A Randomized Trial of Motivational Interviewing

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Catley, Delwyn; Goggin, Kathy; Harris, Kari Jo; Richter, Kimber P.; Williams, Karen; Patten, Christi; Resnicow, Ken; Ellerbeck, Edward F.; Bradley-Ewing, Andrea; Lee, Hyoung S.; Moreno, Jose L.; Grobe, James E.

2015-01-01

Introduction Despite limitations in evidence, the current Clinical Practice Guideline advocates Motivational Interviewing for smokers not ready to quit. This study evaluated the efficacy of Motivational Interviewing (MI) for inducing cessation-related behaviors among smokers with low motivation to quit. Design Randomized clinical trial. Setting/participants Two-hundred fifty-five daily smokers reporting low desire to quit smoking were recruited from an urban community during 2010–2011 and randomly assigned to Motivational Interviewing, health education, or brief advice using a 2:2:1 allocation. Data were analyzed from 2012 to 2014. Intervention Four sessions of Motivational Interviewing utilized a patient-centered communication style that explored patients’ own reasons for change. Four sessions of health education provided education related to smoking cessation while excluding elements characteristic of Motivational Interviewing. A single session of brief advice consisted of brief, personalized advice to quit. Main outcomes measures Self-reported quit attempts, smoking abstinence (biochemically verified), use of cessation pharmacotherapies, motivation, and confidence to quit were assessed at baseline and 3- and 6-month follow-ups. Results Unexpectedly, no significant differences emerged between groups in the proportion who made a quit attempt by 6-month follow-up (Motivational Interviewing, 52.0%; health education, 60.8%; brief advice, 45.1%; p=0.157). Health education had significantly higher biochemically verified abstinence rates at 6 months (7.8%) than brief advice (0.0%) (8% difference, 95% CI=3%, 13%, p=0.003), with the Motivational Interviewing group falling in between (2.9% abstinent, 3% risk difference, 95% CI=0%, 6%, p=0.079). Both Motivational Interviewing and health education groups showed greater increases in cessation medication use, motivation, and confidence to quit relative to brief advice (all pmotivation relative to Motivational Interviewing

Contingency management for college student smokers: The role of drinking as a moderator and mediator of smoking abstinence during treatment.

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Cassidy, Rachel N; Jackson, Kristina M; Rohsenow, Damaris J; Tidey, Jennifer W; Tevyaw, Tracy O' L; Barnett, Nancy P; Monti, Peter M; Miller, Mollie E; Colby, Suzanne M

2018-05-01

Contingency management (CM) is effective for promoting smoking abstinence; however, moderators and mediators of CM treatment efficacy in young adult populations are under-explored. We leveraged fine-grained data from a large randomized controlled trial: 1) to determine whether early attainment of sustained abstinence mediated the effect of treatment on abstinence; 2) to test whether heavy drinking moderated the effect of treatment on abstinence; and 3) to test a serial mediation model of the effects of drinking during early treatment on sustained smoking abstinence. College student smokers (N=110) were randomized to receive either CM treatment or noncontingent reinforcement (NR) over a 21-day treatment period. All participants received $5 for providing twice-daily breath carbon monoxide (CO) samples. In CM, additional money was provided for samples that indicated smoking reduction (Initial Phase; first 7days), and for samples ≤5ppm (Abstinence Phase; following 14days). CM treatment led to greater sustained abstinence relative to NR. Longer sustained abstinence in the Initial Phase partially mediated the effect of treatment on sustained abstinence in the Abstinence Phase. Heavier pretreatment drinkers had shorter periods of sustained abstinence in the Abstinence Phase; this effect was greater in CM. A serial mediation model determined that increased drinking during the Initial Phase led to decreased sustained abstinence, which then led to decreased sustained abstinence in the Abstinence Phase. These data provide a greater understanding of how heavy drinking and early sustained abstinence may affect success during treatment in young adults undergoing contingency management treatment for smoking. Copyright © 2018. Published by Elsevier Ltd.

Commitment contracts and team incentives: a randomized controlled trial for smoking cessation in Thailand.

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White, Justin S; Dow, William H; Rungruanghiranya, Suthat

2013-11-01

Treatment for tobacco dependence is not available in many low-resource settings, especially in developing countries. To test the impact of a novel mix of monetary and social incentives on smoking abstinence in rural communities of Thailand. An RCT of commitment contracts and team incentives for rural smokers to quit smoking. Smokers were not blinded to treatment status, although the assessor of the biochemical urine test was. All adult smokers living in the study area were eligible to participate; 215 adult smokers from 42 villages in Nakhon Nayok province, Thailand, participated. Fourteen smokers who lacked teammates were dropped. A total of 201 smokers were assigned to a two-person team, and then randomly assigned by team (in a 2:1 ratio) with computer-generated random numbers to receive smoking-cessation counseling (control group) or counseling plus offer of a commitment contract, team incentives, and text message reminders for smoking cessation at 3 months (intervention group). The primary outcome was biochemically verified 7-day abstinence at 6 months, assessed on an intention-to-treat basis. Secondary outcomes include study participation, biochemically verified abstinence at 3 months, self-reported abstinence at 14 months, and the incremental cost per quitter of the intervention, nicotine gum, and varenicline in Thailand. Data were collected in 2010-2011 and analyzed in 2012. The trial enrolled 215 (10.5%) of 2055 smokers. The abstinence rate was 46.2% (61/132) in the intervention group and 14.5% (10/69) in the control group (adjusted OR 7.5 [3.0-18.6]) at 3 months; 44.3% (58/131) and 18.8% (13/69) at the primary end point of 6 months (adjusted OR 4.2 [1.8-9.7]); and 42.0% (55/131) and 24.6% (17/69) at 14 months (adjusted OR 2.2 [1.0-4.8]). The purchasing power parity-adjusted incremental cost per quitter from the intervention is $281 (95% CI=$187, $562), less than for nicotine gum ($1780, 95% CI=$1414, $2401) or varenicline ($2073, 95% CI=$1357, $4388) in

Financial incentives for smoking cessation in low-income smokers: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Etter Jean-François

2012-06-01

Full Text Available Abstract Background Tobacco smoking is the leading avoidable cause of death in high-income countries. The smoking-related disease burden is borne primarily by the least educated and least affluent groups. Thus, there is a need for effective smoking cessation interventions that reach to, and are effective in this group. Research suggests that modest financial incentives are not very effective in helping smokers quit. What is not known is whether large financial incentives can enhance longer-term (1 year smoking cessation rates, outside clinical and workplace settings. Trial design A randomized, parallel groups, controlled trial. Methods Participants: Eight hundred low-income smokers in Switzerland (the less affluent third of the population, based on fiscal taxation. Intervention: A smoking cessation program including: (a financial incentives given during 6 months; and (b Internet-based counseling. Financial rewards will be offered for biochemically verified smoking abstinence after 1, 2, and 3 weeks and 1, 3, and 6 months, for a maximum of 1,500 CHF (1,250 EUR, 1,500 USD for those abstinent at all time-points. All participants, including controls, will receive Internet-based, individually-tailored, smoking cessation counseling and self-help booklets, but there will be no in-person or telephone counseling, and participants will not receive medications. The control group will not receive financial incentives. Objective: To increase smoking cessation rates. Outcome: Smoking abstinence after 6 and 18 months, not contradicted by biochemical tests. We will assess relapse after the end of the intervention, to test whether 6-month effects translate into sustained abstinence 12 months after the incentives are withdrawn. Randomization: Will be done using sealed envelopes drawn by participants. Blinding: Is not possible in this context. Discussion Smoking prevention policies and interventions have been least effective in the least educated, low

Contingency management is effective in promoting abstinence and retention in treatment among crack cocaine users in Brazil: A randomized controlled trial.

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Miguel, André Q C; Madruga, Clarice S; Cogo-Moreira, Hugo; Yamauchi, Rodolfo; Simões, Viviane; da Silva, Claudio J; McPherson, Sterling; Roll, John M; Laranjeira, Ronaldo R

2016-08-01

Crack cocaine dependence has become a severe public health problem in Brazil, and current psychosocial approaches to this problem have shown little or no effectiveness. Although contingency management is among the most effective behavioral treatments for substance use disorders, it has never been applied in the treatment of crack cocaine-dependent individuals in Brazil. The aim of this study was to evaluate the efficacy of incorporating contingency management into standard outpatient treatment for crack cocaine dependence, as well as the impact that doing so has on treatment attendance, retention in treatment, maintenance of abstinence, and the frequency of substance use. We evaluated 65 treatment-seeking, crack cocaine-dependent individuals, randomized to receive 12 weeks of standard treatment plus contingency management (STCM; n = 33) or 12 weeks of standard treatment alone (STA; n = 32). Those in the STCM group received monetary incentives for being abstinent, earning up to US$235.50 if they remained abstinent throughout the entire treatment period. The STCM group participants attended a mean of 19.5 (SD = 14.9) treatment sessions, compared with 3.7 (SD = 5.9) for the STA group participants (p retained in treatment at weeks 4, 8, and 12 than were those in the STA group. The likelihood of detecting 4, 8, and 12 weeks of continuous abstinence was 17.7, 9.9, and 18.6 times higher in the STCM group than in the STA group (p < .05). Compared to the STA group, the STCM group submitted a significantly higher proportion of negative samples for crack cocaine, delta-9-tetrahydrocannabinol, and alcohol (p < .001) when all expected samples were included in the denominator but not when only submitted samples were considered. The average monthly cost/participant for incentives was $29.00. Contingency management showed efficacy in a sample of Brazilian crack cocaine users. The intervention holds promise for broader application in international settings. (PsycINFO Database

Improving Adherence to Smoking Cessation Treatment: Smoking Outcomes in a Web-based Randomized Trial.

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Graham, Amanda L; Papandonatos, George D; Cha, Sarah; Erar, Bahar; Amato, Michael S

2018-03-15

Partial adherence in Internet smoking cessation interventions presents treatment and evaluation challenges. Increasing adherence may improve outcomes. To present smoking outcomes from an Internet randomized trial of two strategies to encourage adherence to tobacco dependence treatment components: (i) a social network (SN) strategy to integrate smokers into an online community and (ii) free nicotine replacement therapy (NRT). In addition to intent-to-treat analyses, we used novel statistical methods to distinguish the impact of treatment assignment from treatment utilization. A total of 5,290 current smokers on a cessation website (WEB) were randomized to WEB, WEB + SN, WEB + NRT, or WEB + SN + NRT. The main outcome was 30-day point prevalence abstinence at 3 and 9 months post-randomization. Adherence measures included self-reported medication use (meds), and website metrics of skills training (sk) and community use (comm). Inverse Probability of Retention Weighting and Inverse Probability of Treatment Weighting jointly addressed dropout and treatment selection. Propensity weights were used to calculate Average Treatment effects on the Treated. Treatment assignment analyses showed no effects on abstinence for either adherence strategy. Abstinence rates were 25.7%-32.2% among participants that used all three treatment components (sk+comm +meds).Treatment utilization analyses revealed that among such participants, sk+comm+meds yielded large percentage point increases in 3-month abstinence rates over sk alone across arms: WEB = 20.6 (95% CI = 10.8, 30.4), WEB + SN = 19.2 (95% CI = 11.1, 27.3), WEB + NRT = 13.1 (95% CI = 4.1, 22.0), and WEB + SN + NRT = 20.0 (95% CI = 12.2, 27.7). Novel propensity weighting approaches can serve as a model for establishing efficacy of Internet interventions and yield important insights about mechanisms. NCT01544153.

Intra-individual changes in Stroop-related activations linked to cigarette abstinence in adolescent tobacco smokers: Preliminary findings.

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Yip, Sarah W; Balodis, Iris M; Carroll, Kathleen M; Krishnan-Sarin, Suchitra; Potenza, Marc N

2016-10-01

Adolescence is a crucial time for initiation of tobacco-smoking. Developing more effective treatment interventions for tobacco-smoking in youth is therefore critical to reduce smoking rates in both adolescent and adult populations. Elucidation of the neural mechanisms of successful behavioral change (abstinence) will allow for improvement of therapies based on known brain mechanisms. Twenty-one adolescent tobacco-smokers (14-19 years) participated in functional magnetic resonance imaging (fMRI) during performance of a cognitive control (Stroop) task prior to randomization to smoking cessation treatment (trial of combined nicotine replacement therapy/placebo and contingency management for attendance/abstinence; NCT01145001). Fourteen adolescents also participated in fMRI scanning following completion of the six-week trial. fMRI data were analyzed using random-effects models in SPM12. Paired t-tests were used to identify group-level changes (main effect of treatment exposure) in neural functional responses. Regression models were used to identify individual-level changes associated with treatment-outcomes (percent days abstinent, maximum days of consecutive abstinence). Main effects of Stroop task performance (contrast of incongruent versus congruent trials) were seen across a priori ROIs at both pre- and post-treatment (pFWEoptimal treatment responses in this population. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The effect of financial incentives on top of behavioral support on quit rates in tobacco smoking employees: study protocol of a cluster-randomized trial.

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van den Brand, F A; Nagelhout, G E; Winkens, B; Evers, S M A A; Kotz, D; Chavannes, N H; van Schayck, C P

2016-10-06

Stimulating successful tobacco cessation among employees has multiple benefits. Employees who quit tobacco are healthier, more productive, less absent from work, and longer employable than employees who continue to use tobacco. Despite the evidence for these benefits of tobacco cessation, a successful method to stimulate employees to quit tobacco is lacking. The aim of this study is to evaluate whether adding a financial incentive to behavioral support (compared with no additional incentive) is effective and cost-effective in increasing abstinence rates in tobacco smoking employees participating in a smoking cessation group training. In this cluster-randomized trial employees in the intervention and control group both participate in a smoking cessation group training consisting of seven weekly counseling sessions of ninety minutes each. In addition to the training, employees in the intervention group receive a voucher as an incentive for being abstinent from smoking at the end of the training (€50), after three months (€50), after six months (€50), and after one year (€200). The control group does not receive any incentive. The primary outcome is carbon monoxide validated 12-month continuous abstinence from smoking (Russel's standard). Additionally, an economic evaluation is performed from a societal and an employer perspective. The present paper describes the methods and design of this cluster-randomized trial in detail. We hypothesize that the financial incentive for abstinence in the form of vouchers increases abstinence rates over and above the group training. The results of this study can provide important recommendations for enhancement of employee tobacco cessation. Dutch Trial Register: NTR5657 . First received 27-01-2016.

Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial.

Directory of Open Access Journals (Sweden)

Arthur V Peterson

Full Text Available The Hutchinson Study of High School Smoking was the first randomized trial to show effectiveness of a smoking cessation intervention on 6-months prolonged smoking abstinence at one year post-intervention in a large population-based sample of adolescent smokers. An important question remains: Do the positive effects from teen smoking cessation interventions seen at up to 12 months post-intervention endure into young adulthood? This study examines for the first time whether such positive early effects from teen smoking cessation intervention can endure into young adulthood in the absence of additional intervention.High school smokers (n = 2,151 were proactively recruited into the trial from fifty randomly selected Washington State high schools randomized to the experimental (Motivational Interviewing + Cognitive Behavioral Skills Training telephone counseling intervention or control (no intervention condition. These smokers were followed to 7 years post high school to ascertain rates of six-year prolonged smoking abstinence in young adulthood. All statistical tests are two-sided.No evidence of intervention impact at seven years post high school was observed for the main endpoint of six-year prolonged abstinence, neither among all smokers (14.2% in the experimental condition vs. 13.1% in the control condition, difference = +1.1%, 95% confidence interval (CI = -3.4 to 5.8, p = .61, nor among the subgroups of daily smokers and less-than-daily smokers, nor among other a priori subgroups. But, observed among males was some evidence of an intervention impact on two endpoints related to progress towards quitting: reduction in number of days smoked in the past month, and increase in the length of the longest quit attempt in the past year.There was no evidence from this trial among adolescent smokers that positive effectiveness of the proactive telephone intervention for smoking abstinence, observed previously at one year post-intervention, was sustained

Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial.

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Peterson, Arthur V; Marek, Patrick M; Kealey, Kathleen A; Bricker, Jonathan B; Ludman, Evette J; Heffner, Jaimee L

2016-01-01

The Hutchinson Study of High School Smoking was the first randomized trial to show effectiveness of a smoking cessation intervention on 6-months prolonged smoking abstinence at one year post-intervention in a large population-based sample of adolescent smokers. An important question remains: Do the positive effects from teen smoking cessation interventions seen at up to 12 months post-intervention endure into young adulthood? This study examines for the first time whether such positive early effects from teen smoking cessation intervention can endure into young adulthood in the absence of additional intervention. High school smokers (n = 2,151) were proactively recruited into the trial from fifty randomly selected Washington State high schools randomized to the experimental (Motivational Interviewing + Cognitive Behavioral Skills Training telephone counseling intervention) or control (no intervention) condition. These smokers were followed to 7 years post high school to ascertain rates of six-year prolonged smoking abstinence in young adulthood. All statistical tests are two-sided. No evidence of intervention impact at seven years post high school was observed for the main endpoint of six-year prolonged abstinence, neither among all smokers (14.2% in the experimental condition vs. 13.1% in the control condition, difference = +1.1%, 95% confidence interval (CI) = -3.4 to 5.8, p = .61), nor among the subgroups of daily smokers and less-than-daily smokers, nor among other a priori subgroups. But, observed among males was some evidence of an intervention impact on two endpoints related to progress towards quitting: reduction in number of days smoked in the past month, and increase in the length of the longest quit attempt in the past year. There was no evidence from this trial among adolescent smokers that positive effectiveness of the proactive telephone intervention for smoking abstinence, observed previously at one year post-intervention, was sustained for the long

Comorbidity effects on cocaine dependence treatment and examination of reciprocal relationships between abstinence and depression.

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Milby, Jesse B; Conti, Kimberly; Wallace, Dennis; Mennemeyer, Stephen; Mrug, Sylvie; Schumacher, Joseph E

2015-02-01

We examined comorbid disorders' prevalence, their impact on abstinence, and the impact of depressive symptoms on abstinence and of abstinence on depressive symptoms. A randomized controlled trial's data on outcomes from treating cocaine dependence were used. It compared abstinence-contingent housing and work to contingency management plus behavioral day treatment. Regardless of original trial arm assignment, groups of participants with no additional Axis I disorders (n = 87) and 1 or more additional Axis I disorders (n = 113) were compared for abstinence. Changes in depression symptoms, measured by the Beck Depression Inventory, were analyzed as a function of 4 cohorts of increased consecutive weeks abstinent. An autoregressive cross-lagged path model examined reciprocal relationships between depression and abstinence. Most prevalent additional disorders were depressive disorders, followed by anxiety disorders. Additional disorders did not significantly affect abstinence. Cohorts with more abstinence were linearly related to lower depression symptoms. The cross-lagged model showed that longer abstinence predicted decreases in depressive symptoms at 6 months. However, depressive symptoms did not predict changes in abstinence. Our study adds to others that have found an effective treatment targeted at specific problems such as substance abuse, social anxiety disorder, and posttraumatic stress disorder that may have the side benefit of reducing depression. Additionally, we find that depression does not interfere with effective substance abuse treatment for cocaine dependency. This may be the 1st formal analysis comparing the ability of cocaine abstinence to predict future depressive symptoms versus depressive symptoms to predict future cocaine abstinence. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

Randomized trial of a smartphone mobile application compared to text messaging to support smoking cessation.

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Buller, David B; Borland, Ron; Bettinghaus, Erwin P; Shane, James H; Zimmerman, Donald E

2014-03-01

Text messaging has successfully supported smoking cessation. This study compares a mobile application with text messaging to support smoking cessation. Young adult smokers 18-30 years old (n = 102) participated in a randomized pretest-posttest trial. Smokers received a smartphone application (REQ-Mobile) with short messages and interactive tools or a text messaging system (onQ), managed by an expert system. Self-reported usability of REQ-Mobile and quitting behavior (quit attempts, point-prevalence, 30-day point-prevalence, and continued abstinence) were assessed in posttests. Overall, 60% of smokers used mobile services (REQ-Mobile, 61%, mean of 128.5 messages received; onQ, 59%, mean of 107.8 messages), and 75% evaluated REQ-Mobile as user-friendly. A majority of smokers reported being abstinent at posttest (6 weeks, 53% of completers; 12 weeks, 66% of completers [44% of all cases]). Also, 37% (25%of all cases) reported 30-day point-prevalence abstinence, and 32% (22% of all cases) reported continuous abstinence at 12 weeks. OnQ produced more abstinence (ptext messaging. Text messaging may work better because it is simple, well known, and delivered to a primary inbox. These advantages may disappear as smokers become more experienced with new handsets. Mobile phones may be promising delivery platforms for cessation services using either smartphone applications or text messaging.

Effectiveness of a mood management component as an adjunct to a telephone counselling smoking cessation intervention for smokers with a past major depression: a pragmatic randomized controlled trial

NARCIS (Netherlands)

van der Meer, Regina M.; Willemsen, Marc C.; Smit, Filip; Cuijpers, Pim; Schippers, Gerard M.

2010-01-01

Aims To assess whether the addition of a mood management component to telephone counselling produces higher abstinence rates in smokers with past major depression and helps to prevent recurrence of depressive symptoms. Design Pragmatic randomized controlled trial with two conditions, with follow-up

Effectiveness of a mood management component as an adjunct to a telephone counselling smoking cessation intervention for smokers with a past major depression: A pragmatic randomized controlled trial

NARCIS (Netherlands)

van der Meer, R.; Willemsen, M.C.; Smit, H.F.E.; Cuijpers, P.; Schippers, G.M.

2010-01-01

Aims To assess whether the addition of a mood management component to telephone counselling produces higher abstinence rates in smokers with past major depression and helps to prevent recurrence of depressive symptoms. Design Pragmatic randomized controlled trial with two conditions, with follow-up

Impact of attention-deficit/hyperactivity disorder (ADHD) treatment on smoking cessation intervention in ADHD smokers: a randomized, double-blind, placebo-controlled trial.

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Winhusen, Theresa M; Somoza, Eugene C; Brigham, Gregory S; Liu, David S; Green, Carla A; Covey, Lirio S; Croghan, Ivana T; Adler, Lenard A; Weiss, Roger D; Leimberger, Jeffrey D; Lewis, Daniel F; Dorer, Emily M

2010-12-01

High smoking rates in adults with attention-deficit/hyperactivity disorder (ADHD) and nicotine's amelioration of ADHD suggest that effective ADHD treatment might facilitate abstinence in smokers with ADHD. The present study evaluated if using osmotic-release oral system methylphenidate (OROS-MPH) to treat ADHD enhances response to smoking cessation treatment in smokers with ADHD. A randomized, double-blind, placebo-controlled, 11-week trial with a 1-month follow-up was conducted at 6 clinical sites between December 2005 and January 2008. Adults (aged 18-55 years) meeting DSM-IV criteria for ADHD and interested in quitting smoking were randomly assigned to OROS-MPH titrated to 72 mg/d (n = 127) or placebo (n = 128). All participants received brief weekly individual smoking cessation counseling for 11 weeks and 21 mg/d nicotine patches starting on the smoking quit day (day 27) through study week 11. Outcome measures included prolonged smoking abstinence and DSM-IV ADHD Rating Scale (ADHD-RS) score. Of 255 randomly assigned participants, 204 (80%) completed the trial. Prolonged abstinence rates, 43.3% and 42.2%, for the OROS-MPH and placebo groups, respectively, did not differ significantly (OR = 1.1; 95% CI, 0.63-1.79; P = .81). Relative to placebo, OROS-MPH evidenced a greater reduction in DSM-IV ADHD-RS score (P ADHD did not improve smoking cessation success; OROS-MPH, relative to placebo, effectively treated ADHD and was safe and generally well tolerated in this healthy sample of adult ADHD smokers. clinical trials.gov Identifier: NCT00253747. © Copyright 2010 Physicians Postgraduate Press, Inc.

Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit).

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Naughton, Felix; Cooper, Sue; Foster, Katharine; Emery, Joanne; Leonardi-Bee, Jo; Sutton, Stephen; Jones, Matthew; Ussher, Michael; Whitemore, Rachel; Leighton, Matthew; Montgomery, Alan; Parrott, Steve; Coleman, Tim

2017-07-01

To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service (SMS) text message and key parameters needed to plan a definitive trial. Multi-centre, parallel-group, single-blinded, individual randomized controlled trial. Sixteen antenatal clinics in England. Four hundred and seven participants were randomized to the intervention (n = 203) or usual care (n = 204). Eligible women were 5 pre-pregnancy), were able to receive and understand English SMS texts and were not already using text-based cessation support. All participants received a smoking cessation leaflet; intervention participants also received a 12-week programme of individually tailored, automated, interactive, self-help smoking cessation text messages (MiQuit). Seven smoking outcomes, including validated continuous abstinence from 4 weeks post-randomization until 36 weeks gestation, design parameters for a future trial and cost-per-quitter. Using the validated, continuous abstinence outcome, 5.4% (11 of 203) of MiQuit participants were abstinent versus 2.0% (four of 204) of usual care participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 0.93-9.35]. The Bayes factor for this outcome was 2.23. Completeness of follow-up at 36 weeks gestation was similar in both groups; provision of self-report smoking data was 64% (MiQuit) and 65% (usual care) and abstinence validation rates were 56% (MiQuit) and 61% (usual care). The incremental cost-per-quitter was £133.53 (95% CI = -£395.78 to 843.62). There was some evidence, although not conclusive, that a text-messaging programme may increase cessation rates in pregnant smokers when provided alongside routine NHS cessation care. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention.

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Brendryen, Håvar; Kraft, Pål

2008-03-01

To assess the long-term efficacy of a fully automated digital multi-media smoking cessation intervention. Two-arm randomized control trial (RCT). Setting World Wide Web (WWW) study based in Norway. Subjects (n = 396) were recruited via internet advertisements and assigned randomly to conditions. Inclusion criteria were willingness to quit smoking and being aged 18 years or older. The treatment group received the internet- and cell-phone-based Happy Ending intervention. The intervention programme lasted 54 weeks and consisted of more than 400 contacts by e-mail, web-pages, interactive voice response (IVR) and short message service (SMS) technology. The control group received a self-help booklet. Additionally, both groups were offered free nicotine replacement therapy (NRT). Abstinence was defined as 'not even a puff of smoke, for the last 7 days', and assessed by means of internet surveys or telephone interviews. The main outcome was repeated point abstinence at 1, 3, 6 and 12 months following cessation. Participants in the treatment group reported clinically and statistically significantly higher repeated point abstinence rates than control participants [22.3% versus 13.1%; odds ratio (OR) = 1.91, 95% confidence interval (CI): 1.12-3.26, P = 0.02; intent-to-treat). Improved adherence to NRT and a higher level of post-cessation self-efficacy were observed in the treatment group compared with the control group. As the first RCT documenting the long-term treatment effects of such an intervention, this study adds to the promise of digital media in supporting behaviour change.

Effectiveness of proactive telephone counselling for smoking cessation in parents: Study protocol of a randomized controlled trial

Directory of Open Access Journals (Sweden)

Bricker Jonathan B

2011-09-01

Full Text Available Abstract Background Smoking is the world's fourth most common risk factor for disease, the leading preventable cause of death, and it is associated with tremendous social costs. In the Netherlands, the smoking prevalence rate is high. A total of 27.7% of the population over age 15 years smokes. In addition to the direct advantages of smoking cessation for the smoker, parents who quit smoking may also decrease their children's risk of smoking initiation. Methods/Design A randomized controlled trial will be conducted to evaluate the effectiveness of proactive telephone counselling to increase smoking cessation rates among smoking parents. A total of 512 smoking parents will be proactively recruited through their children's primary schools and randomly assigned to either proactive telephone counselling or a control condition. Proactive telephone counselling will consist of up to seven counsellor-initiated telephone calls (based on cognitive-behavioural skill building and Motivational Interviewing, distributed over a period of three months. Three supplementary brochures will also be provided. In the control condition, parents will receive a standard brochure to aid smoking cessation. Assessments will take place at baseline, three months after start of the intervention (post-measurement, and twelve months after start of the intervention (follow-up measurement. Primary outcome measures will include sustained abstinence between post-measurement and follow-up measurement and 7-day point prevalence abstinence and 24-hours point prevalence abstinence at both post- and follow-up measurement. Several secondary outcome measures will also be included (e.g., smoking intensity, smoking policies at home. In addition, we will evaluate smoking-related cognitions (e.g., attitudes towards smoking, social norms, self-efficacy, intention to smoke in 9-12 year old children of smoking parents. Discussion This study protocol describes the design of a randomized

A Randomized Clinical Trial of a Therapeutic Workplace for Chronically Unemployed, Homeless, Alcohol-Dependent Adults

OpenAIRE

Koffarnus, Mikhail N.; Wong, Conrad J.; Diemer, Karly; Needham, Mick; Hampton, Jacqueline; Fingerhood, Michael; Svikis, Dace S.; Bigelow, George E.; Silverman, Kenneth

2011-01-01

Aims: To assess the efficacy of the Therapeutic Workplace, a substance abuse intervention that promotes abstinence while simultaneously addressing the issues of poverty and lack of job skills, in promoting abstinence from alcohol among homeless alcoholics. Methods: Participants (n = 124) were randomly assigned to conditions either requiring abstinence from alcohol to engage in paid job skills training (Contingent Paid Training group), offering paid job skills training with no abstinence conti...

Population-level effects of automated smoking cessation help programs: a randomized controlled trial.

Science.gov (United States)

Borland, Ron; Balmford, James; Benda, Peter

2013-03-01

To test the population impact of offering automated smoking cessation interventions via the internet and/or by mobile phone. Pragmatic randomized controlled trial with five conditions: offer of (i) minimal intervention control; (ii) QuitCoach personalized tailored internet-delivered advice program; (iii) onQ, an interactive automated text-messaging program; (iv) an integration of both QuitCoach and onQ; and (v) a choice of either alone or the combined program. Australia, via a mix of internet and telephone contacts. A total of 3530 smokers or recent quitters recruited from those interested in quitting, and seeking self-help resources (n = 1335) or cold-contacted from internet panels (n = 2195). The primary outcome was self-report of 6 months sustained abstinence at 7 months post-recruitment. Only 42.5% of those offered one of the interventions took it up to a minimal level. The intervention groups combined had a non-significantly higher 6-month sustained abstinence rate than the control [odds ratio (OR) = 1.48; 95% confidence interval (CI): 0.98-2.24] (missing cases treated as smokers), with no differences between the interventions. Among those who used an intervention, there was a significant overall increase in abstinence (OR = 1.95; CI: 1.04-3.67), but not clearly so when analysing only cases with reported outcomes. Success rates were greater among those recruited after seeking information compared to those cold-contacted. Smokers interested in quitting who were assigned randomly to an offer of either the QuitCoach internet-based support program and/or the interactive automated text-messaging program had non-significantly greater odds of quitting for at least 6 months than those randomized to an offer of a simple information website. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.

Comparison of two approaches in achieving smoking abstinence among patients in an outpatient clinic: a phase 2 randomized controlled trial

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Ka Yan Ho

2018-03-01

Full Text Available Background Having a disease and requiring medical attention present an excellent 'teachable moment' for smoking cessation interventions. However, nicotine is addictive and quitting is difficult, with a high rate of relapse, particularly among chronic smokers. Our previous smoking cessation projects in the community have revealed that many smokers who are reluctant to quit are interested in reducing the number of cigarettes they smoke per day. Therefore, smoking reduction may be an important alternative strategy for promoting smoking cessation. This Phase 2 randomized controlled trial of smokers who had medical follow-ups in an outpatient clinic compared the effectiveness of two approaches to smoking cessation: quitting immediately and cutting down to quit. Methods A total of 100 subjects were randomized into two groups, 50 in the quit immediately group, who received an intervention on abruptly quitting, and 50 in the cut down to quit group, who received an intervention on gradual reduction. All subjects were followed up at 6 and 12 months via telephone, and their smoking status was assessed. The primary outcomes were self-reported 7-day point prevalence of abstinence at 6 and 12 months. Intention-to-treat analysis was employed. Results On average, subjects had smoked 11.31 cigarettes per day over 37 years and 96% had mild nicotine dependence. At the 6-month follow-up, the self-reported quit rate of subjects in the quit immediately group was significantly higher than in the cut down to quit group (18.0% vs. 4.0%, p = 0.04. However, this difference was not significant at the 12-month follow-up (12.0% vs. 4.0%, p = 0.16. Conclusions These data suggest that quitting immediately might be more effective than cutting down to quit in smokers who need to quit sooner, such as those with diseases requiring medical attention. Nevertheless, the effectiveness of the cut down to quit approach requires further testing.

Preventing smoking relapse via Web-based computer-tailored feedback: a randomized controlled trial.

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Elfeddali, Iman; Bolman, Catherine; Candel, Math J J M; Wiers, Reinout W; de Vries, Hein

2012-08-20

Web-based computer-tailored approaches have the potential to be successful in supporting smoking cessation. However, the potential effects of such approaches for relapse prevention and the value of incorporating action planning strategies to effectively prevent smoking relapse have not been fully explored. The Stay Quit for You (SQ4U) study compared two Web-based computer-tailored smoking relapse prevention programs with different types of planning strategies versus a control group. To assess the efficacy of two Web-based computer-tailored programs in preventing smoking relapse compared with a control group. The action planning (AP) program provided tailored feedback at baseline and invited respondents to do 6 preparatory and coping planning assignments (the first 3 assignments prior to quit date and the final 3 assignments after quit date). The action planning plus (AP+) program was an extended version of the AP program that also provided tailored feedback at 11 time points after the quit attempt. Respondents in the control group only filled out questionnaires. The study also assessed possible dose-response relationships between abstinence and adherence to the programs. The study was a randomized controlled trial with three conditions: the control group, the AP program, and the AP+ program. Respondents were daily smokers (N = 2031), aged 18 to 65 years, who were motivated and willing to quit smoking within 1 month. The primary outcome was self-reported continued abstinence 12 months after baseline. Logistic regression analyses were conducted using three samples: (1) all respondents as randomly assigned, (2) a modified sample that excluded respondents who did not make a quit attempt in conformance with the program protocol, and (3) a minimum dose sample that also excluded respondents who did not adhere to at least one of the intervention elements. Observed case analyses and conservative analyses were conducted. In the observed case analysis of the randomized sample

An individually-tailored smoking cessation intervention for rural Veterans: a pilot randomized trial

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Mark W. Vander Weg

2016-08-01

Full Text Available Abstract Background Tobacco use remains prevalent among Veterans of military service and those residing in rural areas. Smokers frequently experience tobacco-related issues including risky alcohol use, post-cessation weight gain, and depressive symptoms that may adversely impact their likelihood of quitting and maintaining abstinence. Telephone-based interventions that simultaneously address these issues may help to increase treatment access and improve outcomes. Methods This study was a two-group randomized controlled pilot trial. Participants were randomly assigned to an individually-tailored telephone tobacco intervention combining counseling for tobacco use and related issues including depressive symptoms, risky alcohol use, and weight concerns or to treatment provided through their state tobacco quitline. Selection of pharmacotherapy was based on medical history and a shared decision interview in both groups. Participants included 63 rural Veteran smokers (mean age = 56.8 years; 87 % male; mean number of cigarettes/day = 24.7. The primary outcome was self-reported 7-day point prevalence abstinence at 12 weeks and 6 months. Results Twelve-week quit rates based on an intention-to-treat analysis did not differ significantly by group (Tailored = 39 %; Quitline Referral = 25 %; odds ratio [OR]; 95 % confidence interval [CI] = 1.90; 0.56, 5.57. Six-month quit rates for the Tailored and Quitline Referral conditions were 29 and 28 %, respectively (OR; 95 % CI = 1.05; 0.35, 3.12. Satisfaction with the Tailored tobacco intervention was high. Conclusions Telephone-based treatment that concomitantly addresses other health-related factors that may adversely affect quitting appears to be a promising strategy. Larger studies are needed to determine whether this approach improves cessation outcomes. Trial registration ClinicalTrials.gov identifier number NCT01592695 registered 11 April 2012.

Family-Based Smoking Cessation Intervention for Smoking Fathers and Nonsmoking Mothers with a Child: A Randomized Controlled Trial.

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Chan, Sophia Siu Chee; Cheung, Yee Tak Derek; Fong, Daniel Yee Tak; Emmons, Karen; Leung, Angela Yee Man; Leung, Doris Yin Ping; Lam, Tai Hing

2017-03-01

To examine whether a family-based intervention targeting both smoking fathers and nonsmoking mothers in well-child health clinics is effective in increasing fathers' abstinence from cigarette smoking. This parallel 2-arm randomized controlled trial recruited a total of 1158 families with a daily-smoking father, a nonsmoking mother, and a child aged 0-18 months from the 22 maternal and child health centers in Hong Kong. The intervention group received the family-based intervention, including 6 nurse-led individual face-to-face and telephone counseling sessions within 1 month after recruitment and a voluntary face-to-face family counseling session (FCS). The control group received a leaflet, a self-help booklet, and brief quitting advice only. Father-reported 7-day and 6-month abstinence, smoking reduction, quit attempts, mother-reported help and support, and child salivary cotinine level were assessed at 12 months. Generalized estimating equation models were used to compare these outcomes between the 2 study groups. Compared with the control group, the intervention group reported a greater prevalence of 7-day (13.7% vs 8.0%; OR, 1.92; 95% CI, 1.16-3.17; P fathers' self-reported abstinence (20.2% vs 12.3%; P = .02), mothers' help (66.1% vs 43.8%; P fathers (55.0% vs 45.4%; P family-based smoking cessation intervention for the families in the well-child healthcare setting was effective in increasing the fathers' self-reported abstinence. Additional participation in the FCS increased mothers' help and support to the fathers. Controlled-trials.com: ISRCTN99111655; Hkuctr.com: HKUCTR-465. Copyright © 2016 Elsevier Inc. All rights reserved.

