Friedman, Kelli E; Reichmann, Simona K; Musante, Gerard J

    2008-04-01

    To evaluate the associations between weight-based stigmatization, psychological distress, and binge eating behavior in a treatment-seeking obese sample. Ninety-three obese adults completed three questionnaires: 1) Stigmatizing Situations Inventory, 2) Brief Symptoms Inventory, and 3) Binge Eating Questionnaire. Correlational analyses were used to evaluate the association between stigmatizing experiences, psychological distress and binge eating behavior. Stigmatizing experiences predicted both binge eating behavior (R(2)=.20, p<.001) and overall psychological distress (R(2)=.18, p<.001). A substantial amount of the variance in binge eating predicted by weight-based stigmatization was due to the effect of psychological distress. Specifically, of the 20% of the variance in binge eating accounted for by stigmatizing experiences, between 7% and 34% (p<.01) was due to the effects of various indicators of psychological distress. These data suggest that weight-based stigmatization predicts binge eating behavior and that psychological distress associated with stigmatizing experiences may be an important mediating factor.

  18. Evaluation and validation of social and psychological markers in randomised trials of complex interventions in mental health: a methodological research programme.

    Science.gov (United States)

    Dunn, Graham; Emsley, Richard; Liu, Hanhua; Landau, Sabine; Green, Jonathan; White, Ian; Pickles, Andrew

    2015-11-01

    The development of the capability and capacity to evaluate the outcomes of trials of complex interventions is a key priority of the National Institute for Health Research (NIHR) and the Medical Research Council (MRC). The evaluation of complex treatment programmes for mental illness (e.g. cognitive-behavioural therapy for depression or psychosis) not only is a vital component of this research in its own right but also provides a well-established model for the evaluation of complex interventions in other clinical areas. In the context of efficacy and mechanism evaluation (EME) there is a particular need for robust methods for making valid causal inference in explanatory analyses of the mechanisms of treatment-induced change in clinical outcomes in randomised clinical trials. The key objective was to produce statistical methods to enable trial investigators to make valid causal inferences about the mechanisms of treatment-induced change in these clinical outcomes. The primary objective of this report is to disseminate this methodology, aiming specifically at trial practitioners. The three components of the research were (1) the extension of instrumental variable (IV) methods to latent growth curve models and growth mixture models for repeated-measures data; (2) the development of designs and regression methods for parallel trials; and (3) the evaluation of the sensitivity/robustness of findings to the assumptions necessary for model identifiability. We illustrate our methods with applications from psychological and psychosocial intervention trials, keeping the technical details to a minimum, leaving the reporting of the more theoretical and mathematically demanding results for publication in appropriate specialist journals. We show how to estimate treatment effects and introduce methods for EME. We explain the use of IV methods and principal stratification to evaluate the role of putative treatment effect mediators and therapeutic process measures. These results are

  19. Cost-effectiveness of exercise as a therapy for behavioural and psychological symptoms of dementia within the EVIDEM-E randomised controlled trial.

    Science.gov (United States)

    D'Amico, Francesco; Rehill, Amritpal; Knapp, Martin; Lowery, David; Cerga-Pashoja, Arlinda; Griffin, Mark; Iliffe, Steve; Warner, James

    2016-06-01

    Although available evidence is modest, exercise could be beneficial in reducing behavioural and psychological symptoms of dementia. We aim to evaluate the cost-effectiveness of a dyadic exercise regimen for individuals with dementia and their main carer as therapy for behavioural and psychological symptoms of dementia. Cost-effectiveness analysis within a two-arm, pragmatic, randomised, controlled, single-blind, parallel-group trial of a dyadic exercise regimen (individually tailored, for 20-30 min at least five times per week). The study randomised 131 community-dwelling individuals with dementia and clinically significant behavioural and psychological symptoms with a carer willing and able to participate in the exercise regimen; 52 dyads provided sufficient cost data for analyses. Mean intervention cost was £284 per dyad. For the subsample of 52 dyads, the intervention group had significantly higher mean cost from a societal perspective (mean difference £2728.60, p = 0.05), but costs were not significantly different from a health and social care perspective. The exercise intervention was more cost-effective than treatment as usual from both societal and health and social care perspectives for the measure of behavioural and psychological symptoms (Neuropsychiatric Inventory). It does not appear cost-effective in terms of cost per quality-adjusted life year gain. The exercise intervention has the potential to be seen as cost-effective when considering behavioural and psychological symptoms but did not appear cost-effective when considering quality-adjusted life year gains. Copyright © 2015 John Wiley & Sons, Ltd.

  20. Psychological Treatments for Borderline Personality Disorder: A Review of Cognitive-Behavioral Oriented Therapies

    Directory of Open Access Journals (Sweden)

    Sofia Marques

    2017-04-01

    Conclusion: In summary, the available studies support cognitive-behavioral psychological treatments as an efficacious intervention in borderline personality disorder. However, the existing scientific literature on this topic is still scarce and there is need for more studies, with higher methodological rigor, that should validate these results.

  1. Psychological treatment of patients with chronic toxic encephalopathy : Lessons from studies of chronic fatigue and whiplash

    NARCIS (Netherlands)

    van Hout, MSE; Wekking, EM; Berg, IJ; Deelman, BG

    2003-01-01

    Background. Chronic toxic encephalopathy (CTE), which can result from long-term exposure to organic solvents, is characterized by problems of attention and memory, fatigue and affective symptoms. There is little experience with (neuro)psychological treatment in this patient group. We reviewed

  2. Chronic Hepatitis C and Antiviral Treatment Regimens: Where Can Psychology Contribute?

    Science.gov (United States)

    Evon, Donna M.; Golin, Carol E.; Fried, Michael W.; Keefe, Francis J.

    2013-01-01

    Objective: Our goal was to evaluate the existing literature on psychological, social, and behavioral aspects of chronic hepatitis C viral (HCV) infection and antiviral treatment; provide the state of the behavioral science in areas that presently hinder HCV-related health outcomes; and make recommendations for areas in which clinical psychology…

  3. Psychological Treatments for Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis

    Science.gov (United States)

    Lackner, Jeffrey M.; Mesmer, Christina; Morley, Stephen; Dowzer, Clare; Hamilton, Simon

    2004-01-01

    This study conducted a systematic review to assess the quality of existing literature on psychological treatments for irritable bowel syndrome and to quantify the evidence for their efficacy. Three independent reviewers (2 from England, 1 from the United States) coded the quality of 32 studies, 17 of which provided data suitable for meta-analysis.…

  4. Effects of Corporal Punishment and Psychological Treatment on Students' Learning and Behavior

    Science.gov (United States)

    Arif, Muhammad Shahbaz; Rafi, Muhammad Shaban

    2007-01-01

    This paper aims to test the effects of corporal punishment and psychological treatment on students' learning and on their behavior. A pilot study, followed with experimental test, was framed in a demographically controlled environment on homogeneous variables at Punjab University Laboratory School, Pakistan over the period of six months.…

  5. Virtual reality therapy: an effective treatment for psychological disorders.

    Science.gov (United States)

    North, M M; North, S M; Coble, J R

    1997-01-01

    Behavioral therapy techniques for treating phobias often includes graded exposure of the patient to anxiety-producing stimuli (Systematic Desensitization). However, in utilizing systematic desensitization, research reviews demonstrate that many patients appear to have difficulty imaging the prescribed anxiety-evoking scene. They also express strong aversion to experiencing real situations. This chapter describes the Virtual Reality Therapy (VRT), a new therapeutical approach that can be used to overcome some of the difficulties inherent in the traditional treatment of phobias. VRT, like current imaginal and in vivo modalities, can generate stimuli that could be utilized in desensitization therapy. Like systematic desensitization therapy, VRT can provide stimuli for patients who have difficulty in imagining scenes and/or are too phobic to experience real situations. Unlike in vivo systematic desensitization, VRT can be performed within the privacy of a room, thus avoiding public embarrassment and violation of patient confidentiality. VRT can generate stimuli of much greater magnitude than standard in vivo techniques. Since VRT is under patient control, it appears safer than in vivo desensitization and at the same time more realistic than imaginal desensitization. Finally, VRT adds the advantage of greater efficiency and economy in delivering the equivalent of in vivo systematic desensitization within the therapist's office. The chapter also describes how to use virtual reality in the treatment of specific phobias: fear of flying, fear of heights, fear of being in certain situations (such as a dark barn, an enclosed bridge over a river, and in the presence of an animal [a black cat] in a dark room), and fear of public speaking.

  6. Day Hospital Mentalization-Based Treatment (MBT-DH) versus treatment as usual in the treatment of severe borderline personality disorder: protocol of a randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Severe borderline personality disorder is associated with a very high psychosocial and economic burden. Current treatment guidelines suggest that several manualized treatments, including day hospital Mentalization-Based Treatment (MBT-DH), are effective in these patients. However, only two randomized controlled trials have compared manualized MBT-DH with treatment as usual. Given the relative paucity of data supporting the efficacy and cost-effectiveness of MBT-DH, the possible influence of researcher allegiance in one of the trials, and potential problems with the generalization of findings to mental health systems in other countries, this multi-site randomized trial aims to investigate the efficacy and cost-effectiveness of manualized MBT-DH compared to manualized specialist treatment as usual in The Netherlands. Methods/design The trial is being conducted at two sites in The Netherlands. Patients with a DSM-IV-TR diagnosis of borderline personality disorder and a score of ≥ 20 on the Borderline Personality Disorder Severity Index were randomly allocated to MBT-DH or treatment as usual. The MBT-DH program consists of a maximum of 18 months’ intensive treatment, followed by a maximum of 18 months of maintenance therapy. Specialist treatment as usual is provided by the City Crisis Service in Amsterdam, a service that specializes in treating patients with personality disorders, offering manualized, non-MBT interventions including family interventions, Linehan training, social skills training, and pharmacotherapy, without a maximum time limit. Patients are assessed at baseline and subsequently every 6 months up to 36 months after the start of treatment. The primary outcome measure is the frequency and severity of manifestations of borderline personality disorder as assessed by the Borderline Personality Disorder Severity Index. Secondary outcome measures include parasuicidal behaviour, symptomatic distress, social and interpersonal functioning

  7. Metric qualities of the cognitive behavioral assessment for outcome evaluation to estimate psychological treatment effects.

    Science.gov (United States)

    Bertolotti, Giorgio; Michielin, Paolo; Vidotto, Giulio; Sanavio, Ezio; Bottesi, Gioia; Bettinardi, Ornella; Zotti, Anna Maria

    2015-01-01

    Cognitive behavioral assessment for outcome evaluation was developed to evaluate psychological treatment interventions, especially for counseling and psychotherapy. It is made up of 80 items and five scales: anxiety, well-being, perception of positive change, depression, and psychological distress. The aim of the study was to present the metric qualities and to show validity and reliability of the five constructs of the questionnaire both in nonclinical and clinical subjects. Four steps were completed to assess reliability and factor structure: criterion-related and concurrent validity, responsiveness, and convergent-divergent validity. A nonclinical group of 269 subjects was enrolled, as was a clinical group comprising 168 adults undergoing psychotherapy and psychological counseling provided by the Italian public health service. Cronbach's alphas were between 0.80 and 0.91 for the clinical sample and between 0.74 and 0.91 in the nonclinical one. We observed an excellent structural validity for the five interrelated dimensions. The clinical group showed higher scores in the anxiety, depression, and psychological distress scales, as well as lower scores in well-being and perception of positive change scales than those observed in the nonclinical group. Responsiveness was large for the anxiety, well-being, and depression scales; the psychological distress and perception of positive change scales showed a moderate effect. The questionnaire showed excellent psychometric properties, thus demonstrating that the questionnaire is a good evaluative instrument, with which to assess pre- and post-treatment outcomes.

  8. Randomised clinical trials with clinician-preferred treatment.

    Science.gov (United States)

    Korn, E L; Baumrind, S

    1991-01-19

    The standard design for randomised clinical trials may be inappropriate when the clinician believes that one of the treatments being tested is superior for the patient, or when the clinician has a preference for one of the treatments. For such instances the suggestion is that the patient is randomly allocated to treatment only when there is clinical disagreement about treatment of choice for that patient, and then the patient is assigned to a clinician who had thought that the regimen allocated is the one most appropriate for that patient.

  9. Healthcare utilization in general practice before and after psychological treatment: a follow-up data linkage study in primary care.

    Science.gov (United States)

    Prins, Marijn A; Verhaak, Peter F M; Smit, Dineke; Verheij, Robert A

    2014-09-01

    Literature suggests that serious mental health problems increase the use of health services and psychological interventions can reduce this effect. This study investigates whether this effect is also found in primary care patients with less serious mental health problems. Routine electronic health records (EHR) from a representative sample of 128 general practices were linked to patient files from 150 primary care psychologists participating in the NIVEL Primary Care Database, using a trusted third party. Data were linked using the date of birth, gender, and postcode. This yielded 503 unique data pairs that were listed in one of the participating GP practices in 2008-2010, for people who had psychological treatment from a psychologist that ended in 2009. The number of contacts, health problems presented, and prescribed medication in general practice were analysed before and after the psychological treatment. Nearly all 503 patients consulted their GP during the six months preceding the psychological treatment (90.9%) and also in the six months after this treatment had ended (83.7%). The frequency of contacts was significantly higher before than after the psychological treatment (6.1 vs. 4.8). Fewer patients contacted their GPs specifically for psychological or social problems (46.3% vs. 38.8%) and fewer patients had anxiolytic drug prescriptions (15.5% vs. 7.6%) after psychological treatment. After psychological treatment, patients contact their GPs less often and present fewer psychological or social problems. Although contact rates seem to decrease, clients of psychologists are still frequent GP attenders.

  10. Review on clinical trials of targeted treatments in malignant mesothelioma

    DEFF Research Database (Denmark)

    Jakobsen, Jan Nyrop; Sørensen, Jens Benn

    2011-01-01

    Malignant mesothelioma (MM) is an aggressive tumor of the serosal surfaces with a poor prognosis. Advances in the understanding of tumor biology have led to the development of several targeted treatments, which have been evaluated in clinical trials. This article is a comprehensive review of all...

  11. Psilocybin with psychological support for treatment-resistant depression: six-month follow-up.

    Science.gov (United States)

    Carhart-Harris, R L; Bolstridge, M; Day, C M J; Rucker, J; Watts, R; Erritzoe, D E; Kaelen, M; Giribaldi, B; Bloomfield, M; Pilling, S; Rickard, J A; Forbes, B; Feilding, A; Taylor, D; Curran, H V; Nutt, D J

    2018-02-01

    Recent clinical trials are reporting marked improvements in mental health outcomes with psychedelic drug-assisted psychotherapy. Here, we report on safety and efficacy outcomes for up to 6 months in an open-label trial of psilocybin for treatment-resistant depression. Twenty patients (six females) with (mostly) severe, unipolar, treatment-resistant major depression received two oral doses of psilocybin (10 and 25 mg, 7 days apart) in a supportive setting. Depressive symptoms were assessed from 1 week to 6 months post-treatment, with the self-rated QIDS-SR16 as the primary outcome measure. Treatment was generally well tolerated. Relative to baseline, marked reductions in depressive symptoms were observed for the first 5 weeks post-treatment (Cohen's d = 2.2 at week 1 and 2.3 at week 5, both p psilocybin. Reductions in depressive symptoms at 5 weeks were predicted by the quality of the acute psychedelic experience. Although limited conclusions can be drawn about treatment efficacy from open-label trials, tolerability was good, effect sizes large and symptom improvements appeared rapidly after just two psilocybin treatment sessions and remained significant 6 months post-treatment in a treatment-resistant cohort. Psilocybin represents a promising paradigm for unresponsive depression that warrants further research in double-blind randomised control trials.

  12. Pena Private Freedom with psychiatric treatment and psychological for Abused

    Directory of Open Access Journals (Sweden)

    Mirza Maria Pedrosa Porto de Mendonça

    2016-06-01

    Full Text Available The research aimed to investigate the opinion of professionals in law and health areas on the profile of the sexual abuser of children within the family and the effectiveness of the type of penalty he suffers. The offender is someone who probably does not enjoy enough sanity to control its inclination to unlawful and may or may not be classified as mentally ill. The research covers the incidence and effects of this event on intra-family life. Deals with this issue in order to establish a new legal paradigm in the context of the penalties in the most private sphere of criminal law. The work aims to demonstrate the social relevance of the topic and the need for an effective regulatory sweater for sexual abusers, especially the intra-family and makes a clear proposal for legislative changes with regard to this type of crime, arguing the need to adapt the law the objective reality. It argues that psychoanalytic treatment of offenders as a means of punishment is more important than the simple deprivation of liberty. It argues that the current legislation is incipient and inadequate for such cases and this opinion supported by a significant number of experts. This is not to defend this criminal who practice sexual abuse, but to seek solutions to impunity and respect for the principle of individualization of punishment.

  13. Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial.

    Directory of Open Access Journals (Sweden)

    Richard A Bryant

    2017-08-01

    Full Text Available Gender-based violence (GBV represents a major cause of psychological morbidity worldwide, and particularly in low- and middle-income countries (LMICs. Although there are effective treatments for common mental disorders associated with GBV, they typically require lengthy treatment programs that may limit scaling up in LMICs. The aim of this study was to test the effectiveness of a new 5-session behavioural treatment called Problem Management Plus (PM+ that lay community workers can be taught to deliver.In this single-blind, parallel, randomised controlled trial, adult women who had experienced GBV were identified through community screening for psychological distress and impaired functioning in Nairobi, Kenya. Participants were randomly allocated in a 1:1 ratio either to PM+ delivered in the community by lay community health workers provided with 8 days of training or to facility-based enhanced usual care (EUC provided by community nurses. Participants were aware of treatment allocation, but research assessors were blinded. The primary outcome was psychological distress as measured by the total score on the 12-item General Health Questionnaire (GHQ-12 assessed at 3 months after treatment. Secondary outcomes were impaired functioning (measured by the WHO Disability Adjustment Schedule [WHODAS], symptoms of posttraumatic stress (measured by the Posttraumatic Stress Disorder Checklist [PCL], personally identified problems (measured by Psychological Outcome Profiles [PSYCHLOPS], stressful life events (measured by the Life Events Checklist [LEC], and health service utilisation. Between 15 April 2015 and 20 August 2015, 1,393 women were screened for eligibility on the basis of psychological distress and impaired functioning. Of these, 518 women (37% screened positive, of whom 421 (81% were women who had experienced GBV. Of these 421 women, 209 were assigned to PM+ and 212 to EUC. Follow-up assessments were completed on 16 January 2016. The primary

  14. Beating the blues after Cancer: randomised controlled trial of a tele-based psychological intervention for high distress patients and carers

    Directory of Open Access Journals (Sweden)

    Hutchison Sandy

    2009-06-01

    Full Text Available Abstract Background The diagnosis and treatment of cancer is a major life stress such that approximately 35% of patients experience persistent clinically significant distress and carers often experience even higher distress than patients. This paper presents the design of a two arm randomised controlled trial with patients and carers who have elevated psychological distress comparing minimal contact self management vs. an individualised tele-based cognitive behavioural intervention. Methods/design 140 patients and 140 carers per condition (560 participants in total will been recruited after being identified as high distress through caller screening at two community-based cancer helplines and randomised to 1 a single 30-minute telephone support and education session with a nurse counsellor with self management materials 2 a tele-based psychologist delivered five session individualised cognitive behavioural intervention. Session components will include stress reduction, problem-solving, cognitive challenging and enhancing relationship support and will be delivered weekly. Participants will be assessed at baseline and 3, 6 and 12 months after recruitment. Outcome measures include: anxiety and depression, cancer specific distress, unmet psychological supportive care needs, positive adjustment, overall Quality of life. Discussion The study will provide recommendations about the efficacy and potential economic value of minimal contact self management vs. tele-based psychologist delivered cognitive behavioural intervention to facilitate better psychosocial adjustment and mental health for people with cancer and their carers. Trial Registration ACTRN12609000301268.

  15. A Randomized Controlled Trial of Internet-Delivered Cognitive Behavior Therapy and Acceptance and Commitment Therapy in the Treatment of Tinnitus

    Science.gov (United States)

    Hesser, Hugo; Gustafsson, Tore; Lunden, Charlotte; Henrikson, Oskar; Fattahi, Kidjan; Johnsson, Erik; Westin, Vendela Zetterqvist; Carlbring, Per; Maki-Torkko, Elina; Kaldo, Viktor; Andersson, Gerhard

    2012-01-01

    Objective: Our aim in this randomized controlled trial was to investigate the effects on global tinnitus severity of 2 Internet-delivered psychological treatments, acceptance and commitment therapy (ACT) and cognitive behavior therapy (CBT), in guided self-help format. Method: Ninety-nine participants (mean age = 48.5 years; 43% female) who were…

  16. The Role of Positive Emotion and Contributions of Positive Psychology in Depression Treatment: Systematic Review

    Science.gov (United States)

    Santos, Veruska; Paes, Flavia; Pereira, Valeska; Arias-Carrión, Oscar; Silva, Adriana Cardoso; Carta, Mauro Giovanni; Nardi, Antonio Egidio; Machado, Sergio

    2013-01-01

    The present study aims to conduct a systematic review of the literature by checking the impact of positive emotion in the treatment of depression and on the use of strategies of positive psychology which involves positive emotion to treat and reduce symptoms of depression. For this purpose, we conducted searches in databases ISI Web of Knowledge, PsycINFO and PubMed and found a total of 3400 studies. After inclusion application and exclusion criteria, 28 articles remained, presented and discussed in this study. The studies have important relations between humor and positive emotion as well as a significant improvement in signs and symptoms of depression using differents strategies of positive psychology. Another relevant aspect is the preventative character of the proposed interventions by positive psychology by the fact that increase well-being and produce elements such as resilience and coping resources that reduce the recurrent relapses in the treatment of depression. The strategies of positive psychology, such as increasing positive emotions, develop personal strengths: seeking direction, meaning and engagement for the day-to-day life of the patients, appear as potentially tools for the prophylaxis and treatment of depression, helping to reduce signs and symptoms as well as for prevention of relapses. PMID:24358052

  17. Do all psychological treatments really work the same in posttraumatic stress disorder?

    Science.gov (United States)

    Ehlers, Anke; Bisson, Jonathan; Clark, David M; Creamer, Mark; Pilling, Steven; Richards, David; Schnurr, Paula P; Turner, Stuart; Yule, William

    2010-03-01

    A recent meta-analysis by Benish, Imel, and Wampold (2008, Clinical Psychology Review, 28, 746-758) concluded that all bona fide treatments are equally effective in posttraumatic stress disorder (PTSD). In contrast, seven other meta-analyses or systematic reviews concluded that there is good evidence that trauma-focused psychological treatments (trauma-focused cognitive behavior therapy and eye movement desensitization and reprocessing) are effective in PTSD; but that treatments that do not focus on the patients' trauma memories or their meanings are either less effective or not yet sufficiently studied. International treatment guidelines therefore recommend trauma-focused psychological treatments as first-line treatments for PTSD. We examine possible reasons for the discrepant conclusions and argue that (1) the selection procedure of the available evidence used in Benish et al.'s (2008)meta-analysis introduces bias, and (2) the analysis and conclusions fail to take into account the need to demonstrate that treatments for PTSD are more effective than natural recovery. Furthermore, significant increases in effect sizes of trauma-focused cognitive behavior therapies over the past two decades contradict the conclusion that content of treatment does not matter. To advance understanding of the optimal treatment for PTSD, we recommend further research into the active mechanisms of therapeutic change, including treatment elements commonly considered to be non-specific. We also recommend transparency in reporting exclusions in meta-analyses and suggest that bona fide treatments should be defined on empirical and theoretical grounds rather than by judgments of the investigators' intent. Copyright 2009 Elsevier Ltd. All rights reserved.

  18. Do all psychological treatments really work the same in posttraumatic stress disorder?

    Science.gov (United States)

    Ehlers, Anke; Bisson, Jonathan; Clark, David M.; Creamer, Mark; Pilling, Steven; Richards, David; Schnurr, Paula P.; Turner, Stuart; Yule, William

    2010-01-01

    A recent meta-analysis by Benish, Imel, and Wampold (2008, Clinical Psychology Review, 28, 746–758) concluded that all bona fide treatments are equally effective in posttraumatic stress disorder (PTSD). In contrast, seven other meta-analyses or systematic reviews concluded that there is good evidence that trauma-focused psychological treatments (trauma-focused cognitive behavior therapy and eye movement desensitization and reprocessing) are effective in PTSD; but that treatments that do not focus on the patients' trauma memories or their meanings are either less effective or not yet sufficiently studied. International treatment guidelines therefore recommend trauma-focused psychological treatments as first-line treatments for PTSD. We examine possible reasons for the discrepant conclusions and argue that (1) the selection procedure of the available evidence used in Benish et al.'s (2008)meta-analysis introduces bias, and (2) the analysis and conclusions fail to take into account the need to demonstrate that treatments for PTSD are more effective than natural recovery. Furthermore, significant increases in effect sizes of trauma-focused cognitive behavior therapies over the past two decades contradict the conclusion that content of treatment does not matter. To advance understanding of the optimal treatment for PTSD, we recommend further research into the active mechanisms of therapeutic change, including treatment elements commonly considered to be non-specific. We also recommend transparency in reporting exclusions in meta-analyses and suggest that bona fide treatments should be defined on empirical and theoretical grounds rather than by judgments of the investigators' intent. PMID:20051310

  19. Controlled trial of balneotherapy in treatment of low back pain.

    Science.gov (United States)

    Konrad, K; Tatrai, T; Hunka, A; Vereckei, E; Korondi, I

    1992-01-01

    Three treatments for non-specific lumbar pain--balneotherapy, underwater traction bath, and underwater massage--were assessed in a randomised prospective controlled trial in 158 outpatients. Each group was treated for four weeks and patients were reviewed at the end of this period and at 12 months after entry to the trial. The prescription of analgesics and the pain score were significantly reduced in all three treated groups, but there was no difference between the three groups. No significant change occurred in spinal motion and the straight leg raising test. After one year only the analgesic consumption was significantly lower than in the control group. PMID:1535495

  20. A narrative review of binge eating disorder in adolescence: prevalence, impact, and psychological treatment strategies

    Directory of Open Access Journals (Sweden)

    Marzilli E

    2018-01-01

    , especially in the internalizing area. Despite the evidence, to date, reviews on possible and effective psychological treatment for BED among young population are rare and focused primarily on adolescent females. Keywords: binge eating, adolescence, prevalence, impact, treatment

  1. Effectiveness of jyoti meditation for patients with chronic neck pain and psychological distress--a randomized controlled clinical trial.

    Science.gov (United States)

    Jeitler, Michael; Brunnhuber, Stefan; Meier, Larissa; Lüdtke, Rainer; Büssing, Arndt; Kessler, Christian; Michalsen, Andreas

    2015-01-01

    Chronic neck pain is a common medical complaint partly mediated by psychosocial distress and having a high socioeconomic impact. There is preliminary evidence that stress reduction by meditation might be beneficial in chronic pain syndromes. We aimed to evaluate the effectiveness of an 8-week meditation program (jyoti meditation) in patients with chronic neck pain by means of a randomized clinical trial. Eighty-nine patients (aged 49.7 ± 10.5 years, 73 female) with chronic neck pain who scored >40 mm on a 100-mm visual analog scale and had concomitant increased perceived stress were randomized to an 8-week meditation program (jyoti meditation) with weekly 90-minute classes (n = 45) or to a home-based exercise program (n = 44) with a wait list offer for meditation. Both groups were instructed to practice at home. Outcomes were assessed at baseline and after 8 weeks. Primary outcome measure was change of mean pain at rest (visual analog scale score) from baseline to week 8. Secondary outcomes included pain at motion, functional disability, pain-related bothersomeness, perceived stress, quality of life, and psychological outcomes. Patients had neck pain for a mean of 11 years. Eighteen patients in the meditation group and 16 patients in the exercise group were lost to follow-up. Meditation training significantly reduced pain when compared to the exercise group after 8 weeks (reduction of 45.5 ± 23.3 mm to 21.6 ± 17.2 mm in the meditation group, and 43.8 ± 22.0 mm to 37.7 ± 21.5 mm in the exercise group; mean difference: 13.2 mm [95% confidence interval: 2.1, 24.4; P = .02]). Pain-related bothersomeness decreased more in the meditation group (group difference 11.0 mm [95% confidence interval: 1.0, 21.0; P = .03]). No significant treatment effects were found for pain at motion, psychological scores, and quality of life, although the meditation group showed nonsignificant greater improvements compared to the exercise group. In conclusion

  2. Day Hospital Mentalization-Based Treatment (MBT-DH) versus treatment as usual in the treatment of severe borderline personality disorder: protocol of a randomized controlled trial.

    Science.gov (United States)

    Laurenssen, Elisabeth M P; Westra, Dieuwertje; Kikkert, Martijn J; Noom, Marc J; Eeren, Hester V; van Broekhuyzen, Anna J; Peen, Jaap; Luyten, Patrick; Busschbach, Jan J V; Dekker, Jack J M

    2014-05-22

    Severe borderline personality disorder is associated with a very high psychosocial and economic burden. Current treatment guidelines suggest that several manualized treatments, including day hospital Mentalization-Based Treatment (MBT-DH), are effective in these patients. However, only two randomized controlled trials have compared manualized MBT-DH with treatment as usual. Given the relative paucity of data supporting the efficacy and cost-effectiveness of MBT-DH, the possible influence of researcher allegiance in one of the trials, and potential problems with the generalization of findings to mental health systems in other countries, this multi-site randomized trial aims to investigate the efficacy and cost-effectiveness of manualized MBT-DH compared to manualized specialist treatment as usual in The Netherlands. The trial is being conducted at two sites in The Netherlands. Patients with a DSM-IV-TR diagnosis of borderline personality disorder and a score of ≥ 20 on the Borderline Personality Disorder Severity Index were randomly allocated to MBT-DH or treatment as usual. The MBT-DH program consists of a maximum of 18 months' intensive treatment, followed by a maximum of 18 months of maintenance therapy. Specialist treatment as usual is provided by the City Crisis Service in Amsterdam, a service that specializes in treating patients with personality disorders, offering manualized, non-MBT interventions including family interventions, Linehan training, social skills training, and pharmacotherapy, without a maximum time limit. Patients are assessed at baseline and subsequently every 6 months up to 36 months after the start of treatment. The primary outcome measure is the frequency and severity of manifestations of borderline personality disorder as assessed by the Borderline Personality Disorder Severity Index. Secondary outcome measures include parasuicidal behaviour, symptomatic distress, social and interpersonal functioning, personality functioning

  3. A Randomized Controlled Trial of Intensive Sleep Retraining (ISR): A Brief Conditioning Treatment for Chronic Insomnia

    Science.gov (United States)

    Harris, Jodie; Lack, Leon; Kemp, Kristyn; Wright, Helen; Bootzin, Richard

    2012-01-01

    sleep, daytime functioning, and psychological variables. Adding ISR to traditional interventions seems to result in a superior treatment response. Citation: Harris J; Lack L; Kemp K; Wright H; Bootzin R. A randomized controlled trial of intensive sleep retraining (ISR): a brief conditioning treatment for chronic insomnia. SLEEP 2012;35(1):49-60. PMID:22215918

  4. Pilot Randomized Controlled Trial of Internet-Delivered Cognitive-Behavioral Treatment for Pediatric Headache.

    Science.gov (United States)

    Law, Emily F; Beals-Erickson, Sarah E; Noel, Melanie; Claar, Robyn; Palermo, Tonya M

    2015-01-01

    To evaluate the feasibility and preliminary effectiveness of an Internet-delivered cognitive-behavioral therapy (CBT) intervention for adolescents with chronic headache. Headache is among the most common pain complaints of childhood. Cognitive-behavioral interventions are efficacious for improving pain among youth with headache. However, many youth do not receive psychological treatment for headache due to poor access, which has led to consideration of alternative delivery modalities such as the Internet. We used a parallel arm randomized controlled trial design to evaluate the feasibility and preliminary effectiveness of an Internet-delivered family-based CBT intervention, Web-based management of adolescent pain. Adolescents were eligible for the trial if they were a new patient being evaluated in a specialized headache clinic, between 11 and 17 years of age, and had recurrent headache for 3 months or more as diagnosed by a pediatric neurologist. Eighty-three youths were enrolled in the trial. An online random number generator was used to randomly assign participants to receive Internet CBT adjunctive to specialized headache treatment (n = 44) or specialized headache treatment alone (n = 39). The primary treatment outcome was headache days. Youth and parents in the Internet CBT group demonstrated high levels of engagement with the web program and reported satisfaction with the intervention. Multilevel modelling (MLM) was used to conduct hypothesis testing for continuous outcomes. For our primary treatment outcome of headache days, adolescents reported a statistically significant reduction in headache days from baseline to post-treatment and baseline to 3-month follow-up in both treatment conditions (main effect for time F(2, 136) = 19.70, P headache treatment group at post-treatment or follow-up (group × time interaction F(2, 134) = 0.94, P = .395). For our secondary treatment outcomes, findings from MLM showed that adolescents in both

  5. Virtual reality in the psychological treatment for mental health problems: An systematic review of recent evidence.

    Science.gov (United States)

    Valmaggia, Lucia R; Latif, Leila; Kempton, Matthew J; Rus-Calafell, Maria

    2016-02-28

    The aim of this paper is to provide a review of controlled studies of the use of Virtual Reality in psychological treatment (VRT). Medline, PsychInfo, Embase and Web of Science were searched. Only studies comparing immersive virtual reality to a control condition were included. The search resulted in 1180 articles published between 2012 and 2015, of these, 24 were controlled studies. The reviewed studies confirm the effectiveness of VRT compared to treatment as usual, and show similar effectiveness when VRT is compared to conventional treatments. Current developments and future research are discussed. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  6. Combining Pharmacological and Psychological Treatments for Binge Eating Disorder: Current Status, Limitations, and Future Directions.

    Science.gov (United States)

    Grilo, Carlos M; Reas, Deborah L; Mitchell, James E

    2016-06-01

    Binge eating disorder (BED) is characterized by recurrent binge eating and marked distress about binge eating without the extreme compensatory behaviors for weight control that characterize other eating disorders. BED is prevalent, associated strongly with obesity, and is associated with heightened levels of psychological, psychiatric, and medical concerns. This article provides an overview of randomized controlled treatments for combined psychological and pharmacological treatment of BED to inform current clinical practice and future treatment research. In contrast to the prevalence and significance of BED, to date, limited research has been performed on combining psychological and pharmacological treatments for BED to enhance outcomes. Our review here found that combining certain medications with cognitive behavioral therapy (CBT) or behavioral weight loss (BWL) interventions produces superior outcomes to pharmacotherapy only but does not substantially improve outcomes achieved with CBT/BWL only. One medication (orlistat) has improved weight losses with CBT/BWL albeit minimally, and only one medication (topiramate) has enhanced reductions achieved with CBT in both binge eating and weight. Implications for future research are discussed.

  7. Recent Treatment Advances and New Trials in Adult Nephrotic Syndrome

    Directory of Open Access Journals (Sweden)

    Eva Königshausen

    2017-01-01

    Full Text Available The etiology of nephrotic syndrome is complex and ranges from primary glomerulonephritis to secondary forms. Patients with nephrotic syndrome often need immunosuppressive treatment with its side effects and may progress to end stage renal disease. This review focuses on recent advances in the treatment of primary causes of nephrotic syndrome (idiopathic membranous nephropathy (iMN, minimal change disease (MCD, and focal segmental glomerulosclerosis (FSGS since the publication of the KDIGO guidelines in 2012. Current treatment recommendations are mostly based on randomized controlled trials (RCTs in children, small RCTs, or case series in adults. Recently, only a few new RCTs have been published, such as the Gemritux trial evaluating rituximab treatment versus supportive antiproteinuric and antihypertensive therapy in iMN. Many RCTs are ongoing for iMN, MCD, and FSGS that will provide further information on the effectiveness of different treatment options for the causative disease. In addition to reviewing recent clinical studies, we provide insight into potential new targets for the treatment of nephrotic syndrome from recent basic science publications.

  8. A randomized trial comparing treatments for varicose veins.

    Science.gov (United States)

    Brittenden, Julie; Cotton, Seonaidh C; Elders, Andrew; Ramsay, Craig R; Norrie, John; Burr, Jennifer; Campbell, Bruce; Bachoo, Paul; Chetter, Ian; Gough, Michael; Earnshaw, Jonothan; Lees, Tim; Scott, Julian; Baker, Sara A; Francis, Jill; Tassie, Emma; Scotland, Graham; Wileman, Samantha; Campbell, Marion K

    2014-09-25

    Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain. In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales. Secondary outcomes included complications and measures of clinical success. After adjustment for baseline scores and other covariates, the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery (P=0.006) but was similar in the laser and surgery groups. There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life. The frequency of procedural complications was similar in the foam group (6%) and the surgery group (7%) but was lower in the laser group (1%) than in the surgery group (Pdisease-specific quality of life in the foam group than in the surgery group. All treatments had similar clinical efficacy, but complications were less frequent after laser treatment and ablation rates were lower after foam treatment. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477.).

  9. A topographical map approach to representing treatment efficacy: a focus on positive psychology interventions.

    Science.gov (United States)

    Gorlin, Eugenia I; Lee, Josephine; Otto, Michael W

    2018-01-01

    A recent meta-analysis by Bolier et al. indicated that positive psychology interventions have overall small to moderate effects on well-being, but results were quite heterogeneous across intervention trials. Such meta-analytic research helps condense information on the efficacy of a broad psychosocial intervention by averaging across many effects; however, such global averages may provide limited navigational guidance for selecting among specific interventions. Here, we introduce a novel method for displaying qualitative and quantitative information on the efficacy of interventions using a topographical map approach. As an initial prototype for demonstrating this method, we mapped 50 positive psychology interventions targeting well-being (as captured in the Bolier et al. [2013] meta-analysis, [Bolier, L., Haverman, M., Westerhof, G. J., Riper, H., Smit, F., & Bohlmeijer, E. (2013). Positive psychology interventions: A meta-analysis of randomized controlled studies. BMC Public Health, 13, 83]). Each intervention domain/subdomain was mapped according to its average effect size (indexed by vertical elevation), number of studies providing effect sizes (indexed by horizontal area), and therapist/client burden (indexed by shading). The geographical placement of intervention domains/subdomains was determined by their conceptual proximity, allowing viewers to gauge the general conceptual "direction" in which promising intervention effects can be found. The resulting graphical displays revealed several prominent features of the well-being intervention "landscape," such as more strongly and uniformly positive effects of future-focused interventions (including, goal-pursuit and optimism training) compared to past/present-focused ones.

  10. Pain, sensory disturbances and psychological distress are common sequelae after treatment of ductal carcinoma in situ

    DEFF Research Database (Denmark)

    Mertz, Birgitte Goldschmidt; Duriaud, Helle Molter; Kroman, Niels

    2017-01-01

    Sequelae such as pain, sensory disturbances and psychological distress are well known after treatment for invasive breast cancer (IBC). Patients treated for ductal carcinoma in situ (DCIS) receive a similar treatment as low-risk IBC. The aim of this cross-sectional study was to describe prevalence......: 1.1–7.0, p = 0.02) and anxiety and depression (measured by HADStotal >15 OR of 3.1 (95% CI: 1.5–6.3, p = 0.003)) were significantly associated with moderate to severe pain. Approximately one-third of the patients reported sensory disturbances such as pins and needles (32%), numbness (37......%) and painful itch (30%) and 94 women (20%) reported anxiety ≥8, 26 (6%) depression and 51 (11%) reported distress. Conclusions: This cross-sectional study showed that women treated for DCIS suffered from pain, sensory disturbances and psychological impairment and had unmet rehabilitation needs. Further...

  11. Efficacy of “Attachment-Based Compassion Therapy” in the Treatment of Fibromyalgia: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Jesús Montero-Marín

    2018-01-01

    Full Text Available ObjectiveThere is a growing interest in evaluating the effectiveness of compassion interventions for treating psychological disorders. The present study evaluated the effectiveness of “attachment-based compassion therapy” (ABCT in the treatment of fibromyalgia (FM, and the role of psychological flexibility as a mediator of improvements.MethodsA total of 42 patients with FM were randomly assigned to ABCT or relaxation (active control group. Both the intervention and control condition were combined with treatment as usual (TAU. The primary outcome was functional status (FIQ, and the secondary outcomes were clinical severity (CGI-S, pain catastrophizing (PCS, anxiety (HADS-A, depression (HADS-D, quality of life (EQ-5D, and psychological flexibility (AAQ-II. Differences between the groups were estimated using mixed-effects models, and mediation assessments were conducted using path analyses.ResultsThe ABCT group demonstrated superior outcomes compared to the relaxation group, including better FIQ values after treatment (B = −3.01; p = 0.003. Differences in FIQ were maintained at 3-month follow-up (B = −3.33; p = 0.001. The absolute risk reduction in ABCT compared to relaxation increased by 40.0%, with an NNT = 3 based on criteria of ≥50% FIQ reduction after treatment. Psychological flexibility had a significant mediating effect on improvements.ConclusionThese results suggest that ABCT combined with TAU appears to be effective in the treatment of FM symptoms.Clinical Trial Registrationhttp://ClinicalTrials.gov, identifier NCT02454244.

  12. The effectiveness of simple psychological and exercise interventions for high prevalence mental health problems in young people: a factorial randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Moller Bridget

    2011-03-01

    Full Text Available Abstract Background The prevalence of mental illness in young people is the highest of any age group, with the onset of depression, anxiety and substance use peaking between 18 and 24 years. Effective treatments that target sub-threshold or mild to moderate levels of disorder in young people are required to reduce the risk of persistence and recurrence. The aims of this study are to evaluate whether treatments that are less intensive than cognitive-behaviour therapy, such as problem solving therapy and exercise treatments, are acceptable and effective in managing depression and anxiety symptoms in young people and to identify possible attributes in those who are likely to respond to these treatments. Methods/design This is a factorial randomised controlled trial conducted at a large, metropolitan youth mental health service. Participants are young help-seekers aged 15-25 years with sub-threshold or mild to moderate levels of depression and anxiety (with or without comorbid substance use. The interventions comprise 4 treatment combinations delivered by psychologists over 6 sessions on a weekly basis: a psychological intervention (problem solving therapy versus supportive counselling and an exercise intervention (behavioural exercise versus psychoeducation. Structured assessments occur at baseline, mid-point, end-point (6 weeks and at a 6- and 12-month follow-up. The primary outcomes are depression and anxiety symptoms as measured by the Beck Depression and Anxiety Inventories. Secondary outcomes include remission (defined as no longer meeting the diagnostic criteria for a disorder if threshold level was reached at baseline, or no longer scoring in the clinical range on scale scores if sub-threshold at baseline, substance use, and functioning. Discussion The effectiveness of less complex psychological and exercise interventions in young help-seekers with sub-threshold or mild to moderate presentations of high prevalence disorders is yet to be

  13. Tailored online cognitive behavioural therapy with or without therapist support calls to target psychological distress in adults receiving haemodialysis: A feasibility randomised controlled trial.

    Science.gov (United States)

    Hudson, Joanna L; Moss-Morris, Rona; Norton, Sam; Picariello, Federica; Game, David; Carroll, Amy; Spencer, Jonathan; McCrone, Paul; Hotopf, Matthew; Yardley, Lucy; Chilcot, Joseph

    2017-11-01

    Psychological distress is prevalent in haemodialysis (HD) patients yet access to psychotherapy remains limited. This study assessed the feasibility and acceptability of online cognitive-behavioural therapy (CBT) tailored for HD patients, with or without therapist support, for managing psychological distress. This feasibility randomised controlled trial recruited patients from a UK HD centre. Following psychological distress screens, patients with mild-moderate psychological distress (Patient Health Questionnaire PHQ-9; score: 5-19 and/or Generalised Anxiety Disorder; GAD-7 score: 5-14) who met remaining inclusion criteria were approached for consent. Consenters were individually randomised (1:1) to online-CBT or online-CBT plus three therapist support calls. Outcomes included recruitment, retention, and adherence rates. Exploratory change analyses were performed for: psychological distress, quality of life (QoL), illness perceptions, and costs. The statistician was blinded to allocation. 182 (44%) out of 410 patients approached completed psychological distress screens. 26% found screening unacceptable; a further 30% found it unfeasible. Psychological distress was detected in 101 (55%) patients, 60 of these met remaining inclusion criteria. The primary reason for ineligibility was poor computer literacy (N=17, 53%). Twenty-five patients were randomised to the supported (N=18) or unsupported arm (N=7); 92% were retained at follow-up. No differences in psychological distress or cost-effectiveness were observed. No trial adverse events occurred. Online CBT appears feasible but only for computer literate patients who identify with the label psychological distress. A definitive trial using the current methods for psychological distress screening and online care delivery is unfeasible. ClinicalTrials.gov Identifier: NCT02352870. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Incorporating Psychological Predictors of Treatment Response into Health Economic Simulation Models: A Case Study in Type 1 Diabetes.

    Science.gov (United States)

    Kruger, Jen; Pollard, Daniel; Basarir, Hasan; Thokala, Praveen; Cooke, Debbie; Clark, Marie; Bond, Rod; Heller, Simon; Brennan, Alan

    2015-10-01

    . Health economic modeling has paid limited attention to the effects that patients' psychological characteristics have on the effectiveness of treatments. This case study tests 1) the feasibility of incorporating psychological prediction models of treatment response within an economic model of type 1 diabetes, 2) the potential value of providing treatment to a subgroup of patients, and 3) the cost-effectiveness of providing treatment to a subgroup of responders defined using 5 different algorithms. . Multiple linear regressions were used to investigate relationships between patients' psychological characteristics and treatment effectiveness. Two psychological prediction models were integrated with a patient-level simulation model of type 1 diabetes. Expected value of individualized care analysis was undertaken. Five different algorithms were used to provide treatment to a subgroup of predicted responders. A cost-effectiveness analysis compared using the algorithms to providing treatment to all patients. . The psychological prediction models had low predictive power for treatment effectiveness. Expected value of individualized care results suggested that targeting education at responders could be of value. The cost-effectiveness analysis suggested, for all 5 algorithms, that providing structured education to a subgroup of predicted responders would not be cost-effective. . The psychological prediction models tested did not have sufficient predictive power to make targeting treatment cost-effective. The psychological prediction models are simple linear models of psychological behavior. Collection of data on additional covariates could potentially increase statistical power. . By collecting data on psychological variables before an intervention, we can construct predictive models of treatment response to interventions. These predictive models can be incorporated into health economic models to investigate more complex service delivery and reimbursement strategies.

  15. Effectiveness of a single-session early psychological intervention for children after road traffic accidents: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Meuli Martin

    2010-02-01

    Full Text Available Abstract Background Road traffic accidents (RTAs are the leading health threat to children in Europe, resulting in 355 000 injuries annually. Because children can suffer significant and long-term mental health problems following RTAs, there is considerable interest in the development of early psychological interventions. To date, the research in this field is scarce, and currently no evidence-based recommendations can be made. Methods To evaluate the effectiveness of a single-session early psychological intervention, 99 children age 7-16 were randomly assigned to an intervention or control group. The manualised intervention was provided to the child and at least one parent around 10 days after the child's involvement in an RTA. It included reconstruction of the accident using drawings and accident-related toys, and psychoeducation. All of the children were interviewed at 10 days, 2 months and 6 months after the accident. Parents filled in questionnaires. Standardised instruments were used to assess acute stress disorder (ASD, posttraumatic stress disorder (PTSD, depressive symptoms and behavioural problems. Results The children of the two study groups showed no significant differences concerning posttraumatic symptoms and other outcome variables at 2 or at 6 months. Interestingly, analyses showed a significant intervention × age-group effect, indicating that for preadolescent children the intervention was effective in decreasing depressive symptoms and behavioural problems. Conclusions This study is the first to show a beneficial effect of a single-session early psychological intervention after RTA in preadolescent children. Therefore, an age-specific approach in an early stage after RTAs may be a promising way for further research. Younger children can benefit from the intervention evaluated here. However, these results have to be interpreted with caution, because of small subgroup sizes. Future studies are needed to examine specific

  16. Positive Psychology Interventions for Patients With Heart Disease: A Preliminary Randomized Trial.

    Science.gov (United States)

    Nikrahan, Gholam Reza; Suarez, Laura; Asgari, Karim; Beach, Scott R; Celano, Christopher M; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Abbas, Rezaei; Huffman, Jeff C

    2016-01-01

    Positive psychologic characteristics have been linked to superior cardiac outcomes. Accordingly, in this exploratory study, we assessed positive psychology interventions in patients who had recently undergone a procedure to treat cardiovascular disease. Participants were randomly assigned to receive 1 of 3 different 6-week face-to-face interventions or a wait-list control condition. We assessed intervention feasibility and compared changes in psychologic outcome measures postintervention (7wk) and at follow-up (15wk) between intervention and control participants. Across the interventions, 74% of assigned sessions were completed. When comparing outcomes between interventions and control participants (N = 55 total), there were no between-group differences post-intervention, but at follow-up intervention participants had greater improvements in happiness (β = 14.43, 95% CI: 8.66-20.2, p psychology intervention for cardiac patients. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

  17. Early psychological intervention in accidentally injured children ages 2–16: a randomized controlled trial

    OpenAIRE

    Kramer, Didier N.; Landolt, Markus A.

    2014-01-01

    Background: Road traffic accidents (RTA) and burns are frequent events in children. Although many children recover spontaneously, a considerable number develop long-term psychological sequelae. Evidence on early psychological interventions to prevent such long-term problems is still scarce for school-age children and completely lacking for pre-school children.Objectives: To evaluate the efficacy of an early two-session cognitive-behavioral intervention in 108 children ages 2–16 after RTAs and...

  18. Reiki for the treatment of fibromyalgia: a randomized controlled trial.

    Science.gov (United States)

    Assefi, Nassim; Bogart, Andy; Goldberg, Jack; Buchwald, Dedra

    2008-11-01

    Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. The study setting was private medical offices in the Seattle, Washington metropolitan area. The subjects were comprised 100 adults with fibromyalgia. Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by self-report. Improvement between groups was examined in an intention-to-treat analysis. Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms.

  19. Integrated psychological treatment for substance use and co-morbid anxiety or depression vs. treatment for substance use alone

    DEFF Research Database (Denmark)

    Hesse, Morten

    2009-01-01

    Background There is a growing consensus in favour of integrated treatment of substance use disorders and co-morbid conditions, such as depression or anxiety. However, up till now no systematic reviews have been published. Methods Based on a systematic search of MedLine and PsychInfo, 10 trials of...

  20. The limitations of using randomised controlled trials as a basis for developing treatment guidelines.

    Science.gov (United States)

    Mulder, Roger; Singh, Ajeet B; Hamilton, Amber; Das, Pritha; Outhred, Tim; Morris, Grace; Bassett, Darryl; Baune, Bernhard T; Berk, Michael; Boyce, Philip; Lyndon, Bill; Parker, Gordon; Malhi, Gin S

    2018-02-01

    Randomised controlled trials (RCTs) are considered the 'gold standard' by which novel psychotropic medications and psychological interventions are evaluated and consequently adopted into widespread clinical practice. However, there are some limitations to using RCTs as the basis for developing treatment guidelines. While RCTs allow researchers to determine whether a given medication or intervention is effective in a specific patient sample, for practicing clinicians it is more important to know whether it will work for their particular patient in their particular setting. This information cannot be garnered from an RCT. These inherent limitations are exacerbated by biases in design, recruitment, sample populations and data analysis that are inevitable in real-world studies. While trial registration and CONSORT have been implemented to correct and improve these issues, it is worrying that many trials fail to achieve such standards and yet their findings are used to inform clinical decision making. This perspective piece questions the assumptions of RCTs and highlights the widespread distortion of findings that currently undermine the credibility of this powerful design. It is recommended that the clinical guidelines include advice as to what should be considered good and relevant evidence and that external bodies continue to monitor RCTs to ensure that the outcomes published indeed reflect reality. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  1. Quantifying the placebo effect in psychological outcomes of exercise training: a meta-analysis of randomized trials.

    Science.gov (United States)

    Lindheimer, Jacob B; O'Connor, Patrick J; Dishman, Rod K

    2015-05-01

    The placebo effect could account for some or all of the psychological benefits attributed to exercise training. The magnitude of the placebo effect in psychological outcomes of randomized controlled exercise training trials has not been quantified. The aim of this investigation was to estimate the magnitude of the population placebo effect in psychological outcomes from placebo conditions used in exercise training studies and compare it to the observed effect of exercise training. Articles published before 1 July 2013 were located using Google Scholar, MEDLINE, PsycINFO, and The Cochrane Library. To be included in the analysis, studies were required to have (1) a design that randomly assigned participants to exercise training, placebo, and control conditions and (2) an assessment of a subjective (i.e., anxiety, depression, energy, fatigue) or an objective (i.e., cognitive) psychological outcome. Meta-analytic and multi-level modeling techniques were used to analyze effects from nine studies involving 661 participants. Hedges' d effect sizes were calculated, and random effects models were used to estimate the overall magnitude of the placebo and exercise training effects. After adjusting for nesting effects, the placebo mean effect size was 0.20 (95% confidence interval [CI] -0.02, 0.41) and the observed effect of exercise training was 0.37 (95% CI 0.11, 0.63). A small body of research suggests both that (1) the placebo effect is approximately half of the observed psychological benefits of exercise training and (2) there is an urgent need for creative research specifically aimed at better understanding the role of the placebo effect in the mental health consequences of exercise training.

  2. Can psychobiotics intake modulate psychological profile and body composition of women affected by normal weight obese syndrome and obesity? A double blind randomized clinical trial.

    Science.gov (United States)

    De Lorenzo, Antonino; Costacurta, Micaela; Merra, Giuseppe; Gualtieri, Paola; Cioccoloni, Giorgia; Marchetti, Massimiliano; Varvaras, Dimitrios; Docimo, Raffaella; Di Renzo, Laura

    2017-06-10

    Evidence of probiotics effects on gut function, brain activity and emotional behaviour were provided. Probiotics can have dramatic effects on behaviour through the microbiome-gut-brain axis, through vagus nerve. We investigated whether chronic probiotic intake could modulate psychological state, eating behaviour and body composition of normal weight obese (NWO) and preobese-obese (PreOB/OB) compared to normal weight lean women (NWL). 60 women were enrolled. At baseline and after a 3-week probiotic oral suspension (POS) intake, all subjects underwent evaluation of body composition by anthropometry and dual X-ray absorptiometry, and psychological profile assessment by self-report questionnaires (i.e. EDI-2, SCL90R and BUT). Statistical analysis was carried out using paired t test or a non-parametric Wilcoxon test to evaluate differences between baseline and after POS intake, one-way ANOVA to compare all three groups and, where applicable, Chi square or t test were used to assess symptoms. Of the 48 women that concluded the study, 24% were NWO, 26% were NWL and 50% were PreOB/OB. Significant differences in body composition were highlighted among groups both at baseline and after a POS (p women. At baseline and after POS intake, all subjects tested were negative to SCL90R_GSI scale, but after treatment subjects positive to BUT_GSI scale were significantly reduced (8.33%) (p women. Further research is needed on a larger population and for a longer period of treatment before definitive conclusions can be made. Trial registration ClinicalTrials.gov Id: NCT01890070.

  3. Aromatherapy for the Treatment of Patients with Behavioral and Psychological Symptoms of Dementia: A Descriptive Analysis of RCTs.

    Science.gov (United States)

    Press-Sandler, Olga; Freud, Tamar; Volkov, Ilya; Peleg, Roni; Press, Yan

    2016-06-01

    Behavioral and psychological symptoms of dementia (BPSD) are a common problem among patients with dementia. This problem is usually treated by drugs, but they have limited efficacy and often cause adverse effects. Aromatherapy is a nonpharmacologic treatment that is simple to use and devoid of significant adverse effects. To review the literature on the effectiveness of aromatherapy treatment in patients with BPSD. A descriptive analysis of randomized clinical trials (RCTs) published in the English-language literature and cited in PubMed. Eleven articles on RCTs were found, of which 1 had fewer than 10 participants, 2 were mistakenly presented as RCTs, and another did not report treatment for BPSD. In all, 7 articles with 417 participants total (range, 15-114) were reviewed. The mean age in all studies was greater than 69 years (range, 69-85 years), and the percentage of women was 55% (range, 50%-57%). The intervention period ranged from 10 days to 12 weeks. Two studies used Melissa oil and 5 others used lavender oil. The studies described different methods of administration for the oils, including spraying and rubbing over various body organs. The duration of treatment differed among the studies. In 3 studies the investigators concluded that the treatment was not effective and in 3 that it was effective; in 1 study no clear conclusion could be drawn. The difference between positive and negative studies was not explained by differences in the study population, the type of oil, or the duration of treatment. The significant difference apparently stems from the method of administration. When the oil was applied close to the olfactory system the outcome was positive. A study should be designed to assess the effect of the site of application of aromatherapy.

  4. Estimation of treatment preference effects in clinical trials when some participants are indifferent to treatment choice

    Directory of Open Access Journals (Sweden)

    Stephen D. Walter

    2017-02-01

    Full Text Available Abstract Background In the two-stage randomised trial design, a randomly sampled subset of study participants are permitted to choose their own treatment, while the remaining participants are randomised to treatment in the usual way. Appropriate analysis of the data from both arms of the study allows investigators to estimate the impact on study outcomes of treatment preferences that patients may have, in addition to evaluating the usual direct effect of treatment. In earlier work, we showed how to optimise this design by making a suitable choice of the proportion of participants who should be assigned to the choice arm of the trial. However, we ignored the possibility of some participants being indifferent to the treatments under study. In this paper, we extend our earlier work to consider the analysis of two-stage randomised trials when some participants have no treatment preference, even if they are assigned to the choice arm and allowed to choose. Methods We compare alternative characterisations of the response profiles of the indifferent or undecided participants, and derive estimates of the treatment and preference effects on study outcomes. We also present corresponding test statistics for these parameters. The methods are illustrated with data from a clinical trial contrasting medical and surgical interventions. Results Expressions are obtained to estimate and test the impact of treatment choices on study outcomes, as well as the impact of the actual treatment received. Contrasts are defined between patients with stated treatment preferences and those with no preference. Alternative assumptions concerning the outcomes of undecided participants are described, and an approach leading to unbiased estimation and testing is identified. Conclusions Use of the two-stage design can provide important insights into determinants of study outcomes that are not identifiable with other designs. The design can remain attractive even in the presence of

  5. Microbicide trials for preventing HIV/AIDS in South Africa: phase II trial partricipants' experiences and psychological needs

    NARCIS (Netherlands)

    Pistorius, A. G.; van de Wijgert, J. H. H. M.; Sebola, M.; Friedland, B.; Nagel, E.; Bokaba, C.; Hoosen, A. A.

    2004-01-01

    The Microbicide Division of the Department of Medical Microbiology at MEDUNSA, South Africa, recently completed a phase II expanded safety trial of the candidate microbicide Carraguard. A microbicide is a vaginal product that women might use, if proven safe and effective, to protect themselves from

  6. A narrative review of binge eating disorder in adolescence: prevalence, impact, and psychological treatment strategies

    Science.gov (United States)

    Marzilli, Eleonora; Cerniglia, Luca; Cimino, Silvia

    2018-01-01

    Binge eating disorder (BED) represents one of the most problematic clinical conditions among youths. Research has shown that the developmental stage of adolescence is a critical stage for the onset of eating disorders (EDs), with a peak prevalence of BED at the age of 16–17 years. Several studies among adults with BED have underlined that it is associated with a broad spectrum of negative consequences, including higher concern about shape and weight, difficulties in social functioning, and emotional-behavioral problems. This review aimed to examine studies focused on the prevalence of BED in the adolescent population, its impact in terms of physical, social, and psychological outcomes, and possible strategies of psychological intervention. The review of international literature was made on paper material and electronic databases ProQuest, PsycArticles, and PsycInfo, and the Scopus index were used to verify the scientific relevance of the papers. Epidemiological research that examined the prevalence of BED in adolescent samples in accordance with Diagnostic and Statistical Manual of Mental Disorders, 4th Edition showed a prevalence ranging from 1% to 4%. More recently, only a few studies have investigated the prevalence of BED, in accordance with the Diagnostic and Statistical Manual of Disorders, Fifth Edition criteria, reporting a prevalence of ~1%–5%. Studies that focused on the possible impact that BED may have on physical, psychological, and social functioning showed that adolescents with BED have an increased risk of developing various adverse consequences, including obesity, social problems, substance use, suicidality, and other psychological difficulties, especially in the internalizing area. Despite the evidence, to date, reviews on possible and effective psychological treatment for BED among young population are rare and focused primarily on adolescent females. PMID:29379325

  7. The implications of starvation induced psychological changes for the ethical treatment of hunger strikers.

    Science.gov (United States)

    Fessler, D M T

    2003-08-01

    To evaluate existing ethical guidelines for the treatment of hunger strikers in light of findings on psychological changes that accompany the cessation of food intake. Electronic databases were searched for (a) editorials and ethical proclamations on hunger strikers and their treatment; (b) studies of voluntary and involuntary starvation, and (c) legal cases pertaining to hunger striking. Additional studies were gathered in a snowball fashion from the published material cited in these databases. Material was included if it (a) provided ethical or legal guidelines; (b) shed light on psychological changes accompanying starvation, or (c) illustrated the practice of hunger striking. Authors' observations, opinions, and conclusions were noted. Although the heterogeneous nature of the sources precluded statistical analysis, starvation appears to be accompanied by marked psychological changes. Some changes clearly impair competence, in which case physicians are advised to follow advance directives obtained early in the hunger strike. More problematic are increases in impulsivity and aggressivity, changes which, while not impairing competence, enhance the likelihood that patients will starve themselves to death.

  8. Effectiveness of chemotherapy counselling on self-esteem and psychological affects among cancer patients in Malaysia: Randomized controlled trial.

    Science.gov (United States)

    Mohd-Sidik, Sherina; Akhtari-Zavare, Mehrnoosh; Periasamy, Ummavathy; Rampal, Lekhraj; Fadhilah, Siti Irma; Mahmud, Rozi

    2018-05-01

    The aim of this study was to implement and evaluate the outcomes of chemotherapy counselling based on the "Managing Patients on Chemotherapy" module on self-esteem and psychological affect (anxiety, depression) of cancer patients by pharmacists in ten selected government hospitals in Peninsular Malaysia. A randomized control trial was conducted among 2120 cancer patients from April 2016 to January 2017 in ten selected government hospitals in Peninsular Malaysia. Cancer patients were randomly assigned to intervention and control groups. The intervention group received chemotherapy counselling by pharmacists based on the "Managing Patients on Chemotherapy" module. The outcomes were assessed at baseline, 1st, 2nd and 3rd follow-ups after counselling. In the course of data analysis; independent sample t-test, chi-square and two-way repeated measures ANOVA were conducted. Mean scores of self-esteem in the intervention group had significant difference in comparison with those of the control group in the 1st, 2nd and 3rd follow-ups after counselling (P self-esteem and psychological affect of cancer patients undergoing chemotherapy in Peninsular Malaysia. This module can be used for all Malaysian cancer patients undergoing chemotherapy to improving self-esteem and psychological affect. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

  9. The decade 1989-1998 in Spanish psychology: an analysis of research in personality, assessment, and psychological treatment (clinical and health psychology).

    Science.gov (United States)

    Sanz, J

    2001-11-01

    The aim of this study is to analyze Spanish research published between 1989 and 1998 in clinical psychology and its most directly related psychological disciplines: personality psychology, psychopathology, differential psychology, health psychology, and psychological assessment. A search was performed in the various databases of the works published in that decade by Spanish university professors who investigate in these areas. Their localization was verified by direct correspondence with the professors, to whom was also sent a questionnaire to evaluate their research field and preferred theoretical approach. The 2,079 works located allowed me to identify 85 different research trends. These research trends are characterized by the predominance of applied studies over basic studies, of empirical research over theoretical research, and of the cognitive-behavioral approach over the rest of the theoretical orientations. In addition, various bibliometrical indicators of production, dissemination, and impact were calculated. They revealed that productivity and dissemination of Spanish research in these areas grew considerably during this 1989-98 period.

  10. Psychological impact of isotretinoin treatment in patients with moderate and severe acne.

    Science.gov (United States)

    Simić, Dubravka; Situm, Mirna; Letica, Edita; Penavić, Jasna Zeljko; Zivković, Maja Vurnek; Tomić, Teo

    2009-12-01

    Acne patients are subject to different degree of psychosocial distress. The emotional impact of acne vulgaris due to disfigurement caused by the disease is undisputed. Most common reactions to the acne are depression and anxiety. The use of isotretinoin, one of the most effective options in acne treatment, increases depression symptoms. The aim of this study was to investigate the psychological status of the patients with moderate to severe acne and to compare patients treated with isotretinoin with patients treated with vitamin C. A total of 85 patients suffering from acne vulgaris were included in the study. The results of this study do not find a significant correlation between the use of isotretinoin and the psychological effects of the drug.

  11. Treatment of psychological factors in a child with difficult asthma: a case report.

    Science.gov (United States)

    Anbar, Ran D; Sachdeva, Shagun

    2011-07-01

    Difficult asthma is defined as the persistence of asthma symptoms, abnormal pulmonary function showing airway obstruction, and continued requirement for short-acting bronchodilator therapy, despite adequate treatment with inhaled corticosteroids. It calls for a thorough evaluation of the patient to look into alternate and complicating diagnoses. The authors report a case of a 9-year-old patient with difficult asthma who failed to respond to conventional therapy. Although it was recognized that he had a number of potential medical complicating factors including allergies, chronic sinusitis, and gastroesophageal reflux, a psychological intervention using hypnosis ultimately appeared to help alleviate his symptoms completely. Thus, psychological evaluation and intervention should be considered early in the course of management of a patient with difficult asthma, because it may help avoid time-consuming and expensive investigations of potential complicating factors, and it may yield rapid improvement in the patient's clinical condition.

  12. From neuroscience to evidence based psychological treatments - The promise and the challenge, ECNP March 2016, Nice, France.

    Science.gov (United States)

    Goodwin, Guy M; Holmes, Emily A; Andersson, Erik; Browning, Michael; Jones, Andrew; Lass-Hennemann, Johanna; Månsson, Kristoffer Nt; Moessnang, Carolin; Salemink, Elske; Sanchez, Alvaro; van Zutphen, Linda; Visser, Renée M

    2018-02-01

    This ECNP meeting was designed to build bridges between different constituencies of mental illness treatment researchers from a range of backgrounds with a specific focus on enhancing the development of novel, evidence based, psychological treatments. In particular we wished to explore the potential for basic neuroscience to support the development of more effective psychological treatments, just as this approach is starting to illuminate the actions of drugs. To fulfil this aim, a selection of clinical psychologists, psychiatrists and neuroscientists were invited to sit at the same table. The starting point of the meeting was the proposition that we know certain psychological treatments work, but we have only an approximate understanding of why they work. The first task in developing a coherent mental health science would therefore be to uncover the mechanisms (at all levels of analysis) of effective psychological treatments. Delineating these mechanisms, a task that will require input from both the clinic and the laboratory, will provide a key foundation for the rational optimisation of psychological treatments. As reviewed in this paper, the speakers at the meeting reviewed recent advances in the understanding of clinical and cognitive psychology, neuroscience, experimental psychopathology, and treatment delivery technology focussed primarily on anxiety disorders and depression. We started by asking three rhetorical questions: What has psychology done for treatment? What has technology done for psychology? What has neuroscience done for psychology? We then addressed how research in five broad research areas could inform the future development of better treatments: Attention, Conditioning, Compulsions and addiction, Emotional Memory, and Reward and emotional bias. Research in all these areas (and more) can be harnessed to neuroscience since psychological therapies are a learning process with a biological basis in the brain. Because current treatment approaches

  13. Effects of Positive Psychology Interventions on Risk Biomarkers in Coronary Patients: A Randomized, Wait-List Controlled Pilot Trial.

    Science.gov (United States)

    Nikrahan, Gholam Reza; Laferton, Johannes A C; Asgari, Karim; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Rezaei, Abbas; Suarez, Laura; Huffman, Jeff C

    2016-01-01

    Among cardiac patients, positive psychologic factors are consistently linked with superior clinical outcomes and improvement in key markers of inflammation and hypothalamic-pituitary-adrenal axis functioning. Further, positive psychology interventions (PPI) have effectively increased psychologic well-being in a wide variety of populations. However, there has been minimal study of PPIs in cardiac patients, and no prior study has evaluated their effect on key prognostic biomarkers of cardiac outcome. Accordingly, we investigated the effect of 3 distinct PPIs on risk biomarkers in cardiac patients. In an exploratory trial, 69 patients with recent coronary artery bypass graft surgery or percutaneous intervention were randomized to (1) one of three 6-week in-person PPIs (based on the work of Seligman, Lyubomirsky, or Fordyce) or (2) a wait-list control group. Risk biomarkers were assessed at baseline, postintervention (7 weeks), and at 15-week follow-up. Between-group differences in change from baseline biomarker levels were examined via random effects models. Compared with the control group, participants randomized to the Seligman (B = -2.06; p = 0.02) and Fordyce PPI (B = -1.54; p = 0.04) had significantly lower high-sensitivity C-reactive protein levels at 7 weeks. Further, the Lyubomirsky PPI (B = -245.86; p = 0.04) was associated with a significantly lower cortisol awakening response at 7 weeks when compared with control participants. There were no other significant between-group differences. Despite being an exploratory pilot study with multiple between-group comparisons, this initial trial offers the first suggestion that PPIs might be effective in reducing risk biomarkers in high-risk cardiac patients. Copyright © 2016 The Academy of Psychosomatic Medicine. All rights reserved.

  14. Psychological intervention with working memory training increases basal ganglia volume: A VBM study of inpatient treatment for methamphetamine use

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    S.J. Brooks, PhD

    2016-01-01

    Conclusions: While psychological intervention is associated with larger volume in mesolimbic reward regions, the utilisation of additional working memory training as an adjunct to treatment may further normalize frontostriatal structure and function.

  15. Urinary and psychological outcomes in women with interstitial cystitis/bladder pain syndrome following hyaluronic acid treatment

    Directory of Open Access Journals (Sweden)

    Ching-Chung Liang

    2018-06-01

    Conclusions: Bladder pain and lower urinary tract symptoms in patients with IC/BPS may improve after a 6-month intravesical HA treatment. However, no significant changes in their psychological and sexual functional scores were found.

  16. Are pre-treatment psychological characteristics influenced by pre-surgical orthodontics?

    Science.gov (United States)

    Cunningham, S J; Gilthorpe, M S; Hunt, N P

    2001-12-01

    A number of investigations have looked at psychological changes occurring in association with orthognathic treatment. However, most of these studies have used a pre-surgery questionnaire as the baseline measurement. There is little data relating to the true baseline, i.e. that prior to any active treatment. Until this aspect is investigated, it is not possible to assume that pre-surgery is an acceptable baseline. This questionnaire based study aimed to assess changes in six psychological outcome measures between T1 (prior to any active treatment) and T2 (following pre-surgical orthodontics/prior to surgery). The outcome variables were: state anxiety, trait anxiety, depression, self-esteem, body image, and facial body image. Sixty-two patients (39 females and 23 males) completed both questionnaires. The results showed that intervention, in the form of orthodontic treatment, had a minimal effect on the chosen psychometric outcome variables. There was a significant reduction in satisfaction with body image amongst patients who initially reported mild to moderate dental/facial problems, whilst a moderate increase in satisfaction occurred in those patients reporting severe conditions initially. Also of note were significant increases in state anxiety amongst older patients whilst trait anxiety showed greater increases in females than males.

  17. Medicinal plants consumption by patients under psychological treatment in a municipality in Chile

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    Rodrigo Ramírez-Tagle

    2018-04-01

    Full Text Available Context: High levels of mental illness are found today in the population of Chile and the consumption of medicinal herbs could be included in the scope of complementary therapies for the treatment of mental illnesses. In Chile there is no information respect to consumption of medicinal herbs in patients under psychological treatment. Aims: To characterize the consumption of medicinal herbs by patients treated in a mental health clinic. Methods: In this quantitative cross-sectional study (n = 100, patients were administered a closed-response survey to determine the frequency of medicinal plant consumption as complementary treatment and subsequently to characterize such consumption. Results: Among the patients surveyed, 36% consumed medicinal herbs to treat a psychological pathology as a complementary treatment. Among those who consumed medicinal herbs, 65% consumed Cannabis sativa (marijuana either exclusively (42% or in conjunction with other plants (23%, 80% reported that their therapist was aware of this behavior, and 35% consumed medicinal herbs once or twice a day. Conclusions: In the present study, there was significant use of medicinal plants by patients treated at the mental health clinic, especially marijuana consuming. This demonstrates the importance of recognizing citizens´ right to free and equal access to healthcare and acknowledging the responsibility of the state to ensure the safety and quality of the services offered to the population.

  18. 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…

  19. Attitudes of psychology students to depression and its treatment: Implications for clinical practice.

    Science.gov (United States)

    Economou, M; Peppou, L E; Geroulanou, K; Kontoangelos, K; Prokopi, A; Pantazi, A; Zervakaki, A; Stefanis, C N

    2017-01-01

    Stigma and mental health literacy affect access to and quality of treatment of major depression. Though mental health professionals seem better able to recognize major depression than the general public, they often hold similarly stigmatizing attitudes towards people suffering from the disorder. These attitudes are shaped jointly by the public stigma attached to mental illnesses as well as by the content and delivery of mental health professionals' undergraduate training. In line with this, the present study aimed to explore psychology students' ability to recognize major depression, their attitudes towards the disorder, and their views surrounding helpfulness of various interventions. A random sample of 167 undergraduate students was recruited from the psychology department of one public university in Athens. During one university hour, students were administered a vignette describing a woman fulfilling the DSM-IV criteria for major depression. A self-report questionnaire exploring students' recognition abilities, attitudes to depression and views on the helpfulness of various treatment modes was also administered. In total, 80.2% of students correctly recognized major depression from the vignette. Concerning their attitudes, students were unsure about the illness and ambivalent towards the person who suffers from it. With regard to available treatments for depression, students considered discussion with a friend to be the most helpful intervention. Counseling, cognitive behavioural therapy and psychoanalysis were also viewed in a positive light. On the contrary, antidepressants were not deemed helpful by most students. Finally, recognition of as well as attitudes towards depression and its treatments seemed to improve during the second year of undergraduate study; however they remained unchanged thereafter. Consistent with these, psychology students seem to have only a rudimentary knowledge on depression, that cannot not be qualified as mental health literacy

  20. The Influence of Causal Explanations and Diagnostic Labeling on Psychology Students' Beliefs About Treatments, Prognosis, Dangerousness and Unpredictability in Schizophrenia.

    Science.gov (United States)

    Magliano, Lorenza; Read, John; Rinaldi, Angela; Costanzo, Regina; De Leo, Renata; Schioppa, Giustina; Petrillo, Miriam

    2016-04-01

    This study explored views of 566 Italian psychology students about schizophrenia. The most frequently cited causes were psychological traumas (68 %) and heredity (54 %). Thirty-three percent of students firmly believed that people with the condition could recover. Reporting heredity among the causes, and identifying schizophrenia were both associated with prognostic pessimism, greater confidence in pharmacological treatments and lower confidence in psychological treatments. Schizophrenia labeling was also associated with higher perception of unpredictability and dangerousness. Compared to first year students, fourth/fifth year students more frequently reported heredity among the causes, and were more pessimistic about schizophrenia recovery. Stigma topics should be included in future psychologists' education.

  1. Treatment of periodontal disease during pregnancy: a randomized controlled trial.

    Science.gov (United States)

    Newnham, John P; Newnham, Ian A; Ball, Colleen M; Wright, Michelle; Pennell, Craig E; Swain, Jonathan; Doherty, Dorota A

    2009-12-01

    To investigate whether treating periodontal disease prevents preterm birth and other major complications of pregnancy. This single-center trial was conducted across six obstetric sites in metropolitan Perth, Western Australia. Pregnant women identified by history to be at risk (n=3,737) were examined for periodontal disease. Approximately 1,000 women with periodontal disease were allocated at random to receive periodontal treatment commencing around 20 weeks of gestation (n=542) or 6 weeks after the pregnancy was completed (controls; n=540). The treatment included mechanical removal of oral biofilms together with oral hygiene instruction and motivation at a minimum of three weekly visits, with further visits if required. There were no differences between the control and treatment groups in preterm birth (9.3% compared with 9.7%, odds ratio [OR] 1.05, 95% confidence interval [CI 0.7-1.58], P=.81), birth weight (3,450 compared with 3,410 g, P=.12), preeclampsia (4.1% compared with 3.4%, OR 0.82, 95% CI 0.44-1.56, P=.55), or other obstetric endpoints. There were four unexplained stillbirths in the control group and no pregnancy losses in the treated group (P=.12). Measures of fetal and neonatal well-being were similar in the two groups, including abnormalities in fetal heart rate recordings (P=.26), umbilical artery flow studies (P=.96), and umbilical artery blood gas values (P=.37). The periodontal treatment was highly successful in improving health of the gums (Pperiodontal disease during pregnancy in this population prevents preterm birth, fetal growth restriction, or preeclampsia. Periodontal treatment was not hazardous to the women or their pregnancies. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00133926. I.

  2. Psychological Treatments for Mental Disorders in Children and Adolescents: A Review of the Evidence of Leading International Organizations.

    Science.gov (United States)

    Gálvez-Lara, Mario; Corpas, Jorge; Moreno, Eliana; Venceslá, José F; Sánchez-Raya, Araceli; Moriana, Juan A

    2018-04-02

    In recent decades, the evidence on psychological treatments for children and adolescents has increased considerably. Several organizations have proposed different criteria to evaluate the evidence of psychological treatment in this age group. The aim of this study was to analyze evidence-based treatments drawn from RCTs, reviews, meta-analyses, guides and lists provided by four leading international organizations. The institutions reviewed were the National Institute for Health and Care Excellence, the Society of Clinical Child and Adolescent Psychology (Division 53) of the American Psychological Association, Cochrane Collaboration and the Australian Psychological Society in relation to mental disorders in children and adolescents. A total of 137 treatments were analyzed for 17 mental disorders and compared to determine the level of agreement among the organizations. The results indicate that, in most cases, there is little agreement among organizations and that there are several discrepancies within certain disorders. These results require reflection on the meaning attributed to evidence-based treatments with regard to psychological treatments in children and adolescents. The possible reasons for these differences could be explained by a combination of different issues: the procedures or committees may be biased, different studies were reviewed, different criteria are used by the organizations or the reviews of existing evidence were conducted in different time periods.

  3. The psychological and neurochemical mechanisms of drug memory reconsolidation: implications for the treatment of addiction.

    Science.gov (United States)

    Milton, Amy L; Everitt, Barry J

    2010-06-01

    Memory reconsolidation is the process by which memories, destabilised at retrieval, require restabilisation to persist in the brain. It has been demonstrated that even old, well-established memories require reconsolidation following retrieval; therefore, memory reconsolidation could potentially be exploited to disrupt, or even erase, aberrant memories that underlie psychiatric disorders, thereby providing a novel therapeutic target. Drug addiction is one such disorder; it is both chronic and relapsing, and one prominent risk factor for a relapse episode is the presentation of environmental cues that have previously been associated with drugs of abuse. This 'cue-induced relapse' can be accounted for in psychological terms by reinforcing memories of the pavlovian association between the cue and the drug, which can thus influence behaviour through at least three psychologically and neurobiologically dissociable mechanisms: conditioned reinforcement, conditioned approach and conditioned motivation. As each of these psychological processes could contribute to the resumption of drug-seeking following abstinence, it is important to develop treatments that can reduce drug-seeking re-established via influences on each or all of these pavlovian processes, in order to minimise the risk of a subsequent relapse. Investigation of the memory reconsolidation mechanisms of the memories underlying conditioned reinforcement, conditioned approach and conditioned motivation indicate that they depend upon different neurochemical systems, including the glutamatergic and adrenergic systems within limbic corticostriatal circuitry. We also discuss here the subsequent translation to the clinic of this preclinical work.

  4. Technology Addiction among Treatment Seekers for Psychological Problems: Implication for Screening in Mental Health Setting.

    Science.gov (United States)

    Das, Aswathy; Sharma, Manoj Kumar; Thamilselvan, P; Marimuthu, P

    2017-01-01

    Technology usage has seen an increase among users. The usage varies from social, personal, and psychological reasons. Users are frequently using to overcome mood states as well as to manage the other psychological states. This work is going to explore the information technology use among subjects with a psychiatric disorder. A total of 75 subjects were assessed using background data sheet, internet addiction impairment index, video game use pattern, pornography addiction screening tool and screening for mobile phone use, from in-patient and out-patient setting of tertiary mental health setting. It showed the presence of addiction to mobile, internet, video game, and pornography. Age was found to be negatively correlated with this addiction. Average usage time had been associated with management of mood states. The addiction to information technology had been associated with a delay in initiation of sleep. This work has implication for screening technology addiction among subjects seeking treatment for psychological problems and motivate them to develop the healthy use of technology.

  5. Meditation awareness training for the treatment of fibromyalgia syndrome: A randomized controlled trial.

    Science.gov (United States)

    Van Gordon, William; Shonin, Edo; Dunn, Thomas J; Garcia-Campayo, Javier; Griffiths, Mark D

    2017-02-01

    The purpose of this study was to conduct the first randomized controlled trial (RCT) to evaluate the effectiveness of a second-generation mindfulness-based intervention (SG-MBI) for treating fibromyalgia syndrome (FMS). Compared to first-generation mindfulness-based interventions, SG-MBIs are more acknowledging of the spiritual aspect of mindfulness. A RCT employing intent-to-treat analysis. Adults with FMS received an 8-week SG-MBI known as meditation awareness training (MAT; n = 74) or an active control intervention known as cognitive behaviour theory for groups (n = 74). Assessments were performed at pre-, post-, and 6-month follow-up phases. Meditation awareness training participants demonstrated significant and sustained improvements over control group participants in FMS symptomatology, pain perception, sleep quality, psychological distress, non-attachment (to self, symptoms, and environment), and civic engagement. A mediation analysis found that (1) civic engagement partially mediated treatment effects for all outcome variables, (2) non-attachment partially mediated treatment effects for psychological distress and sleep quality, and (3) non-attachment almost fully mediated treatment effects for FMS symptomatology and pain perception. Average daily time spent in meditation was found to be a significant predictor of changes in all outcome variables. Meditation awareness training may be a suitable treatment for adults with FMS and appears to ameliorate FMS symptomatology and pain perception by reducing attachment to self. Statement of contribution What is already known on this subject? Designing interventions to treat fibromyalgia syndrome (FMS) continues to be a challenge. There is growing interest into the applications of mindfulness-based interventions for treating FMS. Second-generation mindfulness-based interventions (SG-MBIs) are a key new direction in mindfulness research. What does this study add? Meditation awareness training - an SG-MBI - resulted

  6. Psychological factors and treatment effectiveness in resistant anxiety disorders in highly comorbid inpatients

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    Ociskova M

    2016-06-01

    Full Text Available Marie Ociskova, Jan Prasko, Klara Latalova, Dana Kamaradova, Ales Grambal Department of Psychiatry, Olomouc University Hospital, Faculty of Medicine and Dentistry, Palacký University Olomouc, Czech Republic Background: Anxiety disorders are a group of various mental syndromes that have been related with generally poor treatment response. Several psychological factors may improve or hinder treatment effectiveness. Hope has a direct impact on the effectiveness of psychotherapy. Also, dissociation is a significant factor influencing treatment efficiency in this group of disorders. Development of self-stigma could decrease treatment effectiveness, as well as several temperamental and character traits. The aim of this study was to explore a relationship between selected psychological factors and treatment efficacy in anxiety disorders. Subjects and methods: A total of 109 inpatients suffering from anxiety disorders with high frequency of comorbidity with depression and/or personality disorder were evaluated at the start of the treatment by the following scales: the Mini-International Neuropsychiatric Interview, the Internalized Stigma of Mental Illness scale, the Adult Dispositional Hope Scale, and the Temperament and Character Inventory – revised. The participants, who sought treatment for anxiety disorders, completed the following scales at the beginning and end of an inpatient-therapy program: Clinical Global Impression (objective and subjective the Beck Depression Inventory – second edition, the Beck Anxiety Inventory, and the Dissociative Experiences Scale. The treatment consisted of 25 group sessions and five individual sessions of cognitive behavioral therapy or psychodynamic therapy in combination with pharmacotherapy. There was no randomization to the type of group-therapy program. Results: Greater improvement in psychopathology, assessed by relative change in objective Clinical Global Impression score, was connected with low initial

  7. Psilocybin with psychological support improves emotional face recognition in treatment-resistant depression.

    Science.gov (United States)

    Stroud, J B; Freeman, T P; Leech, R; Hindocha, C; Lawn, W; Nutt, D J; Curran, H V; Carhart-Harris, R L

    2018-02-01

    Depressed patients robustly exhibit affective biases in emotional processing which are altered by SSRIs and predict clinical outcome. The objective of this study is to investigate whether psilocybin, recently shown to rapidly improve mood in treatment-resistant depression (TRD), alters patients' emotional processing biases. Seventeen patients with treatment-resistant depression completed a dynamic emotional face recognition task at baseline and 1 month later after two doses of psilocybin with psychological support. Sixteen controls completed the emotional recognition task over the same time frame but did not receive psilocybin. We found evidence for a group × time interaction on speed of emotion recognition (p = .035). At baseline, patients were slower at recognising facial emotions compared with controls (p psilocybin, this difference was remediated (p = .208). Emotion recognition was faster at follow-up compared with baseline in patients (p = .004, d = .876) but not controls (p = .263, d = .302). In patients, this change was significantly correlated with a reduction in anhedonia over the same time period (r = .640, p = .010). Psilocybin with psychological support appears to improve processing of emotional faces in treatment-resistant depression, and this correlates with reduced anhedonia. Placebo-controlled studies are warranted to follow up these preliminary findings.