Smoking topography and abstinence in adult female smokers.

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McClure, Erin A; Saladin, Michael E; Baker, Nathaniel L; Carpenter, Matthew J; Gray, Kevin M

2013-12-01

Preliminary evidence, within both adults and adolescents, suggests that the intensity with which cigarettes are smoked (i.e., smoking topography) is predictive of success during a cessation attempt. These reports have also shown topography to be superior compared to other variables, such as cigarettes per day, in the prediction of abstinence. The possibility that gender may influence this predictive relationship has not been evaluated but may be clinically useful in tailoring gender-specific interventions. Within the context of a clinical trial for smoking cessation among women, adult daily smokers completed a laboratory session that included a 1-hour ad libitum smoking period in which measures of topography were collected (N=135). Participants were then randomized to active medication (nicotine patch vs. varenicline) and abstinence was monitored for 4weeks. Among all smoking topography measures and all abstinence outcomes, a moderate association was found between longer puff duration and greater puff volume and continued smoking during the active 4-week treatment phase, but only within the nicotine patch group. Based on the weak topography-abstinence relationship among female smokers found in the current study, future studies should focus on explicit gender comparisons to examine if these associations are specific to or more robust in male smokers. © 2013 Elsevier Ltd. All rights reserved.

Randomized Clinical Trial of Family-Based Treatment and Cognitive-Behavioral Therapy for Adolescent Bulimia Nervosa.

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Le Grange, Daniel; Lock, James; Agras, W Stewart; Bryson, Susan W; Jo, Booil

2015-11-01

There is a paucity of randomized clinical trials (RCTs) for adolescents with bulimia nervosa (BN). Prior studies suggest cognitive-behavioral therapy adapted for adolescents (CBT-A) and family-based treatment for adolescent bulimia nervosa (FBT-BN) could be effective for this patient population. The objective of this study was to compare the relative efficacy of these 2 specific therapies, FBT-BN and CBT-A. In addition, a smaller participant group was randomized to a nonspecific treatment (supportive psychotherapy [SPT]), whose data were to be used if there were no differences between FBT-BN and CBT-A at end of treatment. This 2-site (Chicago and Stanford) randomized controlled trial included 130 participants (aged 12-18 years) meeting DSM-IV criteria for BN or partial BN (binge eating and purging once or more per week for 6 months). Outcomes were assessed at baseline, end of treatment, and 6 and 12 months posttreatment. Treatments involved 18 outpatient sessions over 6 months. The primary outcome was defined as abstinence from binge eating and purging for 4 weeks before assessment, using the Eating Disorder Examination. Participants in FBT-BN achieved higher abstinence rates than in CBT-A at end of treatment (39% versus 20%; p = .040, number needed to treat [NNT] = 5) and at 6-month follow-up (44% versus 25%; p = .030, NNT = 5). Abstinence rates between these 2 groups did not differ statistically at 12-month follow-up (49% versus 32%; p = .130, NNT = 6). In this study, FBT-BN was more effective in promoting abstinence from binge eating and purging than CBT-A in adolescent BN at end of treatment and 6-month follow-up. By 12-month follow-up, there were no statistically significant differences between the 2 treatments. Study of Treatment for Adolescents With Bulimia Nervosa; http://clinicaltrials.gov/; NCT00879151. Copyright © 2015 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Dronabinol and lofexidine for cannabis use disorder: A randomized, double-blind, placebo-controlled trial.

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Levin, Frances R; Mariani, John J; Pavlicova, Martina; Brooks, Daniel; Glass, Andrew; Mahony, Amy; Nunes, Edward V; Bisaga, Adam; Dakwar, Elias; Carpenter, Kenneth M; Sullivan, Maria A; Choi, Jean C

2016-02-01

Cannabis use disorder is associated with substantial morbidity and, after alcohol, is the most common drug bringing adolescents and adults into treatment. At present, there are no FDA-approved medications for cannabis use disorder. Combined pharmacologic interventions might be particularly useful in mitigating withdrawal symptoms and promoting abstinence. The purpose of this study was to evaluate the safety and efficacy of dronabinol, a synthetic form of delta-9-tetrahydrocannabinol, a naturally occurring pharmacologically active component of marijuana, and lofexidine, an alpha-2 agonist, in treating cannabis dependence. One hundred fifty six cannabis-dependent adults were enrolled and following a 1-week placebo lead-in phase 122 were randomized in a double-blind, placebo-controlled, 11-week trial. Participants were randomized to receive dronabinol 20mg three times a day and lofexidine 0.6 mg three times a day or placebo. Medications were maintained until the end of week eight, were then tapered over two weeks and patients were monitored off medications during the last study week. All participants received weekly motivational enhancement and relapse prevention therapy. Marijuana use was assessed using the timeline follow-back method. There was no significant difference between treatment groups in the proportion of participants who achieved 3 weeks of abstinence during the maintenance phase of the trial (27.9% for the medication group and 29.5% for the placebo group), although both groups showed a reduction over time. Based on this treatment study, the combined intervention did not show promise as a treatment for cannabis use disorder. Published by Elsevier Ireland Ltd.

Effect of short-term heart rate variability biofeedback on long-term abstinence in alcohol dependent patients - a one-year follow-up.

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Penzlin, Ana Isabel; Barlinn, Kristian; Illigens, Ben Min-Woo; Weidner, Kerstin; Siepmann, Martin; Siepmann, Timo

2017-09-06

A randomized controlled study (RCT) recently showed that short-term heart rate variability (HRV) biofeedback in addition to standard rehabilitation care for alcohol dependence can reduce craving, anxiety and improve cardiovascular autonomic function. In this one-year follow-up study we aimed to explore whether completion of 2-week HRV-Biofeedback training is associated with long-term abstinence. Furthermore, we sought to identify potential predictors of post-treatment abstinence. We conducted a survey on abstinence in patients with alcohol dependence 1 year after completion of an RCT comparing HRV-biofeedback in addition to inpatient rehabilitation treatment alone (controls). Abstinence rates were compared and analysed for association with demographic data as well as psychometric and autonomic cardiac assessment before and after completion of the biofeedback training using bivariate and multivariate regression analyses. Out of 48 patients who participated in the RCT, 27 patients (9 females, ages 42.9 ± 8.6, mean ± SD) completed our one-year follow-up. When including in the analysis only patients who completed follow-up, the rate of abstinence tended to be higher in patients who underwent HRV-biofeedback 1 year earlier compared to those who received rehabilitative treatment alone (66.7% vs 50%, p = ns). This non-significant trend was also observed in the intention-to-treat analysis where patients who did not participate in the follow-up were assumed to have relapsed (46,7% biofeedback vs. 33.3% controls, p = ns). Neither cardiac autonomic function nor psychometric variables were associated with abstinence 1 year after HRV-biofeedback. Our follow-up study provide a first indication of possible increase in long-term abstinence after HRV-biofeedback for alcohol dependence in addition to rehabilitation. The original randomized controlled trial was registered in the German Clinical Trials Register ( DRKS00004618 ). This one-year follow-up survey has not been

A Randomized Double-blind, Placebo Controlled Trial of Venlafaxine-Extended Release for Co-occurring Cannabis Dependence and Depressive Disorders

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Levin, Frances R.; Mariani, John; Brooks, Daniel J.; Pavlicova, Martina; Nunes, Edward V.; Agosti, Vito; Bisaga, Adam; Sullivan, Maria A.; Carpenter, Kenneth M.

2013-01-01

Aim To evaluate whether venlafaxine-extended release (VEN-XR) is an effective treatment for cannabis dependence with concurrent depressive disorders. Design This was a randomized, 12 week, double-blind, placebo-controlled trial of outpatients (n = 103) with DSM-IV cannabis dependence and major depressive disorder or dysthymia. Participants received up to 375 mg VEN-XR on a fixed-flexible schedule or placebo. All patients received weekly individual cognitive-behavioral psychotherapy that primarily targeted marijuana use. Settings The trial was conducted at two university research centers in the United States. Participants One hundred and three cannabis dependent adults participated in the trial. Measurements The primary outcome measures were 1) abstinence from marijuana defined as at least two consecutive urine-confirmed abstinent weeks and 2) improvement in depressive symptoms based on the Hamilton Depression Rating Scale. Findings The proportion of patients achieving a clinically significant mood improvement [50% decrease in Hamilton Depression score from baseline] was high and did not differ between groups receiving VEN-XR (63%) and placebo (69%) (X12=0.48, p-value= 0.49). The proportion of patients achieving abstinence was low overall, but was significantly worse on VEN-XR (11.8%) compared to placebo (36.5%) (X12=7.46, p-valuemarijuana use in the placebo group (F1,179=30.49, p-valuedepressed, cannabis-dependent patients, venlafaxine-extended release does not appear to be effective at reducing depression and may lead to an increase in cannabis use. PMID:23297841

Phenobarbital versus morphine in the management of neonatal abstinence syndrome, a randomized control trial.

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Nayeri, Fatemeh; Sheikh, Mahdi; Kalani, Majid; Niknafs, Pedram; Shariat, Mamak; Dalili, Hosein; Dehpour, Ahmad-Reza

2015-05-15

Evaluating the efficacy of the loading and tapering dose of Phenobarbital versus oral Morphine in the management of NAS. This randomized, open-label, controlled trial was conducted on 60 neonates born to illicit drugs dependent mothers at Vali-Asr and Akbar-Abadi hospitals, Tehran, Iran, who exhibited NAS requiring medical therapy. The neonates were randomized to receive either: Oral Morphine Sulfate or a loading dose of Phenobarbital followed by a tapering dose. The duration of treatment required for NAS resolution, the total hospital stay and the requirement for additional second line treatment were compared between the treatment groups. The Mean ± Standard Deviation for the duration of treatment required for the resolution of NAS was 8.5 ± 5 days in the Morphine group and 8.5 ± 4 days in the Phenobarbital group (P = 0.9). The duration of total hospital stay was 12.6 ± 5.6 days in the Morphine group and 12.5 ± 5.3 days in the Phenobarbital group (P = 0.7). 3.3 % in the Morphine group versus 6.6 % in the Phenobarbital group required adjunctive treatment (P = 0.5). There were no significant differences in the duration of treatment, duration of hospital stay, and the requirement for adjunctive treatment, between the neonates with NAS who received Morphine Sulfate and neonates who received a loading and tapering dose of Phenobarbital. This study is registered at the Iranian Registry of Clinical Trials ( www.irct.ir ) which is a Primary Registry in the WHO Registry Network. (Registration Number =  IRCT201406239568N8 ).

Did you get any help? A post-hoc secondary analysis of a randomized controlled trial of psychoeducation for patients with antisocial personality disorder in outpatient substance abuse treatment programs.

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Thylstrup, Birgitte; Schrøder, Sidsel; Fridell, Mats; Hesse, Morten

2017-01-09

People in treatment for substance use disorder commonly have comorbid personality disorders, including antisocial personality disorder. Little is known about treatments that specifically address comorbid antisocial personality disorder. Self-rated help received for antisocial personality disorder was assessed during follow-ups at 3, 9 and 15 months post-randomization of a randomized trial of psychoeducation for people with comorbid substance use and antisocial personality disorder (n = 175). Randomization to psychoeducation was associated with increased perceived help for antisocial personality disorder. Perceived help for antisocial personality disorder was in turn associated with more days abstinent and higher treatment satisfaction at the 3-month follow-up, and reduced risk of dropping out of treatment after the 3-month follow-up, and perceived help mediated the effects of random assignment on days abstinent at 3-month. Brief psychoeducation for antisocial personality disorder increased patients' self-rated help for antisocial personality disorder in substance abuse treatment, and reporting having received help for antisocial personality disorder was in turn associated with better short-term outcomes, e.g., days abstinent, dropout from treatment and treatment satisfaction. ISRCTN registry, ISRCTN67266318 , retrospectively registered 17/7/2012.

Long-term effectiveness of mailed nicotine replacement therapy: study protocol of a randomized controlled trial 5-year follow-up.

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Kushnir, Vladyslav; Selby, Peter; Zawertailo, Laurie; Tyndale, Rachel F; Leatherdale, Scott T; Cunningham, John A

2017-07-18

Our group recently completed a randomized controlled trial, evaluating the efficacy of providing 5 weeks of free nicotine replacement therapy (NRT; in the form of the nicotine patch) by expedited postal mail without behavioral assistance to regular adult smokers interested in receiving it. The findings revealed that mailed provision of nicotine patches resulted in more than a doubling of quit rates at a six-month follow-up compared to a no intervention control group. While this trial provided evidence for the effectiveness of mailed nicotine patches in promoting cessation, the findings speak only to the short term effectiveness of this approach. As relapse to smoking is known to occur beyond the 6 month period, it is important to evaluate whether the net benefit of NRT in naturalistic settings can be maintained long-term. The present study aims to perform a 5-year follow-up survey of participants in the original trial to evaluate the long-term effectiveness of mailed NRT. Trained interviewers will contact participants in the randomized controlled trial 5 years post-enrollment. A total of 924 participants will be eligible to be contacted. Interviewers will first assess participants' smoking status and their level of nicotine dependence. Participants reporting not currently smoking will be asked whether they have smoked tobacco, even a puff, in the last 30 days (primary outcome measure: 30-day point prevalence abstinence), past 6 months (secondary outcome measure: prolonged 6-month abstinence), and since the 8-week follow-up survey (secondary outcome measure: > 4 year continuous abstinence). Interviewers will be blind to experimental condition at the time the primary outcome measure will be assessed. It is hypothesized that participants who received nicotine patches at baseline will display significantly higher quit rates at the 5-year follow-up as compared to participants who did not receive nicotine patches at baseline. If the study finds that the mailed

Effects of sustained abstinence among treated substance-abusing homeless persons on housing and employment.

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Milby, Jesse B; Schumacher, Joseph E; Wallace, Dennis; Vuchinich, Rudy; Mennemeyer, Stephen T; Kertesz, Stefan G

2010-05-01

We examined whether cocaine-dependent homeless persons had stable housing and were employed 6, 12, and 18 months after they entered a randomized controlled trial comparing 2 treatments. One group (n = 103) received abstinence-contingent housing, vocational training, and work; another group (n = 103) received the same intervention plus cognitive behavioral day treatment. We examined baseline and early treatment variables for association with long-term housing and employment. Although the enhanced-treatment group achieved better abstinence rates, the groups did not differ in long-term housing and employment stability. However, consecutive weeks of abstinence during treatment (and to a lesser extent, older age and male gender) predicted long-term housing and employment stability after adjustment for baseline differences in employment, housing, and treatment. Our data showed a relationship of abstinence with housing stability. Contrasting these results with the increasingly popular Housing First interventions reveals important gaps in our knowledge to be addressed in future research.

Simultaneous vs. sequential treatment for smoking and weight management in tobacco quitlines: 6 and 12 month outcomes from a randomized trial.

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Bush, Terry; Lovejoy, Jennifer; Javitz, Harold; Torres, Alula Jimenez; Wassum, Ken; Tan, Marcia M; Spring, Bonnie

2018-05-31

Smoking cessation often results in weight gain which discourages many smokers from quitting and can increase health risks. Treatments to reduce cessation-related weight gain have been tested in highly controlled trials of in-person treatment, but have never been tested in a real-world setting, which has inhibited dissemination. The Best Quit Study (BQS) is a replication and "real world" translation using telephone delivery of a prior in-person efficacy trial. randomized control trial in a quitline setting. Eligible smokers (n = 2540) were randomized to the standard 5-call quitline intervention or quitline plus simultaneous or sequential weight management. Regression analyses tested effectiveness of treatments on self-reported smoking abstinence and weight change at 6 and 12 months. Study enrollees were from 10 commercial employer groups and three state quitlines. Participants were between ages 18-72, 65.8% female, 68.2% white; 23.0% Medicaid-insured, and 76.3% overweight/obese. The follow-up response rate was lower in the simultaneous group than the control group at 6 months (p = 0.01). While a completers analysis of 30-day point prevalence abstinence detected no differences among groups at 6 or 12 months, multiply imputed abstinence showed quit rate differences at 6 months for:simultaneous (40.3%) vs. sequential (48.3%), p = 0.034 and simultaneous vs. control (44.9%), p = 0.043. At 12 months, multiply imputed abstinence, was significantly lower for the simultaneous group (40.7%) vs. control (46.0%), p sequential (46.3%), p sequential group completed fewer total calls (3.75) vs. control (4.16) and vs. simultaneous group (3.83), p = 0.01, and fewer weight calls (0.94) than simultaneous (2.33), p Simultaneous (vs. sequential) delivery of phone/web weight management with cessation treatment in the quitline setting may adversely affect quit rate. Neither a simultaneous nor sequential approach to addressing weight produced any benefit on

A randomized double-blind, placebo-controlled trial of venlafaxine-extended release for co-occurring cannabis dependence and depressive disorders.

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Levin, Frances R; Mariani, John; Brooks, Daniel J; Pavlicova, Martina; Nunes, Edward V; Agosti, Vito; Bisaga, Adam; Sullivan, Maria A; Carpenter, Kenneth M

2013-06-01

To evaluate whether venlafaxine-extended release (VEN-XR) is an effective treatment for cannabis dependence with concurrent depressive disorders. This was a randomized, 12-week, double-blind, placebo-controlled trial of out-patients (n = 103) with DSM-IV cannabis dependence and major depressive disorder or dysthymia. Participants received up to 375 mg VEN-XR on a fixed-flexible schedule or placebo. All patients received weekly individual cognitive-behavioral psychotherapy that primarily targeted marijuana use. The trial was conducted at two university research centers in the United States. One hundred and three cannabis-dependent adults participated in the trial. The primary outcome measures were (i) abstinence from marijuana defined as at least two consecutive urine-confirmed abstinent weeks and (ii) improvement in depressive symptoms based on the Hamilton Depression Rating Scale. The proportion of patients achieving a clinically significant mood improvement (50% decrease in Hamilton Depression score from baseline) was high and did not differ between groups receiving VEN-XR (63%) and placebo (69%) (χ1 (2)  = 0.48, P = 0.49). The proportion of patients achieving abstinence was low overall, but was significantly worse on VEN-XR (11.8%) compared to placebo (36.5%) (χ1 (2)  = 7.46, P marijuana use in the placebo group (F1,179  = 30.49, P depressed, cannabis-dependent patients, venlafaxine-extended release does not appear to be effective at reducing depression and may lead to an increase in cannabis use. © 2013 Society for the Study of Addiction.

Smoking cessation and reduction in schizophrenia (SCARIS) with e-cigarette: study protocol for a randomized control trial.

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Caponnetto, Pasquale; Polosa, Riccardo; Auditore, Roberta; Minutolo, Giuseppe; Signorelli, Maria; Maglia, Marilena; Alamo, Angela; Palermo, Filippo; Aguglia, Eugenio

2014-03-22

It is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in schizophrenic smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population. We have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in schizophrenic smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product. A ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit ("reducers"). Abstinence from smoking will be calculated at each study visit ("quitters"). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of "reducers" and "quitters" will be defined "non responders". The differences of continuous variables between the three groups will be evaluated with the Kruskal-Wallis Test, followed by the Dunn multiple comparison test. The differences between the three groups for normally distributed data will be evaluated with ANOVA test one way, followed by the Newman-Keuls multiple comparison test. The normality of the distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations between the variables under evaluation will be assessed by Spearman r correlation. To compare qualitative data will be used the Chi-square test. The main strengths of the SCARIS study are the following: it's the first large RCT on schizophrenic patient, involving in and outpatient

Preventing Postpartum Smoking Relapse: A Randomized Clinical Trial.

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Levine, Michele D; Cheng, Yu; Marcus, Marsha D; Kalarchian, Melissa A; Emery, Rebecca L

2016-04-01

Most women who quit smoking during pregnancy will relapse postpartum. Previous efforts to prevent postpartum relapse have been unsuccessful at increasing rates of sustained abstinence. To evaluate the relative efficacy of 2 different approaches to prevent postpartum smoking relapse. Pregnant women who recently had quit smoking were recruited before the end of pregnancy. Intervention sessions were conducted through a combination of telephone calls and in-person visits beginning at delivery and continuing through 24 weeks postpartum. Participants completed assessments at the prenatal baseline and at 12, 24, and 52 weeks postpartum. Participants were recruited between March 2008 and December 2012. The dates of the analysis were April 2014 to February 2015. Women received postpartum-adapted, behavioral smoking relapse prevention intervention and were randomly assigned to an enhanced cognitive behavioral intervention that included additional specialized strategies and content focused on women's postpartum concerns about mood, stress, and weight (Strategies to Avoid Returning to Smoking [STARTS]) or a supportive, time and attention-controlled comparison (SUPPORT). Intervention began before delivery and continued through 24 weeks postpartum. The primary outcome was biochemically confirmed sustained tobacco abstinence at 52 weeks postpartum. Secondary outcomes were self-reported mood, levels of perceived stress, and degree of concern about smoking-related weight gain. The study cohort comprised 300 participants (150 randomly assigned to each group). Their mean (SD) age was 24.99 (5.65) years. Overall, 38.0% (114 of 300), 33.7% (101 of 300), and 24.0% (72 of 300) of the sample maintained abstinence at 12, 24, and 52 weeks' postpartum, respectively. There were no differences between the intervention groups in abstinence or time to relapse. Self-reported depressive symptoms and perceived stress significantly improved over time, and improvements were similar for both

Hypnosis for Smoking Relapse Prevention: A Randomized Trial.

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Carmody, Timothy P; Duncan, Carol L; Solkowitz, Sharon N; Huggins, Joy; Simon, Joel A

2017-10-01

The purpose of this study was to determine whether hypnosis would be more effective than standard behavioral counseling in helping smokers to remain abstinent. A total of 140 current smokers were enrolled in a randomized controlled smoking cessation trial at an urban Veterans Affairs medical center. Participants (n = 102) who were able to quit for at least 3 days received either a hypnosis or behavioral relapse prevention intervention. Both relapse prevention interventions consisted of two 60 min face-to-face sessions and four 20 min follow-up phone calls (two phone calls per week). At 26 weeks, the validate\\d point-prevalence quit rate was 35% for the hypnosis group and 42% for the behavioral counseling group (relative risk = 0.85; 95% confidence interval: 0.52-1.40). At 52 weeks, the validated quit rate was 29% for the hypnosis group and 28% for the behavioral group (relative risk  = 1.03; 95% confidence interval: 0.56-1.91). It was concluded that hypnosis warrants further investigation as an intervention for facilitating maintenance of quitting.

The importance of supporting autonomy and perceived competence in facilitating long-term tobacco abstinence.

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Williams, Geoffrey C; Niemiec, Christopher P; Patrick, Heather; Ryan, Richard M; Deci, Edward L

2009-06-01

The Public Health Service (PHS) Guideline for Treating Tobacco Use and Dependence (Fiore et al. 2000) recommends supporting autonomy and perceived competence to facilitate tobacco abstinence. The aim of the study was to evaluate the effectiveness of an intensive tobacco-dependence intervention based on self-determination theory (SDT) and intended to support autonomy and perceived competence in facilitating long-term tobacco abstinence. One thousand and six adult smokers were recruited into a randomized cessation-induction trial. Community care participants received cessation pamphlets and information on local treatment programs. Intervention participants received the same materials and were asked to meet four times with counselors over 6 months to discuss their health in a manner intended to support autonomy and perceived competence. The primary outcome was 24-month prolonged abstinence from tobacco. The secondary outcome was 7-day point prevalence tobacco abstinence at 24 months postintervention. Smokers in the intervention were more likely to attain both tobacco abstinence outcomes and these effects were partially mediated by change in both autonomous self-regulation and perceived competence from baseline to 6 months. Structural equation modeling confirmed the SDT model of health-behavior change in facilitating long-term tobacco abstinence. An intervention based on SDT and consistent with the PHS Guideline, which was intended to support autonomy and perceived competence, facilitated long-term tobacco abstinence.

Pilot study of a social network intervention for heroin users in opiate substitution treatment: study protocol for a randomized controlled trial.

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Day, Edward; Copello, Alex; Seddon, Jennifer L; Christie, Marilyn; Bamber, Deborah; Powell, Charlotte; George, Sanju; Ball, Andrew; Frew, Emma; Freemantle, Nicholas

2013-08-19

Research indicates that 3% of people receiving opiate substitution treatment (OST) in the UK manage to achieve abstinence from all prescribed and illicit drugs within 3 years of commencing treatment, and there is concern that treatment services have become skilled at engaging people but not at helping them to enter a stage of recovery and drug abstinence. The National Treatment Agency for Substance Misuse recommends the involvement of families and wider social networks in supporting drug users' psychological treatment, and this pilot randomized controlled trial aims to evaluate the impact of a social network-focused intervention for patients receiving OST. In this two-site, early phase, randomized controlled trial, a total of 120 patients receiving OST will be recruited and randomized to receive one of three treatments: 1) Brief Social Behavior and Network Therapy (B-SBNT), 2) Personal Goal Setting (PGS) or 3) treatment as usual. Randomization will take place following baseline assessment. Participants allocated to receive B-SBNT or PGS will continue to receive the same treatment that is routinely provided by drug treatment services, plus four additional sessions of either intervention. Outcomes will be assessed at baseline, 3 and 12 months. The primary outcome will be assessment of illicit heroin use, measured by both urinary analysis and self-report. Secondary outcomes involve assessment of dependence, psychological symptoms, social satisfaction, motivation to change, quality of life and therapeutic engagement. Family members (n = 120) of patients involved in the trial will also be assessed to measure the level of symptoms, coping and the impact of the addiction problem on the family member at baseline, 3 and 12 months. This study will provide experimental data regarding the feasibility and efficacy of implementing a social network intervention within routine drug treatment services in the UK National Health Service. The study will explore the impact of the

Health and economic effects from linking bedside and outpatient tobacco cessation services for hospitalized smokers in two large hospitals: study protocol for a randomized controlled trial

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Fellows Jeffrey L

2012-08-01

Full Text Available Abstract Background Extended smoking cessation follow-up after hospital discharge significantly increases abstinence. Hospital smoke-free policies create a period of ‘forced abstinence’ for smokers, thus providing an opportunity to integrate tobacco dependence treatment, and to support post-discharge maintenance of hospital-acquired abstinence. This study is funded by the National Heart, Lung, and Blood Institute (1U01HL1053231. Methods/Design The Inpatient Technology-Supported Assisted Referral study is a multi-center, randomized clinical effectiveness trial being conducted at Kaiser Permanente Northwest (KPNW and at Oregon Health & Science University (OHSU hospitals in Portland, Oregon. The study assesses the effectiveness and cost-effectiveness of linking a practical inpatient assisted referral to outpatient cessation services plus interactive voice recognition (AR + IVR follow-up calls, compared to usual care inpatient counseling (UC. In November 2011, we began recruiting 900 hospital patients age ≥18 years who smoked ≥1 cigarettes in the past 30 days, willing to remain abstinent postdischarge, have a working phone, live within 50 miles of the hospital, speak English, and have no health-related barriers to participation. Each site will randomize 450 patients to AR + IVR or UC using a 2:1 assignment strategy. Participants in the AR + IVR arm will receive a brief inpatient cessation consult plus a referral to available outpatient cessation programs and medications, and four IVR follow-up calls over seven weeks postdischarge. Participants do not have to accept the referral. At KPNW, UC participants will receive brief inpatient counseling and encouragement to self-enroll in available outpatient services. The primary outcome is self-reported thirty-day smoking abstinence at six months postrandomization for AR + IVR participants compared to usual care. Additional outcomes include self-reported and biochemically confirmed

Abstinence

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... Jobs Sports Expert Answers (Q&A) Staying Safe Videos for Educators Search English Español Abstinence KidsHealth / For Teens / Abstinence Print en español La abstinencia sexual What Is It? Abstinence is not having sex. A person who decides to practice abstinence has ...

Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial

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Andrew M. Busch

2017-04-01

Full Text Available Abstract Background Smoking cessation following hospitalization for Acute Coronary Syndrome (ACS significantly reduces subsequent mortality. Depressed mood is a major barrier to cessation post-ACS. Although existing counseling treatments address smoking and depression independently in ACS patients, no integrated treatment addresses both. We developed an integrated treatment combining gold standard cessation counseling with behavioral activation-based mood management; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS. The purpose of this pilot randomized controlled trial was to test feasibility, acceptability, and preliminary efficacy of BAT-CS vs. Standard of Care (SC. Methods Participants were recruited during hospitalization for ACS and were randomly assigned to BAT-CS or SC. The nicotine patch was offered in both conditions. Smoking, mood, and stress outcomes were collected at end-of-treatment and 24-week follow-up. Results Fifty-nine participants (28 BAT-CS, 31 SC were recruited over 42 weeks, and assessment completion was above 80% in both conditions. Treatment acceptability and fidelity were high. At 24 week follow-up adjusted odds ratios favoring BAT-CS were 1.27 (95% CI: 0.41–3.93 for 7-day point prevalence abstinence and 1.27 (95% CI: 0.42–3.82 for continuous abstinence. Time to first smoking lapse was significantly longer in BAT-CS (62.4 vs. 31.8 days, p = 0.03. At 24-weeks, effect sizes for mood and stress outcomes ranged from η2 partial of.07–.11, with significant between treatment effects for positive affect, negative affect, and stress. Conclusions The design of this study proved feasible and acceptable. Results provide preliminary evidence that combining behavioral activation with standard smoking cessation counseling could be efficacious for this high risk population. A larger trial with longer follow-up is warranted. Trial registration NCT01964898 . First received by clinicaltrials.gov October 15, 2013.

Moderators of smoking cessation outcomes in a randomized-controlled trial of varenicline versus placebo.

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Littlewood, Rae A; Claus, Eric D; Wilcox, Claire E; Mickey, Jessica; Arenella, Pamela B; Bryan, Angela D; Hutchison, Kent E

2017-12-01

Varenicline has gained a reputation as the optimal intervention for treatment resistant smokers, yet more than half of those who try it do not succeed. To better understand individual differences in the effectiveness of varenicline, this study evaluates the effectiveness of varenicline for smoking cessation in a double-blind, placebo-controlled, randomized clinical trial and examines the influence of psychological factors on treatment outcome. Two hundred five cigarette smokers interested in quitting were randomly assigned to 12 weeks of varenicline or placebo. Outcomes examined were CO-confirmed continuous abstinence for the past month, average number of cigarettes smoked per day, and 7-day point prevalence. Varenicline-treated participants were more likely than placebo to achieve continuous abstinence at the end of treatment (OR = 3.29; RR = 2.62), and 7-day point prevalence rates showed an effect of medication at each time point. Participants in both groups significantly reduced their smoking during the course of treatment and follow-up, and the medication by visit interaction was significant in the expected direction. Impulsivity and personality style emerged as moderators of the relationship between medication condition and treatment outcome. In addition to replicating efficacy results for varenicline versus placebo, the present study shows that the efficacy of pharmacotherapy is influenced by psychological factors. In an era where pharmacotherapy is often perceived as the "silver bullet," we are reminded that smoking cessation is a dynamic process and intervention must be adaptable to address individual differences.

Employment-based abstinence reinforcement promotes opiate and cocaine abstinence in out-of-treatment injection drug users.

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Holtyn, August F; Koffarnus, Mikhail N; DeFulio, Anthony; Sigurdsson, Sigurdur O; Strain, Eric C; Schwartz, Robert P; Silverman, Kenneth

2014-01-01

We examined the use of employment-based abstinence reinforcement in out-of-treatment injection drug users, in this secondary analysis of a previously reported trial. Participants (N = 33) could work in the therapeutic workplace, a model employment-based program for drug addiction, for 30 weeks and could earn approximately $10 per hr. During a 4-week induction, participants only had to work to earn pay. After induction, access to the workplace was contingent on enrollment in methadone treatment. After participants met the methadone contingency for 3 weeks, they had to provide opiate-negative urine samples to maintain maximum pay. After participants met those contingencies for 3 weeks, they had to provide opiate- and cocaine-negative urine samples to maintain maximum pay. The percentage of drug-negative urine samples remained stable until the abstinence reinforcement contingency for each drug was applied. The percentage of opiate- and cocaine-negative urine samples increased abruptly and significantly after the opiate- and cocaine-abstinence contingencies, respectively, were applied. These results demonstrate that the sequential administration of employment-based abstinence reinforcement can increase opiate and cocaine abstinence among out-of-treatment injection drug users. © Society for the Experimental Analysis of Behavior.

Smoking-Cessation Interventions for Urban Hospital Patients: A Randomized Comparative Effectiveness Trial.

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Sherman, Scott E; Link, Alissa R; Rogers, Erin S; Krebs, Paul; Ladapo, Joseph A; Shelley, Donna R; Fang, Yixin; Wang, Binhuan; Grossman, Ellie

2016-10-01

Hospitalization is a unique opportunity for smoking cessation, but prior interventions have measured efficacy with narrowly defined populations. The objective of this study was to enroll smokers admitted to two "safety net" hospitals and compare the effectiveness of two post-discharge cessation interventions. A randomized comparative effectiveness trial was conducted. At two New York City public hospitals, every hospitalized patient identified as a smoker (based on admission records) was approached. Inclusion criteria were: smoked cigarettes in the past 30 days; spoke English, Spanish, or Mandarin; had a U.S. phone number; not discharged to an institution where follow-up or smoking was limited; and not pregnant/breastfeeding. Of 18,797 patients identified as current smokers between July 2011 and April 2014, a total of 3,047 (16%) were discharged before being approached, 3,273 (17%) were not current smokers, 4,026 (21%) had no U.S. phone number, 2,831 (15%) were ineligible for other reasons, and 3,983 (21%) refused participation. In total, 1,618 (9%) participants enrolled in the study. During follow-up, 69% of participants were reached at 2 months and 68% at 6 months. At discharge, participants were randomized to multisession telephone counseling from study staff (n=804) or referral to the state quitline for proactive outreach and counseling (n=814). Self-reported abstinence at 6 months was measured. Analyses were conducted in late 2015. One quarter of participants were homeless or in unstable housing, 60% had a history of substance abuse, 43% reported current hazardous drinking, and half had a psychiatric diagnosis other than substance abuse. At follow-up, the rate of abstinence (30-day point prevalence) was higher in the intensive counseling arm than the quitline arm at 2 months (29.0% vs 20.7%; relative risk=1.40; 95% CI=1.13, 1.73) and 6 months (37.4% vs 31.5%; relative risk=1.19; 95% CI=1.01, 1.40). Intensive counseling was more effective than referral to the

Health and economic effects from linking bedside and outpatient tobacco cessation services for hospitalized smokers in two large hospitals: study protocol for a randomized controlled trial.

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Fellows, Jeffrey L; Mularski, Richard; Waiwaiole, Lisa; Funkhouser, Kim; Mitchell, Julie; Arnold, Kathleen; Luke, Sabrina

2012-08-01

Extended smoking cessation follow-up after hospital discharge significantly increases abstinence. Hospital smoke-free policies create a period of 'forced abstinence' for smokers, thus providing an opportunity to integrate tobacco dependence treatment, and to support post-discharge maintenance of hospital-acquired abstinence. This study is funded by the National Heart, Lung, and Blood Institute (1U01HL1053231). The Inpatient Technology-Supported Assisted Referral study is a multi-center, randomized clinical effectiveness trial being conducted at Kaiser Permanente Northwest (KPNW) and at Oregon Health & Science University (OHSU) hospitals in Portland, Oregon. The study assesses the effectiveness and cost-effectiveness of linking a practical inpatient assisted referral to outpatient cessation services plus interactive voice recognition (AR + IVR) follow-up calls, compared to usual care inpatient counseling (UC). In November 2011, we began recruiting 900 hospital patients age ≥18 years who smoked ≥1 cigarettes in the past 30 days, willing to remain abstinent postdischarge, have a working phone, live within 50 miles of the hospital, speak English, and have no health-related barriers to participation. Each site will randomize 450 patients to AR + IVR or UC using a 2:1 assignment strategy. Participants in the AR + IVR arm will receive a brief inpatient cessation consult plus a referral to available outpatient cessation programs and medications, and four IVR follow-up calls over seven weeks postdischarge. Participants do not have to accept the referral. At KPNW, UC participants will receive brief inpatient counseling and encouragement to self-enroll in available outpatient services. The primary outcome is self-reported thirty-day smoking abstinence at six months postrandomization for AR + IVR participants compared to usual care. Additional outcomes include self-reported and biochemically confirmed seven-day abstinence at six months, self-reported seven

The Role of BMI Change on Smoking Abstinence in a Sample of HIV-Infected Smokers

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Gritz, Ellen R.; Kypriotakis, George; Arduino, Roberto C.; Vidrine, Damon J.