  8. Predictors of Psychological Well-Being during Behavioral Obesity Treatment in Women

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    Paulo N. Vieira

    2011-01-01

    Full Text Available This study examined the association of autonomy-related variables, including exercise motivation, with psychological well-being and quality of life, during obesity treatment. Middle-aged overweight/obese women (n=239 participated in a 1-year behavioral program and completed questionnaires measuring need support, general self-determination, and exercise and treatment motivation. General and obesity-specific health-related quality of life (HRQOL, self-esteem, depression, and anxiety were also assessed. Results showed positive correlations of self-determination and perceived need support with HRQOL and self-esteem, and negative associations with depression and anxiety (P<.001. Treatment autonomous motivation correlated positively with physical (P=.004 and weight-related HRQOL (P<.001, and negatively with depression (P=.025 and anxiety (P=.001. Exercise autonomous motivation was positively correlated with physical HRQOL (P<.001, mental HRQOL (P=.003, weight-related HRQOL (P<.001, and self-esteem (P=.003, and negatively with anxiety (P=.016. Findings confirm that self-determination theory's predictions apply to this population and setting, showing that self-determination, perceived need support, and autonomous self-regulation positively predict HRQOL and psychological well-being.

  9. Electromagnetictherapy for Treatment of Insomnia: A clinical Trial Study

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    Fariba Sadeghi movahhed

    2012-04-01

    Full Text Available Background & Objectives: Insomnia is one of the most common sleep disorders in the world. It causes disruption in daily activities and increases the risk of major depression. Hence, clinically the appropriate and persistent treatment of insomnia is very important. Using of hypnotic drugs such as benzodiazepines is the common treatment for insomnia but they show several side effects and it seems that new medications should be used for treatment of sleep disorders. The aim of this study was comparison between the effects of electromagnetic therapy and conventional drug usage in the treatment of insomnia.   Methods: In a blind randomized clinical trial study, 60 people referred to the private office of the psychiatrist and experienced more than 3 months extended primary insomnia were selected. They were diagnosed by DSM-IV criteria and had no other underlying problems. The subjects were divided in two groups: 30 people in each and treated electromagnetically or with Alprazolam for 3 weeks. Before treatment, immediately and one month after treatment, quality of sleep and severity of the insomnia were evaluated by using the standard questionnaires and finally, the results were analyzed statistically.   Results : In this study, 60 individuals participated from whom 28 were male (46.7% and 32 patients were female (53.3%.The mean age was 37.3 years old in a range of 17- 65. The mean point of each questionnaire, before and immediately after treatment significantly didn't show any difference but one month after treatment, there was a significant difference in both groups.   Conclusion : To treat insomnia, electromagnetic therapy appears to be used as a replacement for sedative medicines. It also has more stability in comparison with other sedative medicines and no side effects have been reported yet.

  10. Improving clinical trial design for hepatocellular carcinoma treatments

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    Robert G. Gish

    2011-12-01

    Full Text Available Despite its place as the third leading cause of cancer deaths worldwide, there are currently no approved chemotherapeutic agents, devices or techniques to treat hepatocellular carcinoma. Importantly, there have been no phase III studies demonstrating survival benefit, nor any randomized studies of treatment except for transarterial chemoembolization and most recently sorafenib. The importance of well-designed clinical trials of agents to treat HCC has never been greater. However, general clinical study design issues, combined with HCC-specific issues pose significant challenges in structuring such studies. HCC-related challenges include the heterogeneity of this cancer and the fact that it is frequently accompanied by significant comorbidities at diagnosis, such as active hepatitis B or C virus replication, substantial past or on-going alcohol use, and cirrhosis, itself often a fatal disease. The recently published comparison of a newer treatment, nolatrexed to doxorubicin, and comments about this study’s initial HCC diagnostic criteria, staging system, comparator therapy and choice of endpoints have provided a platform to discuss the challenges unique to the design of HCC clinical trials. The difficulty in accurately framing study results obtained from the constantly changing HCC clinical landscape and approaches to meet these challenges will be reviewed.

  11. A randomized controlled trial of laser treatment among hirsute women with polycystic ovary syndrome.

    Science.gov (United States)

    Clayton, W J; Lipton, M; Elford, J; Rustin, M; Sherr, L

    2005-05-01

    Facial hirsutism is one of the characteristic features of polycystic ovary syndrome (PCOS), and this can lead to high levels of depression and anxiety. To evaluate the impact of laser treatment on the severity of facial hirsutism and on psychological morbidity in women with PCOS. A randomized controlled trial of five high-fluence treatments (intervention) vs. five low-fluence treatments (control) was performed over 6 months in a National Health Service teaching hospital. Subjects were 88 women with facial hirsutism due to PCOS recruited from hospital outpatient clinics and a patient support group in 2001-2002. The main outcomes were self-reported severity of facial hair (measured on a scale of 1-10), depression, anxiety (measured on the Hospital Anxiety and Depression Scale) and quality of life (measured on the WHOQOL-BREF). Self-reported severity of facial hair in the intervention group (n = 51) fell from 7.3 to 3.6 over the 6-month study period; for the control group (n = 37) the corresponding scores were 7.1 and 6.1. The change was significantly greater in the intervention group [ancova F((1,83)) = 24.5, P hair removal declined from 112 to 21 min per week in the intervention group and from 92 to 56 min in the control group [F((1,80)) = 10.2, P Psychological quality of life also improved more in the intervention group, from 49.6 to 61.2 vs. 50.1 to 51.5 in the control group [F((1,84)) = 10.9, P facial hair and time spent on hair removal as well as alleviating depression and anxiety in women with PCOS. These findings suggest that ways of making this method of hair removal more widely available to women with facial hirsutism should be considered.

  12. PAHA study: psychological active and healthy aging: psychological wellbeing, proactive attitude and happiness effects of whole-body vibration versus Multicomponent Training in aged women: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Compare, Angelo; Zarbo, Cristina; Marín, Elena; Meloni, Alessia; Rubio-Arias, Jacobo A; Berengüí, Rosendo; Grossi, Enzo; Shonin, Edo; Martini, Gianmaria; Alcaraz, Pedro E

    2014-05-20

    Evidence demonstrates that physical exercise and psychological wellbeing are closely interlinked, particularly in older-aged women. However, research investigating how different forms of exercise influence mental health in older-aged women is underdeveloped. A randomized controlled trial (N = 300) will assess the relative effectiveness of two different exercise programs (whole-body vibration and Multicomponent Training) for improving psychological wellbeing in older-aged women. The following outcomes will be assessed at three time points (that is, pre, post, and follow-up): psychological wellbeing, proactive attitude, quality of life, and happiness. Results will have important implications for preventing psychological and physiological disease in older-aged women and for managing health-related costs for this population group. Number NCT01966562 on Clinical Gov database the 8 October 2013.

  13. Efficacy of a Multicomponent Positive Psychology Self-Help Intervention: Study Protocol of a Randomized Controlled Trial

    Science.gov (United States)

    Drossaert, Constance HC; Pieterse, Marcel E; Walburg, Jan A; Bohlmeijer, Ernst T

    2015-01-01

    Background Positive psychology interventions have been found to enhance well-being and decrease clinical symptomatology. However, it is still unknown how flourishing can also be increased. Although multicomponent interventions seem to be necessary for this purpose, different formats can be used. A cost-effective approach could be a positive psychology-based self-help book with tailored email support to reach large target groups and to prevent dropout. Objective This study will evaluate the efficacy of a comprehensive multicomponent self-help intervention with or without email support on well-being and flourishing, and will seek to determine the working mechanisms underlying the intervention. Methods In this 3-armed, parallel, randomized controlled trial, 396 participants with low or moderate levels of well-being and without clinical symptomatology will be randomly assigned to (1) a self-help book condition with weekly email support, (2) a self-help book condition without email support but with a weekly information email, or (3) a waiting list control condition. Online measurements will be assessed at baseline, at post-test (3 months after baseline), and at 6 and 12 months after baseline. Results The primary outcomes are well-being and flourishing (ie, high levels of well-being). Secondary outcomes are the well-being components included in the intervention: positive emotion, use of strengths, optimism, self-compassion, resilience, and positive relations. Other measures include depressive and anxiety symptoms, personality traits, direct medical and non-medical costs, life-events, and client satisfaction. Conclusions This study will add knowledge to the efficacy and cost-effectiveness of a multicomponent positive psychology intervention. We will also explore who can benefit most from this intervention. If the intervention is found to be effective, our results will be especially relevant for public mental health services, governments, and primary care. Trial

  14. [Psychological factors associated to patient's treatment compliance in Chilean diabetic teenagers].

    Science.gov (United States)

    Ortiz, Manuel; Ortiz, Eugenia

    2005-03-01

    Treatment compliance among patients with type 1 diabetes mellitus, is low in 50% of diabetic teenagers, becoming a social and medical problem. To determine psycho-social factors associated to treatment compliance among Chilean diabetic type 1 teenagers. A non experimental study of 61 diabetic teenagers (age 14.9+/-1.9 years, 37 male). The number of blood glucose determinations, socioeconomic level and practice of sports was measured. Psychological tests were applied to analyze self-efficiency, motivation of achievement, self-esteem and knowledge of the illness and its treatment. As a measure of patient compliance, glycosilated hemoglobin (HB1Ac) was measured. Six patients had a good control of diabetes (HB1Ac <7%), 24 had HB1Ac values between 7 and 8.9, and 31 (51%) had values of 9% or more, considered as a poor diabetes control. The intensified insulin treatment scheme, the knowledge of the illness and its treatment and the sense of self-efficiency, were the factors associated with a better compliance with treatment. Teenagers of higher socio-economical levels had a better compliance with treatment. Fifty percent of Chilean diabetic teenagers in this sample had a poor control of the disease and the variable knowledge about the disease is the better predictor of patient compliance.

  15. Coping strategies as mediators of the effect of the START (strategies for RelaTives) intervention on psychological morbidity for family carers of people with dementia in a randomised controlled trial.

    Science.gov (United States)

    Li, Ryan; Cooper, Claudia; Barber, Julie; Rapaport, Penny; Griffin, Mark; Livingston, Gill

    2014-10-01

    Family carers of people with dementia frequently become depressed or anxious. In observational studies, more emotion-focused and less dysfunctional coping predict fewer psychological symptoms, but no randomised controlled trial (RCT) has directly investigated emotion-focused coping as mediator of effectiveness of a successful psychological intervention. We hypothesised that emotion-focused coping would mediate the START psychological intervention׳s effects in an RCT. We tested whether mediated effects were moderated by severity of baseline symptoms. 260 family carers from NHS dementia services were randomised to START (manualised coping skills intervention), or treatment-as-usual (TAU). Blinded raters administered the Hospital Anxiety and Depression Scale (HADS-T) and Brief COPE inventory at baseline, 4 and 8 months. HADS-T improved in the intervention group when compared to TAU at all levels of psychological distress. We tested whether coping was a mediator and for moderated mediation, and (post-hoc) subgroup treatment effects on coping. Data were available for 187 carers (71.9%) for the mediation analysis. The reduced HADS-T score in the intervention group was mediated by increased emotion-focused coping only among carers with higher (16+) baseline HADS-T scores (mediated effect=-0.63 [-1.11, -0.15]; proportion of overall effect=33% [3%, 64%]). We did not measure plausible psychosocial treatment mechanisms other than coping. START benefited family carers both in preventing and treating psychological morbidity, through different mechanisms of action. The most psychologically distressed carers increased their emotion-focused coping and did not decrease their dysfunctional coping, while others benefited but not through this mechanism. Copyright © 2014 Elsevier B.V. All rights reserved.

  16. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 2. Psychological Treatments.

    Science.gov (United States)

    Parikh, Sagar V; Quilty, Lena C; Ravitz, Paula; Rosenbluth, Michael; Pavlova, Barbara; Grigoriadis, Sophie; Velyvis, Vytas; Kennedy, Sidney H; Lam, Raymond W; MacQueen, Glenda M; Milev, Roumen V; Ravindran, Arun V; Uher, Rudolf

    2016-09-01

    The Canadian Network for Mood and Anxiety Treatments (CANMAT) has revised its 2009 guidelines for the management of major depressive disorder (MDD) in adults by updating the evidence and recommendations. The target audiences for these 2016 guidelines are psychiatrists and other mental health professionals. Using the question-answer format, we conducted a systematic literature search focusing on systematic reviews and meta-analyses. Evidence was graded using CANMAT-defined criteria for level of evidence. Recommendations for lines of treatment were based on the quality of evidence and clinical expert consensus. "Psychological Treatments" is the second of six sections of the 2016 guidelines. Evidence-informed responses were developed for 25 questions under 5 broad categories: 1) patient characteristics relevant to using psychological interventions; 2) therapist and health system characteristics associated with optimizing outcomes; 3) descriptions of major psychotherapies and their efficacy; 4) additional psychological interventions, such as peer interventions and computer- and technology-delivered interventions; and 5) combining and/or sequencing psychological and pharmacological interventions. First-line psychological treatment recommendations for acute MDD include cognitive-behavioural therapy (CBT), interpersonal therapy (IPT), and behavioural activation (BA). Second-line recommendations include computer-based and telephone-delivered psychotherapy. Where feasible, combining psychological treatment (CBT or IPT) with antidepressant treatment is recommended because combined treatment is superior to either treatment alone. First-line psychological treatments for maintenance include CBT and mindfulness-based cognitive therapy (MBCT). Patient preference, in combination with evidence-based treatments and clinician/system capacity, will yield the optimal treatment strategies for improving individual outcomes in MDD. © The Author(s) 2016.

  17. The psychological impact of IVF failure after two or more cycles of IVF with a mild versus standard treatment strategy

    OpenAIRE

    Klerk, Cora; Macklon, Nick; Heijnen, E.M.; Eijkemans, René; Fauser, Bart; Passchier, Jan; Hunfeld, Joke

    2007-01-01

    textabstractBackground: Failure of IVF treatment after a number of cycles can be devastating for couples. Although mild IVF strategies reduce the psychological burden of treatment, failure may cause feelings of regret that a more aggressive approach, including the transfer of two embryos, was not employed. In this study, the impact of treatment failure after two or more cycles on stress was studied, following treatment with a mild versus a standard treatment strategy. Methods: Randomized cont...

  18. Editorial: Trials and tribulations in child psychology and psychiatry: what is needed for evidence-based practice.

    Science.gov (United States)

    Stringaris, Argyris

    2014-11-01

    If your child had leukaemia you would be distraught. Yet, there would also be hope. Most children with a diagnosis of leukaemia start their treatment as part of ongoing trials. The clinical teams looking after such children are motivated, knowledgeable and work in centres that specialise in the treatment of this lethal illness. The results speak for themselves. Not only have the trials helped oncologists learn more about which treatments work best. For years we have known that those who enter trials do better than those patients with similar characteristics who don't. We have recently also learnt that trials improve survival rates in those cancers population wide: the annual reduction between 1978-2005 in risk of death from childhood cancers ranged from 2.7% to 12.0%. This cancer trial culture is a splendid example of British health care delivery. What is happening in child psychiatry, though? If your child had, say, depression you would have every reason to be distraught too. The mortality rate is higher than in the general population and the burden of disease in the long run heavier than that of cardiovascular illness or cancer. Yet, your child would not have access to a trial. Instead, you would probably struggle to have your child's depression recognised in the first place. The care you would get would be determined by extreme regional variations and by what resources are available to local services and often the ideology or preferences of practitioners. © 2014 Association for Child and Adolescent Mental Health.

  19. A Randomized Controlled Trial Evaluating the Effects of Diosmin in the Treatment of Radicular Pain

    Directory of Open Access Journals (Sweden)

    Yinhe Wang

    2017-01-01

    Full Text Available Diosmin has been widely used to treat patients with vascular pain for its potent anti-inflammatory and analgesic effects. To evaluate the therapeutic effects of Diosmin in the treatment of radicular pain, we conducted an investigator-initiated, randomized, active-controlled noninferiority trial between January 1, 2009, and December 1, 2010. Diosmin (50 mg/kg/day was orally administered to treat the radicular pain in 150 patients for one month. Another 150 patients with the same symptom were given 20% 250 ml mannitol (1 g/kg/day for 7 days and dexamethasone (10 mg/day for 3 days intravenously guttae. Short-term relief and long-term relief were measured. Secondary outcomes include improvement in functional and psychological status, return to work, and reduction in anti-inflammatory analgesic drugs intake. Patients treated with oral Diosmin achieved reduction in radicular pain. The total satisfaction rate of Diosmin group was 84.7% [95% confidence interval (CI: 77.9%, 90.0%], and the complete satisfaction rate was 50.7% (95% CI: 42.4%, 58.9%. No statistically significant difference was found between the Diosmin group and the active-control group regarding patient satisfaction. No adverse effects were found during the study period. Our study suggests that clinical application of Diosmin with a dose of 50 mg/kg/day might reduce the radicular pain. This trial is registered with ISRCTN97157037.

  20. The effect of Baduanjin exercise for physical and psychological wellbeing of college students: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Zheng, Guohua; Li, Moyi; Lan, Xiulu; Yan, Xinghui; Lin, Qiu; Chen, Lidian; Tao, Jing; Zheng, Xin; Li, Junzhe; Chen, Bai; Fang, Qianying

    2013-12-05

    The physical and mental health of college students tends to continuously decline around the world. Since they are in a significant transition period which presents opportunities and challenges in health promotion, it is important to improve their health in this period. As a traditional Chinese exercise form which combines movements with breath and mind, Baduanjin may be one of the selectable effective exercises. However, evidence of Baduanjin exercise for college students has not been completely established. The primary aim of this trial is to evaluate the effectiveness and safety of Baduanjin exercise for physical and mental health of college students through a rigorous randomization, parallel-controlled design. We will conduct a randomized, single-blind, parallel-controlled trial. A total of 222 college students from Fujian University of Traditional Chinese Medicine who meet the eligibility criteria will be recruited and randomly allocated into Baduanjin training or usual exercise control group. Baduanjin training will last 12 weeks (1 h per day, 5 days per week). The physical and psychological outcomes, including lumbar muscle strength, lumbar proprioception function, physical fitness, as well as self-reported symptom intensity, stress, self-esteem, mood, quality of life, quality of sleep, and adverse events, will be evaluated by blinded outcome assessors at baseline, 13 weeks (at the end of intervention), and 25 weeks (after the 12-week follow-up period). This protocol presents an objective design of a randomized, single-blind trial that aims to evaluate the effectiveness and safety of Baduanjin exercise for physical and mental health of college students. If the outcome is positive, the results will provide higher-quality evidence to better inform the college students regarding their selection about whether to receive such exercise. Chinese Clinical Trial Registry: ChiCTR-TRC-13003329. Registration date: 18 July, 2013.

  1. Electroacupuncture treatment for pancreatic cancer pain: a randomized controlled trial.

    Science.gov (United States)

    Chen, Hao; Liu, Tang-Yi; Kuai, Le; Zhu, Ji; Wu, Cai-Jun; Liu, Lu-Ming

    2013-01-01

    Pancreatic cancer is often accompanied by severe abdominal or back pain. It's the first study to evaluate the analgesic effect of electroacupuncture on pancreatic cancer pain. A randomized controlled trial compared electroacupuncture with control acupuncture using the placebo needle. Sixty patients with pancreatic cancer pain were randomly assigned to the electroacupuncture group (n = 30) and the placebo control group (n = 30). Patients were treated on Jiaji (Ex-B2) points T8-T12 bilaterally for 30 min once a day for 3 days. Pain intensity was assessed with numerical rated scales (NRS) before the treatment (Baseline), after 3 treatments, and 2 days follow-up. Baseline characteristics were similar in the two groups. After 3 treatment, pain intensity on NRS decreased compared with Baseline (-1.67, 95% confidence interval [CI] -1.46 to -1.87) in the electroacupuncture group; there was little change (-0.13, 95% CI 0.08 to -0.35) in control group; the difference between two groups was statistically significant (P electroacupuncture group compared with the control group (P Electroacupuncture was an effective treatment for relieving pancreatic cancer pain. Copyright © 2013 IAP and EPC. Published by Elsevier B.V. All rights reserved.

  2. National Emphysema Treatment Trial redux: accentuating the positive.

    Science.gov (United States)

    Sanchez, Pablo Gerardo; Kucharczuk, John Charles; Su, Stacey; Kaiser, Larry Robert; Cooper, Joel David

    2010-09-01

    Under the Freedom of Information Act, we obtained the follow-up data of the National Emphysema Treatment Trial (NETT) to determine the long-term outcome for "a heterogeneous distribution of emphysema with upper lobe predominance," postulated by the NETT hypothesis to be optimal candidates for lung volume reduction surgery. Using the NETT database, we identified patients with heterogeneous distribution of emphysema with upper lobe predominance and analyzed for the first time follow-up data for those receiving lung volume reduction surgery and those receiving medical management. Furthermore, we compared the results of the NETT reduction surgery group with a previously reported consecutive case series of 250 patients undergoing bilateral lung volume reduction surgery using similar selection criteria. Of the 1218 patients enrolled, 511 (42%) conformed to the NETT hypothesis selection criteria and received the randomly assigned surgical or medical treatment (surgical = 261; medical = 250). Lung volume reduction surgery resulted in a 5-year survival benefit (70% vs 60%; P = .02). Results at 3 years compared with baseline data favored surgical reduction in terms of residual volume reduction (25% vs 2%; P George Respiratory Questionnaire quality of life score (12 points vs 0 points; P < .001). For the 513 patients with a homogeneous pattern of emphysema randomized to surgical or medical treatment, lung volume reduction surgery produced no survival advantage and very limited functional benefit. Patients most likely to benefit from lung volume reduction surgery have heterogeneously distributed emphysema involving the upper lung zones predominantly. Such patients in the NETT trial had results nearly identical to those previously reported in a nonrandomized series of similar patients undergoing lung volume reduction surgery. 2010 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  3. Intergenerational and cross-cultural differences in emotional wellbeing, mental health service utilisation, treatment-seeking preferences and acceptability of psychological treatments for Arab Australians.

    Science.gov (United States)

    Kayrouz, Rony; Dear, Blake F; Johnston, Luke; Keyrouz, Liliane; Nehme, Edmond; Laube, Roy; Titov, Nickolai

    2015-08-01

    Little is known about the intergenerational and cross-cultural differences in emotional wellbeing and acceptability of psychological treatments for Arab Australians. To contribute to the emerging data about the mental health status and needs of Arab Australians. An Internet survey examined psychological distress and functional impairment as measured by the Kessler 10 Item scale (K-10) and the Sheehan Disability Scale (SDS) among Arab Australians. Additional questions enquired about their help-seeking behaviours, barriers to accessing psychological treatments and preferences for delivery of psychological treatments. A total of 252 participants were recruited through public talks, media and online promotions. Forty-three percent of the respondents reported moderate-to-severe functional impairment (M = 9.5; standard deviation (SD) = 1.8), 32% reported high psychological distress (M = 28.5; SD = 5.4) and 30% were born overseas. First-generation Arab Australians experiencing high psychological distress (i.e. K-10 ≥ 22), reported a greater preference for Internet-delivered treatment when compared to their second-generation counterparts. Only 18% of the sample reported seeking help from a mental health professional in the past year. The significant barriers reported by respondents with high psychological distress were poor mental health literacy, lack of time and stigma. Respondents preferred face-to-face (90%) over Internet-delivered treatment (55%). Finally, Arab Australians experienced higher psychological distress and underutilised mental health services when compared to the Australian population. Targeted public health campaigns that make culturally relevant interventions such as modifying existing Internet-delivered treatment for Arab Australians may reduce barriers and increase treatment options for this population. © The Author(s) 2014.

  4. Potential psychological & neural mechanisms in binge eating disorder: Implications for treatment.

    Science.gov (United States)

    Kober, Hedy; Boswell, Rebecca G

    2018-03-01

    Binge Eating Disorder (BED) is a newly-established eating disorder diagnosis in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Although systematic research on BED is in its infancy and many studies feature small samples, several observations emerge. First, we review diagnostic, developmental, and socio-demographic features of BED. Next, although BED and obesity are linked and frequently co-occur, we review data suggesting that BED is a distinct phenotype. Importantly, we take a mechanism-focused approach and propose four psychological processes with neurobiological bases that may uniquely differentiate BED from obesity: emotion reactivity, food-cue reactivity, food craving, and cognitive control. Further, we propose that interactions between impairments in cognitive control and increased emotional reactivity, food-cue reactivity, and craving may underlie emotion dysregulation and promote binge eating. Consistently, neuroimaging studies point towards neural alterations in the response to rewards and to food specifically, and suggest preliminary links between impaired cognitive-control-related neural activity and binge eating. However, additional systematic work is required in this area. We conclude with a detailed review of treatment approaches to BED; specifically, we suggest that psychological and pharmacological treatments that target core mechanisms - including cognitive control and emotion/craving dysregulation - may be particularly effective. Copyright © 2018 Elsevier Ltd. All rights reserved.

  5. Drug trajectories among youth undergoing treatment: the influence of psychological problems and delinquency.

    Science.gov (United States)

    Brunelle, Natacha; Bertrand, Karine; Beaudoin, Isabelle; Ledoux, Cinthia; Gendron, Annie; Arseneault, Catherine

    2013-08-01

    Previous research has documented associations of addiction with delinquency and psychological problems. However, few studies have evaluated their influence on adolescent's drug use trajectories. The current study aims to examine the influence of these factors on the recovery trajectories of 199 youths aged 15.6 years on average admitted to inpatient and outpatient addiction treatment centers, followed up three and six months later. Results indicate that youth who show higher severity of drug abuse exhibit greater improvement than youth with a lower severity of drug abuse at the onset of treatment. Although psychological problems were associated with baseline drug use, they did not influence drug use trajectory over time. Only delinquency influenced the recovery trajectories of these youth. Results suggest that a high level of delinquency can have a significant effect on the drug recovery process of adolescents and that interventions should attempt to reduce both drug use and delinquency. Copyright © 2013 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

  6. Regression Discontinuity and Randomized Controlled Trial Estimates: An Application to The Mycotic Ulcer Treatment Trials.

    Science.gov (United States)

    Oldenburg, Catherine E; Venkatesh Prajna, N; Krishnan, Tiruvengada; Rajaraman, Revathi; Srinivasan, Muthiah; Ray, Kathryn J; O'Brien, Kieran S; Glymour, M Maria; Porco, Travis C; Acharya, Nisha R; Rose-Nussbaumer, Jennifer; Lietman, Thomas M

    2018-08-01

    We compare results from regression discontinuity (RD) analysis to primary results of a randomized controlled trial (RCT) utilizing data from two contemporaneous RCTs for treatment of fungal corneal ulcers. Patients were enrolled in the Mycotic Ulcer Treatment Trials I and II (MUTT I & MUTT II) based on baseline visual acuity: patients with acuity ≤ 20/400 (logMAR 1.3) enrolled in MUTT I, and >20/400 in MUTT II. MUTT I investigated the effect of topical natamycin versus voriconazole on best spectacle-corrected visual acuity. MUTT II investigated the effect of topical voriconazole plus placebo versus topical voriconazole plus oral voriconazole. We compared the RD estimate (natamycin arm of MUTT I [N = 162] versus placebo arm of MUTT II [N = 54]) to the RCT estimate from MUTT I (topical natamycin [N = 162] versus topical voriconazole [N = 161]). In the RD, patients receiving natamycin had mean improvement of 4-lines of visual acuity at 3 months (logMAR -0.39, 95% CI: -0.61, -0.17) compared to topical voriconazole plus placebo, and 2-lines in the RCT (logMAR -0.18, 95% CI: -0.30, -0.05) compared to topical voriconazole. The RD and RCT estimates were similar, although the RD design overestimated effects compared to the RCT.

  7. Effect of dignity therapy on end-of-life psychological distress in terminally ill Portuguese patients: A randomized controlled trial.

    Science.gov (United States)

    Julião, Miguel; Oliveira, Fátima; Nunes, Baltazar; Carneiro, António Vaz; Barbosa, António

    2017-12-01

    Dignity therapy (DT) is a brief form of psychotherapy developed for patients living with a life-limiting illness that has demonstrated efficacy in treating several dimensions of end-of-life psychological distress. Our aim was to determine the influence of DT on demoralization syndrome (DS), the desire for death (DfD), and a sense of dignity (SoD) in terminally ill inpatients experiencing a high level of distress in a palliative care unit. A nonblinded phase II randomized controlled trial was conducted with 80 patients who were randomly assigned to one of two groups: the intervention group (DT + standard palliative care [SPC]) or the control group (SPC alone). The main outcomes were DS, DfD, and SoD, as measured according to DS criteria, the Desire for Death Rating Scale, and the Patient Dignity Inventory (PDI), respectively. All scales were assessed at baseline (day 1) and at day 4 of follow-up. This study is registered with http://www.controlled-trials.com/ISRCTN34354086. Of the 80 participants, 41 were randomized to DT and 39 to SPC. Baseline characteristics were similar between the two groups. DT was associated with a significant decrease in DS compared with SPC (DT DS prevalence = 12.1%; SPC DS prevalence = 60.0%; p Dignity therapy had a beneficial effect on the psychological distress encountered by patients near the end of life. Our research suggests that DT is an important psychotherapeutic approach that should be included in clinical care programs, and it could help more patients to cope with their end-of-life experiences.

  8. Tailored educational supportive care programme on sleep quality and psychological distress in patients with heart failure: A randomised controlled trial.

    Science.gov (United States)

    Chang, Yia-Ling; Chiou, Ai-Fu; Cheng, Shu-Meng; Lin, Kuan-Chia

    2016-09-01

    Up to 74% of patients with heart failure report poor sleep in Taiwan. Poor symptom management or sleep hygiene may affect patients' sleep quality. An effective educational programme was important to improve patients' sleep quality and psychological distress. However, research related to sleep disturbance in patients with heart failure is limited in Taiwan. To examine the effects of a tailored educational supportive care programme on sleep disturbance and psychological distress in patients with heart failure. randomised controlled trial. Eighty-four patients with heart failure were recruited from an outpatient department of a medical centre in Taipei, Taiwan. Patients were randomly assigned to the intervention group (n=43) or the control group (n=41). Patients in the intervention group received a 12-week tailored educational supportive care programme including individualised education on sleep hygiene, self-care, emotional support through a monthly nursing visit at home, and telephone follow-up counselling every 2 weeks. The control group received routine nursing care. Data were collected at baseline, the 4th, 8th, and 12th weeks after patients' enrollment. Outcome measures included sleep quality, daytime sleepiness, anxiety, and depression. The intervention group exhibited significant improvement in the level of sleep quality and daytime sleepiness after 12 weeks of the supportive nursing care programme, whereas the control group exhibited no significant differences. Anxiety and depression scores were increased significantly in the control group at the 12th week (p.05). Compared with the control group, the intervention group had significantly greater improvement in sleep quality (β=-2.22, pquality and psychological distress in patients with heart failure. We suggested that this supportive nursing care programme should be applied to clinical practice in cardiovascular nursing. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. The challenger app for social anxiety disorder: New advances in mobile psychological treatment

    Directory of Open Access Journals (Sweden)

    Alexander Miloff

    2015-11-01

    Full Text Available Social anxiety disorder (SAD is a common debilitating mental illness with large negative effects on quality of life and economic productivity. Modern psychotherapy treatments utilizing cognitive–behavioral theory are increasingly delivered over the Internet and more recently using smartphone applications. The Challenger App written natively for the Apple iPhone was developed at the Stockholm University Department of Psychology for the treatment of SAD and uses a number of advanced features not previously seen in past mental health applications; these include real-time location awareness, notifications, anonymous social interaction between users, a high-degree of personalization and use of gamification techniques. This paper explores design considerations for the various components of the app, their theoretical and evidence base, and research opportunities that exist for apps making use of these novel features.

  10. Selection of response criteria for clinical trials of sarcoma treatment.

    Science.gov (United States)

    Schuetze, Scott M; Baker, Laurence H; Benjamin, Robert S; Canetta, Renzo

    2008-01-01

    Soft tissue sarcomas are a heterogeneous group of malignancies arising from mesenchymal tissues. A large number of new therapies are being evaluated in patients with sarcomas, and consensus criteria defining treatment responses are essential for comparison of results from studies completed by different research groups. The 1979 World Health Organization (WHO) handbook set forth operationally defined criteria for response evaluation in solid tumors that were updated in 2000 with the publication of the Response Evaluation Criteria in Solid Tumors (RECIST). There have been significant advances in tumor imaging, however, that are not reflected in the RECIST. For example, computed tomography (CT) slice thickness has been reduced from 10 mm to < or =2.5 mm, allowing for more reproducible and accurate measurement of smaller lesions. Combination of imaging techniques, such as positron emission tomography with fluorine-18-fluorodeoxyglucose (18FDG-PET) and CT can provide investigators and clinicians with both anatomical and functional information regarding tumors, and there is now a large body of evidence demonstrating the effectiveness of PET/CT and other newer imaging methods for the detection and staging of tumors as well as early determination of responses to therapy. The application of newer imaging methods has the potential to decrease both the sample sizes required for, and duration of, clinical trials by providing an early indication of therapeutic response that is well correlated with clinical outcomes, such as time to tumor progression or overall survival. The results summarized in this review support the conclusion that the RECIST and the WHO criteria for evaluation of response in solid tumors need to be modernized. In addition, there is a current need for prospective trials to compare new response criteria with established endpoints and to validate imaging-based response rates as surrogate endpoints for clinical trials of new agents for sarcoma and other solid

  11. Intensive home treatment for patients in acute psychiatric crisis situations: a multicentre randomized controlled trial.

    Science.gov (United States)

    Cornelis, Jurgen; Barakat, Ansam; Dekker, Jack; Schut, Tessy; Berk, Sandra; Nusselder, Hans; Ruhl, Nikander; Zoeteman, Jeroen; Van, Rien; Beekman, Aartjan; Blankers, Matthijs

    2018-02-27

    Hospitalization is a common method to intensify care for patients experiencing a psychiatric crisis. A short-term, specialised, out-patient crisis intervention by a Crisis Resolution Team (CRT) in the Netherlands, called Intensive Home Treatment (IHT), is a viable intervention which may help reduce hospital admission days. However, research on the (cost-)effectiveness of alternatives to hospitalisation such as IHT are scarce. In the study presented in this protocol, IHT will be compared to care-as-usual (CAU) in a randomized controlled trial (RCT). CAU comprises low-intensity outpatient care and hospitalisation if necessary. In this RCT it is hypothesized that IHT will reduce inpatient days by 33% compared to CAU while safety and clinical outcomes will be non-inferior. Secondary hypotheses are that treatment satisfaction of patients and their relatives are expected to be higher in the IHT condition compared to CAU. A 2-centre, 2-arm Zelen double consent RCT will be employed. Participants will be recruited in the Amsterdam area, the Netherlands. Clinical assessments will be carried out at baseline and at 6, 26 and 52 weeks post treatment allocation. The primary outcome measure is the number of admission days. Secondary outcomes include psychological well-being, safety and patients' and their relatives' treatment satisfaction. Alongside this RCT an economic evaluation will be carried out to assess the cost-effectiveness and cost-utility of IHT compared to CAU. RCTs on the effectiveness of crisis treatment in psychiatry are scarce and including patients in studies performed in acute psychiatric crisis care is a challenge due to the ethical and practical hurdles. The Zelen design may offer a feasible opportunity to carry out such an RCT. If our study finds that IHT is a safe and cost-effective alternative for CAU it may help support a further decrease of in-patient bed days and may foster the widespread implementation of IHT by mental health care organisations

  12. Impact of Quran in Treatment of the Psychological Disorder and Spiritual Illness.

    Science.gov (United States)

    Saged, Ali Ali Gobaili; Mohd Yusoff, Mohd Yakub Zulkifli; Abdul Latif, Faizuri; Hilmi, Syed Mohammad; Al-Rahmi, Waleed Mugahed; Al-Samman, Ahmed; Alias, Norma; Zeki, Akram M

    2018-02-26

    This paper studies the effect of Quranic therapy on psychological diseases and spiritual diseases. The experiments have been conducted on a random sample with 121 patients from both genders. The procedures that have been followed were different sessions with the patients, who were given some verses from the Holy Quran to listen within a specific period of time. After that, each patient was given a remedy program. This study aimed to measure the effectiveness and responsiveness of patients to receive treatment through Quran. This study highlighted the employment of a quantitative research, which achieved its objective through validity and reliability. The results of the effectiveness factor came after ability and willingness and gave a result of 92.6% for those who support the contention that the Quran has a significant healing influence. Also, some of the patients who regularly attended Quranic therapy sessions have been successfully cured, 81.8% of the sample believe that Quranic therapy sessions support their health needs. This study has empirically proved that the sound of the Holy Quran is an effective treatment for those who suffer from spiritual and psychological issues. Folk medicine and other traditional methods of treatment are important field of study that require further investigation. The study also illustrates that it's highly important for patient to have confidence in his doctor or healer. Furthermore, our results show that the ability and willingness positively and significantly are related to the effectiveness and responsiveness, also effectiveness positively and significantly related to the responsiveness. Therefore, the patients satisfied to receive treatment through Quran and they have the ability and willingness to do so as they believe that Quran is an essential part of their life.

  13. A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans with PTSD

    Science.gov (United States)

    2015-10-01

    research on combined relapse prevention and exposure-based interventions in the treatment of AUD and PTSD. Presentation 4: Pharmacologic Therapies...psychological interviews to determine diagnostic eligibility [Structured Clinical Interview for DSM-IV (SCID) and the Clinician Administered PTSD Scale ...Psychology of Addictive Behaviors. PRESENTATION AT MOMRP SUSBSTANCE ABUSE IPR IN FT. DETRICK, MD: Presented overview & progress of study and pilot

  14. Heavy particle beam cancer treatment apparatus, HIMAC, and clinical trial

    International Nuclear Information System (INIS)

    Soga, Fuminori

    1994-01-01

    The clinical trial was begun in June, 1994, on the treatment of cancer patients using heavy particle beam for the first time in Japan in National Institute of Radiological Sciences. It is the result of promoting the construction of Heavy Ion Medical Accelerator in Chiba (HIMAC) with the first period construction cost of 32.6 billion yen as a part of the 10 year general strategy against cancer. This is only one facility of this kind in the world. The features of heavy particle beam as radiation therapy are the excellent concentration of dose distribution, biological effect and so on. The nuclides to be used are those having the atomic number from helium to argon. The acceleration energy of ions was set at 800 MeV per nucleon so as to reach 30 cm in human bodies. The beam intensity is 5 Gy/min to finish irradiation within 1 min. The maximum irradiation field is 22 cm in diameter. The specification of the HIMAC accelerator is summarized. The Penning Ionization Gauge and the electron cyclotron resonance ion sources were installed for the reliability. The radio frequency quadrupole linear accelerator is suitable to accelerate low velocity, high intensity beam. Two synchrotrons of 41 m mean diameter are installed. High energy beam transport system, irradiation equipment, and the clinical trial are reported. (K.I.)

  15. Internet-delivered psychological treatments for mood and anxiety disorders: a systematic review of their efficacy, safety, and cost-effectiveness.

    Directory of Open Access Journals (Sweden)

    Filip K Arnberg

    Full Text Available Greater access to evidence-based psychological treatments is needed. This review aimed to evaluate whether internet-delivered psychological treatments for mood and anxiety disorders are efficacious, noninferior to established treatments, safe, and cost-effective for children, adolescents and adults.We searched the literature for studies published until March 2013. Randomized controlled trials (RCTs were considered for the assessment of short-term efficacy and safety and were pooled in meta-analyses. Other designs were also considered for long-term effect and cost-effectiveness. Comparisons against established treatments were evaluated for noninferiority. Two reviewers independently assessed the relevant studies for risk of bias. The quality of the evidence was graded using an international grading system.A total of 52 relevant RCTs were identified whereof 12 were excluded due to high risk of bias. Five cost-effectiveness studies were identified and three were excluded due to high risk of bias. The included trials mainly evaluated internet-delivered cognitive behavioral therapy (I-CBT against a waiting list in adult volunteers and 88% were conducted in Sweden or Australia. One trial involved children. For adults, the quality of evidence was graded as moderate for the short-term efficacy of I-CBT vs. waiting list for mild/moderate depression (d = 0.83; 95% CI 0.59, 1.07 and social phobia (d = 0.85; 95% CI 0.66, 1.05, and moderate for no efficacy of internet-delivered attention bias modification vs. sham treatment for social phobia (d =  -0.04; 95% CI -0.24, 0.35. The quality of evidence was graded as low/very low for other disorders, interventions, children/adolescents, noninferiority, adverse events, and cost-effectiveness.I-CBT is a viable treatment option for adults with depression and some anxiety disorders who request this treatment modality. Important questions remain before broad implementation can be supported. Future research would

  16. Psychological, behavioral, and clinical effects of intra-oral camera: a randomized control trial on adults with gingivitis.

    Science.gov (United States)

    Araújo, Mário-Rui; Alvarez, Maria-João; Godinho, Cristina A; Pereira, Cícero

    2016-12-01

    To evaluate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy (SPT), on the psychological, behavioral, and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework. A group of 78 adult patients with gingivitis receiving an SPT was randomized into two groups: IOC and control. Bleeding on Marginal Probing (BOMP), self-reported dental hygiene behaviors, and psychological determinants of behavior change (outcome expectancies, self-efficacy, and planning) and IOC opinion were evaluated 1 week before or during the appointment and 4 months later. Repeated-measures anova was used to compare groups over time. Almost all the patients brushed their teeth daily, while 78% either never or hardly ever used dental floss. The IOC group showed significant improvements in BOMP index (P < 0.001), self-reported flossing (P < 0.05), and self-efficacy (P < 0.05) compared to the control group. The use of IOC significantly improves clinical, behavioral, and psychological determinants of periodontal health 4 months after treatment. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  17. Social, economic, and psychological impacts of MDR-TB treatment in Tijuana, Mexico: a patient's perspective.

    Science.gov (United States)

    Morris, M D; Quezada, L; Bhat, P; Moser, K; Smith, J; Perez, H; Laniado-Laborin, R; Estrada-Guzman, J; Rodwell, T C

    2013-07-01

    The State of Baja California, Mexico, had the highest prevalence of multidrug-resistant tuberculosis (MDR-TB) in Mexico in 2009. To understand the socio-economic burden of MDR-TB disease and its treatment on patients in Tijuana and Mexicali, Mexico. From July to November 2009, qualitative interviews were conducted with 12 patients enrolled in a US-Mexico binational MDR-TB treatment program, Puentes de Esperanza (Bridges of Hope), which was designed to support MDR-TB patients. In-depth interviews were coded to identify major themes in patient experiences of MDR-TB diagnosis and care. While some patients were able to maintain their pre-MDR-TB lives to a limited extent, most patients reported losing their sense of identity due to their inability to work, social isolation, and stigmatization from family and friends. The majority of participants expressed appreciation for Puentes' role in 'saving their lives'. Being diagnosed with MDR-TB and undergoing treatment imposes significant psychological, social and economic stress on patients. Strong social support elements within Puentes helped alleviate these burdens. Improvements to the program might include peer-support groups for patients undergoing treatment and transitioning back into the community after treatment.

  18. Treatment for symptomatic bacterial vaginosis: a randomized controlled trial

    International Nuclear Information System (INIS)

    Tariq, N.; Basharat, A.; Fahim, A.

    2017-01-01

    Objective: To compare the efficacy of multiple doses of vaginal clindamycin with a single oral dose of secnidazole for the treatment of bacterial vaginosis. Study Design: Double-blinded randomized controlled trial. Place and Duration of Study: Shifa Foundation Community Health Center, from March 2012 till February 2015. Methodology: After obtaining written informed consent, a pelvic examination was performed for the confirmation of symptoms of milky white vaginal discharge on speculum examination, positive Amine test and presence of clue cells on microscopy. Pregnant women, known diabetes or any immunocompromised condition, were excluded. Blinding of the patient, doctor, and the pharmacist was done. Study cohort was then divided into two groups, Group A received medicine pack A which contained active clindamycin and placebo oral preparation, whereas group B was given pack B which contained active 2-gm secnidazole with placebo vaginal cream. Primary outcome and therapeutic success were defined by correction of two out of three (normal Nugent score, negative Amine test, and no milky white discharge) on day 15. Results: At 15th day of treatment, 96.6% participants in vaginal clindamycin group (Group A), recovered from the bacterial vaginosis; whereas, (group B) 23% patients were cured in oral secnidazole group. Conclusion: Multiple doses of vaginal clindamycin are superior to single dose of oral secnidazole for the treatment of bacterial vaginosis. (author)

  19. Biofeedback treatment for Tourette syndrome: a preliminary randomized controlled trial.

    Science.gov (United States)

    Nagai, Yoko; Cavanna, Andrea E; Critchley, Hugo D; Stern, Jeremy J; Robertson, Mary M; Joyce, Eileen M

    2014-03-01

    To study the clinical effectiveness of biofeedback treatment in reducing tics in patients with Tourette syndrome. Despite advances in the pharmacologic treatment of patients with Tourette syndrome, many remain troubled by their tics, which may be resistant to multiple medications at tolerable doses. Electrodermal biofeedback is a noninvasive biobehavioral intervention that can be useful in managing neuropsychiatric and neurologic conditions. We conducted a randomized controlled trial of electrodermal biofeedback training in 21 patients with Tourette syndrome. After training the patients for 3 sessions a week over 4 weeks, we observed a significant reduction in tic frequency and improved indices of subjective well-being in both the active-biofeedback and sham-feedback (control) groups, but there was no difference between the groups in these measurements. Furthermore, the active-treatment group did not demonstrably learn to reduce their sympathetic electrodermal tone using biofeedback. Our findings indicate that this form of biofeedback training was unable to produce a clinical effect greater than placebo. The main confounding factor appeared to be the 30-minute duration of the training sessions, which made it difficult for patients to sustain a reduction in sympathetic tone when their tics themselves were generating competing phasic electrodermal arousal responses. Despite a negative finding in this study, electrodermal biofeedback training may have a role in managing tics if optimal training schedules can be identified.

  20. Heat treatment trials for ITER toroidal field coils

    International Nuclear Information System (INIS)

    Matsui, Kunihiro; Hemmi, Tsutomu; Koizumi, Norikiyo; Nakajima, Hideo; Kimura, Satoshi; Nakamoto, Kazunari

    2012-01-01

    Cable-in-conduit (CIC) conductors using Nb 3 Sn strands are used in ITER toroidal fields (TF) coils. Heat treatment generates thermal strain in CIC conductors because of the difference in thermal expansion between the Nb 3 Sn strands and the stainless-steel jacket. The elongation/shrinkage of the TF conductor may make it impossible to insert a wound TF conductor into the groove of a radial plate. In addition, it is expected that the deformation of the winding due to heat treatment-based release of the residual force in the jacket may also make it impossible to insert the winding in the groove, and that correcting the winding geometry to allow insertion of the winding may influence the superconducting performance of the TF conductor. The authors performed several trials using heat treatment as the part of activities in Phase II of TF coil procurement aiming to resolve the above-mentioned technical issues, and evaluated the elongations of 0.064, 0.074 and 0.072% for the straight and curved conductors and 1/3-scale double-pancake (DP) winding, respectively. It was confirmed that correction if the deformed winding did not influence the superconducting performance of the conductor. (author)

  1. Mental Fatigue Alters Cortical Activation and Psychological Responses, Impairing Performance in a Distance-Based Cycling Trial

    Directory of Open Access Journals (Sweden)

    Flávio O. Pires

    2018-03-01

    Full Text Available Purpose: We sought to verify if alterations in prefrontal cortex (PFC activation and psychological responses would play along with impairments in pacing and performance of mentally fatigued cyclists.Materials and Methods: Eight recreational cyclists performed two preliminary sessions to familiarize them with the rapid visual information processing (RVP test, psychological scales and 20 km cycling time trial (TT20km (session 1, as well as to perform a VO2MAX test (session 2. Thereafter, they performed a TT20km either after a RVP test (30 min or a time-matched rest control session (session 3 and 4 in counterbalanced order. Performance and psychological responses were obtained throughout the TT20km while PFC electroencephalography (EEG was obtained at 10 and 20 km of the TT20km and throughout the RVP test. Increases in EEG theta band power indicated a mental fatigue condition. Repeated-measures mixed models design and post-hoc effect size (ES were used in comparisons.Results: Cyclists completed the trial ~2.7% slower in mental fatigue (34.3 ± 1.3 min than in control (33.4 ± 1.1 min, p = 0.02, very large ES, with a lower WMEAN (224.5 ± 17.9 W vs. 240.2 ± 20.9 W, respectively; p = 0.03; extremely large ES. There was a higher EEG theta band power during RVP test (p = 0.03; extremely large ES, which remained during the TT20km (p = 0.01; extremely large ES. RPE increased steeper in mental fatigue than in control, together with isolated reductions in motivation at 2th km (p = 0.04; extremely large ES, felt arousal at the 2nd and 4th km (p = 0.01; extremely large ES, and associative thoughts to exercise at the 6th and 16th km (p = 0.02; extremely large ES of the TT20km.Conclusions: Mentally fatigued recreational cyclists showed impaired performance, altered PFC activation and faster increase in RPE during a TT20km.

  2. Psychological workshops for children and adolescents suffering from malignant disease: The model of psychosocial support during hospitalization and treatment

    Directory of Open Access Journals (Sweden)

    Klikovac Tamara

    2014-01-01

    Full Text Available Pediatric psycho-oncology within psycho-oncology is a highly developed scientific discipline in the world, both at the level of basic research and the development of theoretical concepts and at the practical level, which refers to the creation and implementation of various models of psychosocial support to children and young people who are suffering from various malignant diseases and their families during all stages of the demanding oncology treatment. One of the models of psychosocial support for children are workshops, as a form of group psychological treatment in which children and young people who are in distress, crisis, shock and even trauma, acquire a new positive experience and which provides new insights and knowledge to empower and boost the quality of life for overcoming severe malignant disease and treatment through meaningful games, all of which leads to overcoming the 'downtime' and regression and encouraging further psychological development. The outcome of workshop activities are various products (drawings, photographs, videos, posters, written material, but also positive feelings and behaviours in children and adolescents. The main objectives of introducing psychological workshops at the department of pediatric hematology-oncology in our community are, on the one hand, to provide professional counselling and support to children and young people during hospitalization and, on the other, to introduce a standard psychological procedure and quality psychological practice of group psychological counselling for sick children and young people in the hospital environment.

  3. Parental psychological distress and anxiety after a successful IVF/ICSI procedure with and without preimplantation genetic screening : Follow-up of a randomised controlled trial

    NARCIS (Netherlands)

    Beukers, F.; Houtzager, B. A.; Paap, M C S; Middelburg, K J; Hadders-Algra, M; Bos, A.F.; Kok, J.H.

    Background: Infertility treatment has an acknowledged psychological impact on women and their partners; however, information about the development of parental well-being after child birth is inconclusive. Preimplantation genetic screening (PGS) has been suggested to increase the efficacy of

  4. Parental psychological distress and anxiety after a successful IVF/ICSI procedure with and without preimplantation genetic screening: Follow-up of a randomised controlled trial

    NARCIS (Netherlands)

    Beukers, F.; Houtzager, B. A.; Paap, M. C. S.; Middelburg, K. J.; Hadders-Algra, M.; Bos, A. F.; Kok, J. H.; Cobben, Jan Maarten; van der Heide, Maaike; Koomen, Alice; Repping, Sjoerd; Silberbusch, Lobke; Twisk, Moniek; Mastenbroek, Sebastiaan; van der Veen, Fulco; Bos, Arend F.; Haadsma, Maaike; Hadders-Algra, Mijna; Heineman, Maas Jan; van Hoften, Jacorina; Jongbloed-Pereboom, Marjolein; Keating, Paul; Seggers, Jorien

    2012-01-01

    Background: Infertility treatment has an acknowledged psychological impact on women and their partners; however, information about the development of parental well-being after child birth is inconclusive. Preimplantation genetic screening (PGS) has been suggested to increase the efficacy of

  5. Integrated psychological therapy for people with bipolar disorder and co-morbid alcohol use: A feasibility and acceptability randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Steven Jones

    2018-06-01

    Full Text Available Background: Co-morbid substance misuse, particularly alcohol, is common in bipolar disorder (BD and associated with worse treatment outcomes. Research into psychological interventions for substance misuse in BD is at an early stage and no studies have specifically targeted problematic alcohol use. This paper describes the context and protocol for a feasibility and acceptability randomised controlled trial (RCT evaluating a novel intervention combining motivational interviewing and cognitive behavioural therapy (MI-CBT for participants with BD and problematic alcohol use, developed in collaboration with people with lived experience of both issues. Methods and design: An RCT will assess the feasibility and acceptability of MI-CBT in addition to treatment as usual (TAU compared with TAU alone. Participants will be recruited from across the North West of England through NHS services and self-referral. The primary outcomes will be the feasibility and acceptability of the intervention assessed by recruitment to target, adherence to intervention, retention rate at follow-up, absence of adverse events and qualitative analysis of participants' reported experiences of intervention. The effect size of the impact of the intervention on alcohol use and mood outcomes will also be estimated. In addition, we will explore a number of potential process variables in therapy. Discussion: This is the first RCT evaluating MI-CBT for BD and problematic alcohol use. Given the prevalence and impact of alcohol problems in BD this novel integrated intervention may have potential to offer important improvements in clinical and functional outcomes. Keywords: Bipolar, Alcohol, Substance, Motivational interviewing, Trial registration number: ISRCTN14774583

  6. Characterization of IGF-II isoforms in binge eating disorder and its group psychological treatment.

    Directory of Open Access Journals (Sweden)

    Giorgio Tasca

    Full Text Available Binge eating disorder (BED affects 3.5% of the population and is characterized by binge eating for at least 2 days a week for 6 months. Treatment options include cognitive behavioral therapy, interpersonal psychotherapy, and pharmacotherapy which are associated with varied success. Little is known about the biology of BED. Since there is evidence that the insulin like growth factor system is implicated in regulation of body weight, insulin sensitivity and feeding behavior, we speculated it may be involved in BED.A cross-sectional comparison was made between three groups of women: overweight with BED, overweight without BED and normal weight without BED. Women were assigned to Group Psychodynamic Interpersonal Psychotherapy. Blood was collected before therapy, at completion and at 6 months follow up for evaluation of IGF-II using Western blot.97 overweight women with BED contributed to the cross-sectional comparison. The two control groups comprised 53 overweight women without BED, and 50 age matched normal weight women without BED. Obese women had significantly lower Big IGF-II than normal weight women, p = .028; Overweight women with BED had higher Mature IGF-II than normal weight women, p<.05. Big IGF-II showed a significant decreasing slope from pre- to post- to six months post-group psychological treatment, unrelated to changes in BMI (p = .008.Levels of IGF-II isoforms differed significantly between overweight and normal weight women. Overweight women with BED display abnormal levels of circulating IGF-II isoforms. BED is characterized by elevated mature IGF-II, an isoform shown to carry significant bioactivity. This finding is not related to BMI or to changes in body weight. The results also provide preliminary evidence that BIG IGF-II is sensitive to change due to group psychological treatment. We suggest that abnormalities in IGF-II processing may be involved in the neurobiology of BED.

  7. Protocol for a systematic review of psychological treatment for methamphetamine use: an analysis of methamphetamine use and mental health symptom outcomes.

    Science.gov (United States)

    Stuart, Alexandra; Baker, Amanda L; Bowman, Jenny; McCarter, Kristen; Denham, Alexandra Mary Janice; Lee, Nicole; Colyvas, Kim; Dunlop, Adrian

    2017-09-07

    People who use methamphetamine (MA) regularly, often experience symptoms of mental ill health associated with the use of the drug. These include symptoms of psychosis, depression, anxiety and also cognitive deficits. Accordingly, psychological treatments aim to reduce MA use and related problems, including symptoms of mental ill health. Although there has been a substantial body of research reporting on the evidence of effectiveness of psychological treatments for MA use, there is a paucity of research addressing the effectiveness of these treatments for coexisting symptoms of mental ill health. We aim to address this gap by providing a comprehensive overview of the evidence for psychological treatments for MA use and associated symptoms of mental ill health in experimental/controlled clinical studies. In addition, a critical evaluation of study methods and the outcomes of psychological interventions on MA use and symptoms of mental ill health will be conducted. The Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement will be used to inform the methods of this review. Eight electronic peer-reviewed databases will be searched. Pilot searches have been conducted for MA literature considering controlled clinical trials only. Eligible articles will be independently assessed against inclusion criteria. Before final analyses are completed, searches will be rerun and if eligible, additional studies will be retrieved for inclusion. A quantitative synthesis of the findings will be reported where possible, and 'summary of findings' tables will be generated for each comparison. Risk ratios and 95% CI (dichotomous outcomes) will be calculated and/or effect size according to Cohen's formula (continuous outcomes) for the primary outcome of each trial. No ethical issues are foreseen. Findings will be disseminated widely to clinicians and researchers via journal publication and conference

  8. Balancing treatment allocations by clinician or center in randomized trials allows unacceptable levels of treatment prediction.

    Science.gov (United States)

    Hills, Robert K; Gray, Richard; Wheatley, Keith

    2009-08-01

    Randomized controlled trials are the standard method for comparing treatments because they avoid the selection bias that might arise if clinicians were free to choose which treatment a patient would receive. In practice, allocation of treatments in randomized controlled trials is often not wholly random with various 'pseudo-randomization' methods, such as minimization or balanced blocks, used to ensure good balance between treatments within potentially important prognostic or predictive subgroups. These methods avoid selection bias so long as full concealment of the next treatment allocation is maintained. There is concern, however, that pseudo-random methods may allow clinicians to predict future treatment allocations from previous allocation history, particularly if allocations are balanced by clinician or center. We investigate here to what extent treatment prediction is possible. Using computer simulations of minimization and balanced block randomizations, the success rates of various prediction strategies were investigated for varying numbers of stratification variables, including the patient's clinician. Prediction rates for minimization and balanced block randomization typically exceed 60% when clinician is included as a stratification variable and, under certain circumstances, can exceed 80%. Increasing the number of clinicians and other stratification variables did not greatly reduce the prediction rates. Without clinician as a stratification variable, prediction rates are poor unless few clinicians participate. Prediction rates are unacceptably high when allocations are balanced by clinician or by center. This could easily lead to selection bias that might suggest spurious, or mask real, treatment effects. Unless treatment is blinded, randomization should not be balanced by clinician (or by center), and clinician-center effects should be allowed for instead by retrospectively stratified analyses. © 2009 Blackwell Publishing Asia Pty Ltd and Chinese

  9. Disseminating Self-Help: Positive Psychology Exercises in an Online Trial

    Science.gov (United States)

    Parks, Acacia C

    2012-01-01

    Background The recent growth of positive psychology has led to a proliferation in exercises to increase positive thoughts, behaviors, and emotions. Preliminary evidence suggests that these exercises hold promise as an approach for reducing depressive symptoms. These exercises are typically researched in isolation as single exercises. The current study examined the acceptability of several multi-exercise packages using online dissemination. Objective The purpose of this study was to investigate methods of dissemination that could increase the acceptability and effectiveness of positive psychology exercises. To achieve this goal, we compared the use of positive psychology exercises when delivered in packages of 2, 4, or 6 exercises. Methods Self-help–seeking participants enrolled in this study by visiting an online research portal. Consenting participants were randomly assigned to receive 2, 4, or 6 positive psychology exercises (or assessments only) over a 6-week period. These exercises drew from the content of group positive psychotherapy. Participants visited an automated website that distributed exercise instructions, provided email reminders, and contained the baseline and follow-up assessments. Following each exercise, participants rated their enjoyment of the exercise, answered how often they had used each technique, and completed outcome measures. Results In total, 1364 individuals consented to participate. Attrition rates across the 2-, 4-, and 6-exercise conditions were similar at 55.5% (181/326), 55.8% (203/364), and 52.7% (168/319) respectively but were significantly greater than the attrition rate of 42.5% (151/355) for the control condition (χ2 3 = 16.40, P < .001). Participants in the 6-exercise condition were significant more likely than participants in the 4-exercise condition to use both the third (F 1,312 = 5.61, P = .02) and fourth (F 1,313 = 6.03, P = .02) exercises. For 5 of the 6 exercises, enjoyment was related to continued use of the

  10. Efficacy and tolerance of the topical application of potassium hydroxide (10% and 15% in the treatment of molluscum contagiosum: Randomized clinical trial: Research protocol

    Directory of Open Access Journals (Sweden)

    Galindo Gisela

    2011-10-01

    Full Text Available Abstract Background Molluscum contagiosum is a non-severe pediatric viral infection. Because it is highly contagious and current treatments have negative aesthetic and psychological effects, we want to test an alternative treatment in the primary care setting, consisting of two different concentrations of potassium hydroxide solution. Methods/design The study design is a double-blind, randomized clinical trial, using three types of topical treatment. The treatment consist of daily applications of potassium hydroxide (KOH in aqueous solution at 10% and 15% concentration, and a placebo administered in the control group. Four follow-up visits (at 15, 30, 45 and 60 days are planned to evaluate treatment effectiveness and patient tolerance. The main outcome measure of the trial will be the healing rate, defined as lesion disappearance in the affected zones after the topic application of the experimental treatment. Secondary measures will be the principal characteristics and evolution of the affected zone (surface area, number of lesions, size and density of lesions, treatment tolerance (hyperpigmentation, itching, burning, pain, recurrence rate and the natural evolution of lesions in the control group. Discussion KOH can potentially be an effective and safe treatment for MC in primary care, and can also reduce referrals to dermatologists and hospital pediatric departments. In addition, KOH may be a valid and less expensive alternative to current invasive treatments (surgical excision. Trial Registration ClinicalTrials.gov: NCT01348386

  11. Bridging the gap: Lessons we have learnt from the merging of psychology and psychiatry for the optimisation of treatments for emotional disorders.

    Science.gov (United States)

    Graham, Bronwyn M; Callaghan, Bridget L; Richardson, Rick

    2014-11-01

    In recent years the gap between psychological and psychiatric research and practice has lessened. In turn, greater attention has been paid toward how psychological and pharmacological treatments interact. Unfortunately, the majority of research has indicated no additive effect of anxiolytics and antidepressants when combined with psychological treatments, and in many cases pharmacological treatments attenuate the effectiveness of psychological treatments. However, as psychology and psychiatry have come closer together, research has started to investigate the neural and molecular mechanisms underlying psychological treatments. Such research has utilised preclinical models of psychological treatments, such as fear extinction, in both rodents and humans to determine multiple neural and molecular changes that may be responsible for the long-term cognitive and behavioural changes that psychological treatments induce. Currently, researchers are attempting to identify pharmacological agents that directly augment these neural/molecular changes, and which may be more effective adjuncts to psychological treatments than traditional anxiolytics and antidepressants. In this review we describe the research that has led to this new wave of thinking about combined psychological/pharmacological treatments. We also argue that an increased emphasis on identifying individual difference factors that predict the effectiveness of pharmacological adjuncts is critical in facilitating the translation of this preclinical research into clinical practice. Copyright © 2014 Elsevier Ltd. All rights reserved.

  12. Intrusive images in psychological disorders: characteristics, neural mechanisms, and treatment implications.

    Science.gov (United States)

    Brewin, Chris R; Gregory, James D; Lipton, Michelle; Burgess, Neil

    2010-01-01

    Involuntary images and visual memories are prominent in many types of psychopathology. Patients with posttraumatic stress disorder, other anxiety disorders, depression, eating disorders, and psychosis frequently report repeated visual intrusions corresponding to a small number of real or imaginary events, usually extremely vivid, detailed, and with highly distressing content. Both memory and imagery appear to rely on common networks involving medial prefrontal regions, posterior regions in the medial and lateral parietal cortices, the lateral temporal cortex, and the medial temporal lobe. Evidence from cognitive psychology and neuroscience implies distinct neural bases to abstract, flexible, contextualized representations (C-reps) and to inflexible, sensory-bound representations (S-reps). We revise our previous dual representation theory of posttraumatic stress disorder to place it within a neural systems model of healthy memory and imagery. The revised model is used to explain how the different types of distressing visual intrusions associated with clinical disorders arise, in terms of the need for correct interaction between the neural systems supporting S-reps and C-reps via visuospatial working memory. Finally, we discuss the treatment implications of the new model and relate it to existing forms of psychological therapy.

  13. Effect of chemotherapy counseling by pharmacists on quality of life and psychological outcomes of oncology patients in Malaysia: a randomized control trial.

    Science.gov (United States)

    Periasamy, Ummavathy; Mohd Sidik, Sherina; Rampal, Lekhraj; Fadhilah, Siti Irma; Akhtari-Zavare, Mehrnoosh; Mahmud, Rozi

    2017-05-15

    Cancer is now becoming a leading cause of death. Chemotherapy is an important treatment for cancer patients. These patients also need consultation during their treatment to improve quality of life and decrease psychological disorders. The objectives of the study were to develop, implement and evaluate the effectiveness of a chemotherapy counseling module by pharmacists among oncology patients on their quality of life and psychological outcomes in Malaysia. A single-blind randomized controlled trial was carried out among 162 oncology patients undergoing chemotherapy from July 2013 to February 2014 in a government hospital with oncology facilities in Malaysia. Participants were randomized to either the intervention group or the control group. Chemotherapy counseling using the module on 'Managing Patients on Chemotherapy' by Pharmacists was delivered to the intervention group. The outcome measures were assessed at baseline, first follow-up and second follow-up and third follow-up post-intervention. Chi-square, independent samples t-test and two-way repeated measures ANOVA were conducted in the course of the data analyses. In assessing the impact of the chemotherapy counseling module, the study revealed that the module along with repetitive counseling showed significant improvement of quality of life in the intervention group as compared to the control group with a large effect size in physical health (p = 0.001, partial Ƞ 2  = 0.66), psychological (p = 0.001, partial Ƞ 2  = 0.65), social relationships (p = 0.001, partial Ƞ 2  = 0.30), and environment (p = 0.001, partial Ƞ 2  = 0.67) and decrease in the anxiety (p = 0.000; partial Ƞ 2  = 0.23), depression (p = 0.000; partial Ƞ 2  = 0.40). The module on 'Managing Patients on Chemotherapy' along with repetitive counseling by pharmacists has been shown to be effective in improving quality of life and decreasing anxiety and depression among oncology patients undergoing chemotherapy

  14. The psychological development of panic disorder: implications for neurobiology and treatment.

    Science.gov (United States)

    Cosci, Fiammetta

    2012-06-01

    The aim of this study was to survey the available literature on psychological development of panic disorder with or without agoraphobia [PD(A)] and its relationship with the neurobiology and the treatment of panic. Both a computerized (PubMed) and a manual search of the literature were performed. Only English papers published in peer-reviewed journals and referring to PD(A) as defined by the diagnostic classifications of the American Psychiatric Association or of the World Health Organization were included. A staging model of panic exists and is applicable in clinical practice. In a substantial proportion of patients with PD(A), a prodromal phase and, despite successful treatment, residual symptoms can be identified. Both prodromes and residual symptoms allow the monitoring of disorder evolution during recovery via the rollback phenomenon. The different stages of the disorder, as well as the steps of the rollback, have a correspondence in the neurobiology and in the treatment of panic. However, the treatment implications of the longitudinal model of PD(A) are not endorsed, and adequate interventions of enduring effects are missing.

  15. Direct-to-consumer marketing of psychological treatments for anxiety disorders.

    Science.gov (United States)

    Gallo, Kaitlin P; Comer, Jonathan S; Barlow, David H

    2013-12-01

    Progress disseminating and implementing evidence-based psychological treatments (EBPTs) for the anxiety disorders has been gradual. To date, the dominant approach for promoting the uptake of EBPTs in clinical settings has been to target the education and training of mental health providers, with many consumers remaining unaware of the potential benefits of EBPTs for anxiety disorders. Direct-to-consumer (DTC) marketing may be a promising vehicle for increasing EBPT utilization rates in the treatment of anxiety disorders. This paper provides an overview of the rationale and important considerations for applying DTC efforts to promote evidence-based care in the treatment of anxiety disorders, and reviews current DTC efforts in this area, including resources on the Internet and other media and in-person events. We conclude with recommendations for future efforts in the DTC marketing of EBPTs for the anxiety disorders, including the need for increased funding and grassroots efforts to inform consumers about anxiety disorders and their most effective treatments. Copyright © 2013 Elsevier Ltd. All rights reserved.

  16. Treatment selection in a randomized clinical trial via covariate-specific treatment effect curves.

    Science.gov (United States)

    Ma, Yunbei; Zhou, Xiao-Hua

    2017-02-01

    For time-to-event data in a randomized clinical trial, we proposed two new methods for selecting an optimal treatment for a patient based on the covariate-specific treatment effect curve, which is used to represent the clinical utility of a predictive biomarker. To select an optimal treatment for a patient with a specific biomarker value, we proposed pointwise confidence intervals for each covariate-specific treatment effect curve and the difference between covariate-specific treatment effect curves of two treatments. Furthermore, to select an optimal treatment for a future biomarker-defined subpopulation of patients, we proposed confidence bands for each covariate-specific treatment effect curve and the difference between each pair of covariate-specific treatment effect curve over a fixed interval of biomarker values. We constructed the confidence bands based on a resampling technique. We also conducted simulation studies to evaluate finite-sample properties of the proposed estimation methods. Finally, we illustrated the application of the proposed method in a real-world data set.

  17. Influence of Acute Multispecies and Multistrain Probiotic Supplementation on Cardiovascular Function and Reactivity to Psychological Stress in Young Adults: A Double-Blind, Randomized, Placebo-Controlled Trial.

    Science.gov (United States)

    Möller, Clara M; Olsa, Eamon J A; Ginty, Annie T; Rapelje, Alyssa L; Tindall, Christina L; Holesh, Laura A; Petersen, Karen L; Conklin, Sarah M

    2017-10-01

    The potential influence of probiotic supplementation on cardiovascular health and stress responsivity remains largely unexplored. Some evidence suggests the possibility that probiotics may influence blood pressure. A separate body of research suggests that exaggerated cardiovascular reactions to acute psychological stress in the laboratory predict cardiovascular morbidity and mortality. The current investigation explored the effect of acute probiotic use on (1) resting cardiovascular measures in healthy young adults and (2) cardiovascular and psychological reactions to an acute psychological stressor in the laboratory. Participants (N = 105, M [SD] age = 20.17 [1.26], 84.8% white) completed a 2-week, double-blind, and placebo-controlled trial of a multispecies and multistrain probiotic. Exclusion criteria included previous probiotic use, diagnosed gastrointestinal disorder, and/or current antibiotic use. At visits 1 and 2, participants completed the Paced Auditory Serial Addition Test, a widely used psychological stress task. Participants were randomly assigned to a probiotic blend or matched placebo. Compared with placebo, 2-week probiotic supplementation did not affect resting measures of cardiovascular function, cardiovascular responses during or recovery from stress, or psychological reactions to acute psychological stress. Contrary to expectations, short-term use of a probiotic supplement in healthy participants did not influence measures of cardiovascular function or responsivity to psychological stress. Future research is needed to determine species- and strain-specific effects of probiotics in healthy participants with various degrees of stress responsiveness, as well as in diseased populations.

  18. THE IMPORTANCE OF PSYCHOLOGICAL CHARACTERISTICS OF THE PATIENT FOR THE EFFECTIVE TREATMENT OF METABOLIC SYNDROME

    Directory of Open Access Journals (Sweden)

    L. A. Zavrazhnyh

    2011-01-01

    Full Text Available The aim – the identification of hormonal and psychological characteristics of patients with metabolic syndrome (MS, determining the effectivenessof drug-free weight loss.Materials and methods. The study included 180 patients with MS (according to the criteria of ATP III, received dietary treatment and thermal bath at the spa. Anthropometric measures, the data of the daily blood pressure monitoring, blood levels of hormones (insulin, leptin, were assessed , following surveys were conducted – the definition of eating disorders (PP tests SANT (estimate well-being, activity, mood,anxiety and LOBI (diagnosis related to types of illness. According to the results of the course non-drug treatment, all patients were divided into 2 groups: group 1 – with a positive effect of therapy (n = 87 and 2nd – no effect (n = 93. The criterion for the division served as the simultaneous presence of four factors: decrease in body weight by 2 kg or more, reduction in waist circumference by 2 cm or more, decreasedlevels of triglycerides and blood glucose.Results. The group of patients therapy who proved to be ineffective, characterized by significantly higher levels of insulin and leptin, a predominance of emotiogenic PP, high self-esteem of his being. In relation to the state of neglect of the disease, its denial, indifference to the fate were prevailing. A correlation of levels of insulin and leptin levels with parameters of arterial pressure, PP, test results SANT.Conclusion. In patients with MS psychological and behavioral pattern that has adverse effects on weight loss and associated with the levels of leptin and insulin are diagnosed. Taking into account of these characteristics will increase the effectiveness of therapy.

  19. THE IMPORTANCE OF PSYCHOLOGICAL CHARACTERISTICS OF THE PATIENT FOR THE EFFECTIVE TREATMENT OF METABOLIC SYNDROME

    Directory of Open Access Journals (Sweden)

    L. A. Zavrazhnyh

    2014-07-01

    Full Text Available The aim – the identification of hormonal and psychological characteristics of patients with metabolic syndrome (MS, determining the effectivenessof drug-free weight loss.Materials and methods. The study included 180 patients with MS (according to the criteria of ATP III, received dietary treatment and thermal bath at the spa. Anthropometric measures, the data of the daily blood pressure monitoring, blood levels of hormones (insulin, leptin, were assessed , following surveys were conducted – the definition of eating disorders (PP tests SANT (estimate well-being, activity, mood,anxiety and LOBI (diagnosis related to types of illness. According to the results of the course non-drug treatment, all patients were divided into 2 groups: group 1 – with a positive effect of therapy (n = 87 and 2nd – no effect (n = 93. The criterion for the division served as the simultaneous presence of four factors: decrease in body weight by 2 kg or more, reduction in waist circumference by 2 cm or more, decreasedlevels of triglycerides and blood glucose.Results. The group of patients therapy who proved to be ineffective, characterized by significantly higher levels of insulin and leptin, a predominance of emotiogenic PP, high self-esteem of his being. In relation to the state of neglect of the disease, its denial, indifference to the fate were prevailing. A correlation of levels of insulin and leptin levels with parameters of arterial pressure, PP, test results SANT.Conclusion. In patients with MS psychological and behavioral pattern that has adverse effects on weight loss and associated with the levels of leptin and insulin are diagnosed. Taking into account of these characteristics will increase the effectiveness of therapy.

  20. Psychology and criminal justice

    OpenAIRE

    Adler, Joanna R.

    2013-01-01

    This chapter is designed to give the reader a flavour of a few areas in which psychology has been applied to criminal justice. It begins by providing some historical context and showing the development of some applications of psychology to criminal justice. The chapter is broadly split into 3 sections: Pre Trial; Trial; and Post Trial. In most of this chapter, the areas considered assess how psychology has had an influence on the law and how psychologists work within criminal justice settings...

  1. Phase II cancer clinical trials for biomarker-guided treatments.

    Science.gov (United States)

    Jung, Sin-Ho

    2018-01-01

    The design and analysis of cancer clinical trials with biomarker depend on various factors, such as the phase of trials, the type of biomarker, whether the used biomarker is validated or not, and the study objectives. In this article, we demonstrate the design and analysis of two Phase II cancer clinical trials, one with a predictive biomarker and the other with an imaging prognostic biomarker. Statistical testing methods and their sample size calculation methods are presented for each trial. We assume that the primary endpoint of these trials is a time to event variable, but this concept can be used for any type of endpoint.

  2. Treatment mechanism in the MRC preschool autism communication trial: implications for study design and parent-focussed therapy for children.

    Science.gov (United States)

    Pickles, Andrew; Harris, Victoria; Green, Jonathan; Aldred, Catherine; McConachie, Helen; Slonims, Vicky; Le Couteur, Ann; Hudry, Kristelle; Charman, Tony

    2015-02-01

    The PACT randomised-controlled trial evaluated a parent-mediated communication-focused treatment for children with autism, intended to reduce symptom severity as measured by a modified Autism Diagnostic Observation Schedule-Generic (ADOS-G) algorithm score. The therapy targeted parental behaviour, with no direct interaction between therapist and child. While nonsignificant group differences were found on ADOS-G score, significant group differences were found for both parent and child intermediate outcomes. This study aimed to better understand the mechanism by which the PACT treatment influenced changes in child behaviour though the targeted parent behaviour. Mediation analysis was used to assess the direct and indirect effects of treatment via parent behaviour on child behaviour and via child behaviour on ADOS-G score. Alternative mediation was explored to study whether the treatment effect acted as hypothesised or via another plausible pathway. Mediation models typically assume no unobserved confounding between mediator and outcome and no measurement error in the mediator. We show how to better exploit the information often available within a trial to begin to address these issues, examining scope for instrumental variable and measurement error models. Estimates of mediation changed substantially when account was taken of the confounder effects of the baseline value of the mediator and of measurement error. Our best estimates that accounted for both suggested that the treatment effect on the ADOS-G score was very substantially mediated by parent synchrony and child initiations. The results highlighted the value of repeated measurement of mediators during trials. The theoretical model underlying the PACT treatment was supported. However, the substantial fall-off in treatment effect highlighted both the need for additional data and for additional target behaviours for therapy. © 2014 The Authors. Journal of Child Psychology and Psychiatry. © 2014 Association for

  3. Cost effectiveness of treatment for alcohol problems: findings of the randomised UK alcohol treatment trial (UKATT).

    Science.gov (United States)

    2005-09-10

    To compare the cost effectiveness of social behaviour and network therapy, a new treatment for alcohol problems, with that of the proved motivational enhancement therapy. Cost effectiveness analysis alongside a pragmatic randomised trial. Seven treatment sites around Birmingham, Cardiff, and Leeds. 742 clients with alcohol problems; 617 (83.2%) were interviewed at 12 months and full economic data were obtained on 608 (98.5% of 617). Main economic measures Quality adjusted life years (QALYs), costs of trial treatments, and consequences for public sector resources (health care, other alcohol treatment, social services, and criminal justice services). Both therapies saved about five times as much in expenditure on health, social, and criminal justice services as they cost. Neither net savings nor cost effectiveness differed significantly between the therapies, despite the average cost of social behaviour and network therapy (221 pounds sterling; 385 dollars; 320 euros) being significantly more than that of motivational enhancement therapy (129 pounds sterling). If a QALY were worth 30,000 pounds sterling, then the motivational therapy would have 58% chance of being more cost effective than the social therapy, and the social therapy would have 42% chance of being more cost effective than the motivational therapy. Participants reported highly significant reductions in drinking and associated problems and costs. The novel social behaviour and network therapy did not differ significantly in cost effectiveness from the proved motivational enhancement therapy.

  4. Suicidal Behavior Among People Living with HIV (PLHIV) in Medical Care in Estonia and Factors Associated with Receiving Psychological Treatment.

    Science.gov (United States)

    Lemsalu, Liis; Rüütel, Kristi; Laisaar, Kaja-Triin; Lõhmus, Liilia; Raidvee, Aire; Uusküla, Anneli

    2017-06-01

    People living with HIV (PLHIV) have higher rates of suicidal behavior than the general population. This study assessed suicidal behavior (ideation and/or attempts, ever and in the past 12 months) among PLHIV receiving outpatient HIV medical care in Estonia and associations between suicidal behavior and psychological treatment. The cross-sectional study collected data from January to November 2013 using a self-report questionnaire. Eight hundred PLHIV participated, 39 % (n = 306) of whom had been suicidal. Lifetime prevalence was 36 % for suicidal ideation and 20 % for attempts. Younger age, incarceration, having ever abused alcohol and also injected drugs, having lived with HIV for more than 10 years, and being depressed were associated with lifetime suicidal behavior. Suicidal behavior within the past 12 months was reported by 20 % (n = 156) of respondents. Of these, 27 % received psychological treatment (counseling and/or psychotherapy), 20 % had taken antidepressants, and 49 % sedatives. Individuals perceiving a need for treatment were significantly more likely to receive psychological treatment when experiencing suicidal behavior (OR 25.65, 95 % CI 2.92-225.47). In conclusion, suicidal behavior is frequent among PLHIV but psychological treatment is not often received. One of the barriers to treatment is patients' lack of perceived need for help.

  5. Aromatherapy as treatment for postoperative nausea: a randomized trial.

    Science.gov (United States)

    Hunt, Ronald; Dienemann, Jacqueline; Norton, H James; Hartley, Wendy; Hudgens, Amanda; Stern, Thomas; Divine, George

    2013-09-01

    Postoperative nausea (PON) is a common complication of anesthesia and surgery. Antiemetic medication for higher-risk patients may reduce but does not reliably prevent PON. We examined aromatherapy as a treatment for patients experiencing PON after ambulatory surgery. Our primary hypothesis was that in comparison with inhaling a placebo, PON will be reduced significantly by aromatherapy with (1) essential oil of ginger, (2) a blend of essential oils of ginger, spearmint, peppermint, and cardamom, or (3) isopropyl alcohol. Our secondary hypothesis was that the effectiveness of aromatherapy will depend upon the agent used. A randomized trial of aromatherapy with patients who reported nausea in the postanesthesia care unit was conducted at one ambulatory surgical center. Eligibility criteria were adult, able to give consent, and no history of coagulation problems or allergy to the aromatherapy agents. Before surgery, demographic and risk factors were collected. Patients with a nausea level of 1 to 3 on a verbal descriptive scale (0-3) received a gauze pad saturated with a randomly chosen aromatherapy agent and were told to inhale deeply 3 times; nausea (0-3) was then measured again in 5 minutes. Prophylactic and postnausea antiemetics were given as ordered by physicians or as requested by the patient. A total of 1151 subjects were screened for inclusion; 303 subjects reporting nausea were enrolled (26.3%), and 301 meeting protocol were analyzed (26.2%). The change in nausea level was significant for the blend (P aromatherapy was also significantly reduced with ginger or blend aromatherapy versus saline (P = 0.002 and P aromatherapy would be effective as a treatment for PON was supported. On the basis of our results, future research further evaluating aromatherapy is warranted. Aromatherapy is promising as an inexpensive, noninvasive treatment for PON that can be administered and controlled by patients as needed.