2016-01-01

The prevalence of cigarette smoking among persons living with HIV/AIDS (PLWHA) is approximately 40%, significantly higher than that of the general population. Identifying predictors of successful smoking cessation for PLWHA is necessary to alleviate the morbidity and mortality associated with smoking in this population. Weight gain has been associated with smoking relapse in the general population, but has not been studied among PLWHA. Data from 474 PLWHA enrolled in a smoking cessation randomized clinical trial were analyzed to examine the effect of BMI change, from baseline to 3-month follow-up, on smoking outcomes using multiple logistic regression. The odds of 7-day smoking abstinence at 3-month follow-up were 4.22 (95% CI=1.65, 10.82) times higher for participants classified as BMI decrease and 4.22 (95% CI=1.62, 11.01) times higher for participants classified as BMI increase as compared to participants with a minimal increase or decrease in BMI. In this sample, both weight gain and loss following smoking cessation were significantly associated with abstinence at 3-month follow-up among HIV-infected smokers. Further research and a better understanding of predictors of abstinence will encourage more tailored interventions, with the potential to reduce morbidity and mortality. PMID:26666313

Quitline Tobacco Interventions in Hospitalized Patients: A Randomized Trial.

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Warner, David O; Nolan, Margaret B; Kadimpati, Sandeep; Burke, Michael V; Hanson, Andrew C; Schroeder, Darrell R

2016-10-01

Hospitalization provides an opportunity for smokers to quit, but tobacco interventions can require specialized services that are not available to many hospitals. This study tests the hypothesis that a brief intervention to facilitate the use of telephone quitline services for both initial and follow-up counseling is effective in helping patients achieve sustained abstinence. This was a population-based RCT. Participants were Olmsted County, MN residents who reported current smoking and were admitted to Mayo Clinic hospitals in Rochester, MN between May 2012 and August 2014. A control group received brief (~5-minute) cessation advice; an intervention group received a brief (~5-minute) quitline facilitation intervention, with either warm handoff or faxed referral to a national quitline provider. All were offered a 2-week supply of nicotine patches at discharge. Outcomes included self-reported 7-day point prevalence abstinence at 6 months after hospitalization and quitline utilization. Data analysis was performed from September 2014 to March 2015. Of the 1,409 eligible patients who were approached, 600 (47%) were randomized. The quitline intake call was completed by 195 subjects (65% of the intervention group). Of these, 128 (66%) completed the first coaching call. Self-reported abstinence rates at 6 months after discharge were identical in both groups (24%). The quitline facilitation intervention did not improve self-reported abstinence rates compared with a standard brief stop-smoking intervention. These results do not support the effectiveness of quitlines in providing tobacco use interventions to a general population of hospitalized smokers. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Randomized controlled trial of a web-based computer-tailored smoking cessation program as a supplement to nicotine patch therapy.

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Strecher, Victor J; Shiffman, Saul; West, Robert

2005-05-01

To assess the efficacy of World Wide Web-based tailored behavioral smoking cessation materials among nicotine patch users. Two-group randomized controlled trial. World Wide Web in England and Republic of Ireland. A total of 3971 subjects who purchased a particular brand of nicotine patch and logged-on to use a free web-based behavioral support program. Web-based tailored behavioral smoking cessation materials or web-based non-tailored materials. Twenty-eight-day continuous abstinence rates were assessed by internet-based survey at 6-week follow-up and 10-week continuous rates at 12-week follow-up. Using three approaches to the analyses of 6- and 12-week outcomes, participants in the tailored condition reported clinically and statistically significantly higher continuous abstinence rates than participants in the non-tailored condition. In our primary analyses using as a denominator all subjects who logged-on to the treatment site at least once, continuous abstinence rates at 6 weeks were 29.0% in the tailored condition versus 23.9% in the non-tailored condition (OR = 1.30; P = 0.0006); at 12 weeks continuous abstinence rates were 22.8% versus 18.1%, respectively (OR = 1.34; P = 0.0006). Moreover, satisfaction with the program was significantly higher in the tailored than in the non-tailored condition. The results of this study demonstrate a benefit of the web-based tailored behavioral support materials used in conjunction with nicotine replacement therapy. A web-based program that collects relevant information from users and tailors the intervention to their specific needs had significant advantages over a web-based non-tailored cessation program.

The safety, effectiveness and cost-effectiveness of cytisine in achieving six-month continuous smoking abstinence in tuberculosis patients - protocol for a double-blind, placebo-controlled randomised trial.

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Dogar, Omara; Barua, Deepa; Boeckmann, Melanie; Elsey, Helen; Fatima, Razia; Gabe, Rhian; Huque, Rumana; Keding, Ada; Khan, Amina; Kotz, Daniel; Kralikova, Eva; Newell, James N; Nohavova, Iveta; Parrott, Steve; Readshaw, Anne; Renwick, Lottie; Sheikh, Aziz; Siddiqi, Kamran

2018-04-20

Tuberculosis (TB) patients who quit smoking have much better disease outcomes than those who continue to smoke. Behavioural support combined with pharmacotherapy is the most effective strategy in helping people to quit, in general populations. However, there is no evidence for the effectiveness of this strategy in TB patients who smoke. We will assess the safety, effectiveness and cost-effectiveness of cytisine - a low-cost plant-derived nicotine substitute - for smoking cessation in TB patients compared with placebo, over and above brief behavioural support. Two-arm, parallel, double-blind, placebo-controlled, multi-centre (30 sites in Bangladesh and Pakistan), individually randomised trial. TB treatment centres integrated into public health care systems in Bangladesh and Pakistan. Newly diagnosed (in the last four weeks) adult pulmonary TB patients who are daily smokers (with or without dual smokeless tobacco use) and are interested in quitting (n= 2,388). The primary outcome measure is biochemically verified continuous abstinence from smoking at six months post-randomization, assessed using Russell Standard criteria. The secondary outcome measures include continuous abstinence at 12 months, lapses and relapses; clinical TB outcomes; nicotine dependency and withdrawal; and adverse events. This is the first smoking cessation trial of cytisine in low- and middle-income countries evaluating both cessation and tuberculosis (TB) outcomes. If found effective, cytisine could become the most affordable cessation intervention to help TB patients who smoke. This article is protected by copyright. All rights reserved.

Randomized Controlled Trial Comparing Exercise to Health Education for Stimulant Use Disorder: Results From the CTN-0037 STimulant Reduction Intervention Using Dosed Exercise (STRIDE) Study.

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Trivedi, Madhukar H; Greer, Tracy L; Rethorst, Chad D; Carmody, Thomas; Grannemann, Bruce D; Walker, Robrina; Warden, Diane; Shores-Wilson, Kathy; Stoutenberg, Mark; Oden, Neal; Silverstein, Meredith; Hodgkins, Candace; Love, Lee; Seamans, Cindy; Stotts, Angela; Causey, Trey; Szucs-Reed, Regina P; Rinaldi, Paul; Myrick, Hugh; Straus, Michele; Liu, David; Lindblad, Robert; Church, Timothy; Blair, Steven N; Nunes, Edward V

To evaluate exercise as a treatment for stimulant use disorders. The STimulant Reduction Intervention using Dosed Exercise (STRIDE) study was a randomized clinical trial conducted in 9 residential addiction treatment programs across the United States from July 2010 to February 2013. Of 497 adults referred to the study, 302 met all eligibility criteria, including DSM-IV criteria for stimulant abuse and/or dependence, and were randomized to either a dosed exercise intervention (Exercise) or a health education intervention (Health Education) control, both augmenting treatment as usual and conducted thrice weekly for 12 weeks. The primary outcome of percent stimulant abstinent days during study weeks 4 to 12 was estimated using a novel algorithm adjustment incorporating self-reported Timeline Followback (TLFB) stimulant use and urine drug screen (UDS) data. Mean percent of abstinent days based on TLFB was 90.8% (SD = 16.4%) for Exercise and 91.6% (SD = 14.7%) for Health Education participants. Percent of abstinent days using the eliminate contradiction (ELCON) algorithm was 75.6% (SD = 27.4%) for Exercise and 77.3% (SD = 25.1%) for Health Education. The primary intent-to-treat analysis, using a mixed model controlling for site and the ELCON algorithm, produced no treatment effect (P = .60). In post hoc analyses controlling for treatment adherence and baseline stimulant use, Exercise participants had a 4.8% higher abstinence rate (78.7%) compared to Health Education participants (73.9%) (P = .03, number needed to treat = 7.2). The primary analysis indicated no significant difference between exercise and health education. Adjustment for intervention adherence showed modestly but significantly higher percent of abstinent days in the exercise group, suggesting that exercise may improve outcomes for stimulant users who have better adherence to an exercise dose. ClinicalTrials.gov identifier: NCT01141608. © Copyright 2017 Physicians Postgraduate Press, Inc.

Integrating smoking cessation and alcohol use treatment in homeless populations: study protocol for a randomized controlled trial.

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Ojo-Fati, Olamide; John, Florence; Thomas, Janet; Joseph, Anne M; Raymond, Nancy C; Cooney, Ned L; Pratt, Rebekah; Rogers, Charles R; Everson-Rose, Susan A; Luo, Xianghua; Okuyemi, Kolawole S

2015-08-29

Despite progress in reducing cigarette smoking in the general U.S. population, smoking rates, cancer morbidity and related heart disease remain strikingly high among the poor and underserved. Homeless individuals' cigarette smoking rate remains an alarming 70% or greater, and this population is generally untreated with smoking cessation interventions. Furthermore, the majority of homeless smokers also abuse alcohol and other drugs, which makes quitting more difficult and magnifies the health consequences of tobacco use. Participants will be randomized to one of three groups, including (1) an integrated intensive smoking plus alcohol intervention using cognitive behavioral therapy (CBT), (2) intensive smoking intervention using CBT or (3) usual care (i.e., brief smoking cessation and brief alcohol counseling). All participants will receive 12-week treatment with a nicotine patch plus nicotine gum or lozenge. Counseling will include weekly individual sessions for 3 months, followed by monthly booster group sessions for 3 months. The primary smoking outcome is cotinine-verified 7-day smoking abstinence at follow-up week 52, and the primary alcohol outcome will be breathalyzer-verified 90-day alcohol abstinence at week 52. This study protocol describes the design of the first community-based controlled trial (n = 645) designed to examine the efficacy of integrating alcohol abuse treatment with smoking cessation among homeless smokers. To further address the gap in effectiveness of evidence-based smoking cessation interventions in the homeless population, we are conducting a renewed smoking cessation clinical trial called Power to Quit among smokers experiencing homelessness. ClinicalTrials.gov Identifier: NCT01932996. Date of registration: 20 November 2014.

Self-perceived ability to cope with stress without smoking predicts successful smoking cessation 12 months later in a quitline setting: a randomized trial

Directory of Open Access Journals (Sweden)

Eva Nohlert

2018-03-01

Full Text Available Background Telephone-based smoking cessation services ('quitlines' are both effective and cost-effective. Knowledge of modifiable baseline factors in real-life settings with heterogeneous participants is essential for the development and improvement of treatment protocols to assist in telephone-based smoking cessation. The aim was to assess self-efficacy as a predictor for abstinence at the 12-month follow-up at the Swedish National Tobacco Quitline (SNTQ. Methods The data were collected from a randomized controlled trial comparing the effectiveness of proactive and reactive service at the SNTQ. Included were 612 clients calling the SNTQ between February 2009 and September 2010. Outcome measures were self-reported point prevalence and 6-month continuous abstinence at the 12-month follow-up. Plausible predictors of smoking cessation were assessed at the first call and in a baseline questionnaire. Self-efficacy was measured by three questions: (1 the likelihood of being smoking free in 1 year; (2 the ability to handle stress and depressive mood without smoking; and (3 the likelihood of using medication against craving if necessary. The associations between predictors and outcome were subjected to logistic regression analysis. Results Of the three self-efficacy predictors for abstinence at month 12, only the perceived ability to handle stress and depressive mood without smoking remained significant in the adjusted analyses (odds ratio, OR, 1.1 for point prevalence and 1.2 for 6-month continuous abstinence. The overall strongest predictor in the adjusted analyses was smoking status in the week before baseline (OR 2.7 for point prevalence and 3.1 for 6-month continuous abstinence. Conclusions The perceived ability to handle stress and depressive mood without smoking at baseline predicted the subjects' abstinence at the 12-month follow-up. An assessment of/adjustment for stress and depressive mood may be appropriate in future smoking cessation

Comparison of a high and a low intensity smoking cessation intervention in a dentistry setting in Sweden – a randomized trial

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Rosenblad Andreas

2009-04-01

Full Text Available Abstract Background Tobacco is still the number one life style risk factor for ill health and premature death and also one of the major contributors to oral problems and diseases. Dentistry may be a potential setting for several aspects of clinical public health interventions and there is a growing interest in several countries to develop tobacco cessation support in dentistry setting. The aim of the present study was to assess the relative effectiveness of a high intensity intervention compared with a low intensity intervention for smoking cessation support in a dental clinic setting. Methods 300 smokers attending dental or general health care were randomly assigned to two arms and referred to the local dental clinic for smoking cessation support. One arm received support with low intensity treatment (LIT, whereas the other group was assigned to high intensity treatment (HIT support. The main outcome measures included self-reported point prevalence and continuous abstinence (≥ 183 days at the 12-month follow-up. Results Follow-up questionnaires were returned from 86% of the participants. People in the HIT-arm were twice as likely to report continuous abstinence compared with the LIT-arm (18% vs. 9%, p = 0.02. There was a difference (not significant between the arms in point prevalence abstinence in favour of the HIT-protocol (23% vs. 16%. However, point prevalence cessation rates in the LIT-arm reporting additional support were relatively high (23% compared with available data assessing abstinence in smokers trying to quit without professional support. Conclusion Screening for willingness to quit smoking within the health care system and offering smoking cessation support within dentistry may be an effective model for smoking cessation support in Sweden. The LIT approach is less expensive and time consuming and may be appropriate as a first treatment option, but should be integrated with other forms of available support in the community. The

Trauma-Focused Smoking Cessation for Smokers Exposed to the World Trade Center Disaster: A Randomized Clinical Trial.

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Gonzalez, Adam; Friedberg, Fred; Li, Xiaotong; Zvolensky, Michael J; Bromet, Evelyn J; Mahaffey, Brittain L; Vujanovic, Anka A; Luft, Benjamin J; Kotov, Roman

2017-08-01

The main objective was to evaluate the efficacy of an 8-session, group-based comprehensive smoking cessation and trauma management (CSC-T) treatment among daily smokers (≥5 cigarettes/day) exposed to the World Trade Center (WTC) disaster with elevated WTC-related post-traumatic stress disorder (PTSD) symptoms. Participants (N = 90) were randomly assigned to CSC-T (N = 44; 63.6% white; 27.3% female; mean age = 51.32 ± 7.87) or comprehensive smoking cessation (CSC) alone (N = 46; 71.7% white; 28.3% female; mean age = 48.74 ± 10.66), which was comparable in length and time. Assessments included a diagnostic clinical interview and self-report measures of PTSD and respiratory symptoms, and smoking behavior, and biologically confirmed smoking abstinence. Evaluations occurred at a baseline visit, each treatment session, and at 1-, 2-, 4-, 12-, and 26-weeks post-treatment. The two treatments did not differ in regard to PTSD symptom improvement. After quit day (week 6), the two groups had similar 7-day (~15%) and 6-month (~20%) abstinence rates as well as average number of cigarettes smoked, and PTSD and respiratory symptoms. It is possible that the Cognitive Behavioral Therapy skills specific to quitting smoking, group-based support, and degree of therapist contact, that were available in both treatments may have played a role in equalizing the abstinence rates between the two conditions. Although the current study found no evidence that the CSC-T was superior to the CSC alone treatment, the abstinence rates observed were high relative to previous trials of smokers with diagnosed PTSD. Further development of smoking cessation programs tailored to the needs of smokers with PTSD symptoms continues to be needed. This study suggests that a CSC program aids in smoking abstinence for smokers with PTSD symptoms and that incorporating trauma management skills, may not add additional benefits for abstinence and PTSD and respiratory symptom relief. Further work is needed to

A Naturalistic, Randomized Pilot Trial of E-Cigarettes: Uptake, Exposure, and Behavioral Effects.

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Carpenter, Matthew J; Heckman, Bryan W; Wahlquist, Amy E; Wagener, Theodore L; Goniewicz, Maciej L; Gray, Kevin M; Froeliger, Brett; Cummings, K Michael

2017-12-01

Background: Most studies of electronic nicotine delivery systems (ENDS) compare self-selected users versus nonusers. The few randomized studies to date generally support a positive impact on reducing smoking behavior, but these studies are focused on guided ENDS use. This study presents a randomized, naturalistic trial of ENDS with prospective outcomes of uptake and behavioral changes in smoking. Methods: Adult smokers with minimal ENDS history were randomized in a 2:1 ratio to receive product for 3 weeks ( n = 46), or not ( n = 22). Changes in nicotine delivery (16 vs. 24 mg), midway through the study allowed a compelling opportunity to examine two ENDS products compared with the control group. Primary outcomes, assessed via daily diaries during sampling period and in-person laboratory visits over 4 months, included uptake and usage of ENDS, cessation-related outcomes, and exposure to smoke constituents. Results: All ENDS participants tried product at least once, with 48% of 24 mg and 30% of 16 mg using their assigned product for the entire sampling period. Within the 24 mg ENDs group, 57% made an independent purchase of ENDS, versus 28% of 16 mg, and 14% of control participants ( P = 0.01). Smokers in both ENDS groups significantly reduced their smoking, whereas control participants did not ( P = 0.03). Cessation behaviors (quit attempts, biologically verified abstinence) numerically but not statistically favored ENDS participants. Conclusions: Results suggest that cigarette smokers are willing to use ENDS with trends toward reduced cigarette smoking and positive changes in cessation-related behaviors. Impact: Randomized, naturalistic trials such as presented herein are needed to understand the population impact of e-cigarettes. Cancer Epidemiol Biomarkers Prev; 26(12); 1795-803. ©2017 AACR . ©2017 American Association for Cancer Research.

Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: A pilot randomized clinical trial.

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Trigo, Jose M; Soliman, Alexandra; Quilty, Lena C; Fischer, Benedikt; Rehm, Jürgen; Selby, Peter; Barnes, Allan J; Huestis, Marilyn A; George, Tony P; Streiner, David L; Staios, Gregory; Le Foll, Bernard

2018-01-01

The current lack of pharmacological treatments for cannabis use disorder (CUD) warrants novel approaches and further investigation of promising pharmacotherapy. We previously showed that nabiximols (27 mg/ml Δ9-tetrahydrocannabinol (THC)/ 25 mg/ml cannabidiol (CBD), Sativex®) can decrease cannabis withdrawal symptoms. Here, we assessed in a pilot study the tolerability and safety of self-titrated nabiximols vs. placebo among 40 treatment-seeking cannabis-dependent participants. Subjects participated in a double blind randomized clinical trial, with as-needed nabiximols up to 113.4 mg THC/105 mg CBD or placebo daily for 12 weeks, concurrently with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). Primary outcome measures were tolerability and abstinence, secondary outcome measures were days and amount of cannabis use, withdrawal, and craving scores. Participants received up to CDN$ 855 in compensation for their time. Medication was well tolerated and no serious adverse events (SAEs) were observed. Rates of adverse events did not differ between treatment arms (F1,39 = 0.205, NS). There was no significant change in abstinence rates at trial end. Participants were not able to differentiate between subjective effects associated with nabiximols or placebo treatments (F1,40 = 0.585, NS). Cannabis use was reduced in the nabiximols (70.5%) and placebo groups (42.6%). Nabiximols reduced cannabis craving but no significant differences between the nabiximols and placebo groups were observed on withdrawal scores. Nabiximols in combination with MET/CBT was well tolerated and allowed for reduction of cannabis use. Future clinical trials should explore the potential of high doses of nabiximols for cannabis dependence.

Motivational, reduction and usual care interventions for smokers who are not ready to quit: a randomized controlled trial.

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Klemperer, Elias M; Hughes, John R; Solomon, Laura J; Callas, Peter W; Fingar, James R

2017-01-01

To test whether, in comparison to usual care, brief motivational or reduction interventions increase quit attempts (QA) or abstinence among smokers who are not ready to quit. A parallel-group randomized controlled trial of brief motivational (n = 185), reduction (n = 186) or usual care (n = 189) telephone interventions delivered over the course of 4 weeks. Outcomes were assessed at 6- and 12-month follow-ups. No medication was provided. United States. A total of 560 adult smokers of ≥ 10 cigarettes per day who were not ready to quit in the next 30 days. The primary outcomes were whether participants made a QA that lasted ≥ 24 hours and whether they made a QA of any length between baseline and 6 months. Secondary outcomes included 7-day point-prevalence abstinence at 6 and 12 months. The 12-month follow-up was added after the study began. A priori-defined comparisons were between motivational versus usual care and reduction versus usual care conditions. The probability of making a QA that lasted ≥ 24 hours was not significantly different between the motivational (38%) or the reduction (31%) conditions and the usual care (34%) condition [motivational versus usual care odds ratio (OR) = 1.19, 95% confidence interval (CI) = 0.78-1.82; reduction versus usual care OR = 0.89, 95% CI = 0.57-1.36]. Bayes factors ranged from 0.13 to 0.18. Findings regarding a QA of any length were similar. At 6 months, the motivational condition had marginally more abstinence than usual care (11 versus 5%, OR = 2.17, 95% CI = 0.99-4.77), but the reduction condition was not significantly different from usual care (8 versus 5%, OR = 1.57, 95% CI = 0.69-3.59). At 12 months, the motivational condition had significantly more abstinence than usual care (10 versus 4%, OR = 2.80, 95% CI = 1.14-6.88) and the reduction condition had marginally more abstinence than usual care (9 versus 4%, OR = 2.45, 95% CI = 0.98-6.09). Among adult smokers who are not ready

Maintenance pharmacotherapy normalizes the relapse curve in recently abstinent tobacco smokers with schizophrenia and bipolar disorder.

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Evins, A Eden; Hoeppner, Susanne S; Schoenfeld, David A; Hoeppner, Bettina B; Cather, Corinne; Pachas, Gladys N; Cieslak, Kristina M; Maravic, Melissa Culhane

2017-05-01

To compare the effect of maintenance pharmacotherapy on sustained abstinence rates between recently abstinent smokers with schizophrenia and bipolar disorder (SBD) and general population smokers without psychiatric illness. We performed a person-level, pooled analysis of two randomized controlled trials of maintenance varenicline, conducted in adult smokers with SBD and general population smokers, controlling for severity of dependence. Smokers abstinent after 12-weeks of open varenicline treatment were randomly assigned to ≥12-weeks maintenance varenicline or identical placebo. In those assigned to maintenance placebo, the abstinence rate at week-24 was lower in those with SBD than for those without psychiatric illness (29.4±1.1% vs. 61.8±0.4%, OR:0.26, 95% CI: 0.13, 0.52, psmokers assigned to maintenance pharmacotherapy, however, there was no effect of diagnosis on abstinence rates at week-24 (87.2±0.8% vs. 81.9±0.2%, OR: 1.68, 95% CI: 0.53, 5.32, p=0.38). Time to first lapse was shortest in those with SBD assigned to maintenance placebo (Q1=12days, 95%CI: 4, 16), longer in those without psychiatric illness assigned to maintenance placebo (Q1=17days, 95%CI: 17, 29), still longer in general-population smokers assigned to maintenance varenicline (Q1=88, 95% CI:58,91, and longest in those with SBD who received maintenance varenicline (Q1>95days, 95%CI:non-est), (Χ 2 3df =96.99, p<0.0001; all pairwise comparisons p<0.001). Following a standard 12-week course of pharmacotherapy, people with schizophrenia and bipolar disorder were more likely to relapse to smoking without maintenance varenicline treatment. Maintenance pharmacotherapy could improve longer-term tobacco abstinence rates and reduce known smoking-related health disparities in those with SMI. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Opiate v CNS depressant therapy in neonatal drug abstinence syndrome.

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Kandall, S R; Doberczak, T M; Mauer, K R; Strashun, R H; Korts, D C

1983-04-01

Paregoric and phenobarbital, administered randomly in 153 passively addicted neonates, initially appeared to control neonatal abstinence signs equally well. However, seven of the 62 phenobarbital-treated newborns had abstinence-associated seizures within the first month of life, while none of 49 paregoric-treated neonates had seizures. Forty-two neonates initially requiring no specific pharmacotherapy for abstinence signs were born to mothers taking less methadone hydrochloride just before delivery. Five of those 42 neonates, however, had seizures within the first 14 days of life. Seizure occurrence could not be predicted from analysis of early abstinence patterns. We consider paregoric to be the treatment of choice for the neonatal abstinence syndrome. Phenobarbital use should be monitored with serum drug levels and modification of recommended dosage regimens considered.

Effectiveness of a Web-based multiple tailored smoking cessation program: a randomized controlled trial among Dutch adult smokers.

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Smit, Eline Suzanne; de Vries, Hein; Hoving, Ciska

2012-06-11

Distributing a multiple computer-tailored smoking cessation intervention through the Internet has several advantages for both provider and receiver. Most important, a large audience of smokers can be reached while a highly individualized and personal form of feedback can be maintained. However, such a smoking cessation program has yet to be developed and implemented in The Netherlands. To investigate the effects of a Web-based multiple computer-tailored smoking cessation program on smoking cessation outcomes in a sample of Dutch adult smokers. Smokers were recruited from December 2009 to June 2010 by advertising our study in the mass media and on the Internet. Those interested and motivated to quit smoking within 6 months (N = 1123) were randomly assigned to either the experimental (n = 552) or control group (n = 571). Respondents in the experimental group received the fully automated Web-based smoking cessation program, while respondents in the control group received no intervention. After 6 weeks and after 6 months, we assessed the effect of the intervention on self-reported 24-hour point prevalence abstinence, 7-day point prevalence abstinence, and prolonged abstinence using logistic regression analyses. Of the 1123 respondents, 449 (40.0%) completed the 6-week follow-up questionnaire and 291 (25.9%) completed the 6-month follow-up questionnaire. We used a negative scenario to replace missing values. That is, we considered respondents lost to follow-up to still be smoking. The computer-tailored program appeared to have significantly increased 24-hour point prevalence abstinence (odds ratio [OR] 1.85, 95% confidence interval [CI] 1.30-2.65), 7-day point prevalence abstinence (OR 2.17, 95% CI 1.44-3.27), and prolonged abstinence (OR 1.99, 95% CI 1.28-3.09) rates reported after 6 weeks. After 6 months, however, no intervention effects could be identified. Results from complete-case analyses were similar. The results presented suggest that the Web-based computer

A Randomized Trial of Motivational Interviewing: Cessation Induction Among Smokers With Low Desire to Quit.

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Catley, Delwyn; Goggin, Kathy; Harris, Kari Jo; Richter, Kimber P; Williams, Karen; Patten, Christi; Resnicow, Ken; Ellerbeck, Edward F; Bradley-Ewing, Andrea; Lee, Hyoung S; Moreno, Jose L; Grobe, James E

2016-05-01

Despite limitations in evidence, the current Clinical Practice Guideline advocates Motivational Interviewing for smokers not ready to quit. This study evaluated the efficacy of Motivational Interviewing for inducing cessation-related behaviors among smokers with low motivation to quit. Randomized clinical trial. Two-hundred fifty-five daily smokers reporting low desire to quit smoking were recruited from an urban community during 2010-2011 and randomly assigned to Motivational Interviewing, health education, or brief advice using a 2:2:1 allocation. Data were analyzed from 2012 to 2014. Four sessions of Motivational Interviewing utilized a patient-centered communication style that explored patients' own reasons for change. Four sessions of health education provided education related to smoking cessation while excluding elements characteristic of Motivational Interviewing. A single session of brief advice consisted of brief, personalized advice to quit. Self-reported quit attempts; smoking abstinence (biochemically verified); use of cessation pharmacotherapies; motivation; and confidence to quit were assessed at baseline and 3- and 6-month follow-ups. Unexpectedly, no significant differences emerged between groups in the proportion who made a quit attempt by 6-month follow-up (Motivational Interviewing, 52.0%; health education, 60.8%; brief advice, 45.1%; p=0.157). Health education had significantly higher biochemically verified abstinence rates at 6 months (7.8%) than brief advice (0.0%) (8% risk difference, 95% CI=3%, 13%, p=0.003), with the Motivational Interviewing group falling in between (2.9% abstinent, 3% risk difference, 95% CI=0%, 6%, p=0.079). Both Motivational Interviewing and health education groups showed greater increases in cessation medication use, motivation, and confidence to quit relative to brief advice (all pmotivation relative to Motivational Interviewing (Cohen's d=0.36, 95% CI=0.12, 0.60). Although Motivational Interviewing was generally

Psycho-education for substance use and antisocial personality disorder: a randomized trial.

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Thylstrup, Birgitte; Schrøder, Sidsel; Hesse, Morten

2015-11-14

Antisocial personality disorder often co-exists with drug and alcohol use disorders. This trial examined the effectiveness of offering psycho-education for antisocial personality disorder in community substance use disorder treatment centers in Denmark. A total of 176 patients were randomly allocated to treatment as usual (TAU, n = 80) or TAU plus a psycho-educative program, Impulsive Lifestyle Counselling (ILC, n = 96) delivered by site clinicians (n = 39). Using follow-up interviews 3 and 9 months after randomization, we examined changes in drug and alcohol use (Addiction Severity Index Composite Scores), percent days abstinent (PDA) within last month, and aggression as measured with the Buss-Perry Aggression Questionnaire-Short Form and the Self-Report of Aggression and Social Behavior Measure. Overall engagement in psychological interventions was modest: 71 (76 %) of participants randomized to psycho-education attended at least one counselling session, and 21 (23 %) attended all six sessions. The Median number of sessions was 2. All patients reduced drug and alcohol problems at 9 months with small within-group effect sizes. Intention-to-treat analyses indicated significant differences between ILC and TAU in mean drugs composite score (p = .018) and in PDA (p = .041) at 3 months. Aggression declined in both groups, but no differences between ILC and TAU were observed in terms of alcohol problems or aggression at any follow-up. Moderate short-term improvements in substance use were associated with randomization to Impulsive Lifestyle Counselling. The findings support the usefulness of providing psycho-education to outpatients with antisocial personality disorder. ISRCTN registry, ISRCTN67266318 , 17/7/2012.

A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder.

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McGovern, Mark P; Lambert-Harris, Chantal; Xie, Haiyi; Meier, Andrea; McLeman, Bethany; Saunders, Elizabeth

2015-07-01

Post-traumatic stress disorder (PTSD) is common among people with substance use disorders, and the comorbidity is associated with negative outcomes. We report on a randomized controlled trial comparing the effect of integrated cognitive-behavioral therapy (ICBT) plus standard care, individual addiction counseling plus standard care and standard care alone on substance use and PTSD symptoms. Three-group, multi-site randomized controlled trial. Seven addiction treatment programs in Vermont and New Hampshire, USA. Recruitment took place between December 2010 and January 2013. In this single-blind study, 221 participants were randomized to one of three conditions: ICBT plus standard care (SC) (n = 73), individual addiction counseling (IAC) plus SC (n = 75) or SC only (n = 73). One hundred and seventy-two patients were assessed at 6-month follow-up (58 ICBT; 61 IAC; 53 SC). Intervention and comparators: ICBT is a manual-guided therapy focused on PTSD and substance use symptom reduction with three main components: patient education, mindful relaxation and flexible thinking. IAC is a manual-guided therapy focused exclusively on substance use and recovery with modules organized in a stage-based approach: treatment initiation, early abstinence, maintaining abstinence and recovery. SC are intensive out-patient program services that include 9-12 hours of face-to-face contact per week over 2-4 days of group and individual therapies plus medication management. Primary outcomes were PTSD severity and substance use severity at 6 months. Secondary outcomes were therapy retention. PTSD symptoms reduced in all conditions with no difference between them. In analyses of covariance, ICBT produced more favorable outcomes on toxicology than IAC or SC [comparison with IAC, parameter estimate: 1.10; confidence interval (CI) = 0.17-2.04; comparison with SC, parameter estimate: 1.13; CI = 0.18-2.08] and had a greater reduction in reported drug use than SC (parameter estimate: -9.92; CI =�

Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial

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Harrington Kathleen F

2012-08-01

Full Text Available Abstract Background E-health tools are a new mechanism to expand patient care, allowing supplemental resources to usual care, including enhanced patient-provider communication. These applications to smoking cessation have yet to be tested in a hospitalized patient sample. This project aims to evaluate the effectiveness and cost-effectiveness of a tailored web-based and e-message smoking cessation program for current smokers that, upon hospital discharge, transitions the patient to continue a quit attempt when home (Decide2Quit. Design A randomized two-arm follow-up design will test the effectiveness of an evidence- and theoretically-based smoking cessation program designed for post-hospitalization. Methods A total of 1,488 patients aged 19 or older, who smoked cigarettes in the previous 30 days, are being recruited from 27 patient care areas of a large urban university hospital. Study-eligible hospitalized patients receiving usual tobacco cessation usual care are offered study referral. Trained hospital staff assist the 744 patients who are being randomized to the intervention arm with registration and orientation to the intervention website. This e-mail and web-based program offers tailored messages as well as education, self-assessment and planning aids, and social support to promote tobacco use cessation. Condition-blind study staff assess participants for tobacco use history and behaviors, tobacco use cost-related information, co-morbidities and psychosocial factors at 0, 3, 6, and 12 months. The primary outcome is self-reported 30-day tobacco abstinence at 6 months follow-up. Secondary outcomes include 7-day point prevalence quit rates at 3-, 6-, and 12-month follow-up, 30-day point prevalence quit rates at 3 and 12 months, biologically confirmed tobacco abstinence at 6-month follow-up, and multiple point-prevalence quit rates based on self-reported tobacco abstinence rates at each follow-up time period. Healthcare utilization and quality

Effects of coffee consumption in chronic hepatitis C: a randomized controlled trial.

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Cardin, Romilda; Piciocchi, Marika; Martines, Diego; Scribano, Laura; Petracco, Marino; Farinati, Fabio

2013-06-01

Coffee is associated with a reduced risk of hepatocellular carcinoma in patients with chronic C hepatitis. This prospective trial was aimed at assessing the mechanisms underlying coffee-related protective effects. Forty patients with chronic hepatitis C were randomized into two groups: the first consumed 4 cups of coffee/day for 30 days, while the second remained coffee "abstinent". At day 30, the groups were switched over for a second month. At baseline, aspartate aminotransferase and alanine aminotransferase were lower in patients drinking 3-5 (Group B) than 0-2 cups/day (Group A) (56 ± 6 vs 74 ± 11/60 ± 3 vs 73 ± 7 U/L p=0.05/p=0.04, respectively). HCV-RNA levels were significantly higher in Group B [(6.2 ± 1.5) × 10(5)vs (3.9 ± 1.0) × 10(5)UI/mL, p=0.05]. During coffee intake, 8-hydroxydeoxyguanosine and collagen levels were significantly lower than during abstinence (15 ± 3 vs 44 ± 16 8-hydroxydeoxyguanosine/10(5)deoxyguanosine, p=0.05 and 56 ± 9 vs 86 ± 21 ng/mL, p=0.04). Telomere length was significantly higher in patients during coffee intake (0.68 ± 0.06 vs 0.48 ± 0.04 Arbitrary Units, p=0.006). Telomere length and 8-hydroxydeoxyguanosine were inversely correlated. In chronic hepatitis C coffee consumption induces a reduction in oxidative damage, correlated with increased telomere length and apoptosis, with lower collagen synthesis, factors that probably mediate the protection exerted by coffee with respect to disease progression. Copyright © 2012 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

A randomized controlled evaluation of the tobacco status project, a Facebook intervention for young adults.

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Ramo, Danielle E; Thrul, Johannes; Delucchi, Kevin L; Hall, Sharon; Ling, Pamela M; Belohlavek, Alina; Prochaska, Judith J

2018-05-24

To test the efficacy of the Tobacco Status Project (TSP) Facebook smoking cessation intervention for young adults relative to referral to an on-line program on biochemically verified 7-day abstinence from smoking. Two-group parallel randomized controlled trial, comparing TSP (n = 251) to on-line control (n = 249) with follow-up to 12 months. On-line, throughout the United States. Young adult cigarette smokers (mean age 21 years; 73% white, 55% female, 87% daily smokers). TSP provided private Facebook groups tailored to stage of change to quit smoking, daily contacts, weekly live counseling sessions, and for those ready to quit, six cognitive behavioral therapy counseling sessions. Some TSP groups were assigned randomly to receive a monetary incentive for engagement. Control provided referral to the National Cancer Institute Smokefree.gov website. PRIMARY OUTCOME: Biochemically verified 7-day abstinence over 12 months. Post-treatment (3-month) abstinence; reported abstinence, quit attempt, reduction in smoking, readiness to quit smoking over 12 months. Verified 7-day abstinence was not significantly different for intervention compared with control over 1 year: month 3 (8.3 versus 3.2%), 6 (6.2 versus 6.0%), and 12 (5.9 versus 10.0%); odds ratio (OR) = 1.07; 95% confidence interval (CI) = 0.23, 4.97; retention = 71%. There was an effect at 3 months (OR = 2.52; CI = 1.56, 4.04; P Facebook smoking cessation intervention did not improve abstinence from smoking over 1 year, but increased abstinence at the end of treatment and was engaging to participants. © 2018 Society for the Study of Addiction.

Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: A pilot randomized clinical trial.

Directory of Open Access Journals (Sweden)

Jose M Trigo

Full Text Available The current lack of pharmacological treatments for cannabis use disorder (CUD warrants novel approaches and further investigation of promising pharmacotherapy. We previously showed that nabiximols (27 mg/ml Δ9-tetrahydrocannabinol (THC/ 25 mg/ml cannabidiol (CBD, Sativex® can decrease cannabis withdrawal symptoms. Here, we assessed in a pilot study the tolerability and safety of self-titrated nabiximols vs. placebo among 40 treatment-seeking cannabis-dependent participants.Subjects participated in a double blind randomized clinical trial, with as-needed nabiximols up to 113.4 mg THC/105 mg CBD or placebo daily for 12 weeks, concurrently with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT. Primary outcome measures were tolerability and abstinence, secondary outcome measures were days and amount of cannabis use, withdrawal, and craving scores. Participants received up to CDN$ 855 in compensation for their time.Medication was well tolerated and no serious adverse events (SAEs were observed. Rates of adverse events did not differ between treatment arms (F1,39 = 0.205, NS. There was no significant change in abstinence rates at trial end. Participants were not able to differentiate between subjective effects associated with nabiximols or placebo treatments (F1,40 = 0.585, NS. Cannabis use was reduced in the nabiximols (70.5% and placebo groups (42.6%. Nabiximols reduced cannabis craving but no significant differences between the nabiximols and placebo groups were observed on withdrawal scores.Nabiximols in combination with MET/CBT was well tolerated and allowed for reduction of cannabis use. Future clinical trials should explore the potential of high doses of nabiximols for cannabis dependence.

Predictors of long-term benzodiazepine abstinence in participants of a randomized controlled benzodiazepine withdrawal program.

NARCIS (Netherlands)

Oude Voshaar, R.C.; Gorgels, W.J.M.J.; Mol, A.J.J.; Balkom, A.J.L.M. van; Mulder, J.; Lisdonk, E.H. van de; Breteler, M.H.M.; Zitman, F.G.

2006-01-01

OBJECTIVE: To identify predictors of resumed benzodiazepine use after participation in a benzodiazepine discontinuation trial. METHOD: We performed multiple Cox regression analyses to predict the long-term outcome of a 3-condition, randomized, controlled benzodiazepine discontinuation trial in

Predictors of long-term benzodiazepine abstinence in participants of a randomized controlled benzodiazepine withdrawal program

NARCIS (Netherlands)

Oude Voshaar, R.C.; Gorgels, W.J.M.J.; Mol, A.J.J.; Balkom, A.J.L.M. van; Mulder, J.; Lisdonk, E.H. van de; Breteler, M.H.M.; Zitman, F.G.

2006-01-01

Objective: To identify predictors of resumed benzodiazepine use after participation in a benzodiazepine discontinuation trial. Method: We performed multiple Cox regression analyses to predict the long-term outcome of a 3-condition, randomized, controlled benzodiazepine discontinuation trial in

Web-Based Aftercare for Women With Bulimia Nervosa Following Inpatient Treatment: Randomized Controlled Efficacy Trial.

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Jacobi, Corinna; Beintner, Ina; Fittig, Eike; Trockel, Mickey; Braks, Karsten; Schade-Brittinger, Carmen; Dempfle, Astrid

2017-09-22

Relapse rates in bulimia nervosa (BN) are high even after successful treatment, but patients often hesitate to take up further treatment. An easily accessible program might help maintain treatment gains. Encouraged by the effects of Web-based eating disorder prevention programs, we developed a manualized, Web-based aftercare program (IN@) for women with BN following inpatient treatment. The objective of this study was to determine the efficacy of the web-based guided, 9-month, cognitive-behavioral aftercare program IN@ for women with BN following inpatient treatment. We conducted a randomized controlled efficacy trial in 253 women with DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, fourth edition) BN and compared the results of IN@ with treatment as usual (TAU). Assessments were carried out at hospital admission (T0), hospital discharge/baseline (T1), postintervention (T2; 9 months after baseline), 9-month follow-up (T3; 18 months after baseline). The primary outcome, abstinence from binge eating and compensatory behaviors during the 2 months preceding T2, was analyzed by intention to treat, using logistic regression analyses. Frequencies of binge eating and vomiting episodes, and episodes of all compensatory behaviors were analyzed using mixed effects models. At T2, data from 167 women were available. There were no significant differences in abstinence rates between the TAU group (n=24, 18.9%) and the IN@ group (n=27, 21.4%; odds ratio, OR=1.29; P=.44). The frequency of vomiting episodes in the IN@ group was significantly (46%) lower than in the TAU group (P=.003). Moderator analyses revealed that both at T2 and T3, women of the intervention group who still reported binge eating and compensatory behaviors after inpatient treatment benefited from IN@, whereas women who were already abstinent after the inpatient treatment did not (P=.004; P=.002). Additional treatment utilization was high in both groups between baseline and follow-up. Overall, data

A pilot randomized clinical trial testing integrated 12-Step facilitation (iTSF) treatment for adolescent substance use disorder.

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Kelly, John F; Kaminer, Yifrah; Kahler, Christopher W; Hoeppner, Bettina; Yeterian, Julie; Cristello, Julie V; Timko, Christine

2017-12-01

The integration of 12-Step philosophy and practices is common in adolescent substance use disorder (SUD) treatment programs, particularly in North America. However, although numerous experimental studies have tested 12-Step facilitation (TSF) treatments among adults, no studies have tested TSF-specific treatments for adolescents. We tested the efficacy of a novel integrated TSF. Explanatory, parallel-group, randomized clinical trial comparing 10 sessions of either motivational enhancement therapy/cognitive-behavioral therapy (MET/CBT; n = 30) or a novel integrated TSF (iTSF; n = 29), with follow-up assessments at 3, 6 and 9 months following treatment entry. Out-patient addiction clinic in the United States. Adolescents [n = 59; mean age = 16.8 (1.7) years; range = 14-21; 27% female; 78% white]. The iTSF integrated 12-Step with motivational and cognitive-behavioral strategies, and was compared with state-of-the-art MET/CBT for SUD. Primary outcome: percentage days abstinent (PDA); secondary outcomes: 12-Step attendance, substance-related consequences, longest period of abstinence, proportion abstinent/mostly abstinent, psychiatric symptoms. Primary outcome: PDA was not significantly different across treatments [b = 0.08, 95% confidence interval (CI) = -0.08 to 0.24, P = 0.33; Bayes' factor = 0.28). during treatment, iTSF patients had substantially greater 12-Step attendance, but this advantage declined thereafter (b = -0.87; 95% CI = -1.67 to 0.07, P = 0.03). iTSF did show a significant advantage at all follow-up points for substance-related consequences (b = -0.42; 95% CI = -0.80 to -0.04, P Step meeting attendance was associated significantly with longer abstinence during (r = 0.39, P = 0.008), and early following (r = 0.30, P = 0.049), treatment. Compared with motivational enhancement therapy/cognitive-behavioral therapy (MET/CBT), in terms of abstinence, a novel integrated 12-Step facilitation treatment for adolescent

Cost-effectiveness of peer-delivered interventions for cocaine and alcohol abuse among women: a randomized controlled trial.

Directory of Open Access Journals (Sweden)

Jennifer Prah Ruger

Full Text Available To determine whether the additional interventions to standard care are cost-effective in addressing cocaine and alcohol abuse at 4 months (4 M and 12 months (12 M from baseline.We conducted a cost-effectiveness analysis of a randomized controlled trial with three arms: (1 NIDA's Standard intervention (SI; (2 SI plus a Well Woman Exam (WWE; and, (3 SI, WWE, plus four Educational Sessions (4ES.To obtain an additional cocaine abstainer, WWE compared to SI cost $7,223 at 4 M and $3,611 at 12 M. Per additional alcohol abstainer, WWE compared to SI cost $3,611 and $7,223 at 4 M and 12 M, respectively. At 12 M, 4ES was dominated (more costly and less effective by WWE for abstinence outcomes.To our knowledge, this is the first cost-effectiveness analysis simultaneously examining cocaine and alcohol abuse in women. Depending on primary outcomes sought and priorities of policy makers, peer-delivered interventions can be a cost-effective way to address the needs of this growing, underserved population.ClinicalTrials.gov NCT01235091.

Effects of exercise on the desire to smoke and physiological responses to temporary smoking abstinence: a crossover trial.

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Roberts, Vaughan; Gant, Nicholas; Sollers, John J; Bullen, Chris; Jiang, Yannan; Maddison, Ralph

2015-03-01

Exercise has been shown to attenuate cigarette cravings during temporary smoking abstinence; however, the mechanisms of action are not clearly understood. The objectives of the study were to compare the effects of three exercise intensities on desire to smoke and explore potential neurobiological mediators of desire to smoke. Following overnight abstinence, 40 participants (25 males, 18-59 years) completed three 15 min sessions of light-, moderate-, or vigorous-intensity exercise on a cycle ergometer in a randomized crossover design. Ratings of desire to smoke were self-reported pre- and post-exercise and heart rate variability was measured throughout. Saliva and blood were analyzed for cortisol and noradrenaline in a sub-sample. Exercise influenced desire to smoke (F [2, 91] = 7.94, p exercise. There were also significant time x exercise intensity interaction effects for heart rate variability and plasma noradrenaline (F [8, 72] = 2.23, p = 0.03), with a bias in noradrenaline occurring between light and vigorous conditions (adjusted mean difference [SE] = 2850 ng/ml [592], p exercise. There was no interaction of time x exercise intensity for plasma and salivary cortisol levels. These findings support the use of vigorous exercise to reduce cigarette cravings, showing potential alterations in a noradrenergic marker.

Trial Protocol: Randomised controlled trial of the effects of very low calorie diet, modest dietary restriction, and sequential behavioural programme on hunger, urges to smoke, abstinence and weight gain in overweight smokers stopping smoking

Directory of Open Access Journals (Sweden)

Hajek Peter

2010-10-01

Full Text Available Abstract Background Weight gain accompanies smoking cessation, but dieting during quitting is controversial as hunger may increase urges to smoke. This is a feasibility trial for the investigation of a very low calorie diet (VLCD, individual modest energy restriction, and usual advice on hunger, ketosis, urges to smoke, abstinence and weight gain in overweight smokers trying to quit. Methods This is a 3 armed, unblinded, randomized controlled trial in overweight (BMI > 25 kg/m2, daily smokers (CO > 10 ppm; with at least 30 participants in each group. Each group receives identical behavioural support and NRT patches (25 mg(8 weeks,15 mg(2 weeks,10 mg(2 weeks. The VLCD group receive a 429-559 kcal/day liquid formula beginning 1 week before quitting and continuing for 4 weeks afterwards. The modest energy restricted group (termed individual dietary and activity planning(IDAP engage in goal-setting and receive an energy prescription based on individual basal metabolic rate(BMR aiming for daily reduction of 600 kcal. The control group receive usual dietary advice that accompanies smoking cessation i.e. avoiding feeling hungry but eating healthy snacks. After this, the VLCD participants receive IDAP to provide support for changing eating habits in the longer term; the IDAP group continues receiving this support. The control group receive IDAP 8 weeks after quitting. This allows us to compare IDAP following a successful quit attempt with dieting concurrently during quitting. It also aims to prevent attrition in the unblinded, control group by meeting their need for weight management. Follow-up occurs at 6 and 12 months. Outcome measures include participant acceptability, measured qualitatively by semi-structured interviewing and quantitatively by recruitment and attrition rates. Feasibility of running the trial within primary care is measured by interview and questionnaire of the treatment providers. Adherence to the VLCD is verified by the presence of

Effectiveness of individually tailored smoking cessation advice letters as an adjunct to telephone counselling and generic self-help materials: randomized controlled trial.

Science.gov (United States)

Sutton, Stephen; Gilbert, Hazel

2007-06-01

To evaluate the effectiveness of individually tailored smoking cessation advice letters as an adjunct to telephone counselling and generic self-help materials. Randomized controlled trial. The UK Quitline. A total of 1508 current smokers and recent ex-smokers. The control group received usual care (telephone counselling and an information pack sent through the post). The intervention group received in addition a computer-generated individually tailored advice letter. All outcomes were assessed at 6-month follow-up. The primary outcome measure was self-reported prolonged abstinence for at least 3 months. Secondary outcomes were self-reported prolonged abstinence for at least 1 month and 7-day and 24-hour point-prevalence abstinence. For the sample as a whole, quit rates did not differ significantly between the two conditions. However, among the majority (n = 1164) who were smokers at baseline, quit rates were consistently higher in the intervention group: prolonged abstinence for 3 months, 12.2% versus 9.0% [odds ratio (OR) = 1.40, 95% confidence interval (CI) = 0.96-2.04, P = 0.080); prolonged abstinence for 1 month, 16.4% versus 11.3% (OR = 1.53, 95% CI = 1.09-2.15, P = 0.013); 7-day point-prevalence abstinence, 18.9% versus 12.7% (OR = 1.59, 95% CI = 1.15-2.19, P = 0.004); 24-hour point-prevalence abstinence, 20.9% versus 15.4% (OR = 1.45, 95% CI = 1.07-1.96, P = 0.015). The results for the smokers are encouraging in showing a small but useful effect of the tailored letter on quit rate. Versions of the tailoring program could be used on the web and in general practices, pharmacies and primary care trusts.

Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

Science.gov (United States)

Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

2012-07-01

Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

Impact of the Choosing the Best Program in Communities Committed to Abstinence Education

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Lisa Lieberman

2012-01-01

Full Text Available States vary in standards for sex education, some requiring an emphasis on abstinence. Schools seek to identify curricula that reflect local community values and meet state standards. Choosing the Best (CTB, a classroom-based abstinence education curriculum, has been implemented in 75 Georgia school districts since 1995. CTB Inc., sought to determine if this popular program had an impact on abstinence attitudes, intentions, and behavior. Six Georgia public schools (1,143 ninth graders participated in the study in 2009-2010. Four randomly assigned schools received the CTB curriculum, taught by trained CTB staff. Two control schools received their usual textbook-based abstinence lessons. Surveys were conducted at the beginning and end of 9th grade, and the beginning of 10th grade. Data demonstrated significant impact of CTB at the end of 9th grade on commitment to abstinence, proabstinence beliefs and attitudes, intentions to maintain abstinence, and lower onset of sexual intercourse, and at the beginning of 10th grade on proabstinence attitudes. In two communities that sought an abstinence education approach, CTB had a short-term impact on abstinence attitudes, commitment, and behaviors, and a longer term impact on abstinence attitudes only.

Effectiveness of intensive practice nurse counselling versus brief general practitioner advice, both combined with varenicline, for smoking cessation: a randomized pragmatic trial in primary care.

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van Rossem, Carolien; Spigt, Mark; Viechtbauer, Wolfgang; Lucas, Annelies E M; van Schayck, Onno C P; Kotz, Daniel

2017-12-01

To study the effectiveness of intensive counselling by a practice nurse (PN) versus brief advice by a general practitioner (GP), each combined with pharmacotherapy, for 6 months' tobacco abstinence (primary outcome). Secondary outcomes included 12-month abstinence, medication adherence and incremental costs per life-year gained. A multi-site (n = 10), two-group, parallel, pragmatic randomized controlled trial. A network of primary health-care centres in the Netherlands. A total of 295 adult daily smokers (mean age = 48 years; mean cigarettes/day = 19). Patients were randomized to receive individual counselling by a practice nurse (PN) (n = 149) or brief advice by a general practitioner (GP) (146). All patients received 12 weeks of open-label varenicline. The primary outcome was prolonged biochemically validated abstinence from weeks 9 to 26 after treatment initiation. Secondary outcomes included abstinence from weeks 9 to 52, good dosing adherence (> 80% days taken) and incremental costs per life-year gained. Abstinence rates in the PN versus GP groups were 32.2% (n = 48) versus 39.0% [n = 57; odds ratio (OR) = 0.71; 95% confidence interval (CI) = 0.44-1.16] from weeks 9 to 26 and 25.5% (n = 38) versus 28.8% (n = 42; OR = 0.84, 95% CI = 0.50-1.43) from weeks 9 to 52, respectively. Values of the Bayes factor indicated that the PN and GP were equally effective. Good dosing adherence was significantly lower in the PN (45.5%, n = 56/123) than in the GP group (62.0%, n = 75/121; OR = 0.45, 95% CI = 0.26-0.77), and the incremental costs per life-year gained were -€416.10. Among people seeking help to stop smoking from their general practice, one-off brief advice from a general practitioner appears to be as effective as several sessions of behavioural support from a practice nurse when smoking cessation medication is provided. © 2017 Society for the Study of Addiction.

Use of an online smoking cessation community promotes abstinence: Results of propensity score weighting.

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Graham, Amanda L; Papandonatos, George D; Erar, Bahar; Stanton, Cassandra A

2015-12-01

We estimated the causal effects of use of an online smoking cessation community on 30-day point prevalence abstinence at 3 months. Participants (N = 492) were adult current smokers in the enhanced Internet arm of The iQUITT Study, a randomized trial of Internet and telephone treatment for smoking cessation. All participants accessed a Web-based smoking-cessation program that included a large, established online community. Automated tracking metrics of passive (e.g., reading forum posts, viewing member profiles) and active (e.g., writing forum posts, sending private messages) community use were extracted from the site at 3 months. Self-selected community use defines the groups of interest: "None," "Passive," and "Both" (passive + active). Inverse probability of treatment weighting corrected for baseline imbalances on demographic, smoking, psychosocial, and medical history variables. Propensity weights estimated via generalized boosted models were used to calculate Average Treatment Effects (ATE) and Average Treatment effects on the Treated (ATT). Patterns of community use were: None = 198 (40.2%), Passive = 110 (22.4%), and Both = 184 (37.4%). ATE-weighted abstinence rates were: None = 4.2% (95% CI = 1.5-6.9); Passive = 15.1% (95% CI = 8.4-21.9); Both = 20.4% (95% CI = 13.9-26.8). ATT-weighted abstinence rates indicated even greater benefits of community use. Community users were more likely to quit smoking at 3 months than nonusers. The estimated benefit from use of online community resources was even larger among subjects with high propensity to use them. No differences in abstinence emerged between passive and passive/active users. Results suggest that lurking in online communities confers specific abstinence benefits. Implications of these findings for online cessation communities are discussed. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

Effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: a randomized controlled trial

Directory of Open Access Journals (Sweden)

Maguy Saffouh El Hajj

2017-02-01

Full Text Available Abstract Background Cigarette smoking is one of the major preventable causes of death and diseases in Qatar. The study objective was to test the effect of a structured smoking cessation program delivered by trained pharmacists on smoking cessation rates in Qatar. Methods A prospective randomized controlled trial was conducted in eight ambulatory pharmacies in Qatar. Eligible participants were smokers 18 years and older who smoked one or more cigarettes daily for 7 days, were motivated to quit, able to communicate in Arabic or English, and attend the program sessions. Intervention group participants met with the pharmacists four times at 2 to 4 week intervals. Participants in the control group received unstructured brief smoking cessation counseling. The primary study outcome was self-reported continuous abstinence at 12 months. Analysis was made utilizing data from only those who responded and also using intent-to-treat principle. A multinomial logistic regression model was fitted to assess the predictors of smoking at 12 months. Analysis was conducted using IBM-SPSS® version 23 and STATA® version 12. Results A total of 314 smokers were randomized into two groups: intervention (n = 167 and control (n = 147. Smoking cessation rates were higher in the intervention group at 12 months; however this difference was not statistically significant (23.9% vs. 16.9% p = 0.257. Similar results were observed but with smaller differences in the intent to treat analysis (12.6% vs. 9.5%, p = 0.391. Nevertheless, the daily number of cigarettes smoked for those who relapsed was significantly lower (by 4.7 and 5.6 cigarettes at 3 and 6 months respectively in the intervention group as compared to the control group (p = 0.041 and p = 0.018 respectively. At 12 months, the difference was 3.2 cigarettes in favor of the intervention group but was not statistically significant (p = 0.246. Years of smoking and daily number of

Effectiveness of Goal-Setting Telephone Follow-Up on Health Behaviors of Patients with Ischemic Stroke: A Randomized Controlled Trial.

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Wan, Li-Hong; Zhang, Xiao-Pei; Mo, Miao-Miao; Xiong, Xiao-Ni; Ou, Cui-Ling; You, Li-Ming; Chen, Shao-Xian; Zhang, Min

2016-09-01

Adopting healthy behaviors is critical for secondary stroke prevention, but many patients fail to follow national guidelines regarding diet, exercise, and abstinence from risk factors. Compliance often decreases with time after hospital discharge, yet few studies have examined programs promoting long-term adherence to health behaviors. Goal setting and telephone follow-up have been proven to be effective in other areas of medicine, so this study evaluated the effectiveness of a guideline-based, goal-setting telephone follow-up program for patients with ischemic stroke. This was a multicenter, assessor-blinded, parallel-group, randomized controlled trial. Ninety-one stroke patients were randomized to either a control group or an intervention group. Intervention consisted of predischarge education and 3 goal-setting follow-up sessions conducted by phone. Data were collected at baseline and during the third and sixth months after hospital discharge. Six months after discharge, patients in the intervention group exhibited significantly higher medication adherence than patients in the control group. There were no statistically significant differences in physical activity, nutrition, low-salt diet adherence, blood pressure monitoring, smoking abstinence, unhealthy use of alcohol, and modified Rankin Scale (mRS) scores between the 2 groups. Goal-setting telephone follow-up intervention for ischemic stroke patients is feasible and leads to improved medication adherence. However, the lack of group differences in other health behavior subcategories and in themRS score indicates a need for more effective intervention strategies to help patients reach guideline-recommended targets. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial.

Science.gov (United States)

Giovancarli, Camille; Malbos, Eric; Baumstarck, Karine; Parola, Nathalie; Pélissier, Marie-Florence; Lançon, Christophe; Auquier, Pascal; Boyer, Laurent

2016-02-19

Successful interventions have been developed for smoking cessation, but the success of smoking relapse prevention interventions has been limited. In particular, cognitive behavioural therapy (CBT) has been hampered by a high relapse rate. Because relapses can be due to the presence of conditions associated with tobacco consumption (such as drinking in bars with friends), virtual reality exposure therapy (VRET) can generate synthetic environments that represent risk situations for the patient in the context of relapse prevention. The primary objective of this study is to evaluate the effectiveness of CBT coupled with VRET, in comparison to CBT alone, in the prevention of smoking relapse. The secondary objectives are to assess the impact of CBT coupled with VRET on anxiety, depression, quality of life, self-esteem and addictive comorbidities (such as alcohol, cannabis, and gambling). A third objective examines the feasibility and acceptability of VR use considering elements such as presence, cybersickness and number of patients who complete the VRET program. The present study is a 14-month (2 months of therapy followed by 12 months of follow-up), prospective, comparative, randomized and open clinical trial, involving two parallel groups (CBT coupled with VRET versus CBT alone). The primary outcome is the proportion of individuals with tobacco abstinence at 6 months after the end of the therapy. Abstinence is defined by the total absence of tobacco consumption assessed during a post-test interview and with an apparatus that measures the carbon monoxide levels expired. A total of 60 individuals per group will be included. This study is the first to examine the efficacy of CBT coupled with VRET in the prevention of smoking relapse. Because VRET is simple to use and has a low cost, this interactive therapeutic method might be easily implemented in clinical practice if the study confirms its efficacy. ClinicalTrials.gov Identifier: NCT02205060 (registered 25 July 2014).

A randomized controlled trial of the therapeutic workplace for community methadone patients: a partial failure to engage.

Science.gov (United States)

Knealing, Todd W; Wong, Conrad J; Diemer, Karly N; Hampton, Jacqueline; Silverman, Kenneth

2006-08-01

The Therapeutic Workplace is an employment-based treatment for drug addiction that uses wages for work to reinforce drug abstinence. The Therapeutic Workplace has promoted abstinence from heroin and cocaine in treatment-resistant mothers in methadone treatment. This study attempted to replicate that effect in crack cocaine users recruited from community-based methadone programs. Participants were randomly assigned to a Therapeutic Workplace (n=22) or usual care control (n=25) group. Therapeutic Workplace participants were invited to work in the workplace and earn vouchers every weekday for 9 months contingent on documented opiate and cocaine abstinence. The two groups did not differ significantly on measures of cocaine or opiate use collected during study participation. Daily attendance and urinalysis results of the Therapeutic Workplace group were analyzed, and only 7 of the 22 participants initiated consistent periods of abstinence and workplace attendance. Two individuals gained access to the workplace on a few days, and 9 participants attempted to gain access to the workplace but never provided a drug-negative urine sample. Possible reasons for differences between the current study and the previous Therapeutic Workplace study are considered. Procedures that increase participant contact with the Therapeutic Workplace and its reinforcement contingencies might increase the likelihood of these individuals being successful in the treatment program.

Treatment seeking as a mechanism of change in a randomized controlled trial of a mobile health intervention to support recovery from alcohol use disorders.

Science.gov (United States)

Glass, Joseph E; McKay, James R; Gustafson, David H; Kornfield, Rachel; Rathouz, Paul J; McTavish, Fiona M; Atwood, Amy K; Isham, Andrew; Quanbeck, Andrew; Shah, Dhavan

2017-06-01

We estimated the efficacy of the Addiction-Comprehensive Health Enhancement Support System (A-CHESS) in increasing the use of services for addiction and examined the extent to which this use of services mediated the effects of A-CHESS on risky drinking days and abstinence from drinking. We conducted secondary data analyses of the A-CHESS randomized controlled trial. Recruitment occurred in five residential treatment programs operated by two addiction treatment organizations. Participants were 349 adults with alcohol use disorders recruited two weeks before discharge from residential treatment. We provided intervention arm participants with a smartphone, the A-CHESS application, and an 8-month service plan. Control arm participants received treatment as usual. Telephone interviews at 4, 8, and 12-month follow-ups assessed past-month risky drinking days, past-month abstinence, and post-discharge service utilization (past-month outpatient addiction treatment and past-week mutual help including Alcoholics Anonymous and Narcotics Anonymous). Using mixed effects latent variable models, we estimated the indirect effects of A-CHESS on drinking outcomes, as mediated by post-discharge service utilization. Approximately 50.5% of participants reported outpatient addiction treatment and 75.5% reported mutual help at any follow-up interview in the year following randomization. Assignment to the A-CHESS intervention was associated with an increased odds of outpatient addiction treatment across follow-ups, but not mutual help. This use of outpatient addiction treatment mediated the effect of A-CHESS on risky drinking days, but not abstinence. The effect of A-CHESS through outpatient addiction treatment appeared to reduce the expected number of risky drinking days across follow-ups by 11%. The mobile health (mHealth) intervention promoted the use of outpatient addiction treatment, which appeared to contribute to its efficacy in reducing risky drinking. Future research should

Computer-assisted delivery of cognitive-behavioral therapy for addiction: a randomized trial of CBT4CBT.

Science.gov (United States)

Carroll, Kathleen M; Ball, Samuel A; Martino, Steve; Nich, Charla; Babuscio, Theresa A; Nuro, Kathryn F; Gordon, Melissa A; Portnoy, Galina A; Rounsaville, Bruce J

2008-07-01

This study evaluated the efficacy of a computer-based version of cognitive-behavioral therapy (CBT) for substance dependence. This was a randomized clinical trial in which 77 individuals seeking treatment for substance dependence at an outpatient community setting were randomly assigned to standard treatment or standard treatment with biweekly access to computer-based training in CBT (CBT4CBT) skills. Treatment retention and data availability were comparable across the treatment conditions. Participants assigned to the CBT4CBT condition submitted significantly more urine specimens that were negative for any type of drugs and tended to have longer continuous periods of abstinence during treatment. The CBT4CBT program was positively evaluated by participants. In the CBT4CBT condition, outcome was more strongly associated with treatment engagement than in treatment as usual; furthermore, completion of homework assignments in CBT4CBT was significantly correlated with outcome and a significant predictor of treatment involvement. These data suggest that CBT4CBT is an effective adjunct to standard outpatient treatment for substance dependence and may provide an important means of making CBT, an empirically validated treatment, more broadly available.

A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The Info Trial Group

DEFF Research Database (Denmark)

Kruse, A Y; Kjaergard, L L; Krogsgaard, K

2000-01-01

To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomized clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about...... and attitude toward randomized clinical trials was assessed in a randomized, parallel group, evaluator-blinded trial among 415 outpatients. The patients were randomized to the following groups: control (no intervention), leaflet, brochure, or booklet. Knowledge was assessed by a 17-item multiple......-choice questionnaire and attitude was assessed by a 32-item Likert questionnaire at entry and 2 weeks after the intervention. The interventions and the questionnaires were pilot tested and power calculations were performed. At entry, the mean knowledge score was 7.9 points. At follow-up, the knowledge scores increased...

Abstinence versus Moderation Goals in Brief Motivational Treatment for Pathological Gambling.

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Stea, Jonathan N; Hodgins, David C; Fung, Tak

2015-09-01

The present study examined the nature and impact of participant goal selection (abstinence versus moderation) in brief motivational treatment for pathological gambling via secondary analyses from a randomized controlled trial. The results demonstrated that the pattern of goal selection over time could be characterized by both fluidity and stability, whereby almost half of participants switched their goal at least one time, over 25% of participants selected an unchanging goal of 'quit most problematic type of gambling', almost 20% selected an unchanging goal of 'quit all types of gambling', and approximately 10% selected an unchanging goal of 'gamble in a controlled manner.' The results also demonstrated that pretreatment goal selection was uniquely associated with three variables, whereby compared to participants who selected the goal to 'cut back on problem gambling', those who selected the goal to 'quit problem gambling' were more likely to have greater gambling problem severity, to have identified video lottery terminal play as problematic, and to have greater motivation to overcome their gambling problem. Finally, the results demonstrated that goal selection over time had an impact on the average number of days gambled over the course of treatment, whereby those with abstinence-based goals gambled significantly fewer days than those with moderation-based goals. Nevertheless, goal selection over time was not related to dollars gambled, dollars per day gambled, or perceived goal achievement. The findings do not support the contention that abstinence-based goals are more advantageous than moderation goals and are discussed in relation to the broader alcohol treatment literature.

A community-engaged randomized controlled trial of an integrative intervention with HIV-positive, methamphetamine-using men who have sex with men

Directory of Open Access Journals (Sweden)

Adam W. Carrico

2016-07-01

Full Text Available Abstract Background Contingency management (CM is an evidence-based intervention providing tangible rewards as positive reinforcement for abstinence from stimulants such as methamphetamine. Integrative approaches targeting affect regulation could boost the effectiveness of CM in community-based settings and optimize HIV/AIDS prevention efforts. Methods/Design This randomized controlled trial with HIV-positive, methamphetamine-using men who have sex with men (MSM is examining the efficacy of a 5-session, individually delivered positive affect regulation intervention – Affect Regulation Treatment to Enhance Methamphetamine Intervention Success (ARTEMIS. ARTEMIS is designed to sensitize individuals to non-drug-related sources of reward as well as assist with managing depression and other symptoms of stimulant withdrawal during CM. HIV-positive, methamphetamine-using MSM who are enrolled in a community-based, 12-week CM program are randomized to receive ARTEMIS or an attention-matched control condition. Follow-up assessments are conducted at 3, 6, 12, and 15 months after enrollment in CM. Four peripheral venous blood samples are collected over the 15-month follow-up with specimen banking for planned biomarker sub-studies. The primary outcome is mean HIV viral load. Secondary outcomes include: sustained HIV viral suppression, T-helper cell count, psychological adjustment, stimulant use, and potentially amplified transmission risk behavior. Discussion Implementation of this randomized controlled trial highlights the importance of delineating boundaries between research activities and community-based service provision. It also provides insights into best practices for integrating the distinct agendas of academic and community partners in clinical research. This trial is currently enrolling and data collection is anticipated to be completed in September of 2018. Trial registration This trial was registered on clinicaltrials.gov ( NCT01926184 on

Trial Protocol: randomised controlled trial of the effects of very low calorie diet, modest dietary restriction, and sequential behavioural programme on hunger, urges to smoke, abstinence and weight gain in overweight smokers stopping smoking.

Science.gov (United States)

Lycett, Deborah; Hajek, Peter; Aveyard, Paul

2010-10-07

Weight gain accompanies smoking cessation, but dieting during quitting is controversial as hunger may increase urges to smoke. This is a feasibility trial for the investigation of a very low calorie diet (VLCD), individual modest energy restriction, and usual advice on hunger, ketosis, urges to smoke, abstinence and weight gain in overweight smokers trying to quit. This is a 3 armed, unblinded, randomized controlled trial in overweight (BMI > 25 kg/m2), daily smokers (CO > 10 ppm); with at least 30 participants in each group. Each group receives identical behavioural support and NRT patches (25 mg(8 weeks),15 mg(2 weeks),10 mg(2 weeks)). The VLCD group receive a 429-559 kcal/day liquid formula beginning 1 week before quitting and continuing for 4 weeks afterwards. The modest energy restricted group (termed individual dietary and activity planning(IDAP)) engage in goal-setting and receive an energy prescription based on individual basal metabolic rate(BMR) aiming for daily reduction of 600 kcal. The control group receive usual dietary advice that accompanies smoking cessation i.e. avoiding feeling hungry but eating healthy snacks. After this, the VLCD participants receive IDAP to provide support for changing eating habits in the longer term; the IDAP group continues receiving this support. The control group receive IDAP 8 weeks after quitting. This allows us to compare IDAP following a successful quit attempt with dieting concurrently during quitting. It also aims to prevent attrition in the unblinded, control group by meeting their need for weight management. Follow-up occurs at 6 and 12 months.Outcome measures include participant acceptability, measured qualitatively by semi-structured interviewing and quantitatively by recruitment and attrition rates. Feasibility of running the trial within primary care is measured by interview and questionnaire of the treatment providers. Adherence to the VLCD is verified by the presence of urinary ketones measured weekly. Daily

Outcomes of the Smoker's Health Project: A Pragmatic Comparative Effectiveness Trial of Tobacco-Dependence Interventions Based on Self-Determination Theory

Science.gov (United States)

Williams, Geoffrey C.; Niemiec, Christopher P.; Patrick, Heather; Ryan, Richard M.; Deci, Edward L.

2016-01-01

A pragmatic comparative effectiveness trial examined whether extending the duration of a cost-effective, intensive tobacco-dependence intervention designed to support autonomy will facilitate long-term tobacco abstinence. Participants were randomly assigned to one of three tobacco-dependence interventions based on self-determination theory,…

A cluster randomized controlled trial of a brief tobacco cessation intervention for low-income communities in India: study protocol.

Science.gov (United States)

Sarkar, Bidyut K; Shahab, Lion; Arora, Monika; Lorencatto, Fabiana; Reddy, K Srinath; West, Robert

2014-03-01

India has 275 million adult tobacco users and tobacco use is estimated to contribute to more than a million deaths in the country each year. There is an urgent need to develop and evaluate affordable, practicable and scalable interventions to promote cessation of tobacco use. Because tobacco use is so harmful, an increase of as little as 1 percentage point in long-term quit success rates can have an important public health impact. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of a brief scalable smoking cessation intervention delivered by trained health professionals as an outreach programme in poor urban communities in India. This is a pragmatic, two-arm, community-based cluster randomized controlled trial focused on tobacco users in low-income communities. The treatment arm is a brief intervention comprising brief advice including training in craving control using simple yogic breathing exercises (BA-YBA) and the control arm is very brief advice (VBA). Of a total of 32 clusters, 16 will be allocated to the intervention arm and 16 to the control arm. Each cluster will have 31 participants, making a total of 992 participants. The primary outcome measure will follow the Russell Standard: self-report of sustained abstinence for at least 6 months following the intervention confirmed at the final follow-up by salivary cotinine. This trial will inform national and international policy on delivery of scalable and affordable brief outreach interventions to promote tobacco use cessation in low resource settings where tobacco users have limited access to physicians and medications. © 2014 Society for the Study of Addiction.

EMPLOYMENT-BASED ABSTINENCE REINFORCEMENT PROMOTES OPIATE AND COCAINE ABSTINENCE IN OUT-OF-TREATMENT INJECTION DRUG USERS

OpenAIRE

Holtyn, August F.; Koffarnus, Mikhail N.; DeFulio, Anthony; Sigurdsson, Sigurdur O.; Strain, Eric C.; Schwartz, Robert P.; Silverman, Kenneth

2014-01-01

We examined the use of employment-based abstinence reinforcement in out-of-treatment injection drug users, in this secondary analysis of a previously reported trial. Participants (N = 33) could work in the therapeutic workplace, a model employment-based program for drug addiction, for 30 weeks and could earn approximately $10 per hr. During a 4-week induction, participants only had to work to earn pay. After induction, access to the workplace was contingent on enrollment in methadone treatmen...

Employment-based abstinence reinforcement following inpatient detoxification in HIV-positive opioid and/or cocaine-dependent patients

OpenAIRE

Dunn, Kelly; Fingerhood, Michael; Wong, Conrad J.; Svikis, Dace S.; Nuzzo, Paul; Silverman, Kenneth

2014-01-01

Employment-based reinforcement interventions have been used to promote abstinence from drugs among chronically unemployed injection drug users. The current study utilized an employment-based reinforcement intervention to promote opiate and cocaine abstinence among opioid-dependent, HIV-positive participants who had recently completed a brief inpatient detoxification. Participants (n=46) were randomly assigned to an Abstinence & Work group that was required to provide negative urine samples in...