  6. The role of psychological flexibility in a self-help acceptance and commitment therapy intervention for psychological distress in a randomized controlled trial.

    Science.gov (United States)

    Fledderus, Martine; Bohlmeijer, Ernst T; Fox, Jean-Paul; Schreurs, Karlein M G; Spinhoven, Philip

    2013-03-01

    This study examined the role of psychological flexibility, as a risk factor and as a process of change, in a self-help Acceptance and Commitment Therapy (ACT) intervention for adults with mild to moderate depression and anxiety. Participants were randomized to the self-help programme with e-mail support (n=250), or to a waiting list control group (n=126). All participants completed measures before and after the intervention to assess depression, anxiety and psychological flexibility. Participants in the experimental condition also completed these measures during the intervention (after three and six weeks) and at a three-month follow-up. With multilevel modelling, it was shown that the effects of the intervention on psychological distress were stronger for participants with higher levels of psychological flexibility. Furthermore, our study showed that improved psychological flexibility mediated the effects of the ACT intervention. With a cross-lagged panel design, it was shown that especially improvements in psychological flexibility in the last three sessions of the intervention were important for further reductions in anxiety. To conclude, our study showed the importance of targeting psychological flexibility during an ACT intervention for a reduction in depressive and anxiety symptoms. Copyright © 2012 Elsevier Ltd. All rights reserved.

  7. Evaluation of the interdisciplinary PSYMEPHY treatment on patients with fibromyalgia: a randomized control trial.

    Science.gov (United States)

    Martín, Josune; Torre, Fernando; Aguirre, Urko; González, Nerea; Padierna, Angel; Matellanes, Begoña; Quintana, José Ma

    2014-04-01

    Fibromyalgia (FM) is a chronic disorder that can have a devastating effect on patients' lives. This study assessed the efficacy of a 6-week interdisciplinary treatment that combines coordinated PSYchological, Medical, Educational, and PHYsiotherapeutic interventions (PSYMEPHY) compared with standard pharmacologic care. The study was a randomized controlled trial (54 participants in the PSYMEPHY group and 56 in the control group [CG] ) with follow-up at 6 months. PSYMEPHY patients were also assessed at 12 months. The main outcomes were changes in total Fibromyalgia Impact Questionnaire (FIQ) score, pain, fatigue, morning tiredness, anxiety, and use of pain coping strategies as measured by the FIQ, the visual analog scale, and the Coping with Chronic Pain Questionnaire. After the 6-month assessment, patients in the CG were offered the PSYMEPHY treatment, and completed all of the instruments immediately after treatment, and at 6- and 12-month follow-up visits (N = 93). Subjects received therapy at two different outpatient clinical locations. Fibromyalgia patients. Six months after the intervention, significant improvements in total FIQ score (P = 0.04), and pain (P = 0.03) were seen in the PSYMEPHY group compared with controls. Twelve months after the intervention, all patients in the PSYMEPHY group maintained statistically significant improvements in total FIQ score, and pain, and showed an improvement in fatigue, rested, anxiety, and current pain compared with baseline. Data from the control patients who underwent the PSYMEPHY intervention corroborated the initial results. This study highlights the beneficial effects of an interdisciplinary treatment for FM patients in a hospital pain management unit. A 6-week interdisciplinary intervention showed significant improvement in key domains of fibromyalgia, as quality of life, pain, fatigue, rested, and anxiety at 12 months. Wiley Periodicals, Inc.

  8. Arthrocentesis as initial treatment for temporomandibular joint arthropathy : A randomized controlled trial

    NARCIS (Netherlands)

    Vos, L. M.; Huddleston Slater, J. J. R.; Stegenga, B.

    Objective: To determine the effectiveness of arthrocentesis compared to conservative treatment as initial treatment with regard to temporomandibular joint pain and mandibular movement. Patients and methods: In this randomized controlled trial, 80 patients with arthralgia of the TMJ (classified

  9. Effects of a psychological intervention on the quality of life of obese adolescents under a multidisciplinary treatment.

    Science.gov (United States)

    Freitas, Camila R M; Gunnarsdottir, Thrudur; Fidelix, Yara L; Tenório, Thiago R S; Lofrano-Prado, Mara C; Hill, James O; Prado, Wagner L

    To investigate the effects of multidisciplinary treatment with and without psychological counseling on obese adolescents' self-reported quality of life. Seventy-six obese adolescents (15.87±1.53 y) were allocated into psychological counseling group (PCG; n=36) or control group (CG; n=40) for 12 weeks. All participants received the same supervised exercise training, nutritional and clinical counseling. Participants in PCG also received psychological counseling. QOL was measured before and after 12 weeks of intervention by Generic Questionnaire for the Evaluation of Quality of Life (SF-36). The dropout rate was higher in GC (22.5%) when compared with PCG (0.0%) (p<0.001). After 12 weeks, participants from PCG presents lower body weight, relative fat mass and higher free fat mass (p<0.001 for all) compared to GC. QOL improved among adolescents from both groups (p<0.05), however, a better QOL was reported from those adolescents enrolled in PCG. The inclusion of a psychological counseling component in multidisciplinary treatment for adolescent obesity appears to provide benefits observed for improved QOL as compared with treatment without psychological counseling. Copyright © 2016 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

  10. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

  11. Early Psychological Counseling for the Prevention of Posttraumatic Stress Induced by Acute Coronary Syndrome: The MI-SPRINT Randomized Controlled Trial.

    Science.gov (United States)

    von Känel, Roland; Barth, Jürgen; Princip, Mary; Meister-Langraf, Rebecca E; Schmid, Jean-Paul; Znoj, Hansjörg; Herbert, Claudia; Schnyder, Ulrich

    2018-01-01

    Acute coronary syndrome (ACS)-induced posttraumatic stress disorder (PTSD) and clinically significant PTSD symptoms (PTSS) are found in 4 and 12% of patients, respectively. We hypothesized that trauma-focused counseling prevents the incidence of ACS-induced PTSS. Within 48 h of hospital admission, 190 patients with high distress during ACS were randomized to a single-session intervention of either trauma-focused counseling or an active control intervention targeting the general role of stress in patients with heart disease. Blind interviewer-rated PTSS (primary outcome) and additional health outcomes were assessed at 3 months of follow-up. Trial results about prevalence were compared with data from previous studies on the natural incidence of ACS-induced PTSS/PTSD. Intention-to-treat analyses revealed no difference in interviewer-rated PTSS between trauma-focused counseling (mean, 11.33; 95% Cl, 9.23-13.43) and stress counseling (9.88; 7.36-12.40; p = 0.40), depressive symptoms (6.01, 4.98-7.03, vs. 4.71, 3.65-5.77; p = 0.08), global psychological distress (5.15, 4.07-6.23, vs. 3.80, 2.60-5.00; p = 0.11), and the risk for cardiovascular-related hospitalization/all-cause mortality (OR, 0.67; 95% CI, 0.37-1.23). Self-rated PTSS indicated less beneficial effects with trauma-focused (6.54; 4.95-8.14) versus stress counseling (3.74; 2.39-5.08; p = 0.017). The completer analysis (154 cases) confirmed these findings. The prevalence rates of interviewer-rated PTSD (0.5%, 1/190) and self-rated PTSS were in this trial much lower than in meta-analyses and observation studies from the same cardiology department. Benefits were not seen for trauma-focused counseling when compared with an active control intervention. Nonetheless, in distressed ACS patients, individual, single-session, early psychological counseling shows potential as a means to prevent posttraumatic responses, but trauma-focused early treatments should probably be avoided. © 2018 S. Karger AG, Basel.

  12. Managing Injuries of the Neck Trial (MINT): a randomised controlled trial of treatments for whiplash injuries.

    Science.gov (United States)

    Lamb, S E; Williams, M A; Williamson, E M; Gates, S; Withers, E J; Mt-Isa, S; Ashby, D; Castelnuovo, E; Underwood, M; Cooke, M W

    2012-01-01

    To examine the clinical effectiveness of a stepped care approach over a 12-month period after an acute whiplash injury; to estimate the costs and cost-effectiveness of each strategy including treatments and subsequent health-care costs; and to gain participants' perspective on experiencing whiplash injury, NHS treatment, and recovery within the context of the Managing Injuries of the Neck Trial (MINT). Two linked, pragmatic, randomised controlled trials. In Step 1, emergency departments (EDs) were cluster randomised to usual care advice (UCA) or The Whiplash Book advice (WBA)/active management advice. In Step 2, participants were individually randomised to either a single session of advice from a physiotherapist or a physiotherapy package of up to six sessions. An economic evaluation and qualitative study were run in parallel with the trial. Twelve NHS trusts in England comprising 15 EDs. People who attended EDs with an acute whiplash injury of whiplash-associated disorder grades I-III were eligible for Step 1. People who had attended EDs with whiplash injuries and had persistent symptoms 3 weeks after ED attendance were eligible for Step 2. In Step 1, the control intervention was UCA and the experimental intervention was a psycho-educational intervention (WBA/active management advice). In Step 2 the control treatment was reinforcement of the advice provided in Step 1 and the experimental intervention was a package of up to six physiotherapy treatments. The primary outcome was the Neck Disability Index (NDI), which measures severity and frequency of pain and symptoms, and a range of activities including self-care, driving, reading, sleeping and recreation. Secondary outcomes included the mental and physical health-related quality-of-life (HRQoL) subscales of the Short Form questionnaire-12 items (SF-12) and the number of work days lost. A total of 3851 patients were recruited to Step 1 of the trial. 1598 patients attending EDs were randomised to UCA, and 2253 were

  13. Factors associated with psychological distress following colposcopy among women with low-grade abnormal cervical cytology: a prospective study within the Trial Of Management of Borderline and Other Low-grade Abnormal smears (TOMBOLA).

    Science.gov (United States)

    Sharp, Linda; Cotton, Seonaidh; Carsin, Anne-Elie; Gray, Nicola; Thornton, Alison; Cruickshank, Margaret; Little, Julian

    2013-02-01

    Little is known about psychological after-effects of colposcopy and associated investigations and treatment in women with low-grade abnormal cervical cytology. We investigated psychological distress following colposcopy and related procedures. Nine hundred and eighty-nine women aged 20-59 years with routine cytology showing low-grade abnormalities were recruited to the Trial of Management of Borderline and other Low-grade Abnormal smears and attended colposcopy. If the cervical transformation zone (TZ) was colposcopically abnormal, women had immediate loop excision or diagnostic punch biopsies, with treatment if these showed cervical intraepithelial neoplasia grade 2/3 (CIN2/3). Women completed socio-demographic and psychosocial questionnaires at recruitment and before colposcopy. Six weeks after their last procedure, women completed the Impact of Event Scale (IES). Logistic regression was used to determine factors associated with significant psychological distress (IES ≥ 9). Analyses were stratified by colposcopic impression. The response rate was 74%. Six weeks after the last procedure, 86 (21%) of 391 women with a normal TZ had significant distress compared with 144 (42%) of 337 with an abnormal TZ. In both groups, significant distress was associated with anxiety pre-colposcopy and pain or discharge afterwards. Additional variables predicting distress in women with a normal TZ were worries about having sex and dissatisfaction with support from others. In women with an abnormal TZ, additional predictors of distress were younger age, CIN2/3, bleeding following colposcopy and worries about having cancer. Substantial proportions of women experience psychological distress after colposcopy and related procedures, even when the colposcopy is normal. This is an important cost of cervical screening. Interventions to alleviate these adverse psychological effects are required. Copyright © 2011 John Wiley & Sons, Ltd.

  14. Psychological interventions for the management of glycemic and psychological outcomes of type 2 diabetes mellitus in China: A systematic review and meta-analyses of randomized controlled trials

    OpenAIRE

    Anna eChapman; Anna eChapman; Shuo eLiu; Stephanie eMerkouris; Stephanie eMerkouris; Joanne C Enticott; Joanne C Enticott; Hui eYang; Colette Joy Browning; Colette Joy Browning; Shane Andrew Thomas

    2015-01-01

    IntroductionChina has the largest number of type 2 diabetes mellitus (T2DM) cases globally and T2DM management has become a critical public health issue in China. Individuals with T2DM have an increased risk of developing mental health disorders, psychological disturbances and functional problems associated with living with their condition. Previous systematic reviews have demonstrated that, generally, psychological interventions are effective in the management of T2DM related outcomes; howev...

  15. Treatment of traumatized refugees with Sertraline versus Venlafaxine in combination with psychotherapy – study protocol for a randomized clinical trial

    Science.gov (United States)

    2013-01-01

    Background Sufficient evidence is lacking to draw final conclusions on the efficiency of medical and psychological treatments of traumatized refugees with PTSD. The pharmacological treatments of choice today for post-traumatic stress disorder are antidepressants from the subgroup selective serotonin reuptake inhibitors, especially Sertraline. The evidence for the use of selective serotonin reuptake inhibitors in the treatment of complex post-traumatic stress disorder in traumatized refugees is very limited. Venlafaxine is a dual-action antidepressant that works on several pathways in the brain. It influences areas in the brain which are responsible for the enhanced anxiety and hyper-arousal experienced by traumatized refugees and which some studies have found to be enlarged among patients suffering from post-traumatic stress disorder. Design This study will include approximately 150 patients, randomized into two different groups treated with either Sertraline or Venlafaxine. Patients in both groups will receive the same manual-based cognitive behavioral therapy, which has been especially adapted to this group of patients. The treatment period will be 6 to 7 months. The trial endpoints will be post-traumatic stress disorder and depressive symptoms and social functioning, all measured on validated ratings scales. Furthermore the study will examine the relation between a psycho-social resources and treatment outcome based on 15 different possible outcome predictors. Discussion This study is expected to bring forward new knowledge on treatment and clinical evaluation of traumatized refugees and the results are expected to be used in reference programs and clinical guidelines. Trial registration ClinicalTrials.gov NCT01569685 PMID:23663588

  16. A Structured, Manual-Based Low-Level Intervention vs. Treatment as Usual Evaluated in a Randomized Controlled Trial for Adolescents with Extreme Obesity - the STEREO Trial

    Directory of Open Access Journals (Sweden)

    Yvonne Mühlig

    2017-08-01

    Full Text Available Background: To compare efficacy and safety of a manual-based low-level psychological intervention with treatment as usual (weight loss treatment. Methods: A two-armed randomized controlled trial without blinding and computer-based stratified block randomization included adolescents and young adults (14.0-24.9 years with a BMI ≥ 30 kg/m2 at five German university hospitals. Primary outcomes were adherence (participation rate ≥ 5/6 sessions and quality of life (DISABKIDS-37 6 months after randomization. Secondary outcomes included depression, self-esteem, and perceived stress scores. Results: Of 397 screened adolescents, 119 (mean BMI 40.4 ± 7.0 kg/m2, 49.6% female were randomized to the manual-based low-level intervention (n = 59 or treatment as usual (n = 60. We observed no group difference for adherence (absolute risk reduction 0.4%, 95% CI -14.7% to 15.5%; p = 1.0 or health-related quality of life (score difference 8.1, 95% CI -2.1 to 18.3; p = 0.11. Among all secondary outcomes, we detected explorative evidence for an effect on the DISABKIDS-37 ‘social exclusion' subscale (score difference 15.5; 95% CI 1.6-29.4; p = 0.03. 18/19 adverse events occurred in 26 participants, none were classified as serious. Conclusion: Adherence to a coping-oriented intervention was comparable to weight loss treatment, although it was weak in both interventions. Psychological interventions may help to overcome social isolation; further confirmation is required.

  17. Novel Psychological Formulation and Treatment of “Tic Attacks” in Tourette Syndrome

    Science.gov (United States)

    Robinson, Sally; Hedderly, Tammy

    2016-01-01

    One important, but underreported, phenomenon in Tourette syndrome (TS) is the occurrence of “tic attacks.” These episodes have been described at conferences as sudden bouts of tics and/or functional tic-like movements, lasting from 15 min to several hours. They have also been described by patients in online TS communities. To date, there are no reports of tic attacks in the literature. The aim of this article is to stimulate discussion and inform clinical practices by describing the clinical presentation of 12 children (mean age 11 years and 3 months; SD = 2 years and 4 months) with TS and tic attacks, with a detailed case report for one case (13-year-old male). These children commonly present acutely to casualty departments and undergo unnecessary medical investigations. Interestingly, all children reported comorbid anxiety, with worries about the tics themselves and an increased internal focus of attention on tics once the attacks had started. In keeping with other children, the index case reported a strong internal focus of attention, with a relationship between physiological sensations/tic urges, worries about having tic attacks, and behavioral responses (e.g., body scanning, situational avoidance, and other responses). In our experience, the attacks reduce with psychological therapy, for example, the index case attended 13 sessions of therapy that included metacognitive and attention training techniques, as well as cognitive–behavioral strategies. Following treatment, an improvement was seen across a range of measures assessing tics, mood, anxiety, and quality of life. Thus, psychological techniques used to treat anxiety disorders are effective at supporting a reduction in tic attacks through modifying attention, worry processes, and negative beliefs. It is hypothesized that an attentional style of threat monitoring, difficulties tolerating internal sensory urges, cognitive misattributions, and maladaptive coping strategies contribute to

  18. Novel Psychological Formulation and Treatment of "Tic Attacks" in Tourette Syndrome.

    Science.gov (United States)

    Robinson, Sally; Hedderly, Tammy

    2016-01-01

    One important, but underreported, phenomenon in Tourette syndrome (TS) is the occurrence of "tic attacks." These episodes have been described at conferences as sudden bouts of tics and/or functional tic-like movements, lasting from 15 min to several hours. They have also been described by patients in online TS communities. To date, there are no reports of tic attacks in the literature. The aim of this article is to stimulate discussion and inform clinical practices by describing the clinical presentation of 12 children (mean age 11 years and 3 months; SD = 2 years and 4 months) with TS and tic attacks, with a detailed case report for one case (13-year-old male). These children commonly present acutely to casualty departments and undergo unnecessary medical investigations. Interestingly, all children reported comorbid anxiety, with worries about the tics themselves and an increased internal focus of attention on tics once the attacks had started. In keeping with other children, the index case reported a strong internal focus of attention, with a relationship between physiological sensations/tic urges, worries about having tic attacks, and behavioral responses (e.g., body scanning, situational avoidance, and other responses). In our experience, the attacks reduce with psychological therapy, for example, the index case attended 13 sessions of therapy that included metacognitive and attention training techniques, as well as cognitive-behavioral strategies. Following treatment, an improvement was seen across a range of measures assessing tics, mood, anxiety, and quality of life. Thus, psychological techniques used to treat anxiety disorders are effective at supporting a reduction in tic attacks through modifying attention, worry processes, and negative beliefs. It is hypothesized that an attentional style of threat monitoring, difficulties tolerating internal sensory urges, cognitive misattributions, and maladaptive coping strategies contribute to the

  19. The mycotic ulcer treatment trial: a randomized trial comparing natamycin vs voriconazole.

    Science.gov (United States)

    Prajna, N Venkatesh; Krishnan, Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Prajna, Lalitha; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; Ray, Kathryn J; Zegans, Michael E; McLeod, Stephen D; Porco, Travis C; Acharya, Nisha R; Lietman, Thomas M

    2013-04-01

    To compare topical natamycin vs voriconazole in the treatment of filamentous fungal keratitis. This phase 3, double-masked, multicenter trial was designed to randomize 368 patients to voriconazole (1%) or natamycin (5%), applied topically every hour while awake until reepithelialization, then 4 times daily for at least 3 weeks. Eligibility included smear-positive filamentous fungal ulcer and visual acuity of 20/40 to 20/400. The primary outcome was best spectacle-corrected visual acuity at 3 months; secondary outcomes included corneal perforation and/or therapeutic penetrating keratoplasty. A total of 940 patients were screened and 323 were enrolled. Causative organisms included Fusarium (128 patients [40%]), Aspergillus (54 patients [17%]), and other filamentous fungi (141 patients [43%]). Natamycintreated cases had significantly better 3-month best spectacle-corrected visual acuity than voriconazole-treated cases (regression coefficient=0.18 logMAR; 95% CI, 0.30 to 0.05; P=.006). Natamycin-treated cases were less likely to have perforation or require therapeutic penetrating keratoplasty (odds ratio=0.42; 95% CI, 0.22 to 0.80; P=.009). Fusarium cases fared better with natamycin than with voriconazole (regression coefficient=0.41 logMAR; 95% CI,0.61 to 0.20; P<.001; odds ratio for perforation=0.06; 95% CI, 0.01 to 0.28; P<.001), while non-Fusarium cases fared similarly (regression coefficient=0.02 logMAR; 95% CI, 0.17 to 0.13; P=.81; odds ratio for perforation=1.08; 95% CI, 0.48 to 2.43; P=.86). Natamycin treatment was associated with significantly better clinical and microbiological outcomes than voriconazole treatment for smear-positive filamentous fungal keratitis, with much of the difference attributable to improved results in Fusarium cases. Voriconazole should not be used as monotherapy in filamentous keratitis. clinicaltrials.gov Identifier: NCT00996736

  20. [Headache in children and adolescents. Epidemiology, biopsychosocial correlates, and psychological treatment approaches].

    Science.gov (United States)

    Kröner-Herwig, B

    2014-08-01

    An abundance of studies have consistently shown that headache is the most prevalent pain in children and adolescents. Weekly headache is experienced by more than 10 % and is distinctly more frequent in girls. The number of headache-affected youths with high disability is lower than expected (~ 4 %). Headache is associated with pain in other body sites, thus multiple pain is experienced more often than isolated headache. Various somatic symptoms and even chronic diseases are also correlated with headache. Headache in parents carries a high risk of also occurring in their children. Various other psychosocial factors such as dysfunctional psychological traits are closely linked with headache, the most prominent being internalizing symptoms. However, externalizing symptoms also correlate with headache. Pain catastrophizing, as well as somatosensory amplification and anxiety sensitivity, have been shown to characterize individuals with headache. Features of the social environment, such as life events, school, as well as family stressors and socioeconomic parameters, are among the risk factors. Psychological interventions such as biofeedback, relaxation, and cognitive-behavioral training have proved their efficacy in headache treatment according to several meta-analyses. The latter has also been conducted in group settings and more recently in self-management focused trainings using electronic media. They mainly aim at the prevention of further headache episodes. The goal of this training is the strengthening of self-efficacy beliefs and active coping strategies. It is proposed that these competencies could contribute to the successful long-term prevention of an adverse course of headache into adulthood.

  1. Traumatic experiences and psychological distress in an urban refugee population seeking treatment services.

    Science.gov (United States)

    Keller, Allen; Lhewa, Dechen; Rosenfeld, Barry; Sachs, Emily; Aladjem, Asher; Cohen, Ilene; Smith, Hawthorne; Porterfield, Katherine

    2006-03-01

    While a growing literature has addressed the psychological consequences of torture and refugee trauma, most studies have focused on homogeneous samples drawn from a single region. Thus, relatively little research has attempted to identify demographic or experiential factors that might help explain different levels of distress in these individuals. We measured depression, anxiety, and posttraumatic stress disorder (PTSD) symptoms in a convenience sample of refugees and survivors of torture seeking treatment in a torture treatment program (N = 325). We found 81.1% of patients had clinically significant anxiety, 84.5% had clinically significant depressive symptoms, and 45.7% had significant PTSD symptoms. Regression analyses revealed that anxiety and depressive symptom were significant higher among women (beta = .08, p = 0.02 and beta = .22, p = 0.0001 for anxiety and depression respectively) and those who reported death threats as part of their traumatic experiences (beta = .10, p = 0.033 and beta = .12, p = 0.036 respectively). Symptoms of PTSD were also predicted by death threats (beta = .22, p = 0.03), but were also influenced by the experience of rape (beta = .33, p < 0.001), family torture experiences (beta = .23, p = 0.022), religion (beta = .21, p = 0.03), and age (beta = -.18, p = 0.004). The clinical implications of these results are discussed.

  2. Hypnosis or cognitive behavioral training for the reduction of pain and nausea during cancer treatment: a controlled clinical trial.

    Science.gov (United States)

    Syrjala, K L; Cummings, C; Donaldson, G W

    1992-02-01

    Few controlled clinical trials have tested the efficacy of psychological techniques for reducing cancer pain or post-chemotherapy nausea and emesis. In this study, 67 bone marrow transplant patients with hematological malignancies were randomly assigned to one of four groups prior to beginning transplantation conditioning: (1) hypnosis training (HYP); (2) cognitive behavioral coping skills training (CB); (3) therapist contact control (TC); or (4) treatment as usual (TAU; no treatment control). Patients completed measures of physical functioning (Sickness Impact Profile; SIP) and psychological functioning (Brief Symptom Inventory; BSI), which were used as covariates in the analyses. Biodemographic variables included gender, age and a risk variable based on diagnosis and number of remissions or relapses. Patients in the HYP, CB and TC groups met with a clinical psychologist for two pre-transplant training sessions and ten in-hospital "booster" sessions during the course of transplantation. Forty-five patients completed the study and provided all covariate data, and 80% of the time series outcome data. Analyses of the principal study variables indicated that hypnosis was effective in reducing reported oral pain for patients undergoing marrow transplantation. Risk, SIP, and BSI pre-transplant were found to be effective predictors of inpatient physical symptoms. Nausea, emesis and opioid use did not differ significantly between the treatment groups. The cognitive behavioral intervention, as applied in this study, was not effective in reducing the symptoms measured.

  3. Exposure to virtual social interactions in the treatment of social anxiety disorder: A randomized controlled trial.

    Science.gov (United States)

    Kampmann, Isabel L; Emmelkamp, Paul M G; Hartanto, Dwi; Brinkman, Willem-Paul; Zijlstra, Bonne J H; Morina, Nexhmedin

    2016-02-01

    This randomized controlled trial investigated the efficacy of a stand-alone virtual reality exposure intervention comprising verbal interaction with virtual humans to target heterogeneous social fears in participants with social anxiety disorder. Sixty participants (Mage = 36.9 years; 63.3% women) diagnosed with social anxiety disorder were randomly assigned to individual virtual reality exposure therapy (VRET), individual in vivo exposure therapy (iVET), or waiting-list. Multilevel regression analyses revealed that both treatment groups improved from pre-to postassessment on social anxiety symptoms, speech duration, perceived stress, and avoidant personality disorder related beliefs when compared to the waiting-list. Participants receiving iVET, but not VRET, improved on fear of negative evaluation, speech performance, general anxiety, depression, and quality of life relative to those on waiting-list. The iVET condition was further superior to the VRET condition regarding decreases in social anxiety symptoms at post- and follow-up assessments, and avoidant personality disorder related beliefs at follow-up. At follow-up, all improvements were significant for iVET. For VRET, only the effect for perceived stress was significant. VRET containing extensive verbal interaction without any cognitive components can effectively reduce complaints of generalized social anxiety disorder. Future technological and psychological improvements of virtual social interactions might further enhance the efficacy of VRET for social anxiety disorder. Copyright © 2015 Elsevier Ltd. All rights reserved.

  4. Meditation awareness training for the treatment of workaholism: A controlled trial.

    Science.gov (United States)

    Van Gordon, William; Shonin, Edo; Dunn, Thomas J; Garcia-Campayo, Javier; Demarzo, Marcelo M P; Griffiths, Mark D

    2017-06-01

    Background and aims Workaholism is a form of behavioral addiction that can lead to reduced life and job satisfaction, anxiety, depression, burnout, work-family conflict, and impaired productivity. Given the number of people affected, there is a need for more targeted workaholism treatments. Findings from previous case studies successfully utilizing second-generation mindfulness-based interventions (SG-MBIs) for treating behavioral addiction suggest that SG-MBIs may be suitable for treating workaholism. This study conducted a controlled trial to investigate the effects of an SG-MBI known as meditation awareness training (MAT) on workaholism. Methods Male and female adults suffering from workaholism (n = 73) were allocated to MAT or a waiting-list control group. Assessments were performed at pre-, post-, and 3-month follow-up phases. Results MAT participants demonstrated significant and sustained improvements over control-group participants in workaholism symptomatology, job satisfaction, work engagement, work duration, and psychological distress. Furthermore, compared to the control group, MAT participants demonstrated a significant reduction in hours spent working but without a decline in job performance. Discussion and conclusions MAT may be a suitable intervention for treating workaholism. Further controlled intervention studies investigating the effects of SG-MBIs on workaholism are warranted.

  5. The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Schakel, L.; Veldhuijzen, D.S.; Middendorp, H. van; Prins, C.; Joosten, S.A.; Ottenhoff, T.H.; Visser, L.G.; Evers, A.W.M.

    2017-01-01

    BACKGROUND: Previous research has provided evidence for the link between psychological processes and psychophysiological health outcomes. Psychological interventions, such as face-to-face or online cognitive behavioral therapy (CBT) and serious games aimed at improving health, have shown promising

  6. A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial).

    Science.gov (United States)

    Paajanen, Hannu; Grönroos, Juha M; Rautio, Tero; Nordström, Pia; Aarnio, Markku; Rantanen, Tuomo; Hurme, Saija; Dean, Kirsti; Jartti, Airi; Mecklin, Jukka-Pekka; Sand, Juhani; Salminen, Paulina

    2013-02-08

    Although the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial. The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18-60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point. The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75-85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting

  7. The Cardiff dental study: a 20-year critical evaluation of the psychological health gain from orthodontic treatment.

    Science.gov (United States)

    Kenealy, Pamela M; Kingdon, Anne; Richmond, Stephen; Shaw, William C

    2007-02-01

    Despite the widespread belief that orthodontics improves psychological well-being and self-esteem, there is little objective evidence to support this (Kenealy et al., 1989a; Shaw, O'Brien, Richmond, & Brook, 1991). A 20 year follow-up study compared the dental and psychosocial status of individuals who received, or did not receive, orthodontics as teenagers. A prospective longitudinal cohort design with four studies of the effect of orthodontic treatment. Secondary analysis of outcome data incorporated orthodontic need at baseline and treatment received in a 2 x 2 factorial design. A multidisciplinary research programme studied a cohort of 1,018, 11-12 year old participants in 1981. Extensive assessment of dental health and psychosocial well-being was conducted; facial and dental photographs and plaster casts of dentition were obtained and rated for attractiveness and pre-treatment need. No recommendations about orthodontic treatment were made, and an observational approach was adopted. At the third follow-up 337 (30-31 year olds) were re-examined in 2001. Participants with a prior need for orthodontic treatment as children who obtained treatment demonstrated better tooth alignment and satisfaction. However when self-esteem at baseline was controlled for, orthodontics had little positive impact on psychological health and quality of life in adulthood. Lack of orthodontic treatment where there was a prior need did not lead to psychological difficulties in later life. Dental status alone was a weak predictor of self-esteem at outcome explaining 8% of the variance. Self-esteem in adulthood was more strongly predicted (65% of the variance) by psychological variables at outcome: perception of quality of life, life satisfaction, self-efficacy, depression, social anxiety, emotional health, and by self-perception of attractiveness. Longitudinal analysis revealed that the observed effect of orthodontic treatment on self esteem at outcome was accounted for by self esteem at

  8. Requirements Elicitation in a Telemedicine Pain-treatment Trial

    NARCIS (Netherlands)

    Widya, I.A.; Bults, Richard G.A.; van Beijnum, Bernhard J.F.; Sandsjö, L.; Schaake, L.; Huis in 't Veld, M.H.A.; Jones, Valerie M.; Hermens, Hermanus J.; Ryan, K.; Robinson, W.

    2009-01-01

    This paper presents the early phase requirements elicitation for a work-related neck-shoulder pain teletreatment trial and the assessment of those requirements in respect of their importance to the trial and the feasibility of the needed software adaptations of the telemedicine system within the

  9. Prevalence and reporting of recruitment, randomisation and treatment errors in clinical trials: A systematic review.

    Science.gov (United States)

    Yelland, Lisa N; Kahan, Brennan C; Dent, Elsa; Lee, Katherine J; Voysey, Merryn; Forbes, Andrew B; Cook, Jonathan A

    2018-06-01

    Background/aims In clinical trials, it is not unusual for errors to occur during the process of recruiting, randomising and providing treatment to participants. For example, an ineligible participant may inadvertently be randomised, a participant may be randomised in the incorrect stratum, a participant may be randomised multiple times when only a single randomisation is permitted or the incorrect treatment may inadvertently be issued to a participant at randomisation. Such errors have the potential to introduce bias into treatment effect estimates and affect the validity of the trial, yet there is little motivation for researchers to report these errors and it is unclear how often they occur. The aim of this study is to assess the prevalence of recruitment, randomisation and treatment errors and review current approaches for reporting these errors in trials published in leading medical journals. Methods We conducted a systematic review of individually randomised, phase III, randomised controlled trials published in New England Journal of Medicine, Lancet, Journal of the American Medical Association, Annals of Internal Medicine and British Medical Journal from January to March 2015. The number and type of recruitment, randomisation and treatment errors that were reported and how they were handled were recorded. The corresponding authors were contacted for a random sample of trials included in the review and asked to provide details on unreported errors that occurred during their trial. Results We identified 241 potentially eligible articles, of which 82 met the inclusion criteria and were included in the review. These trials involved a median of 24 centres and 650 participants, and 87% involved two treatment arms. Recruitment, randomisation or treatment errors were reported in 32 in 82 trials (39%) that had a median of eight errors. The most commonly reported error was ineligible participants inadvertently being randomised. No mention of recruitment, randomisation

  10. Generalized psychological distress among HIV-infected patients enrolled in antiretroviral treatment in Dilla University Hospital, Gedeo zone, Ethiopia

    Directory of Open Access Journals (Sweden)

    Solomon H. Tesfaye

    2014-05-01

    Full Text Available Background: Psychological disorders like depression and anxiety are potentially dangerous conditions. In the context of HIV/AIDS, this can influence health-seeking behavior or uptake of diagnosis and treatment for HIV/AIDS, add to the burden of disease for HIV patients, create difficulty in adherence to treatment, and increase the risk of mortality and morbidity. The objective of this study was to assess the prevalence and correlates of generalized psychological distress among HIV-infected subjects on antiretroviral treatment (ART. Design: An institution-based cross-sectional study was conducted. Interviews were conducted with 500 patients initiating ART at Dilla Referral Hospital. Generalized psychological distress was measured using the Hospital Anxiety and Depression Scale (HADS. A cutoff score ≥19 was used to identify possible cases of patients with generalized psychological distress. Multivariable logistic regression analysis using SPSS Version 20 was performed to identify factors associated with psychological distress. Results: The prevalence of generalized psychological distress among the population of this study was 11.2% (HADS≥19. Factors independently associated with generalized psychological distress were moderate stress (OR=6.87, 95% CI 2.27–20.81, low social support (OR=10.17, 95% CI 2.85–36.29, number of negative life events of six and above (OR=3.99, 95% CI 1.77–8.99, not disclosing HIV status (OR=5.24, 95% CI 1.33–20.62, and CD4 cell count of <200 cells/mm3 (OR=1.98, 95% CI 0.45–0.83 and 200–499 cells/mm3 (OR=3.53, 95% CI 1.62–7.73. Conclusions: This study provides prevalence of psychological distress lower than the prevalence of common mental disorders in Ethiopia and comparable to some other studies in sub-Saharan Africa. The findings are important in terms of their relevance to identifying high-risk groups for generalized psychological distress and preventing distress through integrating mental health

  11. The optimization of treatment and management of schizophrenia in Europe (OPTiMiSE) trial

    DEFF Research Database (Denmark)

    Leucht, Stefan; Winter-van Rossum, Inge; Heres, Stephan

    2015-01-01

    Commission sponsored "Optimization of Treatment and Management of Schizophrenia in Europe" (OPTiMiSE) trial which aims to provide a treatment algorithm for patients with a first episode of schizophrenia. METHODS: We searched Pubmed (October 29, 2014) for randomized controlled trials (RCTs) that examined...... switching the drug in nonresponders to another antipsychotic. We described important methodological choices of the OPTiMiSE trial. RESULTS: We found 10 RCTs on switching antipsychotic drugs. No trial was conclusive and none was concerned with first-episode schizophrenia. In OPTiMiSE, 500 first episode...

  12. A longitudinal study investigating the role of decisional conflicts and regret and short-term psychological adjustment after IVF treatment failure.

    Science.gov (United States)

    Chan, Celia Hoi Yan; Lau, Hi Po Bobo; Tam, Michelle Yi Jun; Ng, Ernest Hung Yu

    2016-12-01

    What is the relationship between decisional conflict, decisional regret and psychological well-being in women following unsuccessful IVF cycles? The mediating effect of decisional regret on the relationship between decisional conflict and fertility-related quality of life (FRQOL) has been found to be moderated by the availability (versus absence) of frozen embryos after an unsuccessful IVF cycle. Infertility treatment is marked by its open-ended nature. Stresses in treatment decision-making could be aggravated by a culture which honours families through procreation. While studies have investigated treatment-related decision-making among infertile women, little is known about the mental health consequences of decisional conflict and decisional regret following an unsuccessful IVF cycle. A study was conducted over a 3-month period with infertile women who had recently experienced a failed IVF cycle (T 0 ). Decisional conflict when they decided on terminating or continuing treatment (T 1 ) and decisional regret 3 months later (T 2 ) were measured. Participants reported their levels of depression, anxiety and FRQOL at three time points. A total of 151 participants completed all time points (attrition rate: 39%). The average age of participants was 37.2 years, and they had had 1.1 cycles (range: 0-8) on average at the time of study intake. The duration of the study was 2 years. Participants were infertile women who were not pregnant following an IVF cycle recruited from a university-affiliated assisted reproduction centre. Following the notification of a negative pregnancy result, patients were invited to complete measures of FRQOL, depression and anxiety across three time points and decisional conflict and decisional regret at T 1 and T 2 respectively. Decisional regret partially mediated the effect of decisional conflict on overall and treatment-specific FRQOL (P IVF cycle (P IVF cycle. Healthcare professionals should be aware of the psychological ramifications of

  13. A pilot feasibility randomised controlled trial of an adjunct brief social network intervention in opiate substitution treatment services.

    Science.gov (United States)

    Day, Ed; Copello, Alex; Seddon, Jennifer L; Christie, Marilyn; Bamber, Deborah; Powell, Charlotte; Bennett, Carmel; Akhtar, Shabana; George, Sanju; Ball, Andrew; Frew, Emma; Goranitis, Ilias; Freemantle, Nick

    2018-01-15

    Approximately 3% of people receiving opioid substitution therapy (OST) in the UK manage to achieve abstinence from prescribed and illicit drugs within three years of commencing treatment. Involvement of families and wider social networks in supporting psychological treatment may be an effective strategy in facilitating recovery, and this pilot study aimed to evaluate the impact of a social network-focused intervention for patients receiving OST. A two-site, open feasibility trial randomised patients receiving OST for at least 12 months but still reporting illicit opiate use in the past 28 days to one of three treatments: 1) treatment as usual (TAU), 2) Brief Social Behaviour and Network Therapy (B-SBNT) + TAU, or 3) Personal Goal Setting (PGS) + TAU. The two active interventions consisted of 4 sessions. There were 3 aims: 1) test the feasibility of recruiting OST patients to a trial of B-SBNT, and following them up over 12 months; 2) test the feasibility of training clinicians to deliver B-SBNT; 3) test whether B-SBNT reduces heroin use 3 and 12 months after treatment, and to explore potential mediating factors. The primary outcome for aim 3 was number of days of heroin use in the past month, and a range of secondary outcome measures were specified in advance (level of drug dependence, mental health, social satisfaction, therapist rapport, treatment satisfaction, social network size and support). A total of 83 participants were randomised, and 70 (84%) were followed-up at 12 months. Fidelity analysis of showed that B-SBNT sessions were clearly distinguishable from PGS and TAU sessions, suggesting it was possible to train clinical staff to an adequate level of competence. No significant differences were found between the 3 intervention arms in the primary or secondary outcome measures. Attendance at psychosocial treatment intervention sessions was low across all three arms (44% overall). Patients receiving OST can be recruited into a trial of a social

  14. Time Course of Leptin in Patients with Anorexia Nervosa during Inpatient Treatment: Longitudinal Relationships to BMI and Psychological Factors.

    Directory of Open Access Journals (Sweden)

    Esther Stroe-Kunold

    Full Text Available Leptin, a hormone secreted by adipose tissue, appears to play a major role in the homeostasis of body weight and psychobiological processes associated with anorexia nervosa (AN. However, there is scarce data on its exact influence on this disorder, in particular data over time.The present study addresses whether leptin changes during inpatient treatment play a role for treatment outcome and psychological factors in underweight AN patients.In order to understand whether leptin's role differs in relation to AN severity, data were assessed from 11 patients with a very low BMI and a higher chronicity (high severity group; HSS; mean BMI at the beginning of the study = 13.6; mean duration of illness = 5.1 years vs. nine with less severe symptoms (LSS; mean BMI = 16.2; mean duration of illness = 3.7 years. During the course of treatment, serum leptin concentrations were assessed weekly while weight (BMI was assessed twice per week. Concomitantly, psychological variables were obtained by means of electronic diaries. Unconditional linear growth models were calculated to evaluate the temporal course of leptin in relation to BMI. For HSS patients, two phases of treatment (BMI < 16 and BMI ≥ 16 kg/m2 were investigated.Leptin increased significantly with BMI in both groups of patients. For HSS patients, the increase of leptin in the first treatment phase did not predict later increases in BMI. Furthermore, the relationship of leptin and psychological factors was modulated by symptom severity. In HSS patients, higher leptin levels were associated with greater feelings of depression, anxiety, and stress whereas in LSS patients a higher leptin level showed the trend to be associated with lower psychological symptom burden.Our results suggest that leptin changes are differently associated with weight gain and psychological symptoms depending on the severity of starvation.

  15. Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway using group-based metacognitive therapy (PATHWAY Group MCT): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Wells, Adrian; McNicol, Kirsten; Reeves, David; Salmon, Peter; Davies, Linda; Heagerty, Anthony; Doherty, Patrick; McPhillips, Rebecca; Anderson, Rebecca; Faija, Cintia; Capobianco, Lora; Morley, Helen; Gaffney, Hannah; Shields, Gemma; Fisher, Peter

    2018-04-03

    Anxiety and depression are prevalent among cardiac rehabilitation patients but pharmacological and psychological treatments have limited effectiveness in this group. Furthermore, psychological interventions have not been systematically integrated into cardiac rehabilitation services despite being a strategic priority for the UK National Health Service. A promising new treatment, metacognitive therapy, may be well-suited to the needs of cardiac rehabilitation patients and has the potential to improve outcomes. It is based on the metacognitive model, which proposes that a thinking style dominated by rumination, worry and threat monitoring maintains emotional distress. Metacognitive therapy is highly effective at reducing this thinking style and alleviating anxiety and depression in mental health settings. This trial aims to evaluate the effectiveness and cost-effectiveness of group-based metacognitive therapy for cardiac rehabilitation patients with elevated anxiety and/or depressive symptoms. The PATHWAY Group-MCT trial is a multicentre, two-arm, single-blind, randomised controlled trial comparing the clinical- and cost-effectiveness of group-based metacognitive therapy plus usual cardiac rehabilitation to usual cardiac rehabilitation alone. Cardiac rehabilitation patients (target sample n = 332) with elevated anxiety and/or depressive symptoms will be recruited across five UK National Health Service Trusts. Participants randomised to the intervention arm will receive six weekly sessions of group-based metacognitive therapy delivered by either cardiac rehabilitation professionals or research nurses. The intervention and control groups will both be offered the usual cardiac rehabilitation programme within their Trust. The primary outcome is severity of anxiety and depressive symptoms at 4-month follow-up measured by the Hospital Anxiety and Depression Scale total score. Secondary outcomes are severity of anxiety/depression at 12-month follow-up, health

  16. Psychological effects of belonging to a Facebook weight management group in overweight and obese adults: Results of a randomised controlled trial.

    Science.gov (United States)

    Jane, Monica; Foster, Jonathan; Hagger, Martin; Ho, Suleen; Kane, Robert; Pal, Sebely

    2018-05-18

    This study was conducted to test whether the weight outcomes in an online social networking group were mediated by changes to psychological outcome measures in overweight and obese individuals, following a weight management programme delivered via Facebook. The data analysed in this study were collected during a three-armed, randomised, controlled clinical weight management trial conducted with overweight and obese adults over 24 weeks. Two intervention groups were given the same weight management programme: one within a Facebook group, along with peer support from other group members (the Facebook Group); the other group received the same programme in a pamphlet (the Pamphlet Group). A Control Group was given standard care. The primary outcome was weight; secondary outcomes included the following domains from self-reported questionnaires: energy intake and expenditure; psychological health, social relationships, physical health, quality of life, depression, anxiety, stress, health anxiety, happiness, as well as Facebook Group participants' opinion of this group. The Facebook Group experienced a reduction in their baseline weight measurement by week 24, significantly compared to the Control Group (p = .016). The Facebook Group recorded a significant increase in the psychological health domain during the trial (at week 12) relative to their baseline measurement, and significant compared to the Control Group (p = .022). Mediation analysis indicated a statistical trend, but not statistical significance, for psychological health as a mediator to weight loss in the Facebook Group. While both intervention groups showed significant changes in psychological outcome measures, the Facebook Group was the only group to experience statistically significant weight loss by the end of the 24 weeks. Therefore, an examination of other psychological and/or behavioural outcome measures undertaken in larger studies in the future may help to identify significant mediators to

  17. A Randomized Controlled Trial on Effects of the Transcendental Meditation Program on Blood Pressure, Psychological Distress, and Coping in Young Adults

    Science.gov (United States)

    Nidich, Sanford I.; Rainforth, Maxwell V.; Haaga, David A.F.; Hagelin, John; Salerno, John W.; Travis, Fred; Tanner, Melissa; Gaylord-King, Carolyn; Grosswald, Sarina; Schneider, Robert H.

    2009-01-01

    Background Psychological distress contributes to the development of hypertension in young adults. This trial assessed the effects of a mind–body intervention on blood pressure (BP), psychological distress, and coping in college students. Methods This was a randomized controlled trial (RCT) of 298 university students randomly allocated to either the Transcendental Meditation (TM) program or wait-list control. At baseline and after 3 months, BP, psychological distress, and coping ability were assessed. A subgroup of 159 subjects at risk for hypertension was analyzed similarly. Results Changes in systolic BP (SBP)/diastolic BP (DBP) for the overall sample were −2.0/−1.2 mm Hg for the TM group compared to +0.4/+0.5 mm Hg for controls (P = 0.15, P = 0.15, respectively). Changes in SBP/DBP for the hypertension risk subgroup were −5.0/−2.8 mm Hg for the TM group compared to +1.3/+1.2 mm Hg for controls (P = 0.014, P = 0.028, respectively). Significant improvements were found in total psychological distress, anxiety, depression, anger/hostility, and coping (P values < 0.05). Changes in psychological distress and coping correlated with changes in SBP (P values < 0.05) and DBP (P values < 0.08). Conclusions This is the first RCT to demonstrate that a selected mind–body intervention, the TM program, decreased BP in association with decreased psychological distress, and increased coping in young adults at risk for hypertension. This mind–body program may reduce the risk for future development of hypertension in young adults. PMID:19798037

  18. A randomised controlled multicentre trial of treatments for adolescent anorexia nervosa including assessment of cost-effectiveness and patient acceptability - the TOuCAN trial.

    Science.gov (United States)

    Gowers, S G; Clark, A F; Roberts, C; Byford, S; Barrett, B; Griffiths, A; Edwards, V; Bryan, C; Smethurst, N; Rowlands, L; Roots, P

    2010-03-01

    to it), limits the assessment of the treatment effect of inpatient care. However, this study provides little support for lengthy inpatient psychiatric treatment on clinical or health economic grounds. These findings are broadly consistent with existing guidelines on the treatment of anorexia nervosa, which suggest that outpatient treatments should be offered to the majority, with inpatient treatment offered in rare cases, though our findings lend little support to a stepped-care approach in which inpatient care is offered to outpatient non-responders. Outpatient care, supported by brief (medical) inpatient management for correction of acute complications may be a preferable approach. The health economic analysis and user views both support NICE guidelines, which suggest that anorexia nervosa should be managed in specialist services that have experience and expertise in its management. Comprehensive general CAMHS might, however, be well placed to manage milder cases. Further research should focus on the specific components of outpatient psychological therapies. Although family-based treatments are well established, trials have not established their effectiveness compared with good-quality individual psychological therapies and the combination of individual and family approaches is untested. Further research is needed to establish which patients (if any) might respond to inpatient psychiatric treatment when unresponsive to outpatient care, the positive and negative components of it and the optimum length of stay. NRR number (National Research Register) N0484056615; Current Controlled Trials ISRCTN39345394.

  19. Psychological mediators related to clinical outcome in cognitive behavioural therapy for coronary heart disease: A sub-analysis from the SUPRIM trial.

    Science.gov (United States)

    Norlund, Fredrika; Olsson, Erik Mg; Pingel, Ronnie; Held, Claes; Svärdsudd, Kurt; Gulliksson, Mats; Burell, Gunilla

    2017-06-01

    Background The Secondary Prevention in Uppsala Primary Healthcare Project (SUPRIM) was a randomized controlled trial of a group-based cognitive behavioural therapy stress management programme for patients with coronary heart disease. The project was successful in reducing the risk of fatal or non-fatal first recurrent cardiovascular events. The aim of this study was to analyse the effect of cognitive behavioural therapy on self-rated stress, somatic anxiety, vital exhaustion and depression and to study the associations of these factors with the reduction in cardiovascular events. Methods A total of 362 patients were randomly assigned to intervention or usual care groups. The psychological outcomes were assessed five times during 24 months and analysed using linear mixed models. The mediating roles of the outcomes were analysed using joint modelling of the longitudinal and time to event data. Results The intervention had a positive effect on somatic anxiety ( p < 0.05), reflecting a beneficial development over time compared with the controls. Stress, vital exhaustion and depression did not differ between the groups over time. Mediator analysis suggested that somatic anxiety may have mediated the effect of treatment on cardiovascular events. Conclusions The intervention had a small positive effect on somatic anxiety, but did not affect stress, vital exhaustion or depression in patients with coronary heart disease. Somatic anxiety was associated with an increased risk of cardiovascular events and might act as a partial mediator in the treatment effect on cardiovascular events. However, the mechanisms between the intervention and the protective cardiovascular outcome remain to be identified.

  20. Meta-analysis of the effectiveness of psychological and medical treatments for binge-eating disorder (MetaBED): study protocol.

    Science.gov (United States)

    Hilbert, Anja; Petroff, David; Herpertz, Stephan; Kersting, Anette; Pietrowsky, Reinhard; Tuschen-Caffier, Brunna; Vocks, Silja; Schmidt, Ricarda

    2017-03-29

    Binge-eating disorder (BED) was included as its own diagnostic entity in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). An increasing number of treatment studies have been published, but an up-to-date comprehensive meta-analysis on diverse treatment approaches for BED is lacking. In an updated and extension of a previous meta-analysis, the goals of this study are to assess the short-term and long-term effectiveness of psychological and medical treatments for BED. We will search bibliographic databases and study registries, including manual searches for studies published before January 2016. The search strategy will include terms relating to binge eating and diverse forms of psychological and medical interventions. Language will be restricted to English. The studies included will be treatment studies, that is, randomised-controlled trials, and non-randomised and non-controlled studies, for individuals with BED (DSM-IV or DSM-5), and studies that provided a pre-treatment and at least one post-treatment or follow-up assessment of binge eating. The primary outcomes will be the number of binge-eating episodes, abstinence from binge eating and diagnosis of BED at post-treatment and/or follow-up(s), and changes from pre-treatment to post-treatment and/or follow-up(s). Likewise, as secondary outcomes, eating disorder and general psychopathology, quality of life, and body weight will be analysed and adverse events and treatment drop-out will be examined. Study search, selection and data extraction, including risk of bias assessment, will be independently performed by 2 reviewers and consensus will be sought. Moderator analyses will be conducted, and equity aspects will be considered. Sensitivity analyses will be conducted to determine the robustness of the results. Ethical approval is not required for this meta-analysis. Published in a peer-reviewed journal and disseminated electronically and in print, this meta-analysis will form

  1. Interrelation and independence of positive and negative psychological constructs in predicting general treatment adherence in coronary artery patients - Results from the THORESCI study.

    Science.gov (United States)

    van Montfort, Eveline; Denollet, Johan; Widdershoven, Jos; Kupper, Nina

    2016-09-01

    In cardiac patients, positive psychological factors have been associated with improved medical and psychological outcomes. The current study examined the interrelation between and independence of multiple positive and negative psychological constructs. Furthermore, the potential added predictive value of positive psychological functioning regarding the prediction of patients' treatment adherence and participation in cardiac rehabilitation (CR) was investigated. 409 percutaneous coronary intervention (PCI) patients were included (mean age = 65.6 ± 9.5; 78% male). Self-report questionnaires were administered one month post-PCI. Positive psychological constructs included positive affect (GMS) and optimism (LOT-R); negative constructs were depression (PHQ-9, BDI), anxiety (GAD-7) and negative affect (GMS). Six months post-PCI self-reported general adherence (MOS) and CR participation were determined. Factor Analysis (Oblimin rotation) revealed two components (r = − 0.56), reflecting positive and negative psychological constructs. Linear regression analyses showed that in unadjusted analyses both optimism and positive affect were associated with better general treatment adherence at six months (p psychological constructs (i.e. optimism) may be of incremental value to negative psychological constructs in predicting patients' treatment adherence. A more complete view of a patients' psychological functioning will open new avenues for treatment. Additional research is needed to investigate the relationship between positive psychological factors and other cardiac outcomes, such as cardiac events and mortality.

  2. Therapist adherence in the strong without anorexia nervosa (SWAN) study: A randomized controlled trial of three treatments for adults with anorexia nervosa.

    Science.gov (United States)

    Andony, Louise J; Tay, Elaine; Allen, Karina L; Wade, Tracey D; Hay, Phillipa; Touyz, Stephen; McIntosh, Virginia V W; Treasure, Janet; Schmidt, Ulrike H; Fairburn, Christopher G; Erceg-Hurn, David M; Fursland, Anthea; Crosby, Ross D; Byrne, Susan M

    2015-12-01

    To develop a psychotherapy rating scale to measure therapist adherence in the Strong Without Anorexia Nervosa (SWAN) study, a multi-center randomized controlled trial comparing three different psychological treatments for adults with anorexia nervosa. The three treatments under investigation were Enhanced Cognitive Behavioural Therapy (CBT-E), the Maudsley Anorexia Nervosa Treatment for Adults (MANTRA), and Specialist Supportive Clinical Management (SSCM). The SWAN Psychotherapy Rating Scale (SWAN-PRS) was developed, after consultation with the developers of the treatments, and refined. Using the SWAN-PRS, two independent raters initially rated 48 audiotapes of treatment sessions to yield inter-rater reliability data. One rater proceeded to rate a total of 98 audiotapes from 64 trial participants. The SWAN-PRS demonstrated sound psychometric properties, and was considered a reliable measure of therapist adherence. The three treatments were highly distinguishable by independent raters, with therapists demonstrating significantly more behaviors consistent with the actual allocated treatment compared to the other two treatment modalities. There were no significant site differences in therapist adherence observed. The findings provide support for the internal validity of the SWAN study. The SWAN-PRS was deemed suitable for use in other trials involving CBT-E, MANTRA, or SSCM. The Authors. International Journal of Eating Disorders Published by Wiley Periodicals, Inc.

  3. Acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee: randomised controlled trial

    Science.gov (United States)

    Vas, Jorge; Méndez, Camila; Perea-Milla, Emilio; Vega, Evelia; Panadero, María Dolores; León, José María; Borge, Miguel Ángel; Gaspar, Olga; Sánchez-Rodríguez, Francisco; Aguilar, Inmaculada; Jurado, Rosario

    2004-01-01

    Objectives To analyse the efficacy of acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee, with respect to pain relief, reduction of stiffness, and increased physical function during treatment; modifications in the consumption of diclofenac during treatment; and changes in the patient's quality of life. Design Randomised, controlled, single blind trial, with blinded evaluation and statistical analysis of results. Setting Pain management unit in a public primary care centre in southern Spain, over a period of two years. Participants 97 outpatients presenting with osteoarthritis of the knee. Interventions Patients were randomly separated into two groups, one receiving acupuncture plus diclofenac (n = 48) and the other placebo acupuncture plus diclofenac (n = 49). Main outcome measures The clinical variables examined included intensity of pain as measured by a visual analogue scale; pain, stiffness, and physical function subscales of the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index; dosage of diclofenac taken during treatment; and the profile of quality of life in the chronically ill (PQLC) instrument, evaluated before and after the treatment programme. Results 88 patients completed the trial. In the intention to treat analysis, the WOMAC index presented a greater reduction in the intervention group than in the control group (mean difference 23.9, 95% confidence interval 15.0 to 32.8) The reduction was greater in the subscale of functional activity. The same result was observed in the pain visual analogue scale, with a reduction of 26.6 (18.5 to 34.8). The PQLC results indicate that acupuncture treatment produces significant changes in physical capability (P = 0.021) and psychological functioning (P = 0.046). Three patients reported bruising after the acupuncture sessions. Conclusions Acupuncture plus diclofenac is more effective than placebo acupuncture plus diclofenac for the symptomatic

  4. The role of psychological flexibility in a self-help acceptance and commitment therapy intervention for psychological distress in a randomized controlled trial.

    NARCIS (Netherlands)

    Fledderus, M.; Bohlmeijer, Ernst Thomas; Fox, Gerardus J.A.; Schreurs, Karlein Maria Gertrudis; Spinhoven, Philip

    2013-01-01

    This study examined the role of psychological flexibility, as a risk factor and as a process of change, in a self-help Acceptance and Commitment Therapy (ACT) intervention for adults with mild to moderate depression and anxiety. Participants were randomized to the self-help programme with e-mail

  5. Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT): modifying the CONSORT statement.

    Science.gov (United States)

    2014-10-01

    Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and a third individual if successful, their offspring (child), who is also the desired outcome of treatment. The primary outcome of interest and many adverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which creates a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existing Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to the CONSORT checklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant after ≥20 weeks' gestation) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and the neonatal period. Routine information should be collected and reported on both male and female participants in the trial. We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and couples

  6. Sexual dysfunctions in MS in relation to neuropsychiatric aspects and its psychological treatment: A scoping review

    Science.gov (United States)

    Rose, Anita; van de Vis, Wim; Engelbrecht, Jannie; Pirard, Michelle; Lau, Stefanie; Heesen, Christoph; Köpke, Sascha

    2018-01-01

    Objective Sexual dysfunction in multiple sclerosis (MS) is a significant, but often underestimated and overlooked suffering. Interventions to treat sexual dysfunction in MS are rare. The relation between sexual dysfunction in MS and psychological as well as neuropsychological aspects is evident. However, this field of research remains markedly underdeveloped in this severe chronic illness. The aim of this scoping review is to describe the relevant knowledge in this area and to identify psychological interventions to treat sexual dysfunctions in MS. Methods A scoping review was conducted to answer the following questions: (1) Which psychological and neuropsychological factors impact on sexual dysfunction in MS and vice versa? (2) What kind of psychological interventions aiming to improve sexual dysfunctions in MS are available? A comprehensive search and review of MEDLINE, PsycINFO, and CINAHL was completed by using a recent methodological framework for scoping reviews. Results 23 publications covering a total of 13,259 people with MS and 532 healthy controls were identified. Sexual dysfunction was found to be very common in MS and there is an obvious relation to psychological disorders as e.g. depression and anxiety and also to psychological aspects as partner relationship and quality of life. The relation between sexual dysfunction in MS and neuropsychological impairment has only rarely been studied and no clear results were found. Only two studies were identified, assessing the effectiveness of psychological intervention studies on sexual dysfunction in people with MS, and a third study presenting a secondary analysis of a study targeting depression. All three studies reported significant improvements in sexual dysfunction as well as partly in psychological variables. Conclusions There is a pressing need for the development and adequate evaluation of psychological interventions for sexual dysfunctions in MS. In addition, sexual dysfunction and its impact on

  7. Parents' and Adolescents' Preferences for Intensified or Reduced Treatment in Randomized Lymphoblastic Leukemia Trials

    DEFF Research Database (Denmark)

    Tulstrup, Morten; Larsen, Hanne Bækgaard; Castor, Anders

    2015-01-01

    compared to younger children in trials with different toxicity profiles. PROCEDURE: Age-dependent participation rates in three consecutive, randomized childhood leukemia trials conducted by the Nordic Society of Paediatric Haematology and Oncology were evaluated. The ALL2000 dexamethasone/vincristine (Dx...... prospectively registered by the treating physicians. RESULTS: Parents of young children favored treatment intensifications (Dx/VCR: 12% refusal; 6MP: 14%; ASP: 21%), whereas parents of adolescents favored treatment reductions (Dx/VCR: 52% refusal; 6MP: 30%; ASP: 8%). Adolescents were more likely to refuse...... intensification trials than young children (adjusted ORs 6.3; P treatment (adjusted OR for median consolidation length 0.15; P = 0...

  8. The effects of a novel psychological attribution and emotional awareness and expression therapy for chronic musculoskeletal pain: A preliminary, uncontrolled trial.

    Science.gov (United States)

    Burger, Amanda J; Lumley, Mark A; Carty, Jennifer N; Latsch, Deborah V; Thakur, Elyse R; Hyde-Nolan, Maren E; Hijazi, Alaa M; Schubiner, Howard

    2016-02-01

    Current psychological and behavioral therapies for chronic musculoskeletal pain only modestly reduce pain, disability, and distress. These limited effects may be due to the failure of current therapies: a) to help patients learn that their pain is influenced primarily by central nervous system psychological processes; and b) to enhance awareness and expression of emotions related to psychological trauma or conflict. We developed and conducted a preliminary, uncontrolled test of a novel psychological attribution and emotional awareness and expression therapy that involves an initial individual consultation followed by 4 group sessions. A series of 72 patients with chronic musculoskeletal pain had the intervention and were assessed at baseline, post-treatment, and 6-month follow-up. Participation and satisfaction were high and attrition was low. Intent-to-treat analyses found significant improvements in hypothesized change processes: psychological attributions for pain, emotional awareness, emotional approach coping, and alexithymia. Pain, interference, depression, and distress showed large effect size improvements at post-treatment, which were maintained or even enhanced at 6 months. Approximately two-thirds of the patients improved at least 30% in pain and other outcomes, and one-third of the patients improved 70%. Changes in attribution and emotional processes predicted outcomes. Higher baseline depressive symptoms predicted greater improvements, and outcomes were comparable for patients with widespread vs. localized pain. This novel intervention may lead to greater benefits than available psychological interventions for patients with chronic musculoskeletal pain, but needs controlled testing. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. Brief psychosocial therapy for the treatment of agitation in Alzheimer disease (the CALM-AD trial).

    Science.gov (United States)

    Ballard, Clive; Brown, Richard; Fossey, Jane; Douglas, Simon; Bradley, Paul; Hancock, Judith; James, Ian A; Juszczak, Edmund; Bentham, Peter; Burns, Alistair; Lindesay, James; Jacoby, Robin; O'Brien, John; Bullock, Roger; Johnson, Tony; Holmes, Clive; Howard, Robert

    2009-09-01

    Good practice guidelines state that a psychological intervention should usually precede pharmacotherapy, but there are no data evaluating the feasibility of psychological interventions used in this way. At the first stage of a randomized blinded placebo-controlled trial, 318 patients with Alzheimer disease (AD) with clinically significant agitated behavior were treated in an open design with a psychological intervention (brief psychosocial therapy [BPST]) for 4 weeks, preceding randomization to pharmacotherapy. The therapy involved social interaction, personalized music, or removal of environmental triggers. Overall, 318 patients with AD completed BPST with an improvement of 5.6 points on the total Cohen-Mansfield Agitation Inventory (CMAI; mean [SD], 63.3 [16.0] to 57.7 [18.4], t = 4.8, df = 317, p 95% of patients. More detailed evaluation of outcome was completed for the 198 patients with AD from these centers, who experienced a mean improvement of 6.6 points on the total CMAI (mean [SD], 62.2 [14.3] to 55.6 [15.8], t = 6.5, df = 197, p < 0.0001). Overall, 43% of participants achieved a 30% improvement in their level of agitation. The specific attributable benefits of BPST cannot be determined from an open trial. However, the BPST therapy was feasible and was successfully delivered according to an operationalized manual. The encouraging outcome indicates the need for a randomized controlled trial of BPST.

  10. The Effectiveness of Mindfulness-based Cognitive Therapy on Psychological Symptoms and Quality of Life in Systemic Lupus Erythematosus Patients: 
A Randomized Controlled Trial.

    Science.gov (United States)

    Solati, Kamal; Mousavi, Mohammad; Kheiri, Soleiman; Hasanpour-Dehkordi, Ali

    2017-09-01

    This study was conducted to determine the efficacy of mindfulness-based cognitive therapy (MBCT) on psychological symptoms and quality of life (QoL) in patients with systemic lupus erythematosus (SLE). We conducted a randomized single-blind clinical trial in patients with SLE referred from the Imam Ali Clinic in Shahrekord, southwest Iran. The patients (46 in total in two groups of 23 each) were randomly assigned into the experimental and control groups. Both groups underwent routine medical care, and the experimental group underwent eight group sessions of MBCT in addition to routine care. The patient , s QoL was assessed using the General Health Questionnaire-28 and 36-Item Short Form Health Survey before, after, and six months after intervention (follow-up). A significant difference was seen in psychological symptoms and QoL between MBCT and control groups immediately after the intervention and at follow-up ( p ≤ 0.050). However, the difference was not significant for the physical components of QoL ( p ≥ 0.050). MBCT contributed to decreased psychological symptoms and improved QoL in patients with SLE with a stable effect on psychological symptoms and psychological components of QoL, but an unstable effect on physical components.

  11. The EVERT (effective verruca treatments trial protocol: a randomised controlled trial to evaluate cryotherapy versus salicylic acid for the treatment of verrucae

    Directory of Open Access Journals (Sweden)

    Cockayne E Sarah

    2010-02-01

    Full Text Available Abstract Background Verrucae are a common, infectious and sometimes painful problem. The optimal treatment for verrucae is unclear due to a lack of high quality randomised controlled trials. The primary objective of this study is to compare the clinical effectiveness of two common treatments for verrucae: cryotherapy using liquid nitrogen versus salicylic acid. Secondary objectives include a comparison of the cost-effectiveness of the treatments, and an investigation of time to clearance of verrucae, recurrence/clearance of verrucae at six months, patient satisfaction with treatment, pain associated with treatment, and use of painkillers for the treatments. Methods/Design This is an open, pragmatic, multicentre, randomised controlled trial with two parallel groups: cryotherapy using liquid nitrogen delivered by a healthcare professional for a maximum of 4 treatments (treatments 2-3 weeks apart or daily self-treatment with 50% salicylic acid for a maximum of 8 weeks. Two hundred and sixty-six patients aged 12 years and over with a verruca are being enrolled into the study. The primary outcome is complete clearance of all verrucae as observed on digital photographs taken at 12 weeks compared with baseline and assessed by an independent healthcare professional. Secondary outcomes include self-reported time to clearance of verrucae, self-reported clearance of verrucae at 6 months, cost-effectiveness of the treatments compared to one another, and patient acceptability of both treatments including possible side effects such as pain. The primary analysis will be intention to treat. It is planned that recruitment will be completed by December 2009 and results will be available by June 2010. Trial registration Current Controlled Trials ISRCTN18994246.

  12. Clinical trial or standard treatment? Shared decision making at the department of oncology

    DEFF Research Database (Denmark)

    Gregersen, Trine Ammentorp; Birkelund, Regner; Ammentorp, Jette

    2016-01-01

    Title: Clinical trial or standard treatment? Shared decision making at the department of oncology. Authors: Ph.d. student, Trine A. Gregersen. Trine.gregersen@rsyd.dk. Department of Oncology. Health Services Research Unit Lillebaelt Hospital / IRS University of Southern Denmark. Professor, Regner...... are involved in difficult treatment decisions including participation in clinical trials. The literature indicates that the decision is very often based on little knowledge about the treatment and that many patients who have consented to participate in a clinical trial are not always aware...... that they are participating in a trial. This place great demand on the healthcare providers’ ability to involve and advise patients in the decisions. The aim of this study is to investigate the characteristics of the communication when decisions about participation in clinical oncology trial are made and the patients...

  13. Let them eat fruit! The effect of fruit and vegetable consumption on psychological well-being in young adults: A randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Tamlin S Conner

    Full Text Available This study tested the psychological benefits of a 14-day preregistered clinical intervention to increase fruit and vegetable (FV consumption in 171 low-FV-consuming young adults (67% female, aged 18-25. Participants were randomly assigned into a diet-as-usual control condition, an ecological momentary intervention (EMI condition involving text message reminders to increase their FV consumption plus a voucher to purchase FV, or a fruit and vegetable intervention (FVI condition in which participants were given two additional daily servings of fresh FV to consume on top of their normal diet. Self-report outcome measures were depressive symptoms and anxiety measured pre- and post-intervention, and daily negative and positive mood, vitality, flourishing, and flourishing behaviors (curiosity, creativity, motivation assessed nightly using a smartphone survey. Vitamin C and carotenoids were measured from blood samples pre- and post-intervention, and psychological expectancies about the benefits of FV were measured post-intervention to test as mediators of psychological change. Only participants in the FVI condition showed improvements to their psychological well-being with increases in vitality, flourishing, and motivation across the 14-days relative to the other groups. No changes were found for depressive symptoms, anxiety, or mood. Intervention benefits were not mediated by vitamin C, carotenoids, or psychological expectancies. We conclude that providing young adults with high-quality FV, rather than reminding them to eat more FV (with a voucher to purchase FV, resulted in significant short-term improvements to their psychological well-being. These results provide initial proof-of-concept that giving young adults fresh fruit and vegetables to eat can have psychological benefits even over a brief period of time.Australian New Zealand Clinical Trials Registry ACTRN12615000183583.

  14. Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial.

    Science.gov (United States)

    Rahman, Atif; Hamdani, Syed Usman; Awan, Naila Riaz; Bryant, Richard A; Dawson, Katie S; Khan, Muhammad Firaz; Azeemi, Mian Mukhtar-Ul-Haq; Akhtar, Parveen; Nazir, Huma; Chiumento, Anna; Sijbrandij, Marit; Wang, Duolao; Farooq, Saeed; van Ommeren, Mark

    2016-12-27

    The mental health consequences of conflict and violence are wide-ranging and pervasive. Scalable interventions to address a range of mental health problems are needed. To test the effectiveness of a multicomponent behavioral intervention delivered by lay health workers to adults with psychological distress in primary care settings. A randomized clinical trial was conducted from November 1, 2014, through January 28, 2016, in 3 primary care centers in Peshawar, Pakistan, that included 346 adult primary care attendees with high levels of both psychological distress and functional impairment according to the 12-item General Health Questionnaire and the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Lay health workers administered 5 weekly 90-minute individual sessions that included empirically supported strategies of problem solving, behavioral activation, strengthening social support, and stress management. The control was enhanced usual care. Primary outcomes, anxiety and depression symptoms, were independently measured at 3 months with the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes were posttraumatic stress symptoms (Posttraumatic Stress Disorder Checklist for DSM-5), functional impairment (WHODAS 2.0), progress on problems for which the person sought help (Psychological Outcome Profiles), and symptoms of depressive disorder (9-item Patient Health Questionnaire). Among 346 patients (mean [SD] age, 33.0 [11.8] years; 78.9% women), 172 were randomly assigned to the intervention and 174 to enhanced usual care; among them, 146 and 160 completed the study, respectively. At baseline, the intervention and control groups had similar mean (SD) HADS scores on symptoms of anxiety (14.16 [3.17] vs 13.64 [3.20]; adjusted mean difference [AMD], 0.52; 95% CI, -0.22 to 1.27) and depression (12.67 [3.27] vs 12.49 [3.34]; AMD, 0.17, 95% CI, -0.54 to 0.89). After 3 months of treatment, the intervention group had significantly lower

  15. Ionising energy treatment for fresh horticultural produce -mandarins and other produce, Trials 1 and 2, May-July 1987

    International Nuclear Information System (INIS)

    McLauchlan, R.L.; Brown, B.I.; Mitchell, G.E.; Aston, J.W.; Wood, A.F.; Isaacs, A.R.; Williams, S.M.; Nottingham, S.M.; Wilson, P.R.; Juffs, H.S.; Johnson, G.I.; Heather, N.W.; Giles, J.E.; Wills, P.A.

    1988-01-01

    Two trials are described on the effect of ionising energy treatment, or irradiation, on the quality, shelf-life and composition of fresh produce, mainly at doses consistent with disinfestation treatment for quarantine purposes. Trial 1, carried out in May 1987, deals with replicated treatments of Imperial mandarins and preliminary observation treatments on a range of other produce. Trial 2 deals with replicated treatments of Ellendale mandarins and preliminary observation treatments on other produce

  16. The ADDITION-Cambridge trial protocol: a cluster – randomised controlled trial of screening for type 2 diabetes and intensive treatment for screen-detected patients

    Directory of Open Access Journals (Sweden)

    Kinmonth Ann

    2009-05-01

    accessible through primary care. It addresses the feasibility of population-based screening for diabetes, as well as the benefits and costs of screening and intensive multifactorial treatment early in the disease trajectory. The intensive treatment algorithm is based on evidence from studies including individuals with clinically diagnosed diabetes and the education materials are informed by psychological theory. ADDITION-Cambridge will provide timely evidence concerning the benefits of early intensive treatment and will inform policy decisions concerning screening for type 2 diabetes. Trial registration Current Controlled trials ISRCTN86769081

  17. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials.

    Science.gov (United States)

    Sateren, Warren B; Trimble, Edward L; Abrams, Jeffrey; Brawley, Otis; Breen, Nancy; Ford, Leslie; McCabe, Mary; Kaplan, Richard; Smith, Malcolm; Ungerleider, Richard; Christian, Michaele C

    2002-04-15

    We chose to examine the impact of socioeconomic factors on accrual to National Cancer Institute (NCI)-sponsored cancer treatment trials. We estimated the geographic and demographic cancer burden in the United States and then identified 24,332 patients accrued to NCI-sponsored cancer treatment trials during a 12-month period. Next, we examined accrual by age, sex, geographic residence, health insurance status, health maintenance organization market penetration, several proxy measures of socioeconomic status, the availability of an oncologist, and the presence of a hospital with an approved multidisciplinary cancer program. Pediatric patients were accrued to clinical trials at high levels, whereas after adolescence, only a small percentage of cancer patients were enrolled onto clinical trials. There were few differences by sex. Black males as well as Asian-American and Hispanic adults were accrued to clinical trials at lower rates than white cancer patients of the same age. Overall, the highest observed accrual was in suburban counties. Compared with the United States population, patients enrolled onto clinical trials were significantly less likely to be uninsured and more like to have Medicare health insurance. Geographic areas with higher socioeconomic levels had higher levels of clinical trial accruals. The number of oncologists and the presence of approved cancer programs both were significantly associated with increased accrual to clinical trials. We must work to increase the number of adults who enroll onto trials, especially among the elderly. Ongoing partnership with professional societies may be an effective approach to strengthen accrual to clinical trials.

  18. The effect of a mindfulness-based intervention in cognitive functions and psychological well-being applied as an early intervention in schizophrenia and high-risk mental state in a Chilean sample: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Langer, Álvaro I; Schmidt, Carlos; Mayol, Rocío; Díaz, Marcela; Lecaros, Javiera; Krogh, Edwin; Pardow, Aída; Vergara, Carolina; Vergara, Guillermo; Pérez-Herrera, Bernardita; Villar, María José; Maturana, Alejandro; Gaspar, Pablo A

    2017-05-25

    According to the projections of the World Health Organization, 15% of all disabilities will be associated with mental illnesses by 2020. One of the mental disorders with the largest social impacts due to high personal and family costs is psychosis. Among the most effective psychological approaches to treat schizophrenia and other psychotic disorders at the world level is cognitive behavioral therapy. Recently, cognitive behavioral therapy has introduced several tools and strategies that promote psychological processes based on acceptance and mindfulness. A large number of studies support the effectiveness of mindfulness in dealing with various mental health problems, including psychosis. This study is aimed at determining the efficiency of a mindfulness-based program in increasing cognitive function and psychological well-being in patients with a first episode of schizophrenia and a high risk mental state (those at risk of developing an episode of psychosis). This is an experimentally designed, multi-center randomized controlled trial, with a 3-month follow-up period. The study participants will be 48 patients diagnosed with schizophrenia (first episode) and 48 with a high-risk mental state, from Santiago, Chile, aged between 15 and 35 years. Participants will be submitted to a mindfulness-based intervention (MBI), which will involve taking part in eight mindfulness workshops adapted for people with psychosis. Workshops will last approximately 1.5 hours and take place once a week, over 8 weeks. The primary outcome will be the cognitive function through Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) and the secondary outcome will be psychological well-being measured by self-reporting questionnaires. The outcomes of this trial will add empirical evidence to the benefits and feasibility of MBIs for the psychotherapeutic treatment of patients with schizophrenia and high-risk mental states in reducing cognitive impairment in

  19. Resource utilization implications of treatment were able to be assessed from appropriately reported clinical trial data

    NARCIS (Netherlands)

    Poole-Wilson, Philip A.; Kirwan, Bridget-Anne; Voko, Zoltan; de Brouwer, Sophie; Dunselman, Peter H. J. M.; van Dalen, Frederik J.; Lubsen, Jacobus

    Background and Objective: Published clinical trial data rarely allow assessment of the health care resource utilization implications of treatment. We give an example of how these can be assessed given appropriate tabulation of data. Methods: Data from a trial comparing long-acting nifedipine

  20. Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials

    NARCIS (Netherlands)

    Reeve, B.B.; Mitchell, S.A.; Dueck, A.C.; Basch, E.; Cella, D.; Miller Reilly, C.; Minasian, L.M.; Denicoff, A.M.; O'Mara, A.M.; Fisch, M.J.; Chauhan, C.; Aaronson, N.K.; Coens, C.; Watkins Bruner, D.

    2014-01-01

    Background: The National Cancer Institute’s Symptom Management and Health-Related Quality of Life Steering Committee held a clinical trials planning meeting (September 2011) to identify a core symptom set to be assessed across oncology trials for the purposes of better understanding treatment

  1. Psychological benefits 2 and 4 weeks after a single treatment with near infrared light to the forehead: a pilot study of 10 patients with major depression and anxiety

    Directory of Open Access Journals (Sweden)

    Teicher Martin H

    2009-12-01

    Full Text Available Abstract Background Many studies have reported beneficial effects from the application of near-infrared (NIR light photobiomodulation (PBM to the body, and one group has reported beneficial effects applying it to the brain in stroke patients. We have reported that the measurement of a patient's left and right hemispheric emotional valence (HEV may clarify data and guide lateralized treatments. We sought to test whether a NIR treatment could 1. improve the psychological status of patients, 2. show a relationship between immediate psychological improvements when HEV was taken into account, and 3. show an increase in frontal pole regional cerebral blood flow (rCBF, and 4. be applied without side effects. Methods We gave 10 patients, (5 M/5 F with major depression, including 9 with anxiety, 7 with a past history of substance abuse (6 with an opiate abuse and 1 with an alcohol abuse history, and 3 with post traumatic stress disorder, a baseline standard diagnostic interview, a Hamilton Depression Rating Scale (HAM-D, a Hamilton Anxiety Rating Scale (HAM-A, and a Positive and Negative Affect Scale (PANAS. We then gave four 4-minute treatments in a random order: NIR to left forehead at F3, to right forehead at F4, and placebo treatments (light off at the same sites. Immediately following each treatment we repeated the PANAS, and at 2-weeks and at 4-weeks post treatment we repeated all 3 rating scales. During all treatments we recorded total hemoglobin (cHb, as a measure of rCBF with a commercial NIR spectroscopy device over the left and the right frontal poles of the brain. Results At 2-weeks post treatment 6 of 10 patients had a remission (a score ≤ 10 on the HAM-D and 7 of 10 achieved this on the HAM-A. Patients experienced highly significant reductions in both HAM-D and HAM-A scores following treatment, with the greatest reductions occurring at 2 weeks. Mean rCBF across hemispheres increased from 0.011 units in the off condition to 0.043 units in

  2. The effects of an oral multivatimin combination with calcium, magnesium, and zinc on psychological well-being in healthy young male volunteers: A double-blind placebo-controlled trial.

    NARCIS (Netherlands)

    Carroll, D.; Ring, C.; Suter, M.; Willemsen, A.H.M.

    2000-01-01

    Rationale: Vitamin and mineral supplements may be associated with improved psychological status. Objective: The present study tested the effects of a multivitamin and mineral supplement (Berocca®) on psychological well-being. Methods: In a double-blind randomised-control trial, 80 healthy male

  3. Stem cells in clinical trials for treatment of retinal degeneration.

    Science.gov (United States)

    Klassen, Henry

    2016-01-01

    After decades of basic science research involving the testing of regenerative strategies in animal models of retinal degenerative diseases, a number of clinical trials are now underway, with additional trials set to begin shortly. These efforts will evaluate the safety and preliminary efficacy of cell-based products in the eyes of patients with a number of retinal conditions, notably including age-related macular degeneration, retinitis pigmentosa and Stargardt's disease. This review considers the scientific work and early trials with fetal cells and tissues that set the stage for the current clinical investigatory work, as well the trials themselves, specifically those either now completed, underway or close to initiation. The cells of interest include retinal pigment epithelial cells derived from embryonic stem or induced pluripotent stem cells, undifferentiated neural or retinal progenitors or cells from the vascular/bone marrow compartment or umbilical cord tissue. Degenerative diseases of the retina represent a popular target for emerging cell-based therapeutics and initial data from early stage clinical trials suggest that short-term safety objectives can be met in at least some cases. The question of efficacy will require additional time and testing to be adequately resolved.

  4. [Post-stroke speech disorder treated with acupuncture and psychological intervention combined with rehabilitation training: a randomized controlled trial].

    Science.gov (United States)

    Wang, Ling; Liu, Shao-ming; Liu, Min; Li, Bao-jun; Hui, Zhen-liang; Gao, Xiang

    2011-06-01

    To assess the clinical efficacy on post-stroke speech disorder treated with acupuncture and psychological intervention combined with rehabilitation training. The multi-central randomized controlled study was adopted. One hundred and twenty cases of brain stroke were divided into a speech rehabilitation group (control group), a speech rehabilitation plus acupuncture group (observation group 1) and a speech rehabilitation plus acupuncture combined with psychotherapy group (observation group 2), 40 cases in each one. The rehabilitation training was conducted by a professional speech trainer. In acupuncture treatment, speech function area in scalp acupuncture, Jinjin (EX-HN 12) and Yuye (EX-HN 13) in tongue acupuncture and Lianquan (CV 23) were the basic points. The supplementary points were selected according to syndrome differentiation. Bloodletting method was used in combination with acupuncture. Psychotherapy was applied by the physician in psychiatric department of the hospital. The corresponding programs were used in each group. Examination of Aphasia of Chinese of Beijing Hospital was adopted to observe the oral speech expression, listening comprehension and reading and writing ability. After 21-day treatment, the total effective rate was 92.5% (37/40) in observation group 1, 97.5% (39/40) in observation group 2 and 87.5% (35/40) in control group. The efficacies were similar in comparison among 3 groups. The remarkable effective rate was 15.0% (6/40) in observation group 1, 50.0% (20/40) in observation group 2 and 2.5% (1/40) in control group. The result in observation group 2 was superior to the other two groups (Prehabilitation training is obviously advantageous in the treatment of post-stroke speech disorder.