Employment-based abstinence reinforcement as a maintenance intervention for the treatment of cocaine dependence: post-intervention outcomes

Science.gov (United States)

DeFulio, Anthony; Silverman, Kenneth

2011-01-01

Aims Due to the chronicity of cocaine dependence, practical and effective maintenance interventions are needed to sustain long-term abstinence. We sought to assess the effects of long-term employment-based reinforcement of cocaine abstinence after discontinuation of the intervention. Design Participants who initiated sustained opiate and cocaine abstinence during a 6-month abstinence reinforcement and training program worked as data entry operators and were randomly assigned to a group that could work independent of drug use (Control, n = 24), or an abstinence-contingent employment (n = 27) group that was required to provide cocaine- and opiate-negative urine samples to work and maintain maximum rate of pay. Setting A nonprofit data entry business. Participants Unemployed welfare recipients who persistently used cocaine while in methadone treatment. Measurements Urine samples and self-reports were collected every six months for 30 months. Findings During the employment year, abstinence-contingent employment participants provided significantly more cocaine-negative samples than controls (82.7% and 54.2%; P = .01, OR = 4.61). During the follow-up year, the groups had similar rates of cocaine-negative samples (44.2% and 50.0%; P = .93), and HIV-risk behaviors. Participants’ social, employment, economic, and legal conditions were similar in the two groups across all phases of the study. Conclusions Employment-based reinforcement effectively maintains long-term cocaine abstinence, but many patients relapse to use when the abstinence contingency is discontinued, even after a year of abstinence-contingent employment. Relapse could be prevented in many patients by leaving employment-based abstinence reinforcement in place indefinitely, which could be facilitated by integrating it into typical workplaces. PMID:21226886

Improving quit rates of web-delivered interventions for smoking cessation: full-scale randomized trial of WebQuit.org versus Smokefree.gov.

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Bricker, Jonathan B; Mull, Kristin E; McClure, Jennifer B; Watson, Noreen L; Heffner, Jaimee L

2018-05-01

Millions of people world-wide use websites to help them quit smoking, but effectiveness trials have an average 34% follow-up data retention rate and an average 9% quit rate. We compared the quit rates of a website using a new behavioral approach called Acceptance and Commitment Therapy (ACT; WebQuit.org) with the current standard of the National Cancer Institute's (NCI) Smokefree.gov website. A two-arm stratified double-blind individually randomized trial (n = 1319 for WebQuit; n = 1318 for Smokefree.gov) with 12-month follow-up. United States. Adults (n = 2637) who currently smoked at least five cigarettes per day were recruited from March 2014 to August 2015. At baseline, participants were mean [standard deviation (SD)] age 46.2 years (13.4), 79% women and 73% white. WebQuit.org website (experimental) provided ACT for smoking cessation; Smokefree.gov website (comparison) followed US Clinical Practice Guidelines for smoking cessation. The primary outcome was self-reported 30-day point prevalence abstinence at 12 months. The 12-month follow-up data retention rate was 88% (2309 of 2637). The 30-day point prevalence abstinence rates at the 12-month follow-up were 24% (278 of 1141) for WebQuit.org and 26% (305 of 1168) for Smokefree.gov [odds ratio (OR) = 0.91; 95% confidence interval (CI) = 0.76, 1.10; P = 0.334] in the a priori complete case analysis. Abstinence rates were 21% (278 of 1319) for WebQuit.org and 23% (305 of 1318) for Smokefree.gov (OR = 0.89 (0.74, 1.07; P = 0.200) when missing cases were imputed as smokers. The Bayes factor comparing the primary abstinence outcome was 0.17, indicating 'substantial' evidence of no difference between groups. WebQuit.org and Smokefree.gov had similar 30-day point prevalence abstinence rates at 12 months that were descriptively higher than those of prior published website-delivered interventions and telephone counselor-delivered interventions. © 2017 Society for the Study of Addiction.

Using Facebook to address smoking and heavy drinking in young adults: Protocol for a randomized, controlled trial.

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Ramo, Danielle E; Kaur, Manpreet; Corpuz, Ella S; Satre, Derek D; Delucchi, Kevin; Brown, Sandra A; Prochaska, Judith J

2018-05-01

Tobacco and alcohol often are used simultaneously by young adults, and their co-use is associated with greater health consequences than from single use. Social media platforms offer low cost and highly accessible channels to reach and engage young people in substance use interventions. The current trial seeks to compare the Facebook Tobacco Status Project (TSP) smoking cessation intervention to an intervention targeting both tobacco use and heavy episodic drinking (TSP + ALC) among young adults who use both substances. This randomized clinical trial will evaluate the feasibility and initial efficacy of TSP + ALC compared to TSP with 225 US young adult smokers reporting heavy drinking. Participants will be recruited online and randomized to one of two conditions (TSP or TSP + ALC), both with assignment to a Facebook group tailored to readiness to quit smoking. Groups will receive a 90-day intervention including daily Facebook postings and weekly live counseling sessions. The TSP + ALC group will include content related to alcohol use. All participants will be offered a 2-week introductory supply of nicotine patch. Participants will complete baseline, 3-, 6-, and 12-month online assessments of substance use and other health risk behaviors. The primary efficacy outcome is biochemically-verified 7-day point prevalence abstinence. Secondary outcomes include alcohol and tobacco use, combined use, and thoughts about each substance. This trial examines an innovative and scalable approach to engaging young adults online in tobacco and alcohol use treatment. Study findings will inform digital health interventions and best practices for treating multiple substance use in young adults. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Effectiveness of smoking-cessation interventions for urban hospital patients: study protocol for a randomized controlled trial

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Grossman Ellie

2012-08-01

Full Text Available Abstract Background Hospitalization may be a particularly important time to promote smoking cessation, especially in the immediate post-discharge period. However, there are few studies to date that shed light on the most effective or cost-effective methods to provide post-discharge cessation treatment, especially among low-income populations and those with a heavy burden of mental illness and substance use disorders. Methods/design This randomized trial will compare the effectiveness and cost-effectiveness of two approaches to smoking cessation treatment among patients discharged from two urban public hospitals in New York City. During hospitalization, staff will be prompted to ask about smoking and to offer nicotine replacement therapy (NRT on admission and at discharge. Subjects will be randomized on discharge to one of two arms: one arm will be proactive multi-session telephone counseling with motivational enhancement delivered by study staff, and the other will be a faxed or online referral to the New York State Quitline. The primary outcome is 30-day point-prevalence abstinence from smoking at 6-month follow-up post-discharge. We will also examine cost-effectiveness from a societal and a payer perspective, as well as explore subgroup analyses related to patient location of hospitalization, race/ethnicity, immigrant status, and inpatient diagnosis. Discussion This study will explore issues of implementation feasibility in a post-hospitalization patient population, as well as add information about the effectiveness and cost-effectiveness of different strategies for designing smoking cessation programs for hospitalized patients. Trial registration Clinicaltrials.gov ID# NCT01363245

Effectiveness of cognitive behavior therapy in tobacco cessation at a dental setting: A hospital-based randomized controlled trial

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A Leena Selvamary

2016-01-01

Full Text Available Introduction: Tobacco use continues to be the leading global cause of preventable death. Dental health professionals play a significant role in the intervention of the tobacco-related epidemic. Aim: The aim of this study was to compare the effectiveness of health education (HE alone and HE with cognitive behavior therapy (CBT at a dental tertiary referral unit of South India. Materials and Methods: Self-reported quit attempt was assessed and the sample size was estimated at 194. Tobacco users who met the inclusion criteria were randomly assigned to one of the two groups - HE only and HE with CBT. Age, sex, socioeconomic status, form of tobacco usage, alcohol usage, addiction and stage of motivation, knowledge, attitude, and behavior regarding tobacco use, and ill effects were assessed at baseline. Follow-up was for 6 months (2nd, 6th, 12th, and 24th weeks to assess reduced use, quit attempt, point prevalence abstinence, continuous abstinence, lapse, relapse, and attrition rates in each visit. The self-reported quit rates were validated using the standardized cotinine test. Pearson's Chi-square test was used to determine the effectiveness of intervention. Results: Continuous abstinence was significantly high in CBT. Reduced use and point prevalence abstinence were significantly higher in HE. Quit attempt in both the groups was equal showing no statistical significance. Attrition was significantly higher in HE compared to CBT. Conclusion: CBT plays a vital role in achieving continuous abstinence, overcoming social factors, and reducing lapse among the tobacco users.

Working Memory Deficits Predict Short-term Smoking Resumption Following Brief Abstinence*

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Patterson, Freda; Jepson, Christopher; Loughead, James; Perkins, Kenneth; Strasser, Andrew A.; Siegel, Steven; Frey, Joseph; Gur, Ruben; Lerman, Caryn

2009-01-01

As many as one-half of smokers relapse in the first week following a quit attempt, and subjective reports of cognitive deficits in early abstinence are associated with increased relapse risk. This study examined whether objective cognitive performance after three days of abstinence predicts smoking resumption in a 7-day simulated quit attempt. Sixty-seven treatment-seeking smokers received either varenicline or placebo (randomized double-blind) for 21 days. Following medication run-up (days 1-10), there was a 3-day mandatory (biochemically confirmed) abstinence period (days 11-13) during which working memory (Letter-N-Back Task) and sustained attention (Continuous Performance Task) were assessed (day 13). Participants were then exposed to a scheduled smoking lapse and instructed to try to remain abstinent for the next 7 days (days 15-21). Poorer cognitive performance (slower correct reaction time on Letter-N-Back task) during abstinence predicted more rapid smoking resumption among those receiving placebo (p=.038) but not among those receiving varenicline. These data lend further support for the growing recognition that cognitive deficits involving working memory are a core symptom of nicotine withdrawal and a potential target for the development of pharmacological and behavioral treatments. PMID:19733449

Electrocardiographic changes associated with smoking and smoking cessation: outcomes from a randomized controlled trial.

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Adam D Gepner

Full Text Available Cardiovascular disease (CVD can be detected and quantified by analysis of the electrocardiogram (ECG; however the effects of smoking and smoking cessation on the ECG have not been characterized.Standard 12-lead ECGs were performed at baseline and 3 years after subjects enrolled in a prospective, randomized, placebo-controlled clinical trial of smoking cessation pharmacotherapies. ECGs were interpreted using the Minnesota Code ECG Classification. The effects of (i smoking burden on the prevalence of ECG findings at baseline, and (ii smoking and smoking cessation on ECG changes after 3 years were investigated by multivariable and multinomial regression analyses.At baseline, 532 smokers were (mean [SD] 43.3 (11.5 years old, smoked 20.6 (7.9 cigarettes/day, with a smoking burden of 26.7 (18.6 pack-years. Major and minor ECG criteria were identified in 87 (16.4% and 131 (24.6% of subjects, respectively. After adjusting for demographic data and known CVD risk factors, higher pack-years was associated with major ECG abnormalities (p = 0.02, but current cigarettes/day (p = 0.23 was not. After 3 years, 42.9% of subjects were abstinent from smoking. New major and minor ECG criteria were observed in 7.2% and 15.6% of subjects respectively, but in similar numbers of abstinent subjects and continuing smokers (p>0.2 for both. Continuing smokers showed significant reduction in current smoking (-8.4 [8.8] cigarettes/day, p<0.001 compared to baseline.In conclusion, major ECG abnormalities are independently associated with lifetime smoking burden. After 3 years, smoking cessation was not associated with a decrease in ECG abnormalities, although cigarettes smoked/day decreased among continuing smokers.

A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

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Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

2014-05-24

The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of

Anterior insula activation during inhibition to smoking cues is associated with ability to maintain tobacco abstinence

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Jodi M. Gilman

2018-06-01

Full Text Available Relapse to smoking after initial abstinence is a major clinical challenge with significant public health consequences. At the brain and behavioral level, those who relapse to tobacco smoking have both greater cue-reactivity and lower inhibitory control than those who remain abstinent. Little is known about neural activation during inhibitory control tasks in the presence of drug-related cues. In the current study, tobacco smokers (SMK; n = 22 and non-smoking controls (CON; n = 19 completed a Go/NoGo task involving smoking cues during a functional magnetic resonance imaging (fMRI scan. Following the scan session, smokers were required to quit smoking, and maintenance of abstinence was evaluated as part of a 12-week smoking cessation trial. We evaluated pre-cessation brain activity during NoGo trials in smokers who were versus were not able to quit smoking. We then compared fMRI and inhibitory control measures between smokers and non-smokers. We did not find differences between SMK and CON in performance or activation to smoking or neutral cues. However, compared to SMK who relapsed, SMK who attained biochemically-validated abstinence at the end of the smoking cessation trial had greater neural activation in the anterior insula during NoGo trials specifically with smoking-related cues. Results indicate that within SMK, decreased inhibitory control activation during direct exposure to drug-related stimuli may be a marker of difficulty quitting and relapse vulnerability. Keywords: Smoking cessation, Tobacco, fMRI, Insula, Cue, Relapse, Anterior cingulate cortex, ACC

Gratitude, abstinence, and alcohol use disorders: Report of a preliminary finding.

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Krentzman, Amy R

2017-07-01

Gratitude is a central component of addiction recovery for many, yet it has received scant attention in addiction research. In a sample of 67 individuals entering abstinence-based alcohol-use-disorder treatment, this study employed gratitude and abstinence variables from sequential assessments (baseline, 6months, 12months) to model theorized causal relationships: gratitude would increase pre-post treatment and gratitude after treatment would predict greater percent days abstinent 6months later. Neither hypothesis was supported. This unexpected result led to the theory that gratitude for sobriety was the construct of interest; therefore, the association between gratitude and future abstinence would be positive among those already abstinent. Thus, post-treatment abstinence was tested as a moderator of the effect of gratitude on future abstinence: this effect was statistically significant. For those who were abstinent after treatment, the relationship between gratitude and future abstinence was positive; for those drinking most frequently after treatment, the relationship between gratitude and future abstinence was negative. In this preliminary study, dispositional tendency to affirm that there is much to be thankful for appeared to perpetuate the status quo-frequent drinkers with high gratitude were drinking frequently 6months later; abstinent individuals with high gratitude were abstinent 6months later. Gratitude exercises might be contraindicated for clients who are drinking frequently and have abstinence as their treatment goal. Copyright © 2017 Elsevier Inc. All rights reserved.

Hypnotherapy is more effective than nicotine replacement therapy for smoking cessation: results of a randomized controlled trial.

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Hasan, Faysal M; Zagarins, Sofija E; Pischke, Karen M; Saiyed, Shamila; Bettencourt, Ann Marie; Beal, Laura; Macys, Diane; Aurora, Sanjay; McCleary, Nancy

2014-02-01

The efficacy of pharmacotherapy for smoking cessation is well documented. However, due to relapse rates and side effects, hypnotherapy is gaining attention as an alternative treatment option. The aim of this one-center randomized study was to compare the efficacy of hypnotherapy alone, as well as hypnotherapy with nicotine replacement therapy (NRT), to conventional NRT in patients hospitalized with a cardiac or pulmonary illness. We evaluated self-reported and biochemically verified 7-day prevalence smoking abstinence rates at 12 and 26 weeks post-hospitalization. Patients (n=164) were randomized into one of three counseling-based treatment groups: NRT for 30 days (NRT; n=41), a 90-min hypnotherapy session (H; n=39), and NRT with hypnotherapy (HNRT; n=37). Treatment groups were compared to a "self-quit" group of 35 patients who refused intervention. Hypnotherapy patients were more likely than NRT patients to be nonsmokers at 12 weeks (43.9% vs. 28.2%; p=0.14) and 26 weeks after hospitalization (36.6% vs. 18.0%; p=0.06). Smoking abstinence rates in the HNRT group were similar to the H group. There was no difference in smoking abstinence rates at 26 weeks between "self quit" and participants in any of the treatment groups. In multivariable regression analysis adjusting for diagnosis and demographic characteristics, H and HNRT were over three times more likely than NRT participants to abstain at 26-weeks post-discharge (RR=3.6; p=0.03 and RR=3.2; p=0.04, respectively). Hypnotherapy is more effective than NRT in improving smoking abstinence in patients hospitalized for a smoking-related illness, and could be an asset to post-discharge smoking cessation programs. Copyright © 2014 Elsevier Ltd. All rights reserved.

A randomized factorial trial of disulfiram and contingency management to enhance cognitive behavioral therapy for cocaine dependence.

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Carroll, Kathleen M; Nich, Charla; Petry, Nancy M; Eagan, Dorothy A; Shi, Julia M; Ball, Samuel A

2016-03-01

This study evaluated the extent to which the addition of disulfiram and contingency management for adherence and abstinence (CM), alone and in combination, might enhance the effects of cognitive behavioral therapy (CBT) for cocaine use disorders. Factorial randomized double blind (for medication condition) clinical trial where CBT served as the platform and was delivered in weekly individual sessions in a community-based outpatient clinic. 99 outpatients who met DSM-IV criteria for current cocaine dependence were assigned to receive either disulfiram or placebo, and either CM or no CM. Cocaine and other substance use was assessed via a daily calendar with thrice weekly urine sample testing for 12 weeks with a one-year follow-up (80% interviewed at one year). The primary hypothesis that CM and disulfiram would produce the best cocaine outcomes was not confirmed, nor was there a main effect for disulfiram. For the primary outcome (percent days of abstinence, self report), there was a significant interaction, with the best cocaine outcomes were seen for the combination of CM and placebo, with the two groups assigned to disulfiram associated with intermediate outcomes, and poorest cocaine outcome among those assigned to placebo and no CM. The secondary outcome (urinalysis) indicated a significant effect favoring CM over no CM but the interaction effect was not significant. One year follow-up data indicated sustained treatment effects across conditions. CM enhances outcomes for CBT treatment of cocaine dependence, but disulfiram provided no added benefit to the combination of CM and CBT. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

A randomized controlled trial of stage-matched intervention for smoking cessation in cardiac out-patients.

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Chan, Sophia S C; Leung, Doris Y P; Wong, David C N; Lau, Chu-Pak; Wong, Vivian T; Lam, Tai-Hing

2012-04-01

To examine the effectiveness of a stage-matched smoking cessation counselling intervention for smokers who had cardiac diseases. A total of 1860 Chinese cardiac patients who smoked at least one cigarette in the past 7 days and aged 18 years or above recruited from cardiac out-patient clinics in Hong Kong hospitals were allocated randomly to an intervention group or control group. The intervention group (n = 938) received counselling matched with their stage of readiness to quit by trained counsellors at baseline, 1 week and 1 month. The control group (n = 922) received brief counselling on healthy diet at baseline. The primary outcomes were self-reported 7-day and 30-day point prevalence (PP) of tobacco abstinence at 12 months after baseline. The secondary outcome measures included biochemically validated abstinence at 12-month follow-up, self-reported 7-day and 30-day PP abstinence and reduction of cigarette consumption by 50% at 3 and 6 months. By intention-to-treat analysis, the intervention and control groups showed no significant difference in self-reported 7-day PP abstinence (intervention: 26.5% versus control: 25.5%; P = 0.60) and 30-day PP (intervention: 25.4% versus control: 24.2%; P = 0.55), biochemically validated abstinence (intervention: 6.6% versus control: 4.9%; P = 0.14) and overall quit attempts of least 24 hours (intervention: 40.3% versus control: 34.3%; P = 0.007) at the 12-month follow-up, adjusted for the baseline stage of readiness to quit smoking. An intervention, based on the Stages of Change model, to promote smoking cessation in cardiac patients in China failed to find any long-term benefit. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

A web application for moderation training: Initial results of a randomized clinical trial1

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Hester, Reid K.; Delaney, Harold D.; Campbell, William; Handmaker, Nancy

2009-01-01

Eighty four heavy drinkers who responded to a newspaper recruitment ad were randomly assigned to receive either: a) training in a moderate drinking protocol via an Internet-based program (www.moderatedrinking.com) and use of the online resources of Moderation Management (MM) (www.moderation.org) or b) use of the online resources of MM alone. Follow-ups are being conducted at 3, 6, and 12 months. Results of the recently completed 3 month follow-up (86% follow-up) indicated both groups significantly reduced their drinking based on these variables: standard drinks per week; percent days abstinent; and mean BAC per drinking day. Both groups also significantly reduced their alcohol-related problems. Relative to the control group the experimental group had better outcomes on percent days abstinent and log Drinks per Drinking Day. These short-term outcome data provide evidence for the effectiveness of both the moderate drinking web application and of the resources available online at MM in helping heavy drinkers reduce their drinking and alcohol-related problems. PMID:19339137

A reinforcement-based therapeutic workplace for the treatment of drug abuse: six-month abstinence outcomes.

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Silverman, K; Svikis, D; Robles, E; Stitzer, M L; Bigelow, G E

2001-02-01

This study evaluated a novel drug abuse treatment, the Therapeutic Workplace. In this treatment, patients are paid to perform jobs or to participate in job training. Salary is linked to abstinence by requiring patients to provide drug-free urine samples to gain access to the workplace. Pregnant and postpartum drug abuse patients (N = 40) were randomly assigned to a Therapeutic Workplace or usual care control group. Therapeutic Workplace participants were invited to work 3 hr every weekday for 6 months and could earn up to $4,030 in vouchers for abstinence, workplace attendance, and performance. On average, 45% of participants attended the workplace per day. Relative to controls, the Therapeutic Workplace nearly doubled patients' abstinence from opiates and cocaine (33% vs. 59% of thrice-weekly urine samples drug negative, respectively, p Workplace can effectively treat heroin and cocaine abuse in pregnant and postpartum women.

Effects of resistance exercise on the HPA axis response to psychological stress during short-term smoking abstinence in men.

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Ho, Jen-Yu; Kraemer, William J; Volek, Jeff S; Vingren, Jakob L; Fragala, Maren S; Flanagan, Shawn D; Maladouangdock, Jesse; Szivak, Tunde K; Hatfield, Disa L; Comstock, Brett A; Dunn-Lewis, Courtenay; Ciccolo, Joseph T; Maresh, Carl M

2014-03-01

The purpose of this study was to examine the effects of resistance exercise on the hypothalamic-pituitary-adrenal axis (HPA) response to mental challenge, withdrawal symptoms, urge to smoke, and cognitive stress during 24-hour smoking abstinence. 8 sedentary smokers (mean±SD age: 20.1±1.7y; height: 171.6±10.8cm; body mass: 70.4±12.0kg; smoking history: 2.9±0.8y) completed a 24-hour ad libitum smoking trial (SMO) followed by two 24-hour smoking abstinence trials. During abstinence trials, participants performed six whole body resistance exercises (EX) or a control condition (CON) in the morning, followed by mental challenge tasks in the afternoon. Plasma adrenocorticotropin hormone (ACTH), and salivary and serum cortisol were measured during each visit at rest (REST), and then before (PRE-EX), immediately after (IP-EX), and 30min after exercise (30-EX); and before (PRE-MC), immediately after (IP-MC), and 30min after mental challenge (30-MC). Resistance exercise significantly (p≤0.05) elevated plasma ACTH and serum cortisol at IP-EX during EX compared with SMO and CON trials. Resting ACTH, salivary and serum cortisol concentrations at Pre-MC did not differ between EX and CON trials. The HPA axis response to mental challenge was similar after EX and CON trials. Finally, resistance exercise did not reduce withdrawal symptoms, urge to smoke, or stress. Resistance exercise did not substantially alter resting HPA hormones or the HPA response to mental challenge tasks during 24h of smoking abstinence. © 2013.

Safety of Reiki Therapy for Newborns at Risk for Neonatal Abstinence Syndrome

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Wright-Esber, Sandra; Zupancic, Julie; Gargiulo, Deb; Woodall, Patricia

2018-01-01

The incidence of opioid abuse and subsequent drug withdrawal is exponentially on the rise in the United States for many populations including newborns who are born to drug-addicted mothers. These newborns often exhibit symptoms of neonatal abstinence syndrome (NAS) within 24 to 72 hours of birth. Treatment of NAS includes monitoring of withdrawal symptoms, managing physiological parameters, and the use of supportive and pharmacologic treatments. Although a few randomized controlled trials exist, studies on supportive intervention are generally limited by small sample sizes, case study reports, expert opinions, and descriptive design. Few studies address the safety of Reiki for newborns at risk for NAS using neonatal parameters. This pilot study addresses feasibility and demonstrates that Reiki is safe when administered to this high-risk population. Considerations for future studies are discussed. PMID:29315084

Mobile access to virtual randomization for investigator-initiated trials.

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Deserno, Thomas M; Keszei, András P

2017-08-01

Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization

Effect of a Brief Memory Updating Intervention on Smoking Behavior: A Randomized Clinical Trial.

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Germeroth, Lisa J; Carpenter, Matthew J; Baker, Nathaniel L; Froeliger, Brett; LaRowe, Steven D; Saladin, Michael E

2017-03-01

Recent research on addiction-related memory processes suggests that protracted extinction training following brief cue-elicited memory retrieval (ie, retrieval-extinction [R-E] training) can attenuate/eradicate the ability of cues to elicit learned behaviors. One study reported that cue-elicited craving among detoxified heroin addicts was substantially attenuated following R-E training and through 6-month follow-up. To build on these impressive findings by examining whether R-E training could attenuate smoking-related craving and behavior. This prospective, mixed-design, human laboratory randomized clinical trial took place between December 2013 and September 2015. Participants were recruited in Charleston, South Carolina. Study sessions took place at the Medical University of South Carolina. The participants were 168 screened volunteer smokers, of whom 88 were randomized; 72 of these 88 participants (81.8%) attended all the follow-up sessions through 1 month. The primary eligibility criteria were current nicotine dependence (DSM criteria), smoking 10 or more cigarettes per day, and a willingness to attempt smoking cessation. Participants were randomly assigned to receive either smoking-related memory retrieval followed by extinction training (the R-E group) or nonsmoking-related retrieval followed by extinction training (the NR-E group). Primary outcomes were cue-elicited craving and physiological responding to familiar and novel cues in the R-E group vs the NR-E group over a 1-month follow-up period. Secondary outcomes were smoking-related behaviors. A total of 44 participants were randomly assigned to the R-E group (mean age, 48.3 years; 72.7% male); a total of 44 participants were randomly assigned to the NR-E group, with 43 attending at least 1 training session (mean age, 46.7 years; 55.8% male). The mean craving response to both familiar and novel smoking cues was significantly lower for participants in the R-E group than for participants in the NR-E group at

A randomized controlled trial of smartphone-based mindfulness training for smoking cessation: a study protocol.

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Garrison, Kathleen A; Pal, Prasanta; Rojiani, Rahil; Dallery, Jesse; O'Malley, Stephanie S; Brewer, Judson A

2015-04-14

Tobacco use is responsible for the death of about 1 in 10 individuals worldwide. Mindfulness training has shown preliminary efficacy as a behavioral treatment for smoking cessation. Recent advances in mobile health suggest advantages to smartphone-based smoking cessation treatment including smartphone-based mindfulness training. This study evaluates the efficacy of a smartphone app-based mindfulness training program for improving smoking cessation rates at 6-months follow-up. A two-group parallel-randomized clinical trial with allocation concealment will be conducted. Group assignment will be concealed from study researchers through to follow-up. The study will be conducted by smartphone and online. Daily smokers who are interested in quitting smoking and own a smartphone (n = 140) will be recruited through study advertisements posted online. After completion of a baseline survey, participants will be allocated randomly to the control or intervention group. Participants in both groups will receive a 22-day smartphone-based treatment program for smoking. Participants in the intervention group will receive mobile mindfulness training plus experience sampling. Participants in the control group will receive experience sampling-only. The primary outcome measure will be one-week point prevalence abstinence from smoking (at 6-months follow-up) assessed using carbon monoxide breath monitoring, which will be validated through smartphone-based video chat. This is the first intervention study to evaluate smartphone-based delivery of mindfulness training for smoking cessation. Such an intervention may provide treatment in-hand, in real-world contexts, to help individuals quit smoking. Clinicaltrials.gov NCT02134509 . Registered 7 May 2014.

The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

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Scardino Peter T

2009-03-01

Full Text Available Abstract Introduction Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients on- and off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization.

Designing a smoking cessation intervention for the unique needs of homeless persons: a community-based randomized clinical trial.

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Goldade, Kate; Whembolua, Guy-Lucien; Thomas, Janet; Eischen, Sara; Guo, Hongfei; Connett, John; Des Jarlais, Don; Resnicow, Ken; Gelberg, Lillian; Owen, Greg; Grant, Jon; Ahluwalia, Jasjit S; Okuyemi, Kolawole S

2011-12-01

Although smoking prevalence remains strikingly high in homeless populations (~70% and three times the US national average), smoking cessation studies usually exclude homeless persons. Novel evidence-based interventions are needed for this high-risk subpopulation of smokers. To describe the aims and design of a first-ever smoking cessation clinical trial in the homeless population. The study was a two-group randomized community-based trial that enrolled participants (n = 430) residing across eight homeless shelters and transitional housing units in Minnesota. The study objective was to test the efficacy of motivational interviewing (MI) for enhancing adherence to nicotine replacement therapy (NRT; nicotine patch) and smoking cessation outcomes. Participants were randomized to one of the two groups: active (8 weeks of NRT + 6 sessions of MI) or control (NRT + standard care). Participants attended six in-person assessment sessions and eight retention visits at a location of their choice over 6 months. Nicotine patch in 2-week doses was administered at four visits over the first 8 weeks of the 26-week trial. The primary outcome was cotinine-verified 7-day point-prevalence abstinence at 6 months. Secondary outcomes included adherence to nicotine patch assessed through direct observation and patch counts. Other outcomes included the mediating and/or moderating effects of comorbid psychiatric and substance abuse disorders. Lessons learned from the community-based cessation randomized trial for improving recruitment and retention in a mobile and vulnerable population included: (1) the importance of engaging the perspectives of shelter leadership by forming and convening a Community Advisory Board; (2) locating the study at the shelters for more visibility and easier access for participants; (3) minimizing exclusion criteria to allow enrollment of participants with stable psychiatric comorbid conditions; (4) delaying the baseline visit from the eligibility visit by a week

A preliminary randomized controlled trial of a behavioral exercise intervention for smoking cessation.

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Abrantes, Ana M; Bloom, Erika Litvin; Strong, David R; Riebe, Deborah; Marcus, Bess H; Desaulniers, Julie; Fokas, Kathryn; Brown, Richard A

2014-08-01

Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation. The preliminary efficacy of a behavioral exercise intervention that incorporated features designed to address prior limitations was tested in a randomized controlled trial (RCT). Sixty-one smokers (65.6% female, mean age = 47.3 years, smoked a mean of 19.7 cigarettes/day) were randomized to receive either a 12-week exercise intervention or a 12-week health education contact control. Participants in both conditions received an 8-week telephone-delivered, standard smoking cessation protocol (with the transdermal nicotine patch). Follow-ups were conducted at the end of treatment (EOT), 6- and 12-month timepoints. There were no differences between conditions with respect to the number of weekly exercise or health education sessions attended (9.3±2.8 vs. 9.3±3.0, respectively). While not statistically significant, participants in the exercise condition demonstrated higher verified abstinence rates (EOT: 40% vs. 22.6%, odds ratio [OR] = 2.28; 6- and 12-month follow-ups: 26.7% vs. 12.9%, OR = 2.46). Irrespective of treatment condition, higher levels of moderate-to-vigorous exercise were associated with lower levels of depressive symptoms during the intervention. The results of this small RCT point toward the benefit of a behavioral exercise intervention designed to address previous methodological limitations for smoking cessation. Given the potential public health impact of the demonstrated efficacy of exercise for smoking cessation, the continued development and optimization of exercise interventions for smokers through larger RCTs merits pursuit. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Evaluating the Flipped Classroom: A Randomized Controlled Trial

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Wozny, Nathan; Balser, Cary; Ives, Drew

2018-01-01

Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…

Drug Metabolizing Enzyme and Transporter Gene Variation, Nicotine Metabolism, Prospective Abstinence, and Cigarette Consumption.

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Andrew W Bergen

Full Text Available The Nicotine Metabolite Ratio (NMR, ratio of trans-3'-hydroxycotinine and cotinine, has previously been associated with CYP2A6 activity, response to smoking cessation treatments, and cigarette consumption. We searched for drug metabolizing enzyme and transporter (DMET gene variation associated with the NMR and prospective abstinence in 2,946 participants of laboratory studies of nicotine metabolism and of clinical trials of smoking cessation therapies. Stage I was a meta-analysis of the association of 507 common single nucleotide polymorphisms (SNPs at 173 DMET genes with the NMR in 449 participants of two laboratory studies. Nominally significant associations were identified in ten genes after adjustment for intragenic SNPs; CYP2A6 and two CYP2A6 SNPs attained experiment-wide significance adjusted for correlated SNPs (CYP2A6 PACT=4.1E-7, rs4803381 PACT=4.5E-5, rs1137115, PACT=1.2E-3. Stage II was mega-regression analyses of 10 DMET SNPs with pretreatment NMR and prospective abstinence in up to 2,497 participants from eight trials. rs4803381 and rs1137115 SNPs were associated with pretreatment NMR at genome-wide significance. In post-hoc analyses of CYP2A6 SNPs, we observed nominally significant association with: abstinence in one pharmacotherapy arm; cigarette consumption among all trial participants; and lung cancer in four case:control studies. CYP2A6 minor alleles were associated with reduced NMR, CPD, and lung cancer risk. We confirmed the major role that CYP2A6 plays in nicotine metabolism, and made novel findings with respect to genome-wide significance and associations with CPD, abstinence and lung cancer risk. Additional multivariate analyses with patient variables and genetic modeling will improve prediction of nicotine metabolism, disease risk and smoking cessation treatment prognosis.

A self-determination multiple risk intervention trial to improve smokers' health.

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Williams, Geoffrey C; McGregor, Holly; Sharp, Daryl; Kouldes, Ruth W; Lévesque, Chantal S; Ryan, Richard M; Deci, Edward L

2006-12-01

Little is known about how interventions motivate individuals to change multiple health risk behaviors. Self-determination theory (SDT) proposes that patient autonomy is an essential factor for motivating change. An SDT-based intervention to enhance autonomous motivation for tobacco abstinence and improving cholesterol was tested. The Smokers' Health Study is a randomized multiple risk behavior change intervention trial. Smokers were recruited to a tobacco treatment center. A total of 1.006 adult smokers were recruited between 1999 and 2002 from physician offices and by newspaper advertisements. A 6-month clinical intervention (4 contacts) to facilitate internalization of autonomy and perceived competence for tobacco abstinence and reduced percent calories from fat was compared with community care. Clinicians elicited patient perspectives and life strivings, provided absolute coronary artery disease risk estimates,enumerated effective treatment options, supported patient initiatives,minimized clinician control, assessed motivation for change, and developed a plan for change. Twelve-month prolonged tobacco abstinence, and change in percent calories from fat and low-density lipoprotein-cholesterol (LDL-C) from baseline to 18 months. RESULTS- Intention to treat analyses revealed that the intervention significantly increased 12-month prolonged tobacco abstinence (6.2% vs 2.4%; odds ratio [OR]=2.7, P=.01, number needed to treat [NNT] =26), and reduced LDL-C (-8.9 vs -4.1 mg/dL; P=.05). There was no effect on percent calories from fat. An intervention focused on supporting smokers'autonomy was effective in increasing prolonged tobacco abstinence and lowering LDL-C. Clinical interventions for behavior change may be improved by increasing patient autonomy and perceived competence.

Electronic prompts significantly increase response rates to postal questionnaires: a randomized trial within a randomized trial and meta-analysis.

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Clark, Laura; Ronaldson, Sarah; Dyson, Lisa; Hewitt, Catherine; Torgerson, David; Adamson, Joy

2015-12-01

To assess the effectiveness of sending electronic prompts to randomized controlled trial participants to return study questionnaires. A "trial within a trial" embedded within a study determining the effectiveness of chronic obstructive pulmonary disease (DOC) screening on smoking cessation. Those participants taking part in DOC who provided a mobile phone number and/or an electronic mail address were randomized to either receive an electronic prompt or no electronic prompt to return a study questionnaire. The results were combined with two previous studies in a meta-analysis. A total of 437 participants were randomized: 226 to the electronic prompt group and 211 to the control group. A total of 285 (65.2%) participants returned the follow-up questionnaire: 157 (69.5%) in the electronic prompt group and 128 (60.7%) in the control group [difference 8.8%; 95% confidence interval (CI): -0.11%, 17.7%; P = 0.05]. The mean time to response was 23 days in the electronic prompt group and 33 days in the control group (hazard ratio = 1.27; 95% CI: 1.105, 1.47). The meta-analysis of all three studies showed an increase in response rate of 7.1% (95% CI: 0.8%, 13.3%). The use of electronic prompts increased response rates and reduces the time to response. Copyright © 2015 Elsevier Inc. All rights reserved.

Anxiety and depressed mood decline following smoking abstinence in adult smokers with Attention Deficit Hyperactivity Disorder

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Covey, Lirio S.; Hu, Mei-Chen; Winhusen, Theresa; Lima, Jennifer; Berlin, Ivan; Nunes, Edward

2015-01-01

Introduction A preponderance of relevant research has indicated reduction in anxiety and depressive symptoms following smoking abstinence. This secondary analysis investigated whether the phenomenon extends to smokers with attention deficit hyperactivity disorder (ADHD). Methods The study setting was an 11-Week double-blind placebo-controlled randomized trial of osmotic release oral system methylphenidate (OROS-MPH) as a cessation aid when added to nicotine patch and counseling. Participants were 255 adult smokers with ADHD. The study outcomes are: anxiety (Beck Anxiety Inventory (BAI)) and depressed mood (Beck Depression Inventory II (BDI)) measured one Week and six Weeks after a target quit day (TQD). The main predictor is point - prevalence abstinence measured at Weeks 1 and 6 after TQD. Covariates are treatment (OROS-MPH vs placebo), past major depression, past anxiety disorder, number of cigarettes smoked daily, demographics (age, gender, education, marital status) and baseline scores on the BAI, BDI, and the DSM-IV ADHD Rating Scale. Results Abstinence was significantly associated with lower anxiety ratings throughout the post-quit period (p<0.001). Depressed mood was lower for abstainers than non-abstainers at Week 1 (p<0.05), but no longer at Week 6 (p=0.83). Treatment with OROS-MPH relative to placebo showed significant reductions at Week 6 after TQD for both anxiety (p<0.05) and depressed mood (p<0.001), but not at Week 1. Differential abstinence effects of gender were observed. Anxiety and depression ratings at baseline predicted increased ratings of corresponding measures during the post-quit period. Conclusion Stopping smoking yielded reductions in anxiety and depressed mood in smokers with ADHD treated with nicotine patch and counseling. Treatment with OROS-MPH yielded mood reductions in delayed manner. PMID:26272693

Web-based cognitive behavioral relapse prevention program with tailored feedback for people with methamphetamine and other drug use problems: protocol for a multicenter randomized controlled trial in Japan.