  5. Sexual orientation and sexual behavior among Latino and Asian Americans: implications for unfair treatment and psychological distress.

    Science.gov (United States)

    Chae, David H; Ayala, George

    2010-09-01

    Research on the sexuality of Asians and Latinos in the United States has been sparse, and the studies that have been done suffer from a number of limitations. Using data from the National Latino and Asian American Study (2002-2003), this study examined self-identified sexual orientation and self-reported sexual behavior among Latinos (n = 2,554; age: M = 38.1, SE = 0.5) and Asians (n = 2,095; age: M = 41.5, SE = 0.8). This study also investigated implications for unfair treatment and psychological distress among sexual minorities identified in the sample. Results indicated heterogeneity in responses to items assessing sexual orientation and sexual behavior including differences in the adoption of lesbian, gay, or bisexual (LGB) identity by gender, ethnicity, nativity, and socioeconomic status. LGB sexual minorities reported higher levels of unfair treatment and psychological distress compared to their non-LGB-identified sexual minority counterparts, and unfair treatment was positively associated with psychological distress. Results highlight the need to consider multiple demographic factors in assessing sexuality, and also suggest that measures of both self-identified sexual orientation and sexual behavior should be collected. In addition, findings provide support for the deleterious influence of unfair treatment among Asians and Latinos in the United States.

  6. Lidcombe Program Webcam Treatment for Early Stuttering: A Randomized Controlled Trial

    Science.gov (United States)

    Bridgman, Kate; Onslow, Mark; O'Brian, Susan; Jones, Mark; Block, Susan

    2016-01-01

    Purpose: Webcam treatment is potentially useful for health care in cases of early stuttering in which clients are isolated from specialized treatment services for geographic and other reasons. The purpose of the present trial was to compare outcomes of clinic and webcam deliveries of the Lidcombe Program treatment (Packman et al., 2015) for early…

  7. Medical prescription of heroin to treatment resistant heroin addicts: two randomised controlled trials

    NARCIS (Netherlands)

    van den Brink, Wim; Hendriks, Vincent M.; Blanken, Peter; Koeter, Maarten W. J.; van Zwieten, Barbara J.; van Ree, Jan M.

    2003-01-01

    OBJECTIVE: To determine whether supervised medical prescription of heroin can successfully treat addicts who do not sufficiently benefit from methadone maintenance treatment. DESIGN: Two open label randomised controlled trials. SETTING: Methadone maintenance programmes in six cities in the

  8. Ursodeoxycholic acid for treatment of primary sclerosing cholangitis: a placebo-controlled trial

    NARCIS (Netherlands)

    Beuers, U.; Spengler, U.; Kruis, W.; AYDEMIR, U.; WIEBECKE, B.; HELDWEIN, W.; WEINZIERL, M.; Pape, G. R.; Sauerbruch, T.; Paumgartner, G.

    1992-01-01

    The efficacy and safety of ursodeoxycholic acid for the treatment of primary sclerosing cholangitis were evaluated in a prospective, randomized, double-blind, placebo-controlled trial. Fourteen patients with primary sclerosing cholangitis documented by cholestatic serum enzyme pattern, liver

  9. Treatment Algorithms Based on Tumor Molecular Profiling: The Essence of Precision Medicine Trials.

    Science.gov (United States)

    Le Tourneau, Christophe; Kamal, Maud; Tsimberidou, Apostolia-Maria; Bedard, Philippe; Pierron, Gaëlle; Callens, Céline; Rouleau, Etienne; Vincent-Salomon, Anne; Servant, Nicolas; Alt, Marie; Rouzier, Roman; Paoletti, Xavier; Delattre, Olivier; Bièche, Ivan

    2016-04-01

    With the advent of high-throughput molecular technologies, several precision medicine (PM) studies are currently ongoing that include molecular screening programs and PM clinical trials. Molecular profiling programs establish the molecular profile of patients' tumors with the aim to guide therapy based on identified molecular alterations. The aim of prospective PM clinical trials is to assess the clinical utility of tumor molecular profiling and to determine whether treatment selection based on molecular alterations produces superior outcomes compared with unselected treatment. These trials use treatment algorithms to assign patients to specific targeted therapies based on tumor molecular alterations. These algorithms should be governed by fixed rules to ensure standardization and reproducibility. Here, we summarize key molecular, biological, and technical criteria that, in our view, should be addressed when establishing treatment algorithms based on tumor molecular profiling for PM trials. © The Author 2015. Published by Oxford University Press.

  10. Factors associated with poor satisfaction with treatment and trial discontinuation in chronic schizophrenia.

    Science.gov (United States)

    Schoemaker, Joep H; Vingerhoets, Ad J J M; Emsley, Robin A

    2018-06-05

    IntroductionDespite consistently high discontinuation rates due to withdrawal of consent (WOC) and insufficient therapeutic effect (ITE) in schizophrenia trials, insight into the underlying factors contributing to poor satisfaction with treatment and dropout is limited. A better understanding of these factors could help to improve trial design and completion rates. Using data from 1,136 trial participants with schizophrenia or schizoaffective disorder, we explored associations between predictor variables with (1) dropout due to WOC and ITE and (2) satisfaction with treatment among patients and investigators by means of hierarchic multiple regression analyses. ITE was associated with poor clinical improvement, poor investigator satisfaction with treatment, and poor patient insight into their own disease, whereas WOC only showed a meaningful association with poor patient satisfaction with treatment. Investigator satisfaction with treatment appeared most strongly associated with Positive and Negative Syndrome Scale (PANSS) positive factor endpoint scores, whereas patient satisfaction with treatment was best predicted by the endpoint score on the PANSS emotional distress factor. The occurrence of severe side effects showed no meaningful association to satisfaction with treatment among investigators and patients, and neither did a patient's experienced psychopathology, nor their self-rating of functional impairment. Whereas trial discontinuation due to ITE is associated with poor treatment effectiveness, a patient's decision to withdraw from an antipsychotic trial remains unpredictable and may occur even when the investigator observes a global clinical improvement and is satisfied with the treatment.

  11. Innovations in the Treatment of Bulimia: Transpersonal Psychology, Relaxation, Imagination, Hypnosis, Myth, and Ritual.

    Science.gov (United States)

    Brown, Michael H.

    1991-01-01

    Written for counselors who must help clients deal with bulimia, this article reviews bulimia's most obvious physical signs and symptoms, etiology, and behavioral characteristics. Considers innovative counseling approaches including Transpersonal Psychology, relaxation training, imagination, fantasy, hypnosis, myths, and rituals. (Author)

  12. Technology Addiction among Treatment Seekers for Psychological Problems: Implication for Screening in Mental Health Setting

    OpenAIRE

    Das, Aswathy; Sharma, Manoj Kumar; Thamilselvan, P.; Marimuthu, P.

    2017-01-01

    Background: Technology usage has seen an increase among users. The usage varies from social, personal, and psychological reasons. Users are frequently using to overcome mood states as well as to manage the other psychological states. This work is going to explore the information technology use among subjects with a psychiatric disorder. Materials and Methods: A total of 75 subjects were assessed using background data sheet, internet addiction impairment index, video game use pattern, pornogra...

  13. A randomized controlled trial of Mindfulness-Based Cognitive Therapy (MBCT) versus treatment-as-usual (TAU) for chronic, treatment-resistant depression: study protocol

    NARCIS (Netherlands)

    Cladder-Micus, M.B.; Vrijsen, J.N.; Becker, E.S.; Donders, A.R.T.; Spijker, J.; Speckens, A.E.M.

    2015-01-01

    Background: Major depression is a common psychiatric disorder, frequently taking a chronic course. Despite provision of evidence-based treatments, including antidepressant medication and psychological treatments like cognitive behavioral therapy or interpersonal therapy, a substantial amount of

  14. A randomized controlled trial of Mindfulness-Based Cognitive Therapy (MBCT) versus treatment-as-usual (TAU) for chronic, treatment-resistant depression: study protocol

    NARCIS (Netherlands)

    Cladder-Micus, M.B.; Vrijsen, J.N.; Becker, E.S.; Donders, A.R.T.; Spijker, J.; Speckens, A.E.M.

    2015-01-01

    BACKGROUND: Major depression is a common psychiatric disorder, frequently taking a chronic course. Despite provision of evidence-based treatments, including antidepressant medication and psychological treatments like cognitive behavioral therapy or interpersonal therapy, a substantial amount of

  15. Systematic review of randomized controlled trials in the treatment of dry eye disease in Sjogren syndrome

    OpenAIRE

    Shih, Kendrick Co; Lun, Christie Nicole; Jhanji, Vishal; Thong, Bernard Yu-Hor; Tong, Louis

    2017-01-01

    Abstract Primary Sjögren’s syndrome is an autoimmune disease characterized by dry eye and dry mouth. We systematically reviewed all the randomized controlled clinical trials published in the last 15 years that included ocular outcomes. We found 22 trials involving 9 topical, 10 oral, 2 intravenous and 1 subcutaneous modalities of treatment. Fluoromethalone eye drops over 8 weeks were more effective than topical cyclosporine in the treatment of dry eye symptoms and signs; similarly, indomethac...

  16. The effects of the Bali Yoga Program (BYP-BC) on reducing psychological symptoms in breast cancer patients receiving chemotherapy: results of a randomized, partially blinded, controlled trial.

    Science.gov (United States)

    Lanctôt, Dominique; Dupuis, Gilles; Marcaurell, Roger; Anestin, Annélie S; Bali, Madan

    2016-12-01

    Background Several cognitive behavioral interventions have been reported to reduce psychological symptoms in breast cancer (BC) patients. The goal of this study was to evaluate the effects of a yoga intervention in reducing depression and anxiety symptoms in BC patients. Methods This study was a randomized, partially blinded, controlled trial comparing a standardized yoga intervention to standard care. It was conducted at three medical centers in Montreal, Canada. Eligible patients were women diagnosed with stage I-III BC receiving chemotherapy. Participants were randomly assigned to receive yoga intervention immediately (experimental group, n=58) or after a waiting period (n=43 control group). The Bali Yoga Program for Breast Cancer Patients (BYP-BC) consisted of 23 gentle Hatha asanas (poses), 2 prayanamas (breathing techniques), shavasanas (relaxation corpse poses) and psychoeducational themes. Participants attended eight weekly sessions lasting 90 min each and received a DVD for home practice with 20- and 40-min sessions. Participants in the wait list control group received standard care during the 8-week waiting period. Results A total of 101 participants took part in the final intention-to-treat analyses. The repeated measures analyses demonstrated that depression symptoms increased in the control group (p=0.007), while no change was reported in the BYP-BC group (p=0.29). Also, depression symptoms decreased in the WL control group after receiving the BYP-BC intervention (p=0.03). Finally, there was no statistical significance in terms of anxiety symptoms (p=0.10). Conclusions Results support the BYP-BC intervention as a beneficial means of reducing and preventing the worsening of depression symptoms during chemotherapy treatment.

  17. Long-term psychological benefits of cognitive-behavioral stress management for women with breast cancer: 11-year follow-up of a randomized controlled trial.

    Science.gov (United States)

    Stagl, Jamie M; Bouchard, Laura C; Lechner, Suzanne C; Blomberg, Bonnie B; Gudenkauf, Lisa M; Jutagir, Devika R; Glück, Stefan; Derhagopian, Robert P; Carver, Charles S; Antoni, Michael H

    2015-06-01

    Breast cancer survivors experience long-term physical and psychological sequelae after their primary treatment that negatively influence their quality of life (QOL) and increase depressive symptoms. Group-based cognitive-behavioral stress management (CBSM) delivered after surgery for early-stage breast cancer was previously associated with better QOL over a 12-month follow-up and with fewer depressive symptoms up to 5 years after study enrollment. This 8- to 15-year follow-up (median, 11 years) of a previously conducted trial (NCT01422551) evaluated whether women in this cohort receiving CBSM had fewer depressive symptoms and better QOL than controls at an 8- to 15-year follow-up. Women with stage 0 to IIIb breast cancer were initially recruited 2 to 10 weeks after surgery and randomized to a 10-week CBSM intervention or a 1-day psychoeducational control group. One hundred women (51 CBSM patients and 49 controls) were recontacted 8 to 15 years after study enrollment to participate in a follow-up assessment. The Center for Epidemiologic Studies-Depression (CES-D) scale and the Functional Assessment of Cancer Therapy-Breast (FACT-B) were self-administered. Multiple regression was employed to evaluate group differences on the CES-D scale and FACT-B over and above effects of confounding variables. Participants assigned to CBSM reported significantly lower depressive symptoms (d, 0.63; 95% confidence interval [CI], 0.56-0.70) and better QOL (d, 0.58; 95% CI, 0.52-0.65) above the effects of the covariates. Women who received CBSM after surgery for early-stage breast cancer reported lower depressive symptoms and better QOL than the control group up to 15 years later. Early implementation of cognitive-behavioral interventions may influence long-term psychosocial functioning in breast cancer survivors. © 2015 American Cancer Society.

  18. What Therapies are Favored in the Treatment of the Psychological Sequelae of Trauma in Human Trafficking Victims?

    Science.gov (United States)

    Salami, Temilola; Gordon, Mollie; Coverdale, John; Nguyen, Phuong T

    2018-03-01

    Human trafficking is a major public health concern that brings about deleterious psychological consequences and sequelae. Although a number of risk and protective factors for the health consequences of human trafficking victims have been identified, there is a dearth of information in the area of treatment. Specifically, we found no articles comparing the different components of prevailing trauma treatment strategies, and the potential usefulness of these strategies in the treatment of human trafficking victims. To this end, we compared and contrasted the different therapeutic treatments typically implemented with victims of trauma (including domestic violence victims and torture victims), and discussed how the different components of these treatments may or may not be helpful for human trafficking victims. We assessed the impact of these treatments on the psychological consequences of trauma and, in particular on posttraumatic stress disorder. We also assessed the potential usefulness of these treatments with co-occurring problems such as substance use, psychosis, dissociation, and other mood and anxiety disorders. On the basis of the prevailing research, we highlighted cognitive therapies as being preferred in addressing the needs of human trafficking victims. Mental health providers who work with human trafficking victims should become aware of and practiced in the use of cognitive therapeutic approaches in treating this population. Efficacy and effectiveness studies are needed to validate our recommendations.

  19. Spontaneous improvement in randomised clinical trials: meta-analysis of three-armed trials comparing no treatment, placebo and active intervention

    DEFF Research Database (Denmark)

    Krogsbøll, Lasse Theis; Hróbjartsson, Asbjørn; Gøtzsche, Peter C

    2009-01-01

    were psychological in 17 trials, physical in 15 trials, and pharmacological in 5 trials. Overall, across all conditions and interventions, there was a statistically significant change from baseline in all three arms. The standardized mean difference (SMD) for change from baseline was -0.24 (95...... uncertainty, as indicated by the confidence intervals for the three SMDs. The conditions that had the most pronounced spontaneous improvement were nausea (45%), smoking (40%), depression (35%), phobia (34%) and acute pain (25%). CONCLUSION: Spontaneous improvement and effect of placebo contributed importantly...

  20. Psychological screening and treatment of post-trauma symptoms for Middle Eastern adolescent refugees: a pilot study

    OpenAIRE

    Locarnini, Ann

    2017-01-01

    Adolescent refugees present with increased levels of PTSD and depression as a result of their refugee experiences. At present, research and clinical practice with this population are hampered by a lack of validated assessment measures to identify cases, as well as clinical guidelines for psychological treatment. The rapid growth in ethnic minority populations in western countries means that interventions that adapt universal principles for different cultural groups are required (Muñoz & Mende...

  1. Establishing HIV treatment as prevention in the HIV Prevention Trials Network 052 randomized trial: an ethical odyssey.

    Science.gov (United States)

    Cohen, Myron S; McCauley, Marybeth; Sugarman, Jeremy

    2012-06-01

    Obtaining the definitive data necessary to determine the safety and efficacy of using antiretroviral treatment (ART) to reduce the sexual transmission of HIV in heterosexual couples encountered an array of ethical challenges that threatened to compromise HIV Prevention Trials Network (HPTN) 052, the multinational clinical trial addressing this issue that has profound public health implications. To describe and analyze the major ethical challenges faced in HPTN 052. The ethical issues and modifications of HPTN 052 in response to these issues were cataloged by the principal investigator, the lead coordinator, and the ethicist working on the trial. The major ethical issues that were unique to the trial were then described and analyzed in light of the published literature as well as guidances and policies. The ethical challenges that must be addressed in many clinical trials, such as those related to obtaining informed consent and making provisions for ancillary care, are not described. When HPTN 052 was being designed, ethical questions emerged related to the relevance of the research question itself given data from observational research and a range of beliefs about the appropriate means of preventing and treating HIV infection and AIDS. Furthermore, ethical challenges were faced regarding site selection since there was a scientific need to conduct the research in settings where HIV incidence was high, but alternatives to study participation should be available. As in most HIV-prevention research, ethical questions surrounded the determination of the appropriate prevention package for all of those enrolled. During the course of the trial, guidance documents and policies emerged that were of direct relevance to the research questions, calling for a balancing of concerns for the research subjects and trial integrity. When the study results were made public, there was a need to ensure access to the treatment shown to be effective that in some cases differed from the

  2. Effectiveness of school-based humanistic counselling for psychological distress in young people: Pilot randomized controlled trial with follow-up in an ethnically diverse sample.

    Science.gov (United States)

    Pearce, Peter; Sewell, Ros; Cooper, Mick; Osman, Sarah; Fugard, Andrew J B; Pybis, Joanne

    2017-06-01

    The aim of this study was to pilot a test of the effectiveness of school-based humanistic counselling (SBHC) in an ethnically diverse group of young people (aged 11-18 years old), with follow-up assessments at 6 and 9 months. Pilot randomized controlled trial, using linear-mixed effect modelling and intention-to-treat analysis to compare changes in levels of psychological distress for participants in SBHC against usual care (UC). ISRCTN44253140. In total, 64 young people were randomized to either SBHC or UC. Participants were aged between 11 and 18 (M = 14.2, SD = 1.8), with 78.1% of a non-white ethnicity. The primary outcome was psychological distress at 6 weeks (mid-therapy), 12 weeks (end of therapy), 6-month follow-up and 9-month follow-up. Secondary measures included emotional symptoms, self-esteem and attainment of personal goals. Recruitment and retention rates for the study were acceptable. Participants in the SBHC condition, as compared with participants in the UC condition, showed greater reductions in psychological distress and emotional symptoms, and greater improvements in self-esteem, over time. However, at follow-up, only emotional symptoms showed significant differences across groups. The study adds to the pool of evidence suggesting that SBHC can be tested and that it brings about short-term reductions in psychological and emotional distress in young people, across ethnicities. However, there is no evidence of longer-term effects. School-based humanistic counselling can be an effective means of reducing the psychological distress experienced by young people with emotional symptoms in the short term. The short-term effectiveness of school-based humanistic counselling is not limited to young people of a White ethnicity. There is no evidence that school-based humanistic counselling has effects beyond the end of therapy. © 2016 The British Psychological Society.

  3. Integrating Estimates of the Social and Individual Costs of Caregiving into Dementia Treatment Trials

    Directory of Open Access Journals (Sweden)

    Charles D. Phillips

    2016-01-01

    Full Text Available A variety of new treatments for dementia are awaiting or undergoing randomized clinical trails. These trials focus on outcomes such as changes in cognitive function, physical function, or amyloid plaques. What is quite important and is too often missing from these trials are estimates of the impact of these treatments on the social and individual costs of providing care for those facing dementia. Until outcomes such as family caregiver time and caregiver burden are included in trails of dementia treatments, the picture of how well these treatments work will be distressingly incomplete.

  4. Parent-focused treatment for adolescent anorexia nervosa: a study protocol of a randomised controlled trial.

    Science.gov (United States)

    Hughes, Elizabeth K; Le Grange, Daniel; Court, Andrew; Yeo, Michele S M; Campbell, Stephanie; Allan, Erica; Crosby, Ross D; Loeb, Katharine L; Sawyer, Susan M

    2014-04-08

    Family-based treatment is an efficacious outpatient intervention for medically stable adolescents with anorexia nervosa. Previous research suggests family-based treatment may be more effective for some families when parents and adolescents attend separate therapy sessions compared to conjoint sessions. Our service developed a novel separated model of family-based treatment, parent-focused treatment, and is undertaking a randomised controlled trial to compare parent-focused treatment to conjoint family-based treatment. This randomised controlled trial will recruit 100 adolescents aged 12-18 years with DSM-IV anorexia nervosa or eating disorder not otherwise specified (anorexia nervosa type). The trial commenced in 2010 and is expected to be completed in 2015. Participants are recruited from the Royal Children's Hospital Eating Disorders Program, Melbourne, Australia. Following a multidisciplinary intake assessment, eligible families who provide written informed consent are randomly allocated to either parent-focused treatment or conjoint family-based treatment. In parent-focused treatment, the adolescent sees a clinical nurse consultant and the parents see a trained mental health clinician. In conjoint family-based treatment, the whole family attends sessions with the mental health clinician. Both groups receive 18 treatment sessions over 6 months and regular medical monitoring by a paediatrician. The primary outcome is remission at end of treatment and 6 and 12 month follow up, with remission defined as being ≥ 95% expected body weight and having an eating disorder symptom score within one standard deviation of community norms. The secondary outcomes include partial remission and changes in eating pathology, depressive symptoms and self-esteem. Moderating and mediating factors will also be explored. This will be first randomised controlled trial of a parent-focused model of family-based treatment of adolescent anorexia nervosa. If found to be efficacious, parent

  5. Anticholinergic versus botulinum toxin A comparison trial for the treatment of bothersome urge urinary incontinence: ABC trial.

    Science.gov (United States)

    Visco, Anthony G; Brubaker, Linda; Richter, Holly E; Nygaard, Ingrid; Paraiso, Marie Fidela; Menefee, Shawn A; Schaffer, Joseph; Wei, John; Chai, Toby; Janz, Nancy; Spino, Cathie; Meikle, Susan

    2012-01-01

    This trial compares the change in urgency urinary incontinence episodes over 6 months, tolerability and cost effectiveness between women receiving daily anticholinergic therapy plus a single intra-detrusor injection of saline versus a single intra-detrusor injection of 100 U of botulinum toxin A plus daily oral placebo tablets. We present the rationale and design of a randomized-controlled trial, Anticholinergic versus Botulinum Toxin, Comparison Trial for the Treatment of Bothersome Urge Urinary Incontinence: ABC trial, conducted by the NICHD-funded Pelvic Floor Disorders Network. We discuss the innovative nature of this trial and the challenges related to choice of patient population, maintaining masking, cost effectiveness, ethical considerations, measuring adherence, and placebo development and testing. Enrollment began in April, 2010. 242 participants will be randomized and primary outcome data analysis is anticipated to begin in mid 2012. Several challenges in the trial design are discussed. Randomization to placebo intra-detrusor injections may limit recruitment, potentially impacting generalizability. Other challenges included the heavy marketing of drugs for overactive bladder which could impact recruitment of drug-naïve women. In addition, anticholinergic medications often cause dry mouth, making masking difficult. Finally, adverse reporting of transient urinary retention is challenging as there is no standardized definition; yet this is the most common adverse event following intra-detrusor botulinum toxin injection. The ABC trial will help women with urgency urinary incontinence balance efficacy, side effects and cost of anticholinergic medication versus botulinum toxin intra-detrusor injection. The results have the potential to fundamentally change the therapeutic approach to this condition. Copyright © 2011 Elsevier Inc. All rights reserved.

  6. Efficacy and tolerance of the topical application of potassium hydroxide (10% and 15%) in the treatment of molluscum contagiosum: randomized clinical trial: research protocol.

    Science.gov (United States)

    Marsal, Josep R; Cruz, Ines; Teixido, Concepcio; Diez, Olga; Martinez, Mireia; Galindo, Gisela; Real, Jordi; Schoenenberger, Joan A; Pera, Helena

    2011-10-19

    Molluscum contagiosum is a non-severe pediatric viral infection. Because it is highly contagious and current treatments have negative aesthetic and psychological effects, we want to test an alternative treatment in the primary care setting, consisting of two different concentrations of potassium hydroxide solution. The study design is a double-blind, randomized clinical trial, using three types of topical treatment. The treatment consist of daily applications of potassium hydroxide (KOH) in aqueous solution at 10% and 15% concentration, and a placebo administered in the control group. Four follow-up visits (at 15, 30, 45 and 60 days) are planned to evaluate treatment effectiveness and patient tolerance. The main outcome measure of the trial will be the healing rate, defined as lesion disappearance in the affected zones after the topic application of the experimental treatment. Secondary measures will be the principal characteristics and evolution of the affected zone (surface area, number of lesions, size and density of lesions), treatment tolerance (hyperpigmentation, itching, burning, pain), recurrence rate and the natural evolution of lesions in the control group. KOH can potentially be an effective and safe treatment for MC in primary care, and can also reduce referrals to dermatologists and hospital pediatric departments. In addition, KOH may be a valid and less expensive alternative to current invasive treatments (surgical excision).

  7. Review of Randomized Controlled Trials on Psychological Interventions in Child Sexual Abuse: Current Status and Emerging Needs in the Indian Context.

    Science.gov (United States)

    Choudhary, Vandana; Satapathy, Sujata; Sagar, Rajesh

    2016-01-01

    Child sexual abuse (CSA) is a critical, psychologically traumatic and sometimes life-threatening incident often associated with sequel of adverse physical, behavioral, and mental health consequences. Factors such as developmental age of the child, severity of abuse, closeness to the perpetrator, availability of medico-legal-social support network and family care, gender stereotypes in the community complicate the psychological trauma. Although the research on the effects of CSA as well as psychological intervention to reduce the victimization and promote the mental health of the child is in its infancy stage in India, the global research in the past three decades has progressed much ahead. A search was performed using MEDLINE, PubMed, PsycINFO, and Google Scholar from 1984 to 2015 and only 17 randomized controlled trials (RCTs) out of 96 potentially relevant studies were included. While nonspecific therapies covering a wide variety of outcome variables were prominent till 1999s, the trend changed to specific and focused forms of trauma-focused therapies in next one-and-half decades. Novel approaches to psychological interventions have also been witnessed. One intervention (non-RCT) study on effects on general counseling has been reported from India.

  8. Isolated hepatic perfusion as a treatment for uveal melanoma liver metastases (the SCANDIUM trial)

    DEFF Research Database (Denmark)

    Olofsson, Roger; Ny, Lars; Eilard, Malin Sternby

    2014-01-01

    for patients with liver metastases is between 6 and 12 months, and no treatment has in randomized trials ever been shown to prolong survival. A previous phase II trial using isolated hepatic perfusion (IHP) has suggested a 14-month increase in overall survival compared with a historic control group consisting...... of the longest surviving patients in Sweden during the same time period (26 versus 12 months). METHODS/DESIGN: This is the protocol for a multicenter phase III trial randomizing patients with isolated liver metastases of uveal melanoma to IHP or best alternative care (BAC). Inclusion criteria include liver....... The planned sample size is 78 patients throughout five years. DISCUSSION: Patients with isolated liver metastases of uveal melanoma origin have a short expected survival and no standard treatment option exists. This is the first randomized clinical trial to evaluate IHP as a treatment option with overall...

  9. Clinical and psychological moderators of the effect of mindfulness-based cognitive therapy on persistent pain in women treated for primary breast cancer - explorative analyses from a randomized controlled trial.

    Science.gov (United States)

    Johannsen, M; O'Toole, M S; O'Connor, M; Jensen, A B; Zachariae, R

    2017-02-01

    Mindfulness-based intervention has been found efficacious in reducing persistent pain in women treated for breast cancer. Little, however, is known about possible moderators of the effect. We explored clinical and psychological moderators of the effect on pain intensity previously found in a randomized controlled trial of mindfulness-based cognitive therapy (MBCT) with women treated for breast cancer with persistent pain. A total of 129 women treated for breast cancer reporting persistent pain were randomized to MBCT or a wait-list control. The primary outcome of pain intensity (11-point numeric rating scale) was measured at baseline, post-intervention, three, and six months follow-up. Proposed clinical moderators included age, axillary lymph node dissection (ALND), radiotherapy, and endocrine treatment. Psychological moderators included psychological distress [the Hospital Anxiety and Depression Scale (HADS)], the adult attachment dimensions anxiety and avoidance [the Experiences in Close Relationships Short Form (the ECR-SF)], and alexithymia [the Toronto Alexithymia Scale (TAS-20)]. Multi-level models were used to test moderation effects over time, i.e. time × group × moderator. Only attachment avoidance (p = 0.03, d = 0.36) emerged as a statistically significant moderator. Higher levels of attachment avoidance predicted a larger effect of MBCT in reducing pain intensity compared with lower levels attachment avoidance. None of the remaining psychological or clinical moderators reached statistical significance. However, based on the effect size, radiotherapy (p = 0.075, d = 0.49) was indicated as a possible clinical moderator of the effect, with radiotherapy being associated with a smaller effect of MBCT on pain intensity over time compared with no radiotherapy. Attachment avoidance, and potentially radiotherapy, may be clinically relevant factors for identifying the patients who may benefit most from MBCT as a pain intervention. Due to

  10. WELL.ME - Wellbeing therapy based on real-time personalized mobile architecture, vs. cognitive therapy, to reduce psychological distress and promote healthy lifestyle in cardiovascular disease patients: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Compare, Angelo; Kouloulias, Vassilis; Apostolos, Vontas; Peña, Wendy Moreno; Molinari, Enrico; Grossi, Enzo; Efstathios, Efstathopoulos; Carenini, Michele

    2012-09-03

    There is compelling evidence that psychological factors may have the same or even greater impact on the possibility of adverse events on cardiac diseases (CD) than other traditional clinical risk factors. Anxiety and depression are predictors of short- and long-term adverse outcomes, increased risk for higher rates of in-hospital complications, re-infarction, malignant arrhythmias, and mortality in CD patients. Despite researchers finding that cognitive behavior therapy (CBT) reduced depressive and anxiety symptoms, the fact that such results are maintained only in the short term and the lack of maintenance of the long-term affects the absence of changes in lifestyles, preventing the possibility of a wide generalization of results. Recently wellbeing therapy (WBT) has been proposed as a useful approach to improve healthy lifestyle behaviors and reduce psychological distress. The present randomized controlled study will test WBT, in comparison with CBT, as far as the reduction of symptoms of depression, anxiety and psychological distress, and the improvement of lifestyle behaviors and quality of life in cardiac patients are concerned. Moreover, innovations in communication technologies allow patients to be constantly followed in real life. Therefore WBT based on personalized mobile technology will allow the testing of its effectiveness in comparison with usual WBT. The present study is a large outpatient study on the treatment of co-morbid depression, anxiety, and psychological distress in cardiac patients. The most important issues of this study are its randomized design, the focus on promotion of health-related behaviors, and the use of innovative technologies supporting patients' wellbeing in real life and in a continuous way. First results are expected in 2012. ClinicalTrials.gov Identifier: NCT01543815.

  11. Brief Report: HIV Drug Resistance in Adults Failing Early Antiretroviral Treatment: Results From the HIV Prevention Trials Network 052 Trial.

    Science.gov (United States)

    Fogel, Jessica M; Hudelson, Sarah E; Ou, San-San; Hart, Stephen; Wallis, Carole; Morgado, Mariza G; Saravanan, Shanmugam; Tripathy, Srikanth; Hovind, Laura; Piwowar-Manning, Estelle; Sabin, Devin; McCauley, Marybeth; Gamble, Theresa; Zhang, Xinyi C; Eron, Joseph J; Gallant, Joel E; Kumwenda, Johnstone; Makhema, Joseph; Kumarasamy, Nagalingeswaran; Chariyalertsak, Suwat; Hakim, James; Badal-Faesen, Sharlaa; Akelo, Victor; Hosseinipour, Mina C; Santos, Breno R; Godbole, Sheela V; Pilotto, Jose H; Grinsztejn, Beatriz; Panchia, Ravindre; Mayer, Kenneth H; Chen, Ying Q; Cohen, Myron S; Eshleman, Susan H

    2016-07-01

    Early initiation of antiretroviral treatment (ART) reduces HIV transmission and has health benefits. HIV drug resistance can limit treatment options and compromise use of ART for HIV prevention. We evaluated drug resistance in 85 participants in the HIV Prevention Trials Network 052 trial who started ART at CD4 counts of 350-550 cells per cubic millimeter and failed ART by May 2011; 8.2% had baseline resistance and 35.3% had resistance at ART failure. High baseline viral load and less education were associated with emergence of resistance at ART failure. Resistance at ART failure was observed in 7 of 8 (87.5%) participants who started ART at lower CD4 cell counts.

  12. Social skills treatment for people with severe, chronic acquired brain injuries: a multicenter trial.

    Science.gov (United States)

    McDonald, Skye; Tate, Robyn; Togher, Leanne; Bornhofen, Cristina; Long, Esther; Gertler, Paul; Bowen, Rebecca

    2008-09-01

    To determine whether social skills deficits including unskilled, inappropriate behavior, problems reading social cues (social perception), and mood disturbances (such as depression and anxiety) could be remediated after severe traumatic brain injuries. Randomized controlled trial comparing a social skills program with social activity alone or with waitlist control. Several participants were reassigned after randomization. Hospital outpatient and community facilities. Fifty-one outpatients from 3 brain injury units in Sydney, Australia, with severe, chronic acquired brain injuries were recruited. A total of 39 people (13 in skills training, 13 in social activity, 13 in waitlist) completed all phases of the study. Twelve-week social skills treatment program encompassing weekly 3-hour group sessions focused on shaping social behavior and remediating social perception and 1-hour individual sessions to address psychologic issues with mood, self-esteem, etc. Primary outcomes were: (1) social behavior during encounters with a confederate as rated on the Behaviorally Referenced Rating System of Intermediary Social Skills-Revised (BRISS-R), (2) social perception as measured by The Awareness of Social Inference Test, and (3) depression and anxiety as measured by the Depression, Anxiety and Stress Scale. Secondary outcomes were: relative report on social behavior and participation using: the Katz Adjustment Scale-R1; the Social Performance Survey Schedule; the La Trobe Communication Questionnaire; and the Sydney Psychosocial Reintegration Scale (both relative and self-report). Repeated-measures analysis of variance indicated that social activity alone did not lead to improved performance relative to waitlist (placebo effect) on any outcome variable. On the other hand, the skills training group improved differentially on the Partner Directed Behavior Scale of the BRISS-R, specifically the self-centered behavior and partner involvement behavior subscales. No treatment effects

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

    Directory of Open Access Journals (Sweden)

    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

  14. Effectiveness of cognitive-behavioural therapy on glycaemic control and psychological outcomes in adults with diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Uchendu, C; Blake, H

    2017-03-01

    Diabetes is a chronic progressive condition presenting physical, social and psychological challenges that increase the risk of comorbid mental health problems. Cognitive-behavioural therapy (CBT) is effective in treating a variety of psychological disorders, and may potentially improve glycaemic control and psychological outcomes in diabetes. This systematic review and meta-analysis aims to establish the effectiveness of CBT on glycaemic control and comorbid diabetes-related distress, depression, anxiety and quality of life in the short, medium and longer term among adults with diabetes. An electronic search was conducted in PubMed, Embase, MEDLINE, PsycINFO, CINAHL, Web of Knowledge, Cochrane Central Register of Controlled Trials and references in reviews. Twelve randomized controlled trials (RCTs) were identified that evaluated the effectiveness of CBT on at least one of: glycaemic control, diabetes-related distress, anxiety, depression or quality of life in adults with Type 1 or Type 2 diabetes. The Cochrane Risk of Bias Tool and Review Manager version 5.3 were used for risk of bias assessment and meta-analysis, respectively. CBT is effective in reducing short-term and medium-term glycaemic control, although no significant effect was found for long-term glycaemic control. CBT improved short- and medium-term anxiety and depression, and long-term depression. Mixed results were found for diabetes-related distress and quality of life. CBT is beneficial in improving depression for adults with diabetes. It may have benefits for improving glycaemic control and other aspects of psychological health, although the findings are inconclusive. © 2016 Diabetes UK.

  15. Risk factors for low vision related functioning in the Mycotic Ulcer Treatment Trial: a randomised trial comparing natamycin with voriconazole.

    Science.gov (United States)

    Rose-Nussbaumer, Jennifer; Prajna, N Venkatesh; Krishnan, Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; O'Brien, Kieran S; Ray, Kathryn J; Porco, Travis C; McLeod, Stephen D; Acharya, Nisha R; Keenan, Jeremy D; Lietman, Thomas M

    2016-07-01

    The Mycotic Ulcer Treatment Trial I (MUTT I) was a double-masked, multicentre, randomised controlled trial, which found that topical natamycin is superior to voriconazole for the treatment of filamentous fungal corneal ulcers. In this study, we determine risk factors for low vision-related quality of life in patients with fungal keratitis. The Indian visual function questionnaire (IND-VFQ) was administered to MUTT I study participants at 3 months. Associations between patient and ulcer characteristics and IND-VFQ subscale score were assessed using generalised estimating equations. 323 patients were enrolled in the trial, and 292 (90.4%) completed the IND-VFQ at 3 months. Out of a total possible score of 100, the average VFQ score for all participants was 81.3 (range 0-100, SD 23.6). After correcting for treatment arm, each logMAR line of worse baseline visual acuity in the affected eye resulted in an average 1.2 points decrease on VFQ at 3 months (95% CI -1.8 to 0.6, p<0.001). Those who required therapeutic penetrating keratoplasty had an average of 25.2 points decrease on VFQ after correcting for treatment arm (95% CI -31.8 to -18.5, p<0.001). Study participants who were unemployed had on average 28.5 points decrease on VFQ (95% CI -46.9 to -10.2, p=0.002) after correcting for treatment arm. Monocular vision loss from corneal opacity due to fungal keratitis reduced vision-related quality of life. Given the relatively high worldwide burden of corneal opacity, improving treatment outcomes of corneal infections should be a public health priority. Clinicaltrials.gov Identifier: NCT00996736. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  16. Matching of treatment-resistant heroin-dependent patients to medical prescription of heroin or oral methadone treatment: results from two randomized controlled trials

    NARCIS (Netherlands)

    Blanken, Peter; Hendriks, Vincent M.; Koeter, Maarten W. J.; van Ree, Jan M.; van den Brink, Wim

    2005-01-01

    AIMS: To investigate which baseline patient characteristics of treatment-resistant heroin addicts differentially predicted treatment response to medical heroin prescription compared to standard methadone maintenance treatment. DESIGN: Two open-label randomized controlled trials; pooled data.

  17. Low-profile stent system for treatment of atherosclerotic renal artery stenosis : The GREAT trial

    NARCIS (Netherlands)

    Sapoval, Marc; Zahringer, Markus; Pattynama, Peter; Rabbia, Claudio; Vignali, Claudio; Maleux, Geert; Boyer, Louis; Szczerbo-Trojanowska, Malgorzata; Jaschke, Werner; Hafsahl, Geir; Downes, Mark; Beregi, Jean Paul; Veeger, Nic; Talen, Aly

    PURPOSE: The Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent in Renal Artery Treatment (GREAT) Trial was designed to assess the safety and performance of a low-profile stent for the treatment of obstructive renal artery disease by looking at 6-month renal artery patency uniformly

  18. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM)

    NARCIS (Netherlands)

    Kemp, Samuel V.; Slebos, Dirk-Jan; Kirk, Alan; Kornaszewska, Malgorzata; Carron, Kris; Ek, Lars; Broman, Gustav; Hillerdal, Gunnar; Mal, Herve; Pison, Christophe; Briault, Amandine; Downer, Nicola; Darwiche, Kaid; Rao, Jagan; Huebner, Ralf-Harto; Ruwwe-Glosenkamp, Christof; Trosini-Desert, Valery; Eberhardt, Ralf; Herth, Felix J.; Derom, Eric; Malfait, Thomas; Shah, Pallav L.; Garner, Justin L.; ten Hacken, Nick H.; Fallouh, Hazem; Leroy, Sylvie; Marquette, Charles H.

    2017-01-01

    Rationale: Single-center randomized controlled trials of the Zephyr endobronchial valve (EBV) treatment have demonstrated benefit in severe heterogeneous emphysema. This is the first multicenter study evaluating this treatment approach. Objectives: To evaluate the efficacy and safety of Zephyr EBVs

  19. Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial

    NARCIS (Netherlands)

    Koeneman, M. M.; Kruse, Arnold-Jan; Kooreman, L. F. S.; zur Hausen, Axel; Hopman, Anton H N; Sep, S. J. S.; Van Gorp, T.; Slangen, B. F. M.; van Beekhuizen, H. J.; de Sande, Michiel A. J. van; Gerestein, Cornelis G.; Nijman, H. W.; Kruitwagen, R. F. M. P.

    2017-01-01

    The "TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia" (TOPIC) trial was stopped preliminary, due to lagging inclusions. This study aimed to evaluate the treatment efficacy and clinical applicability of imiquimod 5% cream in high-grade cervical intraepithelial neoplasia

  20. 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…

  1. QUINT : A tool to detect qualitative treatment-subgroup interactions in randomized controlled trials

    NARCIS (Netherlands)

    Doove, L.L.; Van Deun, K.; Dusseldorp, E.; van Mechelen, I.

    2016-01-01

    Objective: The detection of subgroups involved in qualitative treatment–subgroup interactions (i.e., for one subgroup of clients treatment A outperforms treatment B, whereas for another the reverse holds true) is crucial for personalized health. In typical Randomized Controlled Trials (RCTs), the

  2. Benchmarking recent national practice in rectal cancer treatment with landmark randomized controlled trials

    NARCIS (Netherlands)

    Borstlap, Waa; Deijen, C. L.; den Dulk, M.; Bonjer, H. J.; van de Velde, C. J.; Bemelman, W. A.; Tanis, P. J.; Aalbers, A.; Acherman, Y.; Algie, G. D.; Alting von Geusau, B.; Amelung, F.; Aukema, T. S.; Bakker, I. S.; Basha, S.; Bastiaansen, A. J. N. M.; Belgers, E.; Bleeker, W.; Blok, J.; Bosker, R. J. I.; Bosmans, J. W.; Boute, M. C.; Bouvy, N. D.; Bouwman, H.; Brandt-Kerkhof, A.; Brinkman, D. J.; Bruin, S.; Bruns, E. R. J.; Burbach, J. P. M.; Burger, J. W. A.; Buskens, C. J.; Clermonts, S.; Coenen, P. P. L. O.; Compaan, C.; Consten, E. C. J.; Darbyshire, T.; de Mik, S. M. L.; de Graaf, E. J. R.; de Groot, I.; de Vos Tot Nederveen Cappel, R. J. L.; de Wilt, J. H. W.; van der Wolde, J.; den Boer, F. C.; Dekker, J. W. T.; Demirkiran, A.; van Duijvendijk, P.; Musters, G. D.; van Rossem, C. C.; Schreuder, A. M.; Swank, H. A.

    2017-01-01

    Aim A Snapshot study design eliminates changes in treatment and outcome over time. This population based Snapshot study aimed to determine current practice and outcome of rectal cancer treatment with published landmark randomized controlled trials as a benchmark. Method In this collaborative

  3. Benchmarking recent national practice in rectal cancer treatment with landmark randomized controlled trials

    NARCIS (Netherlands)

    Borstlap, W. A. A.; Deijen, C. L.; den Dulk, M.; Bonjer, H. J.; van de Velde, C. J.; Bemelman, W. A.; Tanis, P. J.; Aalbers, A.; Acherman, Y.; Algie, G. D.; von Geu-sau, B. Alting; Amelung, F.; Aukema, T. S.; Bakker, I. S.; Bartels, S. A.; Basha, S.; Bastiaansen, A. J. N. M.; Belgers, E.; Bleeker, W.; Blok, J.; Bosker, R. J. I.; Bosmans, J. W.; Boute, M. C.; Bouvy, N. D.; Bouwman, H.; Brandt-Kerkhof, A.; Brinkman, D. J.; Bruin, S.; Bruns, E. R. J.; Burbach, J. P. M.; Burger, J. W. A.; Buskens, C. J.; Clermonts, S.; Coene, P. P. L. O.; Compaan, C.; Consten, E. C. J.; Darbyshire, T.; de Mik, S. M. L.; de Graaf, E. J. R.; de Groot, I.; Cappel, R. J. L. de Vos Tot Nederveen; de Wilt, J. H. W.; van der Wolde, J.; den Boer, F. C.; Furnee, E. J. B.; Havenga, K.; Klaase, J.; Holzik, M. F. Lutke; Meerdink, M.; Wevers, K.

    Aim A Snapshot study design eliminates changes in treatment and outcome over time. This population based Snapshot study aimed to determine current practice and outcome of rectal cancer treatment with published landmark randomized controlled trials as a benchmark. Method In this collaborative

  4. Comparing surgical repair with conservative treatment for degenerative rotator cuff tears : a randomized controlled trial

    NARCIS (Netherlands)

    Lambers Heerspink, Okke; van Raay, Jos J. A. M.; Koorevaar, Rinco C. T.; van Eerden, Pepijn J. M.; Westerbeek, Robin E.; van 't Riet, Esther; van den Akker-Scheek, Inge; Diercks, Ronald L.

    Background: Good clinical results have been reported for both surgical and conservative treatment of rotator cuff tears. The primary aim of this randomized controlled trial was to compare functional and radiologic improvement after surgical and conservative treatment of degenerative rotator cuff

  5. Prophylactic treatment of migraine in children. Part 1. A systematic review of non-pharmacological trials

    NARCIS (Netherlands)

    Damen, L; Bruijn, J; Koes, BW; Berger, MY; Passchier, J; Verhagen, AP

    The aim of this study was to assess the efficacy of non-pharmacological prophylactic treatments of migraine in children. Databases were searched from inception to June 2004 and references were checked. We selected controlled trials reporting the effects of non-pharmacological prophylactic treatments

  6. HIV Rapid Testing in Substance Abuse Treatment: Implementation Following a Clinical Trial

    Science.gov (United States)

    Haynes, L. F.; Korte, J. E.; Holmes, B. E.; Gooden, L.; Matheson, T.; Feaster, D. J.; Leff, J. A.; Wilson, L.; Metsch, L. R.; Schackman, B. R.

    2011-01-01

    The Substance Abuse Mental Health Services Administration has promoted HIV testing and counseling as an evidence-based practice. Nevertheless, adoption of HIV testing in substance abuse treatment programs has been slow. This article describes the experience of a substance abuse treatment agency where, following participation in a clinical trial,…

  7. 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

  8. Psychological trauma symptoms and Type 2 diabetes prevalence, glucose control, and treatment modality among American Indians in the Strong Heart Family Study.

    Science.gov (United States)

    Jacob, Michelle M; Gonzales, Kelly L; Calhoun, Darren; Beals, Janette; Muller, Clemma Jacobsen; Goldberg, Jack; Nelson, Lonnie; Welty, Thomas K; Howard, Barbara V

    2013-01-01

    The aims of this paper are to examine the relationship between psychological trauma symptoms and Type 2 diabetes prevalence, glucose control, and treatment modality among 3776 American Indians in Phase V of the Strong Heart Family Study. This cross-sectional analysis measured psychological trauma symptoms using the National Anxiety Disorder Screening Day instrument, diabetes by American Diabetes Association criteria, and treatment modality by four categories: no medication, oral medication only, insulin only, or both oral medication and insulin. We used binary logistic regression to evaluate the association between psychological trauma symptoms and diabetes prevalence. We used ordinary least squares regression to evaluate the association between psychological trauma symptoms and glucose control. We used binary logistic regression to model the association of psychological trauma symptoms with treatment modality. Neither diabetes prevalence (22%-31%; p=0.19) nor control (8.0-8.6; p=0.25) varied significantly by psychological trauma symptoms categories. However, diabetes treatment modality was associated with psychological trauma symptoms categories, as people with greater burden used either no medication, or both oral and insulin medications (odds ratio=3.1, ppsychological trauma symptoms suggests future research investigate patient and provider treatment decision making. © 2013.

  9. 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

  10. Comparison of mania patients suitable for treatment trials versus clinical treatment.

    Science.gov (United States)

    Talamo, Alessandra; Baldessarini, Ross J; Centorrino, Franca

    2008-08-01

    It remains uncertain whether bipolar disorder (BPD) patients in randomized-controlled trials (RCTs) are sufficiently representative of clinically encountered patients as to guide clinical-therapeutic practice. We complied inclusion/exclusion criteria by frequency from reports of 21 RCTs for mania, and applied them in a pilot study of patients hospitalized for DSM-IV BPD manic/mixed states to compare characteristics and clinical responses of patients who did versus did not meet exclusion criteria. From 27 initially identified inclusion/exclusion criteria ranked by citation frequency, we derived six inclusion, and 10 non-redundant-exclusion factors. Of 67 consecutive patients meeting inclusion criteria, 15 (22.4%) potential "research subjects" met all 10 exclusion criteria. The remaining 52 "clinical patients" differed markedly on exclusion criteria, including more psychiatric co-morbidity, substance abuse, involuntary hospitalization, and suicide attempts or violence, but were otherwise similar. In both groups responses to clinically determined inpatient treatments were similar, including improvement in mania ratings. Based on applying reported inclusion/exclusion criteria for RCTs to a pilot sample of hospitalized-manic patients, those likely to be included in modern RCTs were similar to patients who would be excluded, most notably in short-term antimanic-treatment responses. The findings encourage further comparisons of subjects included/excluded from RCTs to test potential clinical generalizability of research findings. The pilot study is limited in numbers and exposure times with which to test for the minor differences between "research subjects" and "clinical patients." (c) 2008 John Wiley & Sons, Ltd.

  11. Effectiveness of psychological interventions to improve quality of life in people with long-term conditions: rapid systematic review of randomised controlled trials.

    Science.gov (United States)

    Anderson, Niall; Ozakinci, Gozde

    2018-03-27

    Long-term conditions may negatively impact multiple aspects of quality of life including physical functioning and mental wellbeing. The rapid systematic review aimed to examine the effectiveness of psychological interventions to improve quality of life in people with long-term conditions to inform future healthcare provision and research. EBSCOhost and OVID were used to search four databases (PsychInfo, PBSC, Medline and Embase). Relevant papers were systematically extracted by one researcher using the predefined inclusion/exclusion criteria based on titles, abstracts, and full texts. Randomized controlled trial psychological interventions conducted between 2006 and February 2016 to directly target and assess people with long-term conditions in order to improve quality of life were included. Interventions without long-term condition populations, psychological intervention and/or patient-assessed quality of life were excluded. From 2223 citations identified, 6 satisfied the inclusion/exclusion criteria. All 6 studies significantly improved at least one quality of life outcome immediately post-intervention. Significant quality of life improvements were maintained at 12-months follow-up in one out of two studies for each of the short- (0-3 months), medium- (3-12 months), and long-term (≥ 12 months) study duration categories. All 6 psychological intervention studies significantly improved at least one quality of life outcome immediately post-intervention, with three out of six studies maintaining effects up to 12-months post-intervention. Future studies should seek to assess the efficacy of tailored psychological interventions using different formats, durations and facilitators to supplement healthcare provision and practice.

  12. Reporting of symptoms in randomized controlled trials of atopic eczema treatments: a systematic review.

    Science.gov (United States)

    Gerbens, L A A; Chalmers, J R; Rogers, N K; Nankervis, H; Spuls, P I

    2016-10-01

    'Symptoms' is a core outcome domain for atopic eczema (AE) trials, agreed by consensus as part of the Harmonising Outcome Measures for Eczema (HOME) initiative. To standardize and validate the core domain symptoms and symptom instruments for AE trials the HOME roadmap is followed. Its first step is to establish if and how symptoms have been measured in published AE treatment trials. Therefore the Global Resource for Eczema Trials database was used to collect all randomized controlled trials (RCTs) of treatments for AE between January 2000 and April 2014. Study selection and data extraction were performed by three reviewers independently. We identified the use of symptoms in 295 of 378 trials (78%). Symptoms as a primary end point were applied by 147 RCTs (50%). Seventeen different symptoms were measured, but mostly itch and sleep loss. Symptoms were assessed by only 37% of trials by a stand-alone symptom measurement. Overall 63% of RCTs used a composite instrument, and 30 different instruments were identified. The Scoring Atopic Dermatitis (SCORAD) index was the most commonly applied, but only 23% of RCTs reported the SCORAD symptom score separately. This systematic review demonstrates that symptoms, most frequently itch and sleep loss, are commonly reported in AE treatment trials, but are measured using many different instruments. Often symptoms are evaluated as part of a composite instrument, and currently it is not possible to extract symptoms-only data from most published studies. Future trials should report symptom scores to permit meta-analysis of the core outcomes. © 2016 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

  13. Clinical psychology of Internet addiction: a review of its conceptualization, prevalence, neuronal processes, and implications for treatment

    Directory of Open Access Journals (Sweden)

    Pontes HM

    2015-05-01

    Full Text Available Halley M Pontes, Daria J Kuss, Mark D Griffiths International Gaming Research Unit, Psychology Division, Nottingham Trent University, Nottingham, UK Abstract: Research into Internet addiction (IA has grown rapidly over the last decade. The topic has generated a great deal of debate, particularly in relation to how IA can be defined conceptually as well as the many methodological limitations. The present review aims to further elaborate and clarify issues that are relevant to IA research in a number of areas including: definition and characterization, incidence and prevalence rates, associated neuronal processes, and implications for treatment, prevention, and patient-specific considerations. It is concluded that there is no consensual definition for IA. Prevalence rates among nationally representative samples across several countries vary greatly (from 1% to 18.7%, most likely reflecting the lack of methodological consistency and conceptual rigor of the studies. The overlaps between IA and other more traditional substance-based addictions and the possible neural substrates implicated in IA are also highlighted. In terms of treatment and prevention, both psychological and pharmacological treatments are examined in light of existing evidence alongside particular aspects inherent to the patient perspective. Based on the evidence analyzed, it is concluded that IA may pose a serious health hazard to a minority of people. Keywords: Internet addiction, review, behavioral addictions, prevalence, neuronal processes, treatment

  14. The mind-body connection in irritable bowel syndrome: A randomised controlled trial of hypnotherapy as a treatment.

    Science.gov (United States)

    Phillips-Moore, Julie S; Talley, Nicholas J; Jones, Michael P

    2015-01-01

    Hypnotherapy has been reported as being beneficial in the treatment of irritable bowel syndrome (IBS). We aimed to test the hypothesis that patients with IBS treated 'holistically' by hypnosis (i.e. by combined psychological and physiological symptom imagery) would have greater improvement in their IBS symptoms than patients treated by hypnosis using standard 'gut-directed' hypnotherapy, and both would be superior to simple relaxation therapy. Patients ( n  = 51) with Rome II criteria were randomised to 'individualised' (holistic) hypnotherapy, standard 'gut-directed' hypnotherapy or relaxation therapy for a period of 11 weeks with two follow-up assessments at 2 weeks and at 3 months after the completion of the trial. The primary outcome was bowel symptom severity scale (BSSS). All the participants in this study improved their IBS symptoms (pain, bloating, constipation and diarrhoea) and physical functioning at the end of the treatment from baseline, but this was not significantly different across the treatment arms. Neither 'individualised' nor 'gut-directed' hypnotherapy is superior to relaxation therapy in IBS.

  15. The mind–body connection in irritable bowel syndrome: A randomised controlled trial of hypnotherapy as a treatment

    Directory of Open Access Journals (Sweden)

    Julie S Phillips-Moore

    2015-01-01

    Full Text Available Background: Hypnotherapy has been reported as being beneficial in the treatment of irritable bowel syndrome (IBS. We aimed to test the hypothesis that patients with IBS treated ‘holistically’ by hypnosis (i.e. by combined psychological and physiological symptom imagery would have greater improvement in their IBS symptoms than patients treated by hypnosis using standard ‘gut-directed’ hypnotherapy, and both would be superior to simple relaxation therapy. Methods: Patients ( n  = 51 with Rome II criteria were randomised to ‘individualised’ (holistic hypnotherapy, standard ‘gut-directed’ hypnotherapy or relaxation therapy for a period of 11 weeks with two follow-up assessments at 2 weeks and at 3 months after the completion of the trial. The primary outcome was bowel symptom severity scale (BSSS. Results: All the participants in this study improved their IBS symptoms (pain, bloating, constipation and diarrhoea and physical functioning at the end of the treatment from baseline, but this was not significantly different across the treatment arms. Conclusion: Neither ‘individualised’ nor ‘gut-directed’ hypnotherapy is superior to relaxation therapy in IBS.

  16. The mind–body connection in irritable bowel syndrome: A randomised controlled trial of hypnotherapy as a treatment

    Science.gov (United States)

    Talley, Nicholas J; Jones, Michael P

    2015-01-01

    Background: Hypnotherapy has been reported as being beneficial in the treatment of irritable bowel syndrome (IBS). We aimed to test the hypothesis that patients with IBS treated ‘holistically’ by hypnosis (i.e. by combined psychological and physiological symptom imagery) would have greater improvement in their IBS symptoms than patients treated by hypnosis using standard ‘gut-directed’ hypnotherapy, and both would be superior to simple relaxation therapy. Methods: Patients (n = 51) with Rome II criteria were randomised to ‘individualised’ (holistic) hypnotherapy, standard ‘gut-directed’ hypnotherapy or relaxation therapy for a period of 11 weeks with two follow-up assessments at 2 weeks and at 3 months after the completion of the trial. The primary outcome was bowel symptom severity scale (BSSS). Results: All the participants in this study improved their IBS symptoms (pain, bloating, constipation and diarrhoea) and physical functioning at the end of the treatment from baseline, but this was not significantly different across the treatment arms. Conclusion: Neither ‘individualised’ nor ‘gut-directed’ hypnotherapy is superior to relaxation therapy in IBS. PMID:28070348

  17. Improving the reporting of clinical trials of infertility treatments (IMPRINT): modifying the CONSORT statement†‡.

    Science.gov (United States)

    Legro, Richard S; Wu, Xiaoke; Barnhart, Kurt T; Farquhar, Cynthia; Fauser, Bart C J M; Mol, Ben

    2014-10-10

    Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and result in a third individual if successful, their offspring (child), who is also the desired outcome of treatment. The primary outcome of interest and many adverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which create a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existing Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to the CONSORT checklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant ≥20 weeks gestations) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and during the neonatal period. Routine information should be collected and reported on both male and female participants in the trial. We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and

  18. Power analysis to detect treatment effects in longitudinal clinical trials for Alzheimer's disease.

    Science.gov (United States)

    Huang, Zhiyue; Muniz-Terrera, Graciela; Tom, Brian D M

    2017-09-01

    Assessing cognitive and functional changes at the early stage of Alzheimer's disease (AD) and detecting treatment effects in clinical trials for early AD are challenging. Under the assumption that transformed versions of the Mini-Mental State Examination, the Clinical Dementia Rating Scale-Sum of Boxes, and the Alzheimer's Disease Assessment Scale-Cognitive Subscale tests'/components' scores are from a multivariate linear mixed-effects model, we calculated the sample sizes required to detect treatment effects on the annual rates of change in these three components in clinical trials for participants with mild cognitive impairment. Our results suggest that a large number of participants would be required to detect a clinically meaningful treatment effect in a population with preclinical or prodromal Alzheimer's disease. We found that the transformed Mini-Mental State Examination is more sensitive for detecting treatment effects in early AD than the transformed Clinical Dementia Rating Scale-Sum of Boxes and Alzheimer's Disease Assessment Scale-Cognitive Subscale. The use of optimal weights to construct powerful test statistics or sensitive composite scores/endpoints can reduce the required sample sizes needed for clinical trials. Consideration of the multivariate/joint distribution of components' scores rather than the distribution of a single composite score when designing clinical trials can lead to an increase in power and reduced sample sizes for detecting treatment effects in clinical trials for early AD.

  19. Clinical trials as treatment option: bioethics and health care disparities in substance dependency.

    Science.gov (United States)

    Timmermans, Stefan; McKay, Tara

    2009-12-01

    Bioethicists have warned against the dangers of mixing research with treatment. They are concerned that research priorities may take precedence over individual patient needs and that research subjects tend to misunderstand the purpose of research or overestimate the direct medical benefits of participating in studies. Yet, other work has questioned whether clinical research can always be separated from therapeutic benefit for participants. Using in-depth interviews with participants in two phase III randomized U.S. clinical trials for methamphetamine dependency, we examine the treatment options available to participants, their experiences with participating in the trials, and potential problems of trial participation. We find that while participants have experience with four alternative treatment modalities - quitting alone, support groups, in-patient treatment facilities, and consulting primary care physicians - the randomized clinical trials compare favorably to alternatives because they provide access to evidence-based behavioral treatments, specialized medical professionals, non-judgmental staff, and the possibility of receiving an experimental drug. We conclude that while randomized clinical trials are imperfect substitutes for clinical care, they constitute a fragile and sporadic therapeutic niche in a country with fundamental problems in access to health care, a mixed punitive-therapeutic drug addiction policy, and a profit-driven pharmaceutical development and approval process.

  20. Trials of Transcranial Stimulation for the Treatment of Parkinson's Disease

    National Research Council Canada - National Science Library

    Hallett, Mark; Lomarev, Mikhail P; Richardson, Sarah P; Wassermann, Eric; Bara, William; Lopez, Grisel

    2007-01-01

    During the first year of the study, we have been mainly working on the protocol "Transcranial Electrical Polarization for the Treatment of Bradykinesia and Rigidity in Patients with Parkinson's Disease...

  1. Cost-effectiveness of treatment for alcohol problems: findings of the randomised UK Alcohol Treatment Trial (UKATT).

    OpenAIRE

    Heather, Nick; Copello, Alex; Godfrey, Christine; Hodgson, Ray; UKATT Research Team

    2005-01-01

    Objective \\ud To compare the cost effectiveness of social behaviour and network therapy, a new treatment for alcohol problems, with that of the proved motivational enhancement therapy. Design Cost effectiveness analysis alongside a pragmatic randomised trial. \\ud \\ud Setting \\ud Seven treatment sites around Birmingham, Cardiff, and Leeds. Participants 742 clients with alcohol problems; 617 (83.2%) were interviewed at 12 months and full economic data were obtained on 608 (98.5% of 617). Main e...

  2. Assessing treatment fidelity and contamination in a cluster randomised controlled trial of motivational interviewing and cognitive behavioural therapy skills in type 2 diabetes.

    Science.gov (United States)

    Magill, Nicholas; Graves, Helen; de Zoysa, Nicole; Winkley, Kirsty; Amiel, Stephanie; Shuttlewood, Emma; Landau, Sabine; Ismail, Khalida

    2018-05-10

    Competencies in psychological techniques delivered by primary care nurses to support diabetes self-management were compared between the intervention and control arms of a cluster randomised controlled trial as part of a process evaluation. The trial was pragmatic and designed to assess effectiveness. This article addresses the question of whether the care that was delivered in the intervention and control trial arms represented high fidelity treatment and attention control, respectively. Twenty-three primary care nurses were either trained in motivational interviewing (MI) and cognitive behavioural therapy (CBT) skills or delivered attention control. Nurses' skills in these treatments were evaluated soon after training (treatment arm) and treatment fidelity was assessed after treatment delivery for sessions midway through regimen (both arms) using the Motivational Interviewing Treatment Integrity (MITI) domains and Behaviour Change Counselling Index (BECCI) based on consultations with 151 participants (45% of those who entered the study). The MITI Global Spirit subscale measured demonstration of MI principles: evocation, collaboration, autonomy/support. After training, median MITI MI-Adherence was 86.2% (IQR 76.9-100%) and mean MITI Empathy was 4.09 (SD 1.04). During delivery of treatment, in the intervention arm mean MITI Spirit was 4.03 (SD 1.05), mean Empathy was 4.23 (SD 0.89), and median Percentage Complex Reflections was 53.8% (IQR 40.0-71.4%). In the attention control arm mean Empathy was 3.40 (SD 0.98) and median Percentage Complex Reflections was 55.6% (IQR 41.9-71.4%). After MI and CBT skills training, detailed assessment showed that nurses had basic competencies in some psychological techniques. There appeared to be some delivery of elements of psychological treatment by nurses in the control arm. This model of training and delivery of MI and CBT skills integrated into routine nursing care to support diabetes self-management in primary care was not

  3. Design paper: The CapOpus trial: a randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis

    DEFF Research Database (Denmark)

    Hjorthøj, Carsten; Fohlmann, Allan; Larsen, Anne-Mette

    2008-01-01

    : The major objective for the CapOpus trial is to evaluate the additional effect on cannabis abuse of a specialized addiction treatment program adding group treatment and motivational interviewing to treatment as usual. DESIGN: The trial is designed as a randomized, parallel-group, observer-blinded clinical...

  4. Using plain English and behaviourally specific language to increase the implementation of clinical guidelines for psychological treatments in schizophrenia.

    Science.gov (United States)

    Ince, Paul; Tai, Sara; Haddock, Gillian

    2015-06-01

    Inequalities in the implementation of recommended psychological interventions for schizophrenia persist. Writing guidance in a particular style has been shown to improve service user intention to implement the recommendations. This current study explored this further in healthcare staff members. Can behaviourally specific and plain English language improve healthcare intentions to perform actions in line with guidance for schizophrenia. An independent measure, single blind, randomised control trial. Guidance was written and disseminated in two formats, the "original" and "alternative". Self-report measures were administered to assess the cognitive determents of behaviour as described by the Theory of Planned Behaviour, actual behaviour consistent with the guidance, comprehension and satisfaction with the guidance. No significant results were found when comparing the original guidance to the alternative for the cognitive determinants of behaviour, actual behaviour, comprehension or satisfaction. Behaviourally specific and plain English language does not affect healthcare professionals' intentions or behaviour to implement recommended guidance for the provision of psychological interventions for schizophrenia. A more multi-factorial approach including organisational culture may be required.

  5. 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

  6. 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

  7. Parent and medical professional willingness to enroll children in a hypothetical pediatric optic neuritis treatment trial

    Directory of Open Access Journals (Sweden)

    Amy eWaldman

    2011-11-01

    Full Text Available The Optic Neuritis Treatment Trial and subsequent studies have had a tremendous impact on the treatment and prognosis of optic neuritis and multiple sclerosis in adults. The results of these studies have been extrapolated to children; however, pediatric data are sparse. Using the method of prospective preference assessment, the willingness of parents and medical professionals to enroll children in a hypothetical Pediatric Optic Neuritis Treatment Trial was assessed using a mock consent form and questionnaire. A 3-arm trial was proposed: 1 intravenous corticosteroids, 2 high-dose oral corticosteroids, and 3 an oral placebo. The forms were completed by 198 parents and 49 physicians. After reviewing the hypothetical scenario, trial design, risks and benefits, and alternatives to the study, 21% of parents would enroll their children in the trial whereas 98% of medical professionals would enroll their patients. With medical professional recommendation, 43% of parents would enroll their children. The manner in which this hypothetical trial was presented to parents, specifically with respect to the recommendation of their child’s health care team, influenced a parent’s willingness to participate.

  8. Effects of a laughter and exercise program on physiological and psychological health among community-dwelling elderly in Japan: randomized controlled trial.

    Science.gov (United States)

    Hirosaki, Mayumi; Ohira, Tetsuya; Kajiura, Mitsugu; Kiyama, Masahiko; Kitamura, Akihiko; Sato, Shinichi; Iso, Hiroyasu

    2013-01-01

    To examine the effects of a once-weekly laughter and exercise program on physical and psychological health among elderly people living in the community. As a regular exercise program can be difficult to maintain, we provided a more enjoyable program to enhance adherence to exercise. A total of 27 individuals aged 60 years or older, without disabilities, were randomly assigned to either an immediate treatment group (n=14) or a delayed treatment group (n=13). The intervention was a 120-min session consisting of laughter and exercise, carried out once a week for 10 consecutive weeks. Measurements taken at baseline, 3 and 6 months included bodyweight, height, body fat, lean mass, bone mineral density, hemoglobin A1c (HbA(1c)), glucose, high-density lipoprotein and low-density lipoprotein cholesterol, and triglycerides, as well as self-rated health and psychological factors. All participants completed the 3-month program. Bone mineral density increased significantly in the immediate treatment group compared with the delayed treatment group during the first 3 months (Plaughter and exercise program might have physiological and psychological health benefits for the elderly. Laughter might be an effective strategy to motivate the elderly to participate in physical activity. © 2012 Japan Geriatrics Society.

  9. Binocular treatment of amblyopia using videogames (BRAVO): study protocol for a randomised controlled trial

    OpenAIRE

    Guo, Cindy X.; Babu, Raiju J.; Black, Joanna M.; Bobier, William R.; Lam, Carly S. Y.; Dai, Shuan; Gao, Tina Y.; Hess, Robert F.; Jenkins, Michelle; Jiang, Yannan; Kowal, Lionel; Parag, Varsha; South, Jayshree; Staffieri, Sandra Elfride; Walker, Natalie

    2016-01-01

    Background Amblyopia is a common neurodevelopmental disorder of vision that is characterised by visual impairment in one eye and compromised binocular visual function. Existing evidence-based treatments for children include patching the nonamblyopic eye to encourage use of the amblyopic eye. Currently there are no widely accepted treatments available for adults with amblyopia. The aim of this trial is to assess the efficacy of a new binocular, videogame-based treatment for amblyopia in older ...

  10. Psychological aspects of the treatment of patients with disorders of sex development.

    Science.gov (United States)

    Sandberg, David E; Gardner, Melissa; Cohen-Kettenis, Peggy T

    2012-10-01

    Research on the psychological development of persons with Disorders of Sex Development (DSD) has focused on understanding the influence of atypical sex hormone exposure during steroid-sensitive periods of prenatal brain development on the process of psychosexual differentiation (i.e., gender identity, gender role, and sexual orientation). In contrast, analysis of clinical management strategies has focused on gender assignment and the desirability and timing of genital surgery. This review focuses on the psychological issues that confront clinicians managing the care of persons born with DSD and their families. Particular attention is paid to processes and factors that potentially mediate or moderate psychosocial and psychosexual outcomes within and across developmental stages. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  11. Psychological Aspects of the Treatment of Patients with Disorders of Sex Development

    Science.gov (United States)

    Sandberg, David E.; Gardner, Melissa; Cohen-Kettenis, Peggy T.

    2013-01-01

    Research on the psychological development of persons with Disorders of Sex Development (DSD) has focused on understanding the influence of atypical sex hormone exposure during steroid-sensitive periods of prenatal brain development on the process of psychosexual differentiation (i.e., gender identity, gender role, and sexual orientation). In contrast, analysis of clinical management strategies has focused on gender assignment and the desirability and timing of genital surgery. This review focuses on the psychological issues that confront clinicians managing the care of persons born with DSD and their families. Particular attention is paid to processes and factors that potentially mediate or moderate psychosocial and psychosexual outcomes within and across developmental stages. PMID:23044882

  12. Cognitive Behavioral Therapy versus Short Psychodynamic Supportive Psychotherapy in the outpatient treatment of depression: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kool Simone

    2007-10-01

    -effectiveness. Clinical predictors of treatment outcome include demographic variables, psychiatric symptoms, cognitive and psychological patient characteristics and the quality of the therapeutic relationship. Discussion This study evaluates Short Psychodynamic Supportive Psychotherapy as a treatment for depressed outpatients by comparing it to the established evidence-based treatment Cognitive Behavioral Therapy. Specific strengths of this study include its strong external validity and the clinical relevance of its research aims. Limitations of the study are discussed. Trial registration Current Controlled Trails ISRCTN31263312

  13. Psychological Therapy for People with Tinnitus: A Scoping Review of Treatment Components

    OpenAIRE

    Thompson, Dean M.; Hall, Deborah A.; Walker, Dawn-Marie; Hoare, Derek J.

    2017-01-01

    Background: Tinnitus is associated with depression and anxiety disor- ders, severely and adversely affecting the quality of life and functional health status for some people. With the dearth of clinical psychologists embedded in audiology services and the cessation of training for hearing therapists in the UK, it is left to audiologists to meet the psychological needs of many patients with tinnitus. However, there is no universally standardized training or manualized intervention specifically...

  14. Deontology of a therapeutist: psychological and therapeutic ways of behaviour during dental examination and treatment

    OpenAIRE

    Savina Е.А.; Bulkina N.V.; Lomakina D.О.; Olevskaya О.A.

    2011-01-01

    The aim of the research is to improve interpersonal interactions in the doctor-patient relationship by developing recommendations for a differentiated deontological approach to patients with characteristic personality traits. In conducting in-depth clinical and psychological study (Leonhard questionnaire and clinical interview) characteristic features of patients were identified and allowed to develop recommendations that enhance the interaction in the doctor — patient relationship. Correct d...

  15. The problem of mental disorders and psychological effects of antitumour treatment in children with cancer pathology

    Directory of Open Access Journals (Sweden)

    Оксана Владимировна Пионтковская

    2015-07-01

    Full Text Available Aim – analysis of the problem of psychological and psychiatrical aspects of impact of cancer disease on child and its parents for detection of the main directions of medical and psychological help to this contingent.Results. In the younger age group the most stress factors that provoke the development of psychogenic fears, anxiety states and the derivative mood disorders are the “hospital routine” – limitation of activity (playing, motor, subjectively heavy procedures and manipulations, pain. In the group of elder children and teenagers the main stress stimulus is connected with a fear of social consequences of disease and the fact of mortally dangerous disease is interpreted in mind as a threat to the successful social functioning as something that spread its negative impact on the future life. Reactively caused mood disorders prevail in this age group over the other psychogenic formations. Behavior reactions in these cases are the secondary ones relating to the mood disorders – to the acceptance or rejection the situation of disease (as an anxious hypochondriacal fixation or as an emotional denial and ignoring the possible grave effects of cancer process.Conclusion. The diversity of problems in child psycho-oncology causes the multilevelness and versatility of medical, psychological and psychosocial help and psycho rehabilitation of children and their parents

  16. Universal Internet-based prevention for alcohol and cannabis use reduces truancy, psychological distress and moral disengagement: a cluster randomised controlled trial.

    Science.gov (United States)

    Newton, Nicola C; Andrews, Gavin; Champion, Katrina E; Teesson, Maree

    2014-08-01

    A universal Internet-based preventive intervention has been shown to reduce alcohol and cannabis use. The aim of this study was to examine if this program could also reduce risk-factors associated with substance use in adolescents. A cluster randomised controlled trial was conducted in Sydney, Australia in 2007-2008 to assess the effectiveness of the Internet-based Climate Schools: Alcohol and Cannabis course. The evidence-based course, aimed at reducing alcohol and cannabis use, consists of two sets of six lessons delivered approximately six months apart. A total of 764 students (mean 13.1years) from 10 secondary schools were randomly allocated to receive the preventive intervention (n=397, five schools), or their usual health classes (n=367, five schools) over the year. Participants were assessed at baseline, immediately post, and six and twelve months following the intervention on their levels of truancy, psychological distress and moral disengagement. Compared to the control group, students in the intervention group showed significant reductions in truancy, psychological distress and moral disengagement up to twelve months following completion of the intervention. These intervention effects indicate that Internet-based preventive interventions designed to prevent alcohol and cannabis use can concurrently reduce risk-factors associated with substance use in adolescents. Australian Clinical Trials Registry ACTRN: 012607000312448. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. Chiropractic Treatment for Gastrointestinal Problems: A Systematic Review of Clinical Trials

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    E Ernst

    2011-01-01

    Full Text Available Many chiropractors believe that chiropractic treatments are effective for gastrointestinal disorders. The aim of the present systematic review was to critically evaluate the evidence from controlled clinical trials supporting or not supporting this notion. Six electronic databases were searched for relevant studies. No limits were applied to language or publication date. Prospective, controlled, clinical trials of any type of chiropractic treatment for any type of gastrointestinal problem, except infant colic, were included. Only two trials were found – one was a pilot study, and the other had reached a positive conclusion; however, both had serious methodological flaws. There is no supportive evidence that chiropractic is an effective treatment for gastrointestinal disorders.

  18. Psychological skills training and a mindfulness-based intervention to enhance functional athletic performance: design of a randomized controlled trial using ambulatory assessment.

    Science.gov (United States)

    Röthlin, Philipp; Birrer, Daniel; Horvath, Stephan; Grosse Holtforth, Martin

    2016-07-26

    Struggling to deliver performance in competitions is one of the main reasons why athletes seek the advice of sport psychologists. Psychologists apply a variety of intervention techniques, many of which are not evidence-based. Evidence-based techniques promote quality management and could help athletes, for example, to increase and maintain functional athletic behavior in competitions/games (i.e., being focused on task relevant cues and executing movements and actions in high quality). However, well-designed trials investigating the effectiveness of sport psychological interventions for performance enhancement are scarce. The planed study is founded by the Swiss National Science Foundation and examines the effectiveness of two interventions with elite and sub-elite athletes. A psychological skills training (PST) and a mindfulness-based intervention (MI), administered as group-program, will be compared to a waiting-list control group concerning how they enhance functional athletic behavior - which is a prerequisite for optimal performance. Furthermore, we will investigate underlying mechanisms (mediators) and moderators (e.g., task difficulty, individual characteristics, intervention-expectancy and intervention-integrity). The presented trial uses a randomized controlled design with three groups, comparing PST, MI and a waiting list control condition. Both group interventions will last 5 weeks, consist of four 2 h sessions and will be administered by a trained sport psychologist. Primary outcome is functional athletic behavior assessed using ambulatory assessment in a competition/game. As secondary outcomes competition anxiety, cognitive interference and negative outcome expectations will be assessed. Assessments are held at pre- and post-intervention as well as at 2 months follow up. The study has been approved by the ethical committee of the Swiss Federal Institute of Sport. Both PST and MI are expected to help improve functional behavior in athletes. By

  19. Fulfilling the psychological and information need of the family members of critically ill patients using interactive mobile technology: A randomised controlled trial.

    Science.gov (United States)

    Chiang, Vico Chung Lim; Lee, Rainbow Lai Ping; Ho, Fung Mei; Leung, Chi Kwong; Tang, Yi Pui; Wong, Wing Sze; Ho, Yee Sin; Tung, Yan Wai; Lai, Hang Louie

    2017-08-01

    Intensive care nurses may have an important role in empowering families by providing psychological support and fulfilling the family's pivotal need for information. To determine whether 'education of families by tab' about the patient's condition was more associated with improved anxiety, stress, and depression levels than the 'education of families by routine'. A randomized control trial of 74 main family caregivers (intervention: 39; control: 35). An adult intensive care unit. Depression Anxiety Stress Scale, and Communication and Physical Comfort Scale. Although information need satisfaction was not significantly different between intervention and control groups, the former reported significantly better depression score on Depression Anxiety Stress Scale comparing to the control group (psize. Reduction of anxiety in the intervention group were clinically significant. The results suggest that use of 'education of family by tab' is promising for intensive care nurses to provide psychological support for family members. More studies are needed to investigate this aspect of family care for better psychological support and information need satisfaction that contributes to the evidence-based practice of intensive care nursing. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  1. A novel design for randomized immuno-oncology clinical trials with potentially delayed treatment effects

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    Pei He

    2015-10-01

    Full Text Available The semi-parametric proportional hazards model is widely adopted in randomized clinical trials with time-to-event outcomes, and the log-rank test is frequently used to detect a potential treatment effect. Immuno-oncology therapies pose unique challenges to the design of a trial as the treatment effect may be delayed, which violates the proportional hazards assumption, and the log-rank test has been shown to markedly lose power under the non-proportional hazards setting. A novel design and analysis approach for immuno-oncology trials is proposed through a piecewise treatment effect function, which is capable of detecting a potentially delayed treatment effect. The number of events required for the trial will be determined to ensure sufficient power for both the overall log-rank test without a delayed effect and the test beyond the delayed period when such a delay exists. The existence of a treatment delay is determined by a likelihood ratio test with resampling. Numerical results show that the proposed design adequately controls the Type I error rate, has a minimal loss in power under the proportional hazards setting and is markedly more powerful than the log-rank test with a delayed treatment effect.

  2. Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal

    Directory of Open Access Journals (Sweden)

    Kent David M

    2010-08-01

    Full Text Available Abstract Mounting evidence suggests that there is frequently considerable variation in the risk of the outcome of interest in clinical trial populations. These differences in risk will often cause clinically important heterogeneity in treatment effects (HTE across the trial population, such that the balance between treatment risks and benefits may differ substantially between large identifiable patient subgroups; the "average" benefit observed in the summary result may even be non-representative of the treatment effect for a typical patient in the trial. Conventional subgroup analyses, which examine whether specific patient characteristics modify the effects of treatment, are usually unable to detect even large variations in treatment benefit (and harm across risk groups because they do not account for the fact that patients have multiple characteristics simultaneously that affect the likelihood of treatment benefit. Based upon recent evidence on optimal statistical approaches to assessing HTE, we propose a framework that prioritizes the analysis and reporting of multivariate risk-based HTE and suggests that other subgroup analyses should be explicitly labeled either as primary subgroup analyses (well-motivated by prior evidence and intended to produce clinically actionable results or secondary (exploratory subgroup analyses (performed to inform future research. A standardized and transparent approach to HTE assessment and reporting could substantially improve clinical trial utility and interpretability.

  3. 76 FR 39883 - Design of Clinical Trials for Systemic Antibacterial Drugs for the Treatment of Acute Otitis...

    Science.gov (United States)

    2011-07-07

    ...] Design of Clinical Trials for Systemic Antibacterial Drugs for the Treatment of Acute Otitis Media... Clinical Trials for Systemic Antibacterial Agents for the Treatment of Acute Otitis Media. This public... the treatment of acute otitis media (middle ear infection). Discussions will focus on [[Page 39884...

  4. The value of psychological treatment for borderline personality disorder: Systematic review and cost offset analysis of economic evaluations

    Science.gov (United States)

    Meuldijk, Denise; McCarthy, Alexandra; Bourke, Marianne E.; Grenyer, Brin F. S.

    2017-01-01

    Aim Borderline Personality Disorder (BPD) is a common mental health condition with high patterns of service utilisation of inpatient and community treatment. Over the past five years there has been significant growth in research with economic data, making this systematic review a timely update. Methods Empirical studies written in English or German, published up to December 2015, and cited in major electronic databases were examined using the PRISMA systematic review method. Papers were included that had one of the following: data related to cost of BPD to society, the individual, the carer or families; cost benefits of interventions. Reported cost data were inflated to the year 2015 and converted into US- dollars (USD $) using purchasing power parities. Results We identified 30 economic evaluations providing cost data related to interventions for BPD across 134,136 patients. The methodological quality was good, almost all studies fulfilled ≥ 50% of the quality criteria. The mean cost saving for treating BPD with evidence-based psychotherapy across studies was USD $2,987.82 per patient per year. A further mean weighted reduction of USD $1,551 per patient per year (range $83 - $29,392) was found compared to treatment as usual. Evidence-based psychological treatment was both less expensive as well as more effective, despite considerable differences in health cost arrangements between individual studies and countries. Where it was able to be calculated, a significant difference in cost-savings between different types of evidence-based psychotherapies was found. Discussion Individuals with BPD consistently demonstrate high patterns of service utilization and therefore high costs. The findings of this review present a strong argument in favour of prioritizing BPD treatments in reimbursement decisions, both for the affected individual and the family. The provision of evidence based treatment, irrespective of the type of psychological treatment, may lead to widespread

  5. The value of psychological