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Takano, Ayumi; Miyamoto, Yuki; Kawakami, Norito; Matsumoto, Toshihiko; Shinozaki, Tomohiro; Sugimoto, Takashi

2016-04-04

Despite the effectiveness of psychosocial programs for recovery from drug use problems, there have been challenges in implementation of treatment. Internet-based and computerized approaches have been known to be effective in treatment dissemination. The study purpose is to assess the effects of a web-based psychosocial relapse prevention program with a multicenter randomized controlled trial. Recruitment began in January 2015 for outpatient participants diagnosed with drug abuse or dependence who have used a primary abused drug in the past year at psychiatric hospitals and a clinic. Participants are randomized either to a web-based relapse prevention program or a self-monitoring group. The intervention is a web-based relapse prevention program named "e-SMARPP" that consists of six relapse prevention program modules with tailored feedback from health care professionals and 8 weeks of self-monitoring. The content is adapted from a face-to-face relapse prevention program which is based on cognitive behavioral therapy and motivational enhancement. The primary outcomes are relapse risk assessed by the Stimulant Relapse Risk Scale (baseline, 2-, 5- and 8-month) and the longest duration of consecutive abstinent days from primary abused drug during the intervention. Secondary outcomes will include motivation to change, self-efficacy for drug use and craving, abstinent days in the past 28 or 56 days, quality of life, sense of coherence, cost of substance use, medical cost, retention of treatment and use of self-help group. Completion, usability and satisfaction of the program will be also assessed to explore feasibility. This study protocol was approved by the Ethics Committee of The University of Tokyo and each recruiting hospital and clinic. To our knowledge, this study is the first clinical trial to assess the effects of a web-based therapeutic program for drug users in Japan. If successful, this program is a promising approach for drug user treatment in Japan, where the

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial.

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Graham, Amanda L; Burke, Michael V; Jacobs, Megan A; Cha, Sarah; Croghan, Ivana T; Schroeder, Darrell R; Moriarty, James P; Borah, Bijan J; Rasmussen, Donna F; Brookover, M Jody; Suesse, Dale B; Midthun, David E; Hays, J Taylor

2017-11-28

Delivering effective tobacco dependence treatment that is feasible within lung cancer screening (LCS) programs is crucial for realizing the health benefits and cost savings of screening. Large-scale trials and systematic reviews have demonstrated that digital cessation interventions (i.e. web-based and text message) are effective, sustainable over the long-term, scalable, and cost-efficient. Use of digital technologies is commonplace among older adults, making this a feasible approach within LCS programs. Use of cessation treatment has been improved with models that proactively connect smokers to treatment rather than passive referrals. Proactive referral to cessation treatment has been advanced through healthcare systems changes such as modifying the electronic health record to automatically link smokers to treatment. This study evaluates the impact of a proactive enrollment strategy that links LCS-eligible smokers with an evidence-based intervention comprised of a web-based (WEB) program and integrated text messaging (TXT) in a three-arm randomized trial with repeated measures at one, three, six, and 12 months post randomization. The primary outcome is biochemically confirmed abstinence at 12 months post randomization. We will randomize 1650 smokers who present for a clinical LCS to: (1) a usual care control condition (UC) which consists of Ask-Advise-Refer; (2) a digital (WEB + TXT) cessation intervention; or (3) a digital cessation intervention combined with tobacco treatment specialist (TTS) counseling (WEB + TXT + TTS). The scalability and sustainability of a digital intervention may represent the most cost-effective and feasible approach for LCS programs to proactively engage large numbers of smokers in effective cessation treatment. We will also evaluate the impact and cost-effectiveness of adding proven clinical intervention provided by a TTS. We expect that a combined digital/clinical intervention will yield higher quit rates than digital

Effectiveness of Short Message Service Text-Based Smoking Cessation Intervention Among University Students: A Randomized Clinical Trial.

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Müssener, Ulrika; Bendtsen, Marcus; Karlsson, Nadine; White, Ian R; McCambridge, Jim; Bendtsen, Preben

2016-03-01

Smoking is globally the most important preventable cause of ill health and death. Mobile telephone interventions and, in particular, short message service (SMS) text messaging, have the potential to overcome access barriers to traditional health services, not least among young people. To determine the effectiveness of a text-based smoking cessation intervention among young people. A single-blind, 2-arm, randomized clinical trial (Nicotine Exit [NEXit]) was conducted from October 23, 2014, to April 17, 2015; data analysis was performed from April 23, 2014, to May 22, 2015. Participants included daily or weekly smokers willing to set a quit date within 1 month of enrollment. The study used email to invite all college and university students throughout Sweden to participate. The NEXit core program is initiated with a 1- to 4-week motivational phase during which participants can choose to set a stop date. The intervention group then received 157 text messages based on components of effective smoking cessation interventions for 12 weeks. The control group received 1 text every 2 weeks thanking them for participating in the study, with delayed access to the intervention. The primary outcomes were self-reported prolonged abstinence (not having smoked >5 cigarettes over the past 8 weeks) and 4-week point prevalence of complete smoking cessation shortly after the completion of the intervention (approximately 4 months after the quit date). A total of 1590 participants, mainly between 21 and 30 years of age, were randomized into the study; 827 (573 [69.3%] women) were allocated to the intervention group and 763 (522 [68.4%] women) were included in the control group. Primary outcome data were available for 783 (94.7%) of the intervention group and 719 (94.2%) of the control group. At baseline, participants were smoking a median (range) of 63 (1-238) and 70 (2-280) cigarettes per week, respectively. Eight-week prolonged abstinence was reported by 203 participants (25.9%) in the

The transitive fallacy for randomized trials: If A bests B and B bests C in separate trials, is A better than C?

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Kramer Barnett S

2002-11-01

Full Text Available Abstract Background If intervention A bests B in one randomized trial, and B bests C in another randomized trial, can one conclude that A is better than C? The problem was motivated by the planning of a randomized trial, where A is spiral-CT screening, B is x-ray screening, and C is no screening. On its surface, this would appear to be a straightforward application of the transitive principle of logic. Methods We extended the graphical approach for omitted binary variables that was originally developed to illustrate Simpson's paradox, applying it to hypothetical, but plausible scenarios involving lung cancer screening, treatment for gastric cancer, and antibiotic therapy for clinical pneumonia. Results Graphical illustrations of the three examples show different ways the transitive fallacy for randomized trials can arise due to changes in an unobserved or unadjusted binary variable. In the most dramatic scenario, B bests C in the first trial, A bests B in the second trial, but C bests A at the time of the second trial. Conclusion Even with large sample sizes, combining results from a previous randomized trial of B versus C with results from a new randomized trial of A versus B will not guarantee correct inference about A versus C. A three-arm trial of A, B, and C would protect against this problem and should be considered when the sequential trials are performed in the context of changing secular trends in important omitted variables such as therapy in cancer screening trials.

Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

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Paul P Christopher

Full Text Available Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials.This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50, and willingness to participate in the clinical trial.154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female; 74 (48.1% had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004 in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017. Willingness to participate in the hypothetical trial was not significantly different (p = 0.603 between intervention (52.1%, 95% CI [40.2% to 62.4%] and control (56.3%, 95% CI [45.3% to 66.6%] groups.An enhanced educational intervention augmenting

Randomized cross-over trial of short-term water-only fasting: metabolic and cardiovascular consequences.

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Horne, B D; Muhlestein, J B; Lappé, D L; May, H T; Carlquist, J F; Galenko, O; Brunisholz, K D; Anderson, J L

2013-11-01

Routine, periodic fasting is associated with a lower prevalence of coronary artery disease (CAD). Animal studies show that fasting may increase longevity and alter biological parameters related to longevity. We evaluated whether fasting initiates acute changes in biomarker expression in humans that may impact short- and long-term health. Apparently-healthy volunteers (N = 30) without a recent history of fasting were enrolled in a randomized cross-over trial. A one-day water-only fast was the intervention and changes in biomarkers were the study endpoints. Bonferroni correction required p ≤ 0.00167 for significance (p fasting intervention acutely increased human growth hormone (p = 1.1 × 10⁻⁴), hemoglobin (p = 4.8 × 10⁻⁷), red blood cell count (p = 2.5 × 10⁻⁶), hematocrit (p = 3.0 × 10⁻⁶), total cholesterol (p = 5.8 × 10⁻⁵), and high-density lipoprotein cholesterol (p = 0.0015), and decreased triglycerides (p = 1.3 × 10⁻⁴), bicarbonate (p = 3.9 × 10⁻⁴), and weight (p = 1.0 × 10⁻⁷), compared to a day of usual eating. For those randomized to fast the first day (n = 16), most factors including human growth hormone and cholesterol returned to baseline after the full 48 h, with the exception of weight (p = 2.5 × 10⁻⁴) and (suggestively significant) triglycerides (p = 0.028). Fasting induced acute changes in biomarkers of metabolic, cardiovascular, and general health. The long-term consequences of these short-term changes are unknown but repeated episodes of periodic short-term fasting should be evaluated as a preventive treatment with the potential to reduce metabolic disease risk. Clinical trial registration (ClinicalTrials.gov): NCT01059760 (Expression of Longevity Genes in Response to Extended Fasting [The Fasting and Expression of Longevity Genes during Food abstinence {FEELGOOD} Trial]). Copyright © 2012 Elsevier B.V. All rights reserved.

Drug Stroop: Mechanisms of response to computerized cognitive behavioral therapy for cocaine dependence in a randomized clinical trial.

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DeVito, Elise E; Kiluk, Brian D; Nich, Charla; Mouratidis, Maria; Carroll, Kathleen M

2018-02-01

Poor performance on Drug Stroop tasks, which could indicate attentional bias to drug-related cues, craving, poor cognitive control (including poor response inhibition), has been associated with substance use severity, treatment retention and substance use treatment outcomes. Cognitive Behavioral Therapy (CBT) focuses on training in appraisal and coping strategies, including strategies to minimize the negative impact of triggers and coping with drug-cue-induced craving. One mechanism of action of CBT may be the strengthening of cognitive control processes and reduction of attentional bias to drug-related stimuli. Methadone-maintained individuals with cocaine-use disorders, participating in a randomized controlled trial of treatment as usual (TAU) versus TAU plus access to computer-based CBT (CBT4CBT), completed a computerized Drug Stroop task at pre- and post-treatment. Analyses determined whether attentional bias toward drug-related stimuli changed differentially by treatment group or cocaine use outcomes across the treatment period and whether engagement in components of CBT4CBT or TAU treatment related to changes in attentional bias toward drug-related stimuli at post- versus pre-treatment. Participants achieving a longer duration of cocaine abstinence during treatment (3+ weeks) showed greater reductions in Drug Stroop Effect than those with shorter maximum continuous abstinence. Reductions in Drug Stroop Effect across treatment were associated with greater engagement with CBT4CBT-specific treatment components, but not TAU-specific treatment components. Reduction in attentional bias to drug-related cues and craving and/or improved executive cognitive control and response inhibition may contribute to the mechanism of action of CBT4CBT. Copyright © 2017 Elsevier B.V. All rights reserved.

Acupuncture for alcohol withdrawal: a randomized controlled trial.

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Trümpler, François; Oez, Suzan; Stähli, Peter; Brenner, Hans Dieter; Jüni, Peter

2003-01-01

Previous trials on acupuncture in alcohol addiction were in outpatients and focused on relapse prevention. Rates of dropout were high and interpretation of results difficult. We compared auricular laser and needle acupuncture with sham laser stimulation in reducing the duration of alcohol withdrawal. Inpatients undergoing alcohol withdrawal were randomly allocated to laser acupuncture (n = 17), needle acupuncture (n = 15) or sham laser stimulation (n = 16). Attempts were made to blind patients, therapists and outcome assessors, but this was not feasible for needle acupuncture. The duration of withdrawal symptoms (as assessed using a nurse-rated scale) was the primary outcome; the duration of sedative prescription was the secondary outcome. Patients randomized to laser and sham laser had identical withdrawal symptom durations (median 4 days). Patients randomized to needle stimulation had a shorter duration of withdrawal symptoms (median 3 days; P = 0.019 versus sham intervention), and tended to have a shorter duration of sedative use, but these differences diminished after adjustment for baseline differences. The data from this pilot trial do not suggest a relevant benefit of auricular laser acupuncture for alcohol withdrawal. A larger trial including adequate sham interventions is needed, however, to reliably determine the effectiveness of any type of auricular acupuncture in this condition.

The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial

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William F. Clark

2017-08-01

Full Text Available Background: In observational studies, drinking more water associates with a slower rate of kidney function decline; whether the same is true in a randomized controlled trial is unknown. Objective: To examine the 1-year effect of a higher vs usual water intake on estimated glomerular filtration rate (eGFR in patients with chronic kidney disease. Design: Parallel-group randomized controlled trial. Setting: Nine centers in Ontario, Canada. Enrollment and randomization occurred between May 2013 and May 2016; follow-up for the primary outcome will continue until June 2017. Participants: Adults (n = 631 with stage 3 chronic kidney disease (eGFR 30-60 mL/min/1.73 m 2 and microalbuminuria. Intervention: The high water intake group was coached to increase their oral water intake by 1.0 to 1.5 L/day (depending on sex and weight, over and above usual consumed beverages, for a period of 1 year. The control group was coached to maintain their usual water intake during this time. Measures: Participants provided 24-hour urine samples at baseline and at 6 and 12 months after randomization; urine samples were analyzed for volume, creatinine, osmolality, and the albumin-to-creatinine ratio. Blood samples were obtained at baseline and at 3- to 6-month intervals after randomization, and analyzed for creatinine, copeptin, osmolality, and electrolytes. Other measures collected included health-related quality of life, blood pressure, body mass index, and diet. Primary outcome: The between-group change in eGFR from baseline (prerandomization to 12 months after randomization. Secondary outcomes: Change in plasma copeptin concentration, 24-hour urine albumin-to-creatinine ratio, measured creatinine clearance, estimated 5-year risk of kidney failure (using the 4-variable Kidney Failure Risk Equation, and health-related quality of life. Planned analysis: The primary analysis will follow an intention-to-treat approach. The between-group change in eGFR will be compared using

A randomized controlled trial of directive and nondirective smoking cessation coaching through an employee quitline

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Walton Sumner

2016-07-01

Full Text Available Abstract Background Telephone quitlines can help employees quit smoking. Quitlines typically use directive coaching, but nondirective, flexible coaching is an alternative. Call-2-Quit used a worksite-sponsored quitline to compare directive and nondirective coaching modes, and evaluated employee race and income as potential moderators. Methods An unblinded randomized controlled trial compared directive and nondirective telephone coaching by trained laypersons. Participants were smoking employees and spouses recruited through workplace smoking cessation campaigns in a hospital system and affiliated medical school. Coaches were four non-medical women trained to use both coaching modes. Participants were randomized by family to coaching mode. Participants received up to 7 calls from coaches who used computer assisted telephone interview software to track topics and time. Outcomes were reported smoking abstinence for 7 days at last contact, 6 or 12 months after coaching began. Both worksites implemented new tobacco control policies during the study. Results Most participants responded to an insurance incentive introduced at the hospital. Call-2-Quit coached 518 participants: 22 % were African-American; 45 % had incomes below $30,000. Income, race, and intervention did not affect coaching completion rates. Cessation rates were comparable with directive and nondirective coaching (26 % versus 30 % quit, NS. A full factorial logistic regression model identified above median income (odds ratio = 1.8, p = 0.02, especially among African Americans (p = 0.04, and recent quit attempts (OR = 1.6, p = 0.03 as predictors of cessation. Nondirective coaching was associated with high cessation rates among subgroups of smokers reporting income above the median, recent quit attempts, or use of alternative therapies. Waiting up to 4 weeks to start coaching did not affect cessation. Of 41 highly addicted or depressed smokers who had never quit

Prospective, randomized, controlled trial using best-selling smoking-cessation book.

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Foshee, James P; Oh, Anita; Luginbuhl, Adam; Curry, Joseph; Keane, William; Cognetti, David

2017-07-01

Our prospective, randomized, controlled trial aimed to evaluate the efficacy of the self-help book, The Easy Way to Stop Smoking, by Allen Carr, in promoting smoking cessation in patients with head and neck cancer. We assessed active smokers for their willingness to read a smoking cessation book. Participants were randomized to either receive the book from our department or recommended to purchase the book. All patients received smoking cessation counseling at recruitment. Phone surveys were conducted at short- and long-term intervals to determine if the patients had purchased and/or read the book and whether they were still smoking. One hundred twelve patients were recruited, 52 of whom completed follow-up surveys. Those who received the book for free were more likely to read the book (p = 0.05). Reading the book did not correlate with successful smoking cessation (p = 0.81). Some 26% of the 27 patients who received the book quit smoking compared with 32% of the 25 patients who were recommended the book (p = 0.76). Patients who indicated motivation to quit smoking were more likely to succeed. In our study, smoking cessation did not appear to be influenced by reading The Easy Way to Stop Smoking. Despite 80.8% of the cohort indicating at least a readiness to quit smoking at recruitment, only 28.8% of patients managed to achieve successful smoking cessation at long-term follow-up. Patient motivation remains an important factor in achieving long-term smoking abstinence. Quitting smoking remains a daunting challenge for patients, with multiple interventions likely needed to achieve cessation.

AA Attendance and Abstinence for Dually Diagnosed Patients: A Meta-Analytic Review.

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Scott Tonigan, J; Pearson, Matthew R; Magill, Molly; Hagler, Kylee J

2018-05-29

There is consensus that best clinical practice for dual diagnosis (DD) is integrated mental health and substance use treatment augmented with Alcoholics Anonymous (AA) attendance. This is the first quantitative review of the direction and magnitude of the association between AA attendance and alcohol abstinence for DD patients. A systematic literature search (1993-2017) identified 22 studies yielding 24 effect sizes that met our inclusion criteria (8,075 patients). Inverse-variance weighting of correlation coefficients (r) was used to aggregate sample-level findings and study aims were addressed using random and mixed effect models. Sensitivity and publication bias analyses were conducted to assess the likelihood of bias in the overall estimate of AA-related benefit. AA exposure and abstinence for DD patients were significantly and positively associated (r w =.249; 95% CI.203-.293; Tau=.097). There was also significant heterogeneity in the distribution of effect sizes, (Q(23)=90.714, pAA-related benefit did not differ between 6 (k=7) and 12 (k=12) month follow-up, (Q=.068, pAA benefit was not adversely or substantively impacted by pooling RCT and observational samples (Q=.763, pAA (Q=.023, pAA) is common and, in many cases, DD patients who attend AA will report higher rates of alcohol abstinence relative to DD patients who do not attend AA. This article is protected by copyright. All rights reserved.

Melatonin for sedative withdrawal in older patients with primary insomnia: a randomized double-blind placebo-controlled trial

Science.gov (United States)

Lähteenmäki, Ritva; Puustinen, Juha; Vahlberg, Tero; Lyles, Alan; Neuvonen, Pertti J; Partinen, Markku; Räihä, Ismo; Kivelä, Sirkka-Liisa

2014-01-01

Aim We compared the efficacy of melatonin and placebo as adjuvants in the withdrawal of patients from long term temazepam, zopiclone or zolpidem (here ‘BZD’) use. Methods A double-blind, placebo-controlled, randomized trial was conducted in a primary health care outpatient clinic. Ninety-two men or women (≥55 years) with primary insomnia and chronic BZD use received controlled release melatonin 2 mg (CRM) (n = 46) or placebo (n = 46) during the 1 month withdrawal from BZDs. Psychosocial support was provided. Follow-up continued for up to 6 months. Successful BZD withdrawal by the end of 1 month was confirmed by BZD plasma determinations, while reduction in BZD use and abstinence continuing for 6 months were noted. Results There were two drop-outs on CRM and one on placebo. After a 1 month withdrawal, 31 participants (67%; 95% CI 54, 81) on CRM and 39 (85%; 74, 95) on placebo had withdrawn completely (intention-to-treat analysis between groups, P = 0.051; per protocol P = 0.043). Reduction in BZD use was similar or even more rare in the CRM than in the placebo group (P = 0.052 per protocol). After 6 months, 14 participants in the CRM group and 20 in the placebo group remained non-users of BZD (NS between groups). BZD doses were higher in the CRM than in the placebo group at the end of the 6 month follow-up (P = 0.025). Withdrawal symptoms did not differ between the groups. Conclusions Gradual dose reduction of BZDs combined with CRM or placebo, and psychosocial support produced high short term and moderate long term BZD abstinence. CRM showed no withdrawal benefit compared with placebo. PMID:24286360

Functional impairments for outcomes in a randomized trial of unruptured brain AVMs

NARCIS (Netherlands)

Mohr, J.P.; Overbey, J.R.; Kummer, R. von; Stefani, M.A.; Libman, R.; Stapf, C.; Parides, M.K.; Pile-Spellman, J.; Moquete, E.; Moy, C.S.; Vicaut, E.; Moskowitz, A.J.; Harkness, K.; Cordonnier, C.; Biondi, A.; Houdart, E.; Berkefeld, J.; Klijn, C.J.M.; Barreau, X.; Kim, H.; Hartmann, A.

2017-01-01

OBJECTIVE: To investigate the effects of medical vs interventional management on functional outcome in A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA). METHODS: We used the initial results of a nonblinded, randomized, controlled, parallel-group trial involving adults >/=18

Functional impairments for outcomes in a randomized trial of unruptured brain AVMs

NARCIS (Netherlands)

Mohr, J P; Overbey, Jessica R; von Kummer, Ruediger; Stefani, Marco A; Libman, Richard; Stapf, Christian; Parides, Michael K; Pile-Spellman, John; Moquete, Ellen; Moy, Claudia S; Vicaut, Eric; Moskowitz, Alan J; Harkness, Kirsty; Cordonnier, Charlotte; Biondi, Alessandra; Houdart, Emmanuel; Berkefeld, Joachim; Klijn, Karin J M; Barreau, Xavier; Kim, Helen; Hartmann, Andreas; van Dijk, J. Marc C.; Luijckx, Gert Jan

2017-01-01

OBJECTIVE: To investigate the effects of medical vs interventional management on functional outcome in A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA). METHODS: We used the initial results of a nonblinded, randomized, controlled, parallel-group trial involving adults ≥18

A theory-based video messaging mobile phone intervention for smoking cessation: randomized controlled trial.

Science.gov (United States)

Whittaker, Robyn; Dorey, Enid; Bramley, Dale; Bullen, Chris; Denny, Simon; Elley, C Raina; Maddison, Ralph; McRobbie, Hayden; Parag, Varsha; Rodgers, Anthony; Salmon, Penny

2011-01-21

Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones. This social cognitive theory-based intervention (called "STUB IT") used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques. The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation. A randomized controlled trial was conducted with 6-month follow-up. Participants had to be 16 years of age or over, be current daily smokers, be ready to quit, and have a video message-capable phone. Recruitment targeted younger adults predominantly through radio and online advertising. Registration and data collection were completed online, prompted by text messages. The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date, role model, and timing of messages. Extra messages were available on demand to beat cravings and address lapses. The control group also set a quit date and received a general health video message sent to their phone every 2 weeks. The target sample size was not achieved due to difficulty recruiting young adult quitters. Of the 226 randomized participants, 47% (107/226) were female and 24% (54/226) were Maori (indigenous population of New Zealand). Their mean age was 27 years (SD 8.7), and there was a high level of nicotine addiction. Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8). Feedback from participants indicated that the support provided by the video role models was important and appreciated. This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone. However, there was

[Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial].

Science.gov (United States)

Rozenberg, P; Deruelle, P; Sénat, M-V; Desbrière, R; Winer, N; Simon, E; Ville, Y; Kayem, G; Boutron, I

2018-04-01

The data from literature show that trial of labor and elective repeat cesarean delivery after a prior cesarean delivery both present significant risks and benefits, and these risks and benefits differ for the woman and her fetus. The benefits to the woman can be at the expense of her fetus and vice-versa. This uncertainty is compounded by the scarcity of high-level evidence that preclude accurate quantification of the risks and benefits that could help provide a fair counseling about a trial of labor and elective repeat cesarean delivery. An interesting way of research is to evaluate the potential benefits of a decision rule associated to the ultrasound measurement of the lower uterine segment (LUS). Indeed, ultrasonography may be helpful in determining a specific risk for a given patient by measuring the thickness of the LUS, i,e, the thickness of the cesarean delivery scar area. Although only small and often methodologically biased data have been published, they look promising as their results are concordant: ultrasonographic measurements of the LUS thickness is highly correlated with the intraoperative findings at cesarean delivery. Furthermore, the thinner the LUS becomes on ultrasound, the higher the likelihood of a defect in the LUS. Finally, ultrasound assessment of LUS has an excellent negative predictive value for the risk of uterine defect. Therefore, this exam associated with a rule of decision could help to reduce the rate of elective repeat cesarean delivery and especially to reduce the fetal and maternal mortality and morbidity related to trial of labor after a prior cesarean delivery. This is a pragmatic open multicenter randomized trial with two parallel arms. Randomization will be centralized and computerized. Since blindness is impossible, an adjudication committee will evaluate the components of the primary composite outcome in order to avoid evaluation bias. An interim analysis will be planned mid-strength of the trial. Ultrasound will be

A systematic review of the usage of flow diagram in cluster randomized trials

Directory of Open Access Journals (Sweden)

Kostić M.

2014-01-01

Full Text Available Flow diagram represent an integral part of consolidated standards of reporting trials (CONSORT. Its use in reporting cluster randomization trials is highly recommended. The aim of this article is to present frequency of the use of flow diagram in cluster randomized trials in accordance with standards of reporting. The team has researched Medline database and singled-out 474 studies with cluster randomization for analysis. The studies were reviewed to identify the use of graphic representation, compliance with standards of reporting and the date when study was published. Depending from its duration, studies were divided on completed, and those still ongoing. Usage of CONSORT is recorded in 145 (31% literature units. Frequency of flow diagram was statistically much higher in studies which were in compliance with standards (86,2%, in comparison to those which did not use CONSORT guidelines (71,4%, as well as in completed studies (81,2% in comparison to pilot project studies (54,3%. Number of cluster randomized trials gathered through MEDLINE's search of key words 'cluster randomized trial [ti]' and 'cluster randomised trial [ti]', as well as the use of CONSORT in the reports of cluster randomized trials, are showing linear growth over time (p<0,001. Frequency of flow diagram is higher in the reports of cluster randomized trials that were done in accordance with the standards of reporting.

Web-based screening and brief intervention for poly-drug use among teenagers: study protocol of a multicentre two-arm randomized controlled trial.

Science.gov (United States)

Arnaud, Nicolas; Bröning, Sonja; Drechsel, Magdalena; Thomasius, Rainer; Baldus, Christiane

2012-09-26

Mid to late adolescence is characterised by a vulnerability to problematic substance use since the consumption of alcohol and illicit drugs is frequently initiated and increased in this life period. While the detrimental long- and short-term effects of problematic consumption patterns in adolescence pose a major public health concern, current prevention programs targeting alcohol- and other substance-using adolescents are scarce. The study described in this protocol will test the effectiveness of a web-based brief intervention aimed at reducing problematic alcohol use and promoting abstinence from illegal drugs in adolescents with risky substance use aged 16 to 18 years old in four EU-countries. To determine the effectiveness of our web-BI, we apply a two-arm randomized controlled trial (RCT) study design, with baseline assessment at study entry and a three month follow-up assessment. Adolescents aged 16 to 18 years from Belgium, the Czech Republic, Germany, and Sweden will be randomly assigned to either the fully electronically delivered brief intervention group (N = 400) or an assessment only control group (N = 400) depending on their screening for risky substance use (using the CRAFFT). Recruitment, informed consent, randomization, intervention and follow-up will be implemented online. Primary outcomes are reductions in frequency and quantity of use of alcohol and drugs other than alcohol over a 30 day period, as well as consumption per typical occasion. Secondary outcomes concern changes in substance use related cognitions including the constructs of the Theory of Planned Behaviour, implementation intentions, and stages of change. Moreover the study addresses a number of moderator variables, including age of first use, general psychopathology and quality of parent-child relationship. The trial is expected to contribute to the growing literature on theory- and web-based brief interventions for adolescents. We will explore the potential of using web

Maximizing scientific knowledge from randomized clinical trials

DEFF Research Database (Denmark)

Gustafsson, Finn; Atar, Dan; Pitt, Bertram

2010-01-01

Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly vari...

Cannabis abstinence during treatment and one-year follow-up: relationship to neural activity in men.

Science.gov (United States)

Kober, Hedy; DeVito, Elise E; DeLeone, Cameron M; Carroll, Kathleen M; Potenza, Marc N

2014-09-01

Cannabis is among the most frequently abused substances in the United States. Cognitive control is a contributory factor in the maintenance of substance-use disorders and may relate to treatment response. Therefore, we assessed whether cognitive-control-related neural activity before treatment differs between treatment-seeking cannabis-dependent and healthy individuals and relates to cannabis-abstinence measures during treatment and 1-year follow-up. Cannabis-dependent males (N=20) completed a functional magnetic resonance imaging (fMRI) cognitive-control (Stroop) task before a 12-week randomized controlled trial of cognitive-behavioral therapy and/or contingency management. A healthy-comparison group (N=20) also completed the fMRI task. Cannabis use was assessed by urine toxicology and self-report during treatment, and by self-report across a 1-year follow-up period (N=18). The cannabis-dependent group displayed diminished Stroop-related neural activity relative to the healthy-comparison group in multiple regions, including those strongly implicated in cognitive-control and addiction-related processes (eg, dorsolateral prefrontal cortex and ventral striatum). The groups did not differ significantly in response times (cannabis-dependent, N=12; healthy-comparison, N=14). Within the cannabis-dependent group, greater Stroop-related activity in regions including the dorsal anterior cingulate cortex was associated with less cannabis use during treatment. Greater activity in regions including the ventral striatum was associated with less cannabis use during 1-year posttreatment follow-up. These data suggest that lower cognitive-control-related neural activity in classic 'control' regions (eg, dorsolateral prefrontal cortex and dorsal anterior cingulate) and classic 'salience/reward/learning' regions (eg, ventral striatum) differentiates cannabis-dependent individuals from healthy individuals and relates to less abstinence within-treatment and during long-term follow

Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

DEFF Research Database (Denmark)

Kreiner, Frederik; Galbo, Henrik

2010-01-01

To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR....

Abstinent adult daily smokers show reduced anticipatory but elevated saccade-related brain responses during a rewarded antisaccade task.

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Geier, Charles F; Sweitzer, Maggie M; Denlinger, Rachel; Sparacino, Gina; Donny, Eric C

2014-08-30

Chronic smoking may result in reduced sensitivity to non-drug rewards (e.g., money), a phenomenon particularly salient during abstinence. During a quit attempt, this effect may contribute to biased decision-making (smoking>alternative reinforcers) and relapse. Although relevant for quitting, characterization of reduced reward function in abstinent smokers remains limited. Moreover, how attenuated reward function affects other brain systems supporting decision-making has not been established. Here, we use a rewarded antisaccade (rAS) task to characterize non-drug reward processing and its influence on inhibitory control, key elements underlying decision-making, in abstinent smokers vs. non-smokers. Abstinent (12-hours) adult daily smokers (N=23) and non-smokers (N=11) underwent fMRI while performing the rAS. Behavioral performances improved on reward vs. neutral trials. Smokers showed attenuated activation in ventral striatum during the reward cue and in superior precentral sulcus and posterior parietal cortex during response preparation, but greater responses during the saccade response in posterior cingulate and parietal cortices. Smokers' attenuated anticipatory responses suggest reduced motivation from monetary reward, while heightened activation during the saccade response suggests that additional circuitry may be engaged later to enhance inhibitory task performance. Overall, this preliminary study highlights group differences in decision-making components and the utility of the rAS to characterize these effects. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy

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Vickers Andrew J

2012-02-01

Full Text Available Abstract Background Numerous technical modifications to radical prostatectomy have been proposed. Such modifications are likely to lead to only slight improvements in outcomes. Although small differences would be worthwhile, an appropriately powered randomized trial would need to be very large, and thus of doubtful feasibility given the expense, complexity and regulatory burden of contemporary clinical trials. We have proposed a novel methodology, the clinically-integrated randomized trial, which dramatically streamlines trial procedures in order to reduce the marginal cost of an additional patient towards zero. We aimed to determine the feasibility of implementing such a trial for radical prostatectomy. Methods Patients undergoing radical prostatectomy as initial treatment for prostate cancer were randomized in a factorial design to involvement of the fascia during placement of the anastomotic sutures, urethral irrigation, both or neither. Endpoint data were obtained from routine clinical documentation. Accrual and compliance rates were monitored to determine the feasibility of the trial. Results From a total of 260 eligible patients, 154 (59% consented; 56 patients declined to participate, 20 were not approached on recommendation of the treating surgeon, and 30 were not approached for logistical reasons. Although recording by surgeons of the procedure used was incomplete (~80%, compliance with randomization was excellent when it was recorded, with only 6% of procedures inconsistent with allocation. Outcomes data was received from 71% of patients at one year. This improved to 83% as the trial progressed. Conclusions A clinically-integrated randomized trial was conducted at low cost, with excellent accrual, and acceptable compliance with treatment allocation and outcomes reporting. This demonstrates the feasibility of the methodology. Improved methods to ensure documentation of surgical procedures would be required before wider implementation

The impact of adolescent binge drinking and sustained abstinence on affective state.

Science.gov (United States)

Bekman, Nicole M; Winward, Jennifer L; Lau, Lily L; Wagner, Chase C; Brown, Sandra A

2013-08-01

While it is clear that affect is negatively impacted by heavy drinking in adulthood and that it improves with abstinence, little is known about effects of heavy drinking on mood during adolescence. This study examined negative mood states among 2 groups of 16- to 18-year-old high school students; youth with a history of recent heavy episodic drinking (HED; n = 39) and comparison youth with limited lifetime drinking experience (CON; n = 26). Affect was assessed at 3 time points during a 4- to 6-week period of monitored abstinence using the Hamilton Rating Scales for Anxiety and Depression; self-reports were obtained with the state portion of the State-Trait Anxiety Inventory, and experience sampling of current affect was assessed via daily text messages sent at randomly determined times in the morning, afternoon, and evening. Youth with a recent history of HED reported more negative affect compared with nondrinking youth during early stages of abstinence (days since last HED at assessment 1: M = 6.46; SD = 5.06); however, differences in affect were not observed after 4 to 6 weeks of abstinence. Sex differences were evident, with HED girls reporting greater depression and anxiety than HED male peers. Although not significant, response patterns indicated that boys may experience faster resolution of negative emotional states than girls with sustained abstinence. Findings suggest that high-dose drinking is associated with elevated negative affect for adolescents and that negative mood states may take longer to resolve for girls than for boys following heavy drinking episodes. Future research clarifying naturally occurring changes in affective response during early and sustained abstinence is necessary for improving programs designed to promote adolescent decision-making and to reduce risk for relapse. Copyright © 2013 by the Research Society on Alcoholism.

Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial

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Li Ying

2012-07-01

Full Text Available Abstract Background Whether acupuncture is effective for patients with functional constipation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using acupuncture to treat functional constipation. Design A randomized, controlled, four-arm design, large-scale trial is currently undergoing in China. Seven hundred participants are randomly assigned to three acupuncture treatment groups and Mosapride Citrate control group in a 1:1:1:1 ratio. Participants in acupuncture groups receive 16 sessions of acupuncture treatment, and are followed up for a period of 9 weeks after randomization. The acupuncture groups are: (1 Back-Shu and Front-Mu acupoints of Large Intestine meridians (Shu-Mu points group; (2 He-Sea and Lower He-Sea acupoints of Large Intestine meridians (He points group; (3 Combining used Back-Shu, Front-Mu, He-Sea, and Lower He-Sea acupoints of Large Intestine meridians (Shu-Mu-He points group. The control group is Mosapride Citrate group. The primary outcome is frequency of defecation per week at the fourth week after randomization. The secondary outcomes include Bristol stool scale, the extent of difficulty during defecating, MOS 36-item Short Form health survey (SF-36, Self-Rating Anxiety Scale (SAS, and Self-rating Depression Scale (SDS. The first two of second outcomes are measured 1 week before randomization and 2, 4, and 8 weeks after randomization. Other second outcomes are measured 1 week before randomization and 2 and 4 weeks after randomization, but SF-36 is measured at randomization and 4 weeks after randomization. Discussion The result of this trial (which will be available in 2012 will confirm whether acupuncture is effective to treat functional constipation and whether traditional acupuncture theories play an important role in it. Trials registration Clinical Trials.gov NCT01411501

Web-based screening and brief intervention for poly-drug use among teenagers: study protocol of a multicentre two-arm randomized controlled trial

Directory of Open Access Journals (Sweden)

Arnaud Nicolas

2012-09-01

Full Text Available Abstract Background Mid to late adolescence is characterised by a vulnerability to problematic substance use since the consumption of alcohol and illicit drugs is frequently initiated and increased in this life period. While the detrimental long- and short-term effects of problematic consumption patterns in adolescence pose a major public health concern, current prevention programs targeting alcohol- and other substance-using adolescents are scarce. The study described in this protocol will test the effectiveness of a web-based brief intervention aimed at reducing problematic alcohol use and promoting abstinence from illegal drugs in adolescents with risky substance use aged 16 to 18 years old in four EU-countries. Methods/design To determine the effectiveness of our web-BI, we apply a two-arm randomized controlled trial (RCT study design, with baseline assessment at study entry and a three month follow-up assessment. Adolescents aged 16 to 18 years from Belgium, the Czech Republic, Germany, and Sweden will be randomly assigned to either the fully electronically delivered brief intervention group (N = 400 or an assessment only control group (N = 400 depending on their screening for risky substance use (using the CRAFFT. Recruitment, informed consent, randomization, intervention and follow-up will be implemented online. Primary outcomes are reductions in frequency and quantity of use of alcohol and drugs other than alcohol over a 30 day period, as well as consumption per typical occasion. Secondary outcomes concern changes in substance use related cognitions including the constructs of the Theory of Planned Behaviour, implementation intentions, and stages of change. Moreover the study addresses a number of moderator variables, including age of first use, general psychopathology and quality of parent–child relationship. Discussion The trial is expected to contribute to the growing literature on theory- and web-based brief interventions

A randomized, controlled trial of oral propranolol in infantile hemangioma.

Science.gov (United States)

Léauté-Labrèze, Christine; Hoeger, Peter; Mazereeuw-Hautier, Juliette; Guibaud, Laurent; Baselga, Eulalia; Posiunas, Gintas; Phillips, Roderic J; Caceres, Hector; Lopez Gutierrez, Juan Carlos; Ballona, Rosalia; Friedlander, Sheila Fallon; Powell, Julie; Perek, Danuta; Metz, Brandie; Barbarot, Sebastien; Maruani, Annabel; Szalai, Zsuzsanna Zsofia; Krol, Alfons; Boccara, Olivia; Foelster-Holst, Regina; Febrer Bosch, Maria Isabel; Su, John; Buckova, Hana; Torrelo, Antonio; Cambazard, Frederic; Grantzow, Rainer; Wargon, Orli; Wyrzykowski, Dariusz; Roessler, Jochen; Bernabeu-Wittel, Jose; Valencia, Adriana M; Przewratil, Przemyslaw; Glick, Sharon; Pope, Elena; Birchall, Nicholas; Benjamin, Latanya; Mancini, Anthony J; Vabres, Pierre; Souteyrand, Pierre; Frieden, Ilona J; Berul, Charles I; Mehta, Cyrus R; Prey, Sorilla; Boralevi, Franck; Morgan, Caroline C; Heritier, Stephane; Delarue, Alain; Voisard, Jean-Jacques

2015-02-19

Oral propranolol has been used to treat complicated infantile hemangiomas, although data from randomized, controlled trials to inform its use are limited. We performed a multicenter, randomized, double-blind, adaptive, phase 2-3 trial assessing the efficacy and safety of a pediatric-specific oral propranolol solution in infants 1 to 5 months of age with proliferating infantile hemangioma requiring systemic therapy. Infants were randomly assigned to receive placebo or one of four propranolol regimens (1 or 3 mg of propranolol base per kilogram of body weight per day for 3 or 6 months). A preplanned interim analysis was conducted to identify the regimen to study for the final efficacy analysis. The primary end point was success (complete or nearly complete resolution of the target hemangioma) or failure of trial treatment at week 24, as assessed by independent, centralized, blinded evaluations of standardized photographs. Of 460 infants who underwent randomization, 456 received treatment. On the basis of an interim analysis of the first 188 patients who completed 24 weeks of trial treatment, the regimen of 3 mg of propranolol per kilogram per day for 6 months was selected for the final efficacy analysis. The frequency of successful treatment was higher with this regimen than with placebo (60% vs. 4%, P<0.001). A total of 88% of patients who received the selected propranolol regimen showed improvement by week 5, versus 5% of patients who received placebo. A total of 10% of patients in whom treatment with propranolol was successful required systemic retreatment during follow-up. Known adverse events associated with propranolol (hypoglycemia, hypotension, bradycardia, and bronchospasm) occurred infrequently, with no significant difference in frequency between the placebo group and the groups receiving propranolol. This trial showed that propranolol was effective at a dose of 3 mg per kilogram per day for 6 months in the treatment of infantile hemangioma. (Funded by

Randomized Trial of a Lifestyle Program in Obese Infertile Women

NARCIS (Netherlands)

Mutsaerts, Meike A. Q.; van Oers, Anne M.; Groen, Henk; Burggraaff, Jan M.; Kuchenbecker, Walter K. H.; Perquin, Denise A. M.; Koks, Carolien A. M.; van Golde, Ron; Kaaijk, Eugenie M.; Schierbeek, Jaap M.; Oosterhuis, Gerrit J. E.; Broekmans, Frank J.; Bemelmans, Wanda J. E.; Lambalk, Cornelis B.; Verberg, Marieke F. G.; van der Veen, Fulco; Klijn, Nicole F.; Mercelina, Patricia E. A. M.; van Kasteren, Yvonne M.; Nap, Annemiek W.; Brinkhuis, Egbert A.; Vogel, Niels E. A.; Mulder, Robert J. A. B.; Gondrie, Ed T. C. M.; de Bruin, Jan P.; Sikkema, J. Marko; de Greef, Mathieu H. G.; ter Bogt, Nancy C. W.; Land, Jolande A.; Mol, Ben W. J.; Hoek, Annemieke

2016-01-01

BACKGROUND Small lifestyle-intervention studies suggest that modest weight loss increases the chance of conception and may improve perinatal outcomes, but large randomized, controlled trials are lacking. METHODS We randomly assigned infertile women with a body-mass index (the weight in kilograms

Effects of cue-exposure treatment on neural cue reactivity in alcohol dependence: a randomized trial.

Science.gov (United States)

Vollstädt-Klein, Sabine; Loeber, Sabine; Kirsch, Martina; Bach, Patrick; Richter, Anne; Bühler, Mira; von der Goltz, Christoph; Hermann, Derik; Mann, Karl; Kiefer, Falk

2011-06-01

In alcohol-dependent patients, alcohol-associated cues elicit brain activation in mesocorticolimbic networks involved in relapse mechanisms. Cue-exposure based extinction training (CET) has been shown to be efficacious in the treatment of alcoholism; however, it has remained unexplored whether CET mediates its therapeutic effects via changes of activity in mesolimbic networks in response to alcohol cues. In this study, we assessed CET treatment effects on cue-induced responses using functional magnetic resonance imaging (fMRI). In a randomized controlled trial, abstinent alcohol-dependent patients were randomly assigned to a CET group (n = 15) or a control group (n = 15). All patients underwent an extended detoxification treatment comprising medically supervised detoxification, health education, and supportive therapy. The CET patients additionally received nine CET sessions over 3 weeks, exposing the patient to his/her preferred alcoholic beverage. Cue-induced fMRI activation to alcohol cues was measured at pretreatment and posttreatment. Compared with pretreatment, fMRI cue-reactivity reduction was greater in the CET relative to the control group, especially in the anterior cingulate gyrus and the insula, as well as limbic and frontal regions. Before treatment, increased cue-induced fMRI activation was found in limbic and reward-related brain regions and in visual areas. After treatment, the CET group showed less activation than the control group in the left ventral striatum. The study provides first evidence that an exposure-based psychotherapeutic intervention in the treatment of alcoholism impacts on brain areas relevant for addiction memory and attentional focus to alcohol-associated cues and affects mesocorticolimbic reward pathways suggested to be pathophysiologically involved in addiction. Copyright © 2011 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

Exercise and Counseling for Smoking Cessation in Smokers With Depressive Symptoms: A Randomized Controlled Pilot Trial.

Science.gov (United States)

Bernard, Paquito; Ninot, Gregory; Cyprien, Fabienne; Courtet, Philippe; Guillaume, Sebastien; Georgescu, Vera; Picot, Marie-Christine; Taylor, Adrian; Quantin, Xavier

2015-01-01

Despite various strategies to help smokers with depressive disorders to quit, the smoking relapse rate remains high. The purpose of this pilot study was to estimate the effects of adding an exercise and counseling intervention to standard smoking cessation treatment for smokers with depressive disorders. We hypothesized that the exercise and counseling intervention would lead to improved abstinence, reduced depressive symptoms, and increased physical activity. Seventy smokers with current depressive disorders were randomly assigned to standard smoking cessation treatment plus exercise and counseling (n = 35) or standard treatment plus a time-to-contact control intervention on health education (n = 35). Both programs involved 10 sessions over 8 weeks. The primary outcome was continuous abstinence since the quit date and was measured at week 8 (end of the intervention) and again at 12-, 24-, and 52-week follow-ups. Nearly 60% of participants were female (n = 41), 38 (52.3%) were single, 37 (52.9%) had education beyond high school, and 32 (45.7%) met criteria for major depressive disorder or dysthymia. Participants in the two treatment conditions differed at baseline only in marital status (χ(2) = 4.28, df = 1, p =.04); and smoking abstinence self-efficacy, t(66) = -2.04, p =.04). The dropout rate did not differ significantly between groups and participants attended 82% and 75% of the intervention and control sessions, respectively. Intention-to-treat analysis showed that, at 12 weeks after the beginning of the intervention, continuous abstinence did not vary significantly between the intervention and control groups: 48.5% versus 28.5%, respectively, ORadj = 0.40, 95% CI [0.12-1.29], p =.12. There were no group differences in depressive symptoms, but the intervention group did outperform the control group on the 6-minute walking test (Mint = 624.84, SD = 8.17, vs. Mcon = 594.13, SD = 8.96, p =.015) and perceived physical control (Mint = 2.84, SD = 0.16, vs. Mcon = 2

Breastfeeding and abstinence among the Yoruba.

Science.gov (United States)

Dow, T E

1977-08-01

Contemporary patterns of breastfeeding and postpartum abstinence among the Yoruba of Nigera are examined. Quite extensive periods of postpartum abstinence are still observed by most rural and poorer urban women to prolong breastfeeding and increase child survivorship. Differentials in duration of breastfeeding and abstinence relate to both socioeconomic factors and age, suggesting the likelihood of large future reductions. Implications for family planning prospects and policies are noted.

Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice

Directory of Open Access Journals (Sweden)

Tulledge-Scheitel Sidna M

2009-12-01

Full Text Available Abstract Background Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1 preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE for postmenopausal women at risk for osteoporotic fractures; and (2 assess the feasibility and validity (i.e., absence of contamination of patient-level randomization (vs. cluster randomization in pilot trials of decision aid efficacy. Methods/Design This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of STEOPOROSIS CHOICE on five outcomes: (a patient knowledge regarding osteoporosis risk factors and treatment; (b quality of the decision-making process for both the patient and clinician; (c patient and clinician acceptability and satisfaction with the decision aid; (d rate of bisphosphonate use and adherence, and (e trial processes (e.g., ability to recruit participants, collect patient outcomes. To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination. Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months. Discussion This pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach -- decision aids -- to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform

Integrated care for comorbid alcohol dependence and anxiety and/or depressive disorder: study protocol for an assessor-blind, randomized controlled trial.

Science.gov (United States)

Morley, Kirsten C; Baillie, Andrew; Sannibale, Claudia; Teesson, Maree; Haber, Paul S

2013-11-19

A major barrier to successful treatment in alcohol dependence is psychiatric comorbidity. During treatment, the time to relapse is shorter, the drop-out rate is increased, and long-term alcohol consumption is greater for those with comorbid major depression or anxiety disorder than those with an alcohol use disorder with no comorbid mental disorder. The treatment of alcohol dependence and psychological disorders is often the responsibility of different services, and this can hinder the treatment process. Accordingly, there is a need for an effective integrated treatment for alcohol dependence and comorbid anxiety and/or depression. We aim to assess the effectiveness of a specialized, integrated intervention for alcohol dependence with comorbid anxiety and/or mood disorder using a randomized design in an outpatient hospital setting. Following a three-week stabilization period (abstinence or significantly reduced consumption), participants will undergo complete formal assessment for anxiety and depression. Those patients with a diagnosis of an anxiety and/or depressive disorder will be randomized to either 1) integrated intervention (cognitive behavioral therapy) for alcohol, anxiety, and/or depression; or 2) usual counseling care for alcohol problems. Patients will then be followed up at weeks 12, 16, and 24. The primary outcome measure is alcohol consumption (total abstinence, time to lapse, and time to relapse). Secondary outcome measures include changes in alcohol dependence severity, depression, or anxiety symptoms and changes in clinician-rated severity of anxiety and depression. The study findings will have potential implications for clinical practice by evaluating the implementation of specialized integrated treatment for comorbid anxiety and/or depression in an alcohol outpatient service. ClinicalTrials.gov Identifier: NCT01941693.

A random walk model for evaluating clinical trials involving serial observations.

Science.gov (United States)

Hopper, J L; Young, G P

1988-05-01

For clinical trials where the variable of interest is ordered and categorical (for example, disease severity, symptom scale), and where measurements are taken at intervals, it might be possible to achieve a greater discrimination between the efficacy of treatments by modelling each patient's progress as a stochastic process. The random walk is a simple, easily interpreted model that can be fitted by maximum likelihood using a maximization routine with inference based on standard likelihood theory. In general the model can allow for randomly censored data, incorporates measured prognostic factors, and inference is conditional on the (possibly non-random) allocation of patients. Tests of fit and of model assumptions are proposed, and application to two therapeutic trials of gastroenterological disorders are presented. The model gave measures of the rate of, and variability in, improvement for patients under different treatments. A small simulation study suggested that the model is more powerful than considering the difference between initial and final scores, even when applied to data generated by a mechanism other than the random walk model assumed in the analysis. It thus provides a useful additional statistical method for evaluating clinical trials.

RTOG: Updated results of randomized trials

International Nuclear Information System (INIS)

Curran, Walter J.

1997-01-01

Objective: To review the background, rationale and available results for recently completed randomized comparative clinical trials of the Radiation Therapy Oncology Group (RTOG), including inter group trials in which the RTOG has been the managing group or a major participant. When available, laboratory studies will be correlated with clinical results

Using smartphones to decrease substance use via self-monitoring and recovery support: study protocol for a randomized control trial.

Science.gov (United States)

Scott, Christy K; Dennis, Michael L; Gustafson, David H

2017-08-10

Alcohol abuse, other substance use disorders, and risk behaviors associated with the human immunodeficiency virus (HIV) represent three of the top 10 modifiable causes of mortality in the US. Despite evidence that continuing care is effective in sustaining recovery from substance use disorders and associated behaviors, patients rarely receive it. Smartphone applications (apps) have been effective in delivering continuing care to patients almost anywhere and anytime. This study tests the effectiveness of two components of such apps: ongoing self-monitoring through Ecological Momentary Assessments (EMAs) and immediate recovery support through Ecological Momentary Interventions (EMIs). The target population, adults enrolled in substance use disorder treatment (n = 400), are being recruited from treatment centers in Chicago and randomly assigned to one of four conditions upon discharge in a 2 × 2 factorial design. Participants receive (1) EMAs only, (2) EMIs only, (3) combined EMAs + EMIs, or (4) a control condition without EMA or EMI for 6 months. People in the experimental conditions receive smartphones with the apps (EMA and/or EMI) specific to their condition. Phones alert participants in the EMA and EMA + EMI conditions at five random times per day and present participants with questions about people, places, activities, and feelings that they experienced in the past 30 min and whether these factors make them want to use substances, support their recovery, or have no impact. Those in the EMI and EMA + EMI conditions have continual access to a suite of support services. In the EMA + EMI condition, participants are prompted to use the EMI(s) when responses to the EMA(s) indicate risk. All groups have access to recovery support as usual. The primary outcome is days of abstinence from alcohol and other drugs. Secondary outcomes are number of HIV risk behaviors and whether abstinence mediates the effects of EMA, EMI, or EMA + EMI on HIV

Effect of Providing Ankle-Foot Orthoses in Patients with Acute and Subacute Stroke: a Randomized Controlled Trial : A randomized controlled trial

NARCIS (Netherlands)

Nikamp-Simons, Corien D.M.; Buurke, Jaap H.; Van Der Palen, Job; Hermens, Hermie J.; Rietman, Johan S.; Ibánez, Jaime; Azorín, José María; Akay, Metin; Pons, José Luis

2017-01-01

Despite frequent application of ankle-foot orthoses (AFOs), little scientific evidence is available to guide AFO-provision early after stroke. A randomized controlled trial was conducted to study the effects of AFO-provision in (sub-) acute stroke patients. Primary aim: to study effects of the

Improving Language Comprehension in Preschool Children with Language Difficulties: A Cluster Randomized Trial

Science.gov (United States)

Hagen, Åste M.; Melby-Lervåg, Monica; Lervåg, Arne

2017-01-01

Background: Children with language comprehension difficulties are at risk of educational and social problems, which in turn impede employment prospects in adulthood. However, few randomized trials have examined how such problems can be ameliorated during the preschool years. Methods: We conducted a cluster randomized trial in 148 preschool…

Exercise to Enhance Smoking Cessation: the Getting Physical on Cigarette Randomized Control Trial.

Science.gov (United States)

Prapavessis, Harry; De Jesus, Stefanie; Fitzgeorge, Lindsay; Faulkner, Guy; Maddison, Ralph; Batten, Sandra

2016-06-01

Exercise has been proposed as a useful smoking cessation aid. The purpose of the present study is to determine the effect of an exercise-aided smoking cessation intervention program, with built-in maintenance components, on post-intervention 14-, 26- and 56-week cessation rates. Female cigarette smokers (n = 413) participating in a supervised exercise and nicotine replacement therapy (NRT) smoking cessation program were randomized to one of four conditions: exercise + smoking cessation maintenance, exercise maintenance + contact control, smoking cessation maintenance + contact control or contact control. The primary outcome was continuous smoking abstinence. Abstinence differences were found between the exercise and equal contact non-exercise maintenance groups at weeks 14 (57 vs 43 %), 26 (27 vs 21 %) and 56 (26 vs 23.5 %), respectively. Only the week 14 difference approached significance, p = 0.08. An exercise-aided NRT smoking cessation program with built-in maintenance components enhances post-intervention cessation rates at week 14 but not at weeks 26 and 56.

The Design of Cluster Randomized Trials with Random Cross-Classifications

Science.gov (United States)

Moerbeek, Mirjam; Safarkhani, Maryam

2018-01-01

Data from cluster randomized trials do not always have a pure hierarchical structure. For instance, students are nested within schools that may be crossed by neighborhoods, and soldiers are nested within army units that may be crossed by mental health-care professionals. It is important that the random cross-classification is taken into account…

Using WhatsApp and Facebook Online Social Groups for Smoking Relapse Prevention for Recent Quitters: A Pilot Pragmatic Cluster Randomized Controlled Trial

Science.gov (United States)

Chan, Ching Han Helen; Lai, Chi-Keung Jonah; Chan, Wai Fung Vivian; Wang, Man Ping; Li, Ho Cheung William; Chan, Sophia Siu Chee; Lam, Tai-Hing

2015-01-01

Background Quit attempters often have episodes of smoking relapse before they eventually quit. Interactive text messaging through mobile phones has been shown to increase abstinence. This service can be potentially applied on the platform of a social networking service to help quitters maintain abstinence. Objective Our aim was to determine if the group discussion and reminders via the WhatsApp or Facebook social group were effective to prevent smoking relapse in quitters who had stopped smoking recently. Methods This was a single-blinded, parallel, 3-arm pilot cluster randomized controlled trial allocating recent quitters, who had completed an 8-week treatment and reported abstinence for at least 7 days, to WhatsApp (n=42), Facebook (n=40), and a control group (n=54). The 2 intervention groups participated in a 2-month online group discussion with either WhatsApp or Facebook moderated by a trained smoking cessation counselor and received a self-help booklet on smoking cessation. The control group only received the booklet. The primary outcome was the 2- and 6-month relapse rates, defined as the proportion of participants who smoked at least 5 cigarettes in 3 consecutive days. Results Fewer participants in the WhatsApp group (17%, 7/42) reported relapse than the control group (42.6%, 23/54) at 2-month (OR 0.27, 95% CI 0.10-0.71) and 6-month (40.5%, 17/42 vs 61.1%, 33/54; OR 0.43, 95% CI 0.19-0.99) follow-ups. The Facebook group (30.0%, 12/40) had an insignificantly lower relapse rate than the control group (42.6%, 23/54) at 2-month (OR 0.58, 95% CI 0.24-1.37) and 6-month (52.5%, 13/40 vs 61.1%, 33/54; OR 0.70, 95% CI 0.31-1.61) follow-ups. The WhatsApp social groups had more moderators’ posts (median 60, IQR 25 vs median 32, IQR 7; P=.05) and participants’ posts (median 35, IQR 50 vs median 6, IQR 9; P=.07) than their Facebook counterparts, but the difference was insignificant. Conclusions The intervention via the WhatsApp social group was effective in reducing

Group hypnosis vs. relaxation for smoking cessation in adults: a cluster-randomised controlled trial

Science.gov (United States)

2013-01-01

Background Despite the popularity of hypnotherapy for smoking cessation, the efficacy of this method is unclear. We aimed to investigate the efficacy of a single-session of group hypnotherapy for smoking cessation compared to relaxation in Swiss adult smokers. Methods This was a cluster-randomised, parallel-group, controlled trial. A single session of hypnosis or relaxation for smoking cessation was delivered to groups of smokers (median size = 11). Participants were 223 smokers consuming ≥ 5 cigarettes per day, willing to quit and not using cessation aids (47.1% females, M = 37.5 years [SD = 11.8], 86.1% Swiss). Nicotine withdrawal, smoking abstinence self-efficacy, and adverse reactions were assessed at a 2-week follow-up. The main outcome, self-reported 30-day point prevalence of smoking abstinence, was assessed at a 6-month follow up. Abstinence was validated through salivary analysis. Secondary outcomes included number of cigarettes smoked per day, smoking abstinence self-efficacy, and nicotine withdrawal. Results At the 6-month follow up, 14.7% in the hypnosis group and 17.8% in the relaxation group were abstinent. The intervention had no effect on smoking status (p = .73) or on the number of cigarettes smoked per day (p = .56). Smoking abstinence self-efficacy did not differ between the interventions (p = .14) at the 2-week follow-up, but non-smokers in the hypnosis group experienced reduced withdrawal (p = .02). Both interventions produced few adverse reactions (p = .81). Conclusions A single session of group hypnotherapy does not appear to be more effective for smoking cessation than a group relaxation session. Trial registration Current Controlled Trials ISRCTN72839675. PMID:24365274

Mediation and moderation of an efficacious theory-based abstinence-only intervention for African American adolescents.

Science.gov (United States)

Zhang, Jingwen; Jemmott, John B; Jemmott, Loretta Sweet

2015-12-01

This secondary data analysis sought to determine what mediated reductions in self-reported sexual initiation over the 24-month postintervention period in early adolescents who received "Promoting Health among Teens," a theory-based, abstinence-only intervention (Jemmott, Jemmott, & Fong, 2010). African American Grade 6 and 7 students at inner-city public middle schools were randomized to 1 of 5 interventions grounded in social-cognitive theory and the theory of reasoned action: 8-hr abstinence-only targeting reduced sexual intercourse; 8-hr safer-sex-only targeting increased condom use; 8-hr and 12-hr comprehensive interventions targeting sexual intercourse and condom use; 8-hr control intervention targeting physical activity and diet. Primary outcome was self-report of vaginal intercourse by 24 months postintervention. Potential mediators, assessed immediately postintervention, were theory-of-reasoned-action variables, including behavioral beliefs about positive consequences of abstinence and negative consequences of sex, intention to have sex, normative beliefs about sex, and HIV and sexually transmitted infection (STI) knowledge. We tested single and serial mediation models using the product-of-coefficients approach. Of 509 students reporting never having vaginal intercourse at baseline (324 girls and 185 boys; mean age = 11.8 years, SD = 0.8), 500 or 98.2% were included in serial mediation analyses. Consistent with the theory of reasoned action, the abstinence-only intervention increased positive behavioral beliefs about abstinence, which reduced intention to have sex, which in turn reduced sexual initiation. Negative behavioral beliefs about sex, normative beliefs about sex, and HIV/STI knowledge were not mediators. Abstinence-only interventions should stress the gains to be realized from abstinence rather than the deleterious consequences of sexual involvement. (c) 2015 APA, all rights reserved).

Subjective and objective outcomes in randomized clinical trials

DEFF Research Database (Denmark)

Moustgaard, Helene; Bello, Segun; Miller, Franklin G

2014-01-01

explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial......OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...

A randomized controlled trial of directive and nondirective smoking cessation coaching through an employee quitline.

Science.gov (United States)

Sumner, Walton; Walker, Mark S; Highstein, Gabrielle R; Fischer, Irene; Yan, Yan; McQueen, Amy; Fisher, Edwin B

2016-07-11

Telephone quitlines can help employees quit smoking. Quitlines typically use directive coaching, but nondirective, flexible coaching is an alternative. Call-2-Quit used a worksite-sponsored quitline to compare directive and nondirective coaching modes, and evaluated employee race and income as potential moderators. An unblinded randomized controlled trial compared directive and nondirective telephone coaching by trained laypersons. Participants were smoking employees and spouses recruited through workplace smoking cessation campaigns in a hospital system and affiliated medical school. Coaches were four non-medical women trained to use both coaching modes. Participants were randomized by family to coaching mode. Participants received up to 7 calls from coaches who used computer assisted telephone interview software to track topics and time. Outcomes were reported smoking abstinence for 7 days at last contact, 6 or 12 months after coaching began. Both worksites implemented new tobacco control policies during the study. Most participants responded to an insurance incentive introduced at the hospital. Call-2-Quit coached 518 participants: 22 % were African-American; 45 % had incomes below $30,000. Income, race, and intervention did not affect coaching completion rates. Cessation rates were comparable with directive and nondirective coaching (26 % versus 30 % quit, NS). A full factorial logistic regression model identified above median income (odds ratio = 1.8, p = 0.02), especially among African Americans (p = 0.04), and recent quit attempts (OR = 1.6, p = 0.03) as predictors of cessation. Nondirective coaching was associated with high cessation rates among subgroups of smokers reporting income above the median, recent quit attempts, or use of alternative therapies. Waiting up to 4 weeks to start coaching did not affect cessation. Of 41 highly addicted or depressed smokers who had never quit more than 30 days, none quit. Nondirective

Employment-based abstinence reinforcement following inpatient detoxification in HIV-positive opioid and/or cocaine-dependent patients.

Science.gov (United States)

Dunn, Kelly E; Fingerhood, Michael; Wong, Conrad J; Svikis, Dace S; Nuzzo, Paul; Silverman, Kenneth

2014-02-01

Employment-based reinforcement interventions have been used to promote abstinence from drugs among chronically unemployed injection drug users. The current study used an employment-based reinforcement intervention to promote opioid and cocaine abstinence among opioid and/or cocaine-dependent, HIV-positive participants who had recently completed a brief inpatient detoxification. Participants (n = 46) were randomly assigned to an abstinence and work group that was required to provide negative urine samples in order to enter the workplace and to earn incentives for work (n = 16), a work-only group that was permitted to enter the workplace and to earn incentives independent of drug use (n = 15), and a no-voucher control group that did not receive any incentives for working (n = 15) over a 26-week period. The primary outcome was urinalysis-confirmed opioid, cocaine, and combined opioid/cocaine abstinence. Participants were 78% male and 89% African American. Results showed no significant between-groups differences in urinalysis-verified drug abstinence or HIV risk behaviors during the 6-month intervention. The work-only group had significantly greater workplace attendance, and worked more minutes per day when compared to the no-voucher group. Several features of the study design, including the lack of an induction period, setting the threshold for entering the workplace too high by requiring immediate abstinence from several drugs, and increasing the risk of relapse by providing a brief detoxification that was not supported by any continued pharmacological intervention, likely prevented the workplace from becoming established as a reinforcer that could be used to promote drug abstinence. However, increases in workplace attendance have important implications for adult training programs.

Protracted abstinence from distinct drugs of abuse shows regulation of a common gene network.

Science.gov (United States)

Le Merrer, Julie; Befort, Katia; Gardon, Olivier; Filliol, Dominique; Darcq, Emmanuel; Dembele, Doulaye; Becker, Jerome A J; Kieffer, Brigitte L

2012-01-01

Addiction is a chronic brain disorder. Prolonged abstinence from drugs of abuse involves dysphoria, high stress responsiveness and craving. The neurobiology of drug abstinence, however, is poorly understood. We previously identified a unique set of hundred mu-opioid receptor-dependent genes in the extended amygdala, a key site for hedonic and stress processing in the brain. Here we examined these candidate genes either immediately after chronic morphine, nicotine, Δ9-tetrahydrocannabinol or alcohol, or following 4 weeks of abstinence. Regulation patterns strongly differed among chronic groups. In contrast, gene regulations strikingly converged in the abstinent groups and revealed unforeseen common adaptations within a novel huntingtin-centered molecular network previously unreported in addiction research. This study demonstrates that, regardless the drug, a specific set of transcriptional regulations develops in the abstinent brain, which possibly contributes to the negative affect characterizing protracted abstinence. This transcriptional signature may represent a hallmark of drug abstinence and a unitary adaptive molecular mechanism in substance abuse disorders. © 2011 The Authors, Addiction Biology © 2011 Society for the Study of Addiction.

Ibudilast may improve attention during early abstinence from methamphetamine.

Science.gov (United States)

Birath, J Brandon; Briones, Marisa; Amaya, Stephanie; Shoptaw, Steven; Swanson, Aimee-Noelle; Tsuang, John; Furst, Benjamin; Heinzerling, Keith; Obermeit, Lisa; Maes, Lauryn; McKay, Charles; Wright, Matthew J

2017-09-01

Inattention is a deficit related to instilling abstinence from methamphetamine (MA) dependence. This study aimed to determine whether ibudilast (IB; 50mg bid) improves attentional abilities compared to placebo during early abstinence from MA dependence. Attention was assessed in 11 MA-dependent non-treatment seeking participants in a phase IB safety-interaction trial. The Conners' Continuous Performance Test-II (CPT-II), a measure of sustained attention and response inhibition, was administered at baseline and on day 22, 48h post a MA challenge under placebo (P; n=6) or IB 50mg bid (n=5). Group differences were compared using Mann-Whitney U Tests. Groups were similar at baseline in premorbid intellectual functioning, attention deficit hyperactivity symptom scores, impulsivity ratings, and education level, but differed in age. Demographically corrected T-scores for CPT-II performances were utilized. Although no group differences in sustained attention existed at baseline, at follow-up, the IB group (Mdn=44.4) showed reduced variability in response times compared with the P group (Mdn=69.9), U=0.00, z=-2.74, p=.006, r=.83. The IB group (Mdn=45.8) also gave fewer perseverative responses than the P group (Mdn=67.0), U=2.00, z=-2.50, p=.01, r=.75. No other significant differences were observed. Findings suggest that IB may have a protective effect on sustained attention during early abstinence from MA dependence. This may guide thinking about mechanism of action should IB demonstrate efficacy as a treatment for MA dependence. Copyright © 2017 Elsevier B.V. All rights reserved.

A randomized controlled trial to increase information, motivation, and behavioral skills in Ugandan adolescents

Science.gov (United States)

Ybarra, Michele L.; Korchmaros, Josephine D.; Prescott, Tonya L.; Birungi, Ruth

2015-01-01

Background One in twenty-five Ugandan adolescents is HIV positive. Purpose Examine the impact of an Internet-based HIV prevention program on Information-Motivation-Behavior Skills Model-related constructs. Methods Three hundred and sixty-six sexually experienced and inexperienced students 12-18+ years-old in Mbarara, Uganda were randomly assigned to: the five-lesson CyberSenga program or treatment-as-usual. Half of the intervention participants were further randomized to a booster session. Assessments were collected at three and six months post-baseline. Results Participants’ HIV-related information improved over time at a greater rate for the intervention groups compared to the control group. Motivation for condom use changed to a greater degree over time for the intervention group – especially those in the intervention+booster group - compared to the control group. Behavioral skills for condom use, and motivation and behavioral skills for abstinence were statistically similar over time for both groups. Conclusions CyberSenga improves HIV preventive information and motivation to use condoms. PMID:25633626

A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

African Journals Online (AJOL)

A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

A Data Management System Integrating Web-based Training and Randomized Trials: Requirements, Experiences and Recommendations.

Science.gov (United States)

Muroff, Jordana; Amodeo, Maryann; Larson, Mary Jo; Carey, Margaret; Loftin, Ralph D

2011-01-01

This article describes a data management system (DMS) developed to support a large-scale randomized study of an innovative web-course that was designed to improve substance abuse counselors' knowledge and skills in applying a substance abuse treatment method (i.e., cognitive behavioral therapy; CBT). The randomized trial compared the performance of web-course-trained participants (intervention group) and printed-manual-trained participants (comparison group) to determine the effectiveness of the web-course in teaching CBT skills. A single DMS was needed to support all aspects of the study: web-course delivery and management, as well as randomized trial management. The authors briefly reviewed several other systems that were described as built either to handle randomized trials or to deliver and evaluate web-based training. However it was clear that these systems fell short of meeting our needs for simultaneous, coordinated management of the web-course and the randomized trial. New England Research Institute's (NERI) proprietary Advanced Data Entry and Protocol Tracking (ADEPT) system was coupled with the web-programmed course and customized for our purposes. This article highlights the requirements for a DMS that operates at the intersection of web-based course management systems and randomized clinical trial systems, and the extent to which the coupled, customized ADEPT satisfied those requirements. Recommendations are included for institutions and individuals considering conducting randomized trials and web-based training programs, and seeking a DMS that can meet similar requirements.

Radiation Therapy Intensification for Solid Tumors: A Systematic Review of Randomized Trials

Energy Technology Data Exchange (ETDEWEB)

Yamoah, Kosj [Department of Radiation Oncology, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL (United States); Showalter, Timothy N. [Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia (United States); Ohri, Nitin, E-mail: ohri.nitin@gmail.com [Department of Radiation Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York (United States)

2015-11-15

Purpose: To systematically review the outcomes of randomized trials testing radiation therapy (RT) intensification, including both dose escalation and/or the use of altered fractionation, as a strategy to improve disease control for a number of malignancies. Methods and Materials: We performed a literature search to identify randomized trials testing RT intensification for cancers of the central nervous system, head and neck, breast, lung, esophagus, rectum, and prostate. Findings were described qualitatively. Where adequate data were available, pooled estimates for the effect of RT intensification on local control (LC) or overall survival (OS) were obtained using the inverse variance method. Results: In primary central nervous system tumors, esophageal cancer, and rectal cancer, randomized trials have not demonstrated that RT intensification improves clinical outcomes. In breast cancer and prostate cancer, dose escalation has been shown to improve LC or biochemical disease control but not OS. Radiation therapy intensification may improve LC and OS in head and neck and lung cancers, but these benefits have generally been limited to studies that did not incorporate concurrent chemotherapy. Conclusions: In randomized trials, the benefits of RT intensification have largely been restricted to trials in which concurrent chemotherapy was not used. Novel strategies to optimize the incorporation of RT in the multimodality treatment of solid tumors should be explored.

Objective and Subjective Measures of Simultaneous vs Sequential Bilateral Cochlear Implants in Adults A Randomized Clinical Trial : A Randomized Clinical Trial

NARCIS (Netherlands)

Kraaijenga, Véronique J C; Ramakers, Geerte G J; Smulders, Yvette E; van Zon, Alice; Stegeman, Inge; Smit, Adriana L; Stokroos, Robert J; Hendrice, Nadia; Free, Rolien H; Maat, Bert; Frijns, Johan H M; Briaire, Jeroen J; Mylanus, E A M; Huinck, Wendy J; Van Zanten, Gijsbert A; Grolman, Wilko

IMPORTANCE To date, no randomized clinical trial on the comparison between simultaneous and sequential bilateral cochlear implants (BiCIs) has been performed. OBJECTIVE To investigate the hearing capabilities and the self-reported benefits of simultaneous BiCIs compared with those of sequential

Financial management of a large multisite randomized clinical trial.

Science.gov (United States)

Sheffet, Alice J; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E; Longbottom, Mary E; Howard, Virginia J; Marler, John R; Brott, Thomas G

2014-08-01

The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years' funding ($21 112 866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2500 randomized participants at 40 sites. Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Projections of the original grant's fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant's fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2500 targeted sample size, 138 (5·5%) were randomized during the first five years and 1387 (55·5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13 845) of the projected per-patient costs ($152 992) of the fixed model. Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. © 2014 The Authors. International Journal of Stroke © 2014 World Stroke Organization.

Complementary feeding: a Global Network cluster randomized controlled trial

Directory of Open Access Journals (Sweden)

Pasha Omrana

2011-01-01

Full Text Available Abstract Background Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. Methods/Design A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months; neurocognitive development (12 and 18 months; and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Discussion Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will

A Data Management System Integrating Web-Based Training and Randomized Trials

Science.gov (United States)

Muroff, Jordana; Amodeo, Maryann; Larson, Mary Jo; Carey, Margaret; Loftin, Ralph D.

2011-01-01

This article describes a data management system (DMS) developed to support a large-scale randomized study of an innovative web-course that was designed to improve substance abuse counselors' knowledge and skills in applying a substance abuse treatment method (i.e., cognitive behavioral therapy; CBT). The randomized trial compared the performance…

Cognitive performance in long-term abstinent elderly alcoholics.

Science.gov (United States)

Fein, George; McGillivray, Shannon

2007-11-01

To date, there is a wealth of literature describing the deleterious effects of active alcoholism on cognitive function. There is also a growing body of literature on the extent of cognitive recovery that can occur with abstinence. However, there is still a dearth of published findings on cognitive functioning in very long-term abstinence alcoholics, especially in the elderly population. The current study examines 91 elderly abstinent alcoholics (EAA) (49 men and 42 women) with an average age of 67.3 years, abstinent for an average of 14.8 years (range 0.5 to 45 years), and age and gender comparable light/nondrinking controls. The EAA group was divided into 3 subgroups: individuals that attained abstinence before age 50 years, between the ages 50 and 60 years, and after age 60 years. Attention, verbal fluency, abstraction/cognitive flexibility, psychomotor, immediate memory, delayed memory, reaction time, spatial processing, and auditory working memory were assessed. The AMNART and cranium size were used as estimates of brain reserve capacity, and the association of all variables with alcohol use measures was examined. Overall, the EAA groups performed comparably to controls on the assessments of cognitive function. Only the abstinent in group before 50 years of age performed worse than controls, and this was only in the domain of auditory working memory. EAAs had larger craniums than their controls. This effect was strongest for those who drank the longest and had the shortest abstinence. Such individuals also performed better cognitively. Our data showed that elderly alcoholics that drank late into life, but with at least 6 months abstinence can exhibit normal cognitive functioning. Selective survivorship and selection bias probably play a part in these findings. Cognitively healthier alcoholics, with more brain reserve capacity, may be more likely to live into their 60s, 70s, or 80s of age with relatively intact cognition, and to volunteer for studies such as

Efficacy of a medical food in mild Alzheimer's disease: A randomized, controlled trial.

NARCIS (Netherlands)

Scheltens, P.; Kamphuis, P.J.; Verhey, F.R.J.; Olde Rikkert, M.G.M.; Wurtman, R.J.; Wilkinson, D.; Twisk, J.W.R.; Kurz, A.

2010-01-01

OBJECTIVE: To investigate the effect of a medical food on cognitive function in people with mild Alzheimer's disease (AD). METHODS: A total of 225 drug-naive AD patients participated in this randomized, double-blind controlled trial. Patients were randomized to active product, Souvenaid, or a

A controlled trial of an expert system and self-help manual intervention based on the stages of change versus standard self-help materials in smoking cessation.

Science.gov (United States)

Aveyard, Paul; Griffin, Carl; Lawrence, Terry; Cheng, K K

2003-03-01

To examine the population impact and effectiveness of the Pro-Change smoking cessation course based on the Transtheoretical Model (TTM) compared to standard self-help smoking cessation literature. Randomized controlled trial. Sixty-five West Midlands general practices. Randomly sampled patients recorded as smokers by their general practitioners received an invitation letter and 2471 current smokers agreed. Responders were randomized to one of four interventions. The control group received standard self-help literature. In the Manual intervention group, participants received the Pro-Change system, a self-help workbook and three questionnaires at 3-monthly intervals, which generated individually tailored feedback. In the Phone intervention group, participants received the Manual intervention plus three telephone calls. In the Nurse intervention group, participants received the Manual intervention plus three visits to the practice nurse. Biochemically confirmed point prevalence of being quit and 6-month sustained abstinence, 12 months after study commencement. A total of 9.1% of registered current smokers participated, of whom 83.0% were not ready to quit. Less than half of participants returned questionnaires to generate second and third individualized feedback. Telephone calls reached 75% of those scheduled, but few participants visited the nurse. There were small differences between the three Pro-Change arms. The odds ratio (95% confidence intervals) for all Pro-Change arms combined versus the control arm were 1.50 (0.85-2.67) and 1.53 (0.76-3.10), for point prevalence and 6-month abstinence, respectively. This constitutes 2.1% of the TTM group versus 1.4% of the control group achieving confirmed 6-month sustained abstinence. There was no statistically significant benefit of the intervention apparent in this trial and the high relapse of quitters means that any population impact is small.

Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial.

Science.gov (United States)

Arabi, Yaseen; Al-Hameed, Fahad; Burns, Karen E A; Mehta, Sangeeta; Alsolamy, Sami; Almaani, Mohammed; Mandourah, Yasser; Almekhlafi, Ghaleb A; Al Bshabshe, Ali; Finfer, Simon; Alshahrani, Mohammed; Khalid, Imran; Mehta, Yatin; Gaur, Atul; Hawa, Hassan; Buscher, Hergen; Arshad, Zia; Lababidi, Hani; Al Aithan, Abdulsalam; Jose, Jesna; Abdukahil, Sheryl Ann I; Afesh, Lara Y; Dbsawy, Maamoun; Al-Dawood, Abdulaziz

2018-03-15

The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults. In this multicenter randomized trial, critically ill patients receiving pharmacologic thromboprophylaxis will be randomized to an IPC or a no IPC (control) group. The primary outcome is "incident" proximal lower-extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation, whereas the patients and treating team will be unblinded. The trial has 80% power to detect a 3% absolute risk reduction in the rate of proximal DVT from 7% to 4%. Consistent with international guidelines, we have developed a detailed plan to guide the analysis of the PREVENT trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes, and defines covariates for adjusted analyses a priori. Application of this statistical analysis plan to the PREVENT trial will facilitate unbiased analyses of clinical data. ClinicalTrials.gov , ID: NCT02040103 . Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506 . Registered on 30 October 2013.

Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Bouwense Stefan A

2012-11-01

Full Text Available Abstract Background After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after discharge for mild biliary pancreatitis. During this waiting period, the patient is at risk of recurrent biliary events. In current clinical practice, surgeons usually postpone cholecystectomy for 6 weeks due to a perceived risk of a more difficult dissection in the early days following pancreatitis and for logistical reasons. We hypothesize that early laparoscopic cholecystectomy minimizes the risk of recurrent biliary pancreatitis or other complications of gallstone disease in patients with mild biliary pancreatitis without increasing the difficulty of dissection and the surgical complication rate compared with interval laparoscopic cholecystectomy. Methods/Design PONCHO is a randomized controlled, parallel-group, assessor-blinded, superiority multicenter trial. Patients are randomly allocated to undergo early laparoscopic cholecystectomy, within 72 hours after randomization, or interval laparoscopic cholecystectomy, 25 to 30 days after randomization. During a 30-month period, 266 patients will be enrolled from 18 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite endpoint of mortality and acute re-admissions for biliary events (that is, recurrent biliary pancreatitis, acute cholecystitis, symptomatic/obstructive choledocholithiasis requiring endoscopic retrograde cholangiopancreaticography including cholangitis (with/without endoscopic sphincterotomy, and uncomplicated biliary colics occurring within 6 months following randomization. Secondary endpoints include the individual endpoints of the composite endpoint, surgical and other complications, technical difficulty of cholecystectomy and costs. Discussion The PONCHO trial is designed to show that early

Efficacy of a medical food in mild Alzheimer's disease: a randomized, controlled trial

NARCIS (Netherlands)

Scheltens, P.; Kamphuis, P.J.G.H.; Verhey, F.R.J.; Olde Rikkert, M.G.M.; Wurtman, R.J.; Wilkinson, D.; Twisk, J.W.R.; Kurz, A.

2010-01-01

Objective: To investigate the effect of a medical food on cognitive function in people with mild Alzheimer's disease (AD). Methods: A total of 225 drug-naïve AD patients participated in this randomized, double-blind controlled trial. Patients were randomized to active product, Souvenaid, or a

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.

Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial.

Science.gov (United States)

Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A

2016-12-01

To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO 2 ), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (pmusic days (pmusic during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

Abstinence-Only Sex Education: College Students' Evaluations and Responses

Science.gov (United States)

Gardner, Emily A.

2015-01-01

This qualitative study explores the abstinence-only sex education experiences of a small group of young adults in the southeastern USA. Most participants felt that their abstinence-only sex education had mixed value and low overall impact in their lives. Perceptions about abstinence, virginity, and marriage varied significantly from those stressed…

Characterizing Smoking and Drinking Abstinence from Social Media.

Science.gov (United States)

Tamersoy, Acar; De Choudhury, Munmun; Chau, Duen Horng

2015-09-01

Social media has been established to bear signals relating to health and well-being states. In this paper, we investigate the potential of social media in characterizing and understanding abstinence from tobacco or alcohol use. While the link between behavior and addiction has been explored in psychology literature, the lack of longitudinal self-reported data on long-term abstinence has challenged addiction research. We leverage the activity spanning almost eight years on two prominent communities on Reddit: StopSmoking and StopDrinking. We use the self-reported "badge" information of nearly a thousand users as gold standard information on their abstinence status to characterize long-term abstinence. We build supervised learning based statistical models that use the linguistic features of the content shared by the users as well as the network structure of their social interactions. Our findings indicate that long-term abstinence from smoking or drinking (~one year) can be distinguished from short-term abstinence (~40 days) with 85% accuracy. We further show that language and interaction on social media offer powerful cues towards characterizing these addiction-related health outcomes. We discuss the implications of our findings in social media and health research, and in the role of social media as a platform for positive behavior change and therapy.

Pregnant womens' concerns when invited to a randomized trial: a qualitative case control study

NARCIS (Netherlands)

Oude Rengerink, Katrien; Logtenberg, Sabine; Hooft, Lotty; Bossuyt, Patrick M.; Mol, Ben Willem

2015-01-01

Pregnant women were excluded from clinical trials until the 1990s, but the Food and Drug Administration nowadays allows--and even encourages--responsible inclusion of pregnant women in trials with adequate safety monitoring. Still, randomized trials in pregnant women face specific enrolment

Pregnant womens' concerns when invited to a randomized trial : a qualitative case control study

NARCIS (Netherlands)

Oude Rengerink, Katrien; Logtenberg, Sabine; Hooft, Lotty; Bossuyt, Patrick M; Mol, Ben Willem; Oude Rengerink, K

2015-01-01

BACKGROUND: Pregnant women were excluded from clinical trials until the 1990s, but the Food and Drug Administration nowadays allows--and even encourages--responsible inclusion of pregnant women in trials with adequate safety monitoring. Still, randomized trials in pregnant women face specific

Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

Directory of Open Access Journals (Sweden)

Callahan Christopher M

2012-06-01

Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

Standards for reporting randomized controlled trials in neurosurgery.

Science.gov (United States)

Kiehna, Erin N; Starke, Robert M; Pouratian, Nader; Dumont, Aaron S

2011-02-01

The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996 to standardize the reporting and improve the quality of clinical trials. Despite having been endorsed by major medical journals and shown to improve the quality of reported trials, neurosurgical journals have yet to formally adopt these reporting criteria. The purpose of this study is to evaluate the quality and reporting of randomized controlled trials (RCTs) in neurosurgery and the factors that may affect the quality of reported trials. The authors evaluated all neurosurgical RCTs published in 2006 and 2007 in the principal neurosurgical journals (Journal of Neurosurgery; Neurosurgery; Surgical Neurology; Journal of Neurology, Neurosurgery, and Psychiatry; and Acta Neurochirurgica) and in 3 leading general medical journals (Journal of the American Medical Association, Lancet, and the New England Journal of Medicine). Randomized controlled trials that addressed operative decision making or the treatment of neurosurgical patients were included in this analysis. The RCT quality was evaluated using the Jadad score and the CONSORT checklist. In 2006 and 2007, 27 RCTs relevant to intracranial neurosurgery were reported. Of these trials, only 59% had a Jadad score ≥ 3. The 3 major medical journals all endorsed the CONSORT guidelines, while none of the neurosurgical journals have adopted these guidelines. Randomized controlled trials published in the 3 major medical journals had a significantly higher mean CONSORT score (mean 41, range 39-44) compared with those published in neurosurgical journals (mean 26.4, range 17-38; p journals (mean 3.42, range 2-5) than neurosurgical journals (mean 2.45, range 1-5; p = 0.05). Despite the growing volume of RCTs in neurosurgery, the quality of reporting of these trials remains suboptimal, especially in the neurosurgical journals. Improved awareness of the CONSORT guidelines by journal editors, reviewers, and authors of these papers could

Aspiring to physical health: the role of aspirations for physical health in facilitating long-term tobacco abstinence.

Science.gov (United States)

Niemiec, Christopher P; Ryan, Richard M; Deci, Edward L; Williams, Geoffrey C

2009-02-01

To assess aspirations for physical health over 18 months. To examine whether maintained importance of aspirations for physical health mediated and/or moderated the effect of an intensive intervention on long-term tobacco abstinence. Participants were randomly assigned to an intervention based on self-determination theory or to community care, and provided data at baseline and at 18 and 30 months post-randomization. Aspirations for physical health were better maintained over 18 months among participants in the intervention (mean change=.05), relative to community care (mean change=-.13), t=2.66, p<.01. Maintained importance of aspirations for physical health partially mediated the treatment condition effects on seven-day point prevalence tobacco abstinence (z'=1.68, p<.01) and the longest number of days not smoking (z'=2.16, p<.01), and interacted with treatment condition to facilitate the longest number of days not smoking (beta=.08, p<.05). Maintained importance of aspirations for physical health facilitated tobacco abstinence. Smokers may benefit from discussing aspirations for physical health within autonomy-supportive interventions. Patients may benefit from discussing aspirations during counseling about therapeutic lifestyle change and medication use.

External validity of randomized controlled trials in older adults, a systematic review.

Directory of Open Access Journals (Sweden)

Floor J van Deudekom

Full Text Available To critically assess the external validity of randomized controlled trials (RCTs it is important to know what older adults have been enrolled in the trials. The aim of this systematic review is to study what proportion of trials specifically designed for older patients report on somatic status, physical and mental functioning, social environment and frailty in the patient characteristics.PubMed was searched for articles published in 2012 and only RCTs were included. Articles were further excluded if not conducted with humans or only secondary analyses were reported. A random sample of 10% was drawn. The current review analyzed this random sample and further selected trials when the reported mean age was ≥ 60 years. We extracted geriatric assessments from the population descriptives or the in- and exclusion criteria.In total 1396 trials were analyzed and 300 trials included. The median of the reported mean age was 66 (IQR 63-70 and the median percentage of men in the trials was 60 (IQR 45-72. In 34% of the RCTs specifically designed for older patients somatic status, physical and mental functioning, social environment or frailty were reported in the population descriptives or the in- and exclusion criteria. Physical and mental functioning was reported most frequently (22% and 14%. When selecting RCTs on a mean age of 70 or 80 years the report of geriatric assessments in the patient characteristics was 46% and 85% respectively but represent only 5% and 1% of the trials.Somatic status, physical and mental functioning, social environment and frailty are underreported even in RCTs specifically designed for older patients published in 2012. Therefore, it is unclear for clinicians to which older patients the results can be applied. We recommend systematic to transparently report these relevant characteristics of older participants included in RCTs.

Outpatient treatment of alcohol use disorders among subjects 60+ years: design of a randomized clinical trial conducted in three countries (Elderly Study).

Science.gov (United States)

Andersen, Kjeld; Bogenschutz, Michael P; Bühringer, Gerhard; Behrendt, Silke; Bilberg, Randi; Braun, Barbara; Ekstrøm, Claus Thorn; Forcehimes, Alyssa; Lizarraga, Christine; Moyers, Theresa B; Nielsen, Anette Søgaard

2015-11-14

The proportion of 60+ years with excessive alcohol intake varies in western countries between 6-16 % among men and 2-7 % among women. Specific events related to aging (e.g. loss of job, physical and mental capacity, or spouse) may contribute to onset or continuation of alcohol use disorders (AUD). We present the rationale and design of a multisite, multinational AUD treatment study for subjects aged 60+ years. 1,000 subjects seeking treatment for AUD according to DSM-5 in outpatient clinics in Denmark, Germany, and New Mexico (USA) are invited to participate in a RCT. Participants are randomly assigned to four sessions of Motivational Enhancement Treatment (MET) or to MET plus an add-on with eight sessions based on the Community Reinforcement Approach (CRA), which include a new module targeting specific problems of older adults. A series of assessment instruments is applied, including the Form-90, Alcohol Dependence Scale, Penn Alcohol Craving Scale, Brief Symptom Inventory and WHO Quality of Life. Enrolment will be completed by April 2016 and data collection by April 2017. The primary outcome is the proportion in each group who are abstinent or have a controlled use of alcohol six months after treatment initiation. Controlled use is defined as maximum blood alcohol content not exceeding 0.05 % during the last month. Total abstinence is a secondary outcome, together with quality of life andcompliance with treatment. The study will provide new knowledge about brief treatment of AUD for older subjects. As the treatment is manualized and applied in routine treatment facilities, barriers for implementation in the health care system are relatively low. Finally, as the study is being conducted in three different countries it will also provide significant insight into the possible interaction of service system differences and related patient characteristics in predictionof treatment outcome. Clinical Trials.gov NCT02084173 , March 7, 2014.

Financial Management of a Large Multi-site Randomized Clinical Trial

Science.gov (United States)

Sheffet, Alice J.; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E.; Longbottom, Mary E.; Howard, Virginia J.; Marler, John R.; Brott, Thomas G.

2014-01-01

Background The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years’ funding ($21,112,866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2,500 randomized participants at 40 sites. Aims Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Methods Projections of the original grant’s fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant’s fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Results Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2,500 targeted sample size, 138 (5.5%) were randomized during the first five years and 1,387 (55.5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13,845) of the projected per-patient costs ($152,992) of the fixed model. Conclusions Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. PMID:24661748

Testing a Violence-Prevention Intervention for Incarcerated Women Using a Randomized Control Trial

Science.gov (United States)

Kubiak, Sheryl Pimlott; Kim, Woo Jong; Fedock, Gina; Bybee, Deborah

2015-01-01

Objective: Beyond Violence (BV), a new prevention program for women with assaultive offenses, demonstrated feasibility in previous studies. This study's purpose is to assess the efficacy of BV using a randomized control trial. Method: Eligible women were randomly assigned to treatment as usual (TAU) and the experimental condition (BV). Measures of…

Validity of randomized clinical trials in gastroenterology from 1964-2000

DEFF Research Database (Denmark)

Kjaergard, Lise L; Frederiksen, Sarah L; Gluud, Christian

2002-01-01

The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000.......The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000....

Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial.

Science.gov (United States)

Fleischmann, Robert; Decker, Anne-Marie; Kraft, Antje; Mai, Knut; Schmidt, Sein

2017-12-01

Regulations, study design complexity and amounts of collected and shared data in clinical trials render efficient data handling procedures inevitable. Recent research suggests that electronic data capture can be key in this context but evidence is insufficient. This randomized controlled parallel group study tested the hypothesis that time efficiency is superior when electronic (eCRF) instead of paper case report forms (pCRF) are used for data collection. We additionally investigated predictors of time saving effects and data integrity. This study was conducted on top of a clinical weight loss trial performed at a clinical research facility over six months. All study nurses and patients participating in the clinical trial were eligible to participate and randomly allocated to enter cross-sectional data obtained during routine visits either through pCRF or eCRF. A balanced randomization list was generated before enrolment commenced. 90 and 30 records were gathered for the time that 27 patients and 2 study nurses required to report 2025 and 2037 field values, respectively. The primary hypothesis, that eCRF use is faster than pCRF use, was tested by a two-tailed t-test. Analysis of variance and covariance were used to evaluate predictors of entry performance. Data integrity was evaluated by descriptive statistics. All randomized patients were included in the study (eCRF group n = 13, pCRF group n = 14). eCRF, as compared to pCRF, data collection was associated with significant time savings  across all conditions (8.29 ± 5.15 min vs. 10.54 ± 6.98 min, p = .047). This effect was not defined by participant type, i.e. patients or study nurses (F (1,112)  = .15, p = .699), CRF length (F (2,112)  = .49, p = .609) or patient age (Beta = .09, p = .534). Additional 5.16 ± 2.83 min per CRF were saved with eCRFs due to data transcription redundancy when patients answered questionnaires directly in eCRFs. Data integrity was

Neighborhood Effects in a Behavioral Randomized Controlled Trial

OpenAIRE

Pruitt, Sandi L.; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

2014-01-01

Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5,628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient’s CRC test use. This potentially import...

Rapid detoxification from opioid dependence under general anaesthesia versus standard methadone tapering : abstinence rates and withdrawal distress experiences

NARCIS (Netherlands)

Krabbe, Paul F M; Koning, Jeroen P F; Heinen, Nadia; Laheij, Robert J F; van Cauter, R M Victory; De Jong, Cor A J

The aim of this work was to study abstinence rates and withdrawal effects of rapid detoxification of opioid-dependents under general anaesthesia (RD-GA) compared to standard methadone tapering (SMT) using a prospective clinical trial with a follow-up of 3 months, as a preliminary study at the

Rapid detoxification from opioid dependence under general anaesthesia versus standard methadone tapering: abstinence rates and withdrawal distress experiences.

NARCIS (Netherlands)

Krabbe, P.F.M.; Koning, J.P.; Heinen, N.; Laheij, R.J.F.; Cauter, R.M.V. van; Jong, C.A.J. de

2003-01-01

The aim of this work was to study abstinence rates and withdrawal effects of rapid detoxification of opioid-dependents under general anaesthesia (RD-GA) compared to standard methadone tapering (SMT) using a prospective clinical trial with a follow-up of 3 months, as a preliminary study at the

Group hypnosis vs. relaxation for smoking cessation in adults: a cluster-randomised controlled trial.

Science.gov (United States)

Dickson-Spillmann, Maria; Haug, Severin; Schaub, Michael P

2013-12-23

Despite the popularity of hypnotherapy for smoking cessation, the efficacy of this method is unclear. We aimed to investigate the efficacy of a single-session of group hypnotherapy for smoking cessation compared to relaxation in Swiss adult smokers. This was a cluster-randomised, parallel-group, controlled trial. A single session of hypnosis or relaxation for smoking cessation was delivered to groups of smokers (median size = 11). Participants were 223 smokers consuming ≥ 5 cigarettes per day, willing to quit and not using cessation aids (47.1% females, M = 37.5 years [SD = 11.8], 86.1% Swiss). Nicotine withdrawal, smoking abstinence self-efficacy, and adverse reactions were assessed at a 2-week follow-up. The main outcome, self-reported 30-day point prevalence of smoking abstinence, was assessed at a 6-month follow up. Abstinence was validated through salivary analysis. Secondary outcomes included number of cigarettes smoked per day, smoking abstinence self-efficacy, and nicotine withdrawal. At the 6-month follow up, 14.7% in the hypnosis group and 17.8% in the relaxation group were abstinent. The intervention had no effect on smoking status (p = .73) or on the number of cigarettes smoked per day (p = .56). Smoking abstinence self-efficacy did not differ between the interventions (p = .14) at the 2-week follow-up, but non-smokers in the hypnosis group experienced reduced withdrawal (p = .02). Both interventions produced few adverse reactions (p = .81). A single session of group hypnotherapy does not appear to be more effective for smoking cessation than a group relaxation session. Current Controlled Trials ISRCTN72839675.

Withdrawal-Related Changes in Delay Discounting Predict Short-Term Smoking Abstinence.

Science.gov (United States)

Miglin, Rickie; Kable, Joseph W; Bowers, Maureen E; Ashare, Rebecca L

2017-06-01

Impulsive decision making is associated with smoking behavior and reflects preferences for smaller, immediate rewards and intolerance of temporal delays. Nicotine withdrawal may alter impulsive decision making and time perception. However, little is known about whether withdrawal-related changes in decision making and time perception predict smoking relapse. Forty-five smokers (14 female) completed two laboratory sessions, one following 24-hour abstinence and one smoking-as-usual (order counterbalanced; biochemically verified abstinence). During each visit, participants completed measures of time perception, decision making (ie, discount rates), craving, and withdrawal. Following the second laboratory session, subjects underwent a well-validated model of short-term abstinence (quit week) with small monetary incentives for each day of biochemically confirmed abstinence. Smokers significantly overestimated time during abstinence, compared to smoking-as-usual (p = .021), but there were no abstinence effects on discount rates (p = .6). During the quit week, subjects were abstinent for 3.5 days (SD = 2.15) and smoked a total of 12.9 cigarettes (SD = 15.8). Importantly, higher discount rates (ie, preferences for immediate rewards) during abstinence (abstinence minus smoking difference score) predicted greater number of days abstinent (p = .01) and fewer cigarettes smoked during the quit week (p = .02). Withdrawal-related change in time reproduction did not predict relapse (p = .2). These data suggest that individuals who have a greater preference for immediate rewards during abstinence (vs. smoking-as-usual) may be more successful at maintaining short-term abstinence when provided with frequent (eg, daily) versus less frequent incentive schedules (eg, 1 month). Abstinence-induced changes in decision making may be important for identifying smokers who may benefit from interventions that incentivize abstinence such as contingency management (CM). The present results

Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial: study protocol for a randomized controlled trial

International Nuclear Information System (INIS)

Poh, Catherine F; Durham, J Scott; Brasher, Penelope M; Anderson, Donald W; Berean, Kenneth W; MacAulay, Calum E; Lee, J Jack; Rosin, Miriam P

2011-01-01

Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of translational research, may result in

A contingent payment model of smoking cessation: effects on abstinence and withdrawal.

Science.gov (United States)

Heil, Sarah H; Tidey, Jennifer W; Holmes, Heather W; Badger, Gary J; Higgins, Stephen T

2003-04-01

The present study was designed to characterize nicotine withdrawal during a 5-day period in which smokers who were not trying to quit were offered monetary incentives to abstain while residing in their usual environments. Participants were randomly assigned to one of three groups. In two groups, monetary payment was delivered contingent on breath carbon monoxide levels (CO< or =8 ppm) indicating recent smoking abstinence, with the amount of payment differing between the two groups. The third group was a control group in which payment was delivered independent of smoking status. Participants provided CO samples three times per day (morning, afternoon- and evening) for 5 days (Monday-Friday). At each evening visit, all participants completed a nicotine withdrawal questionnaire and other questionnaires. Contingent payment significantly decreased expired-air CO and salivary cotinine levels as compared with the control group. No significant differences in abstinence were noted as a function of the amount paid. Participants in both contingent payment groups reported significantly more withdrawal symptoms than those in the noncontingent control group, including increases in anxiety and nervousness, impatience and restlessness, hunger, and desire to smoke. Such contingent payment procedures may provide an effective method for studying nicotine withdrawal in smokers that does not require the costly and inconvenient practice of housing research participants on a closed ward to prevent smoking.

Reporting funding source or conflict of interest in abstracts of randomized controlled trials, no evidence of a large impact on general practitioners' confidence in conclusions, a three-arm randomized controlled trial.

Science.gov (United States)

Buffel du Vaure, Céline; Boutron, Isabelle; Perrodeau, Elodie; Ravaud, Philippe

2014-04-28

Systematic reporting of funding sources is recommended in the CONSORT Statement for abstracts. However, no specific recommendation is related to the reporting of conflicts of interest (CoI). The objective was to compare physicians' confidence in the conclusions of abstracts of randomized controlled trials of pharmaceutical treatment indexed in PubMed. We planned a three-arm parallel-group randomized trial. French general practitioners (GPs) were invited to participate and were blinded to the study's aim. We used a representative sample of 75 abstracts of pharmaceutical industry-funded randomized controlled trials published in 2010 and indexed in PubMed. Each abstract was standardized and reported in three formats: 1) no mention of the funding source or CoI; 2) reporting the funding source only; and 3) reporting the funding source and CoI. GPs were randomized according to a computerized randomization on a secure Internet system at a 1:1:1 ratio to assess one abstract among the three formats. The primary outcome was GPs' confidence in the abstract conclusions (0, not at all, to 10, completely confident). The study was planned to detect a large difference with an effect size of 0.5. Between October 2012 and June 2013, among 605 GPs contacted, 354 were randomized, 118 for each type of abstract. The mean difference (95% confidence interval) in GPs' confidence in abstract findings was 0.2 (-0.6; 1.0) (P = 0.84) for abstracts reporting the funding source only versus no funding source or CoI; -0.4 (-1.3; 0.4) (P = 0.39) for abstracts reporting the funding source and CoI versus no funding source and CoI; and -0.6 (-1.5; 0.2) (P = 0.15) for abstracts reporting the funding source and CoI versus the funding source only. We found no evidence of a large impact of trial report abstracts mentioning funding sources or CoI on GPs' confidence in the conclusions of the abstracts. ClinicalTrials.gov identifier: NCT01679873.

Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial

Directory of Open Access Journals (Sweden)

Guallar Eliseo

2010-12-01

Full Text Available Abstract Background Overweight and obesity are highly prevalent among persons with serious mental illness. These conditions likely contribute to premature cardiovascular disease and a 20 to 30 percent shortened life expectancy in this vulnerable population. Persons with serious mental illness need effective, appropriately tailored behavioral interventions to achieve and maintain weight loss. Psychiatric rehabilitation day programs provide logical intervention settings because mental health consumers often attend regularly and exercise can take place on-site. This paper describes the Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE. The goal of the study is to determine the effectiveness of a behavioral weight loss intervention among persons with serious mental illness that attend psychiatric rehabilitation programs. Participants randomized to the intervention arm of the study are hypothesized to have greater weight loss than the control group. Methods/Design A targeted 320 men and women with serious mental illness and overweight or obesity (body mass index ≥ 25.0 kg/m2 will be recruited from 10 psychiatric rehabilitation programs across Maryland. The core design is a randomized, two-arm, parallel, multi-site clinical trial to compare the effectiveness of an 18-month behavioral weight loss intervention to usual care. Active intervention participants receive weight management sessions and physical activity classes on-site led by study interventionists. The intervention incorporates cognitive adaptations for persons with serious mental illness attending psychiatric rehabilitation programs. The initial intensive intervention period is six months, followed by a twelve-month maintenance period in which trained rehabilitation program staff assume responsibility for delivering parts of the intervention. Primary outcomes are weight loss at six and 18 months. Discussion Evidence-based approaches to the high burden

A randomized controlled Alzheimer's disease prevention trial's evolution into an exposure trial: the PREADViSE Trial.

Science.gov (United States)

Kryscio, R J; Abner, E L; Schmitt, F A; Goodman, P J; Mendiondo, M; Caban-Holt, A; Dennis, B C; Mathews, M; Klein, E A; Crowley, J J

2013-01-01

To summarize the ongoing prevention of Alzheimer's disease (AD) by vitamin E and selenium (PREADViSE) trial as an ancillary study to SELECT (a large prostate cancer prevention trial) and to present the blinded results of the first year as an exposure study. PREADViSE was designed as a double blind randomized controlled trial (RCT). SELECT terminated after median of 5.5 years of exposure to supplements due to a futility analysis. Both trials then converted into an exposure study. In the randomized component PREADViSE enrolled 7,547 men age 62 or older (60 if African American). Once the trial terminated 4,246 of these men volunteered for the exposure study. Demographics were similar for both groups with exposure volunteers having baseline mean age 67.3 ± 5.2 years, 15.3 ± 2.4 years of education, 9.8% African Americans, and 22.0% reporting a family history of dementia. In the RCT men were randomly assigned to either daily doses of 400 IU of vitamin E or placebo and 200 µg of selenium or placebo using a 2x2 factorial structure. In the RCT, participants completed the memory impairment screen (MIS), and if they failed, underwent a longer screening (based on an expanded Consortium to Establish a Registry in AD [CERAD] battery). CERAD failure resulted in visits to their clinician for medical examination with records of these examinations forwarded to the PREADViSE center for further review. In the exposure study, men are contacted by telephone and complete the telephone version of the memory impairment screen (MIS-T) screen. If they fail the MIS-T, a modified telephone interview of cognitive status (TICS-M) exam is given. A failed TICS-M exam also leads to a visit to their clinician for an in-depth examination and forwarding of records for a centralized consensus diagnosis by expert clinicians. A subgroup of the men who pass the MIS-T also take the TICS-M exam for validation purposes. While this ancillary trial was open to all 427 SELECT clinical sites, only 130 (30

Mindfulness-based stress reduction for residents: A randomized controlled trial

NARCIS (Netherlands)

Verweij, H.; Ravesteijn, H.J. van; Hooff, M.L.M. van; Lagro-Janssen, A.L.M.; Speckens, A.E.M.

2018-01-01

Background: Burnout is highly prevalent in residents. No randomized controlled trials have been conducted measuring the effects of Mindfulness-Based Stress Reduction (MBSR) on burnout in residents. Objective: To determine the effectiveness of MBSR in reducing burnout in residents. Design: A

Comparison of randomization techniques for clinical trials with data from the HOMERUS-trial

NARCIS (Netherlands)

Verberk, W. J.; Kroon, A. A.; Kessels, A. G. H.; Nelemans, P. J.; van Ree, J. W.; Lenders, J. W. M.; Thien, T.; Bakx, J. C.; van Montfrans, G. A.; Smit, A. J.; Beltman, F. W.; de Leeuw, P. W.

2005-01-01

Background. Several methods of randomization are available to create comparable intervention groups in a study. In the HOMERUS-trial, we compared the minimization procedure with a stratified and a non-stratified method of randomization in order to test which one is most appropriate for use in

Comparison of randomization techniques for clinical trials with data from the HOMERUS-trial.

NARCIS (Netherlands)

Verberk, W.J.; Kroon, A.A.; Kessels, A.G.H.; Nelemans, P.J.; Ree, J.W. van; Lenders, J.W.M.; Thien, Th.; Bakx, J.C.; Montfrans, G.A. van; Smit, A.J.; Beltman, F.W.; Leeuw, P.W. de

2005-01-01

BACKGROUND: Several methods of randomization are available to create comparable intervention groups in a study. In the HOMERUS-trial, we compared the minimization procedure with a stratified and a non-stratified method of randomization in order to test which one is most appropriate for use in

Fundamentals of randomized clinical trials in wound care

DEFF Research Database (Denmark)

Eskes, Anne M; Brölmann, Fleur E; Sumpio, Bauer E

2012-01-01

randomization is a necessary feature of a robust comparative study, it is not sufficient to ensure a study at low risk of bias. Randomized clinical trials should also ensure adequate allocation concealment and blinding of outcome assessors, apply intention-to-treat analysis, and use patient-oriented outcomes...

From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology.

Science.gov (United States)

Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C; Hobbs, Brian P; Berry, Donald A; Pentz, Rebecca D; Tam, Alda; Hong, Waun K; Ellis, Lee M; Abbruzzese, James; Overman, Michael J

2015-11-01

The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P medicine, additional initiatives are needed to minimize selective reporting. © 2015 by American Society of Clinical Oncology.

Selection bias and subject refusal in a cluster-randomized controlled trial

Directory of Open Access Journals (Sweden)

Rochelle Yang

2017-07-01

Full Text Available Abstract Background Selection bias and non-participation bias are major methodological concerns which impact external validity. Cluster-randomized controlled trials are especially prone to selection bias as it is impractical to blind clusters to their allocation into intervention or control. This study assessed the impact of selection bias in a large cluster-randomized controlled trial. Methods The Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE study examined the impact of a remote pharmacist-led intervention in twelve medical offices. To assess eligibility, a standardized form containing patient demographics and medical information was completed for each screened patient. Eligible patients were approached by the study coordinator for recruitment. Both the study coordinator and the patient were aware of the site’s allocation prior to consent. Patients who consented or declined to participate were compared across control and intervention arms for differing characteristics. Statistical significance was determined using a two-tailed, equal variance t-test and a chi-square test with adjusted Bonferroni p-values. Results were adjusted for random cluster variation. Results There were 2749 completed screening forms returned to research staff with 461 subjects who had either consented or declined participation. Patients with poorly controlled diabetes were found to be significantly more likely to decline participation in intervention sites compared to those in control sites. A higher mean diastolic blood pressure was seen in patients with uncontrolled hypertension who declined in the control sites compared to those who declined in the intervention sites. However, these findings were no longer significant after adjustment for random variation among the sites. After this adjustment, females were now found to be significantly more likely to consent than males (odds ratio = 1.41; 95% confidence interval = 1.03, 1

Cue exposure therapy for the treatment of opiate addiction: results of a randomized controlled clinical trial

NARCIS (Netherlands)

Marissen, Marlies A. E.; Franken, Ingmar H. A.; Blanken, Peter; van den Brink, Wim; Hendriks, Vincent M.

2007-01-01

BACKGROUND: Persistent cue reactivity to drug-related stimuli is a well-known phenomenon among abstinent drug users and has been found to be a predictor of relapse. Cue exposure therapy (CET) aims to reduce this cue reactivity by exposing abstinent drug users to conditioned drug-related stimuli

Predictors of Missed Research Appointments in a Randomized Placebo-Controlled Trial

Directory of Open Access Journals (Sweden)

Stéphanie J.E. Becker

2014-09-01

 Younger patients with no college education, who believe their health can be controlled, are more likely to miss a research appointment when enrolled in a randomized placebo injection-controlled trial. 

Nitrates and bone turnover (NABT) - trial to select the best nitrate preparation: study protocol for a randomized controlled trial.

Science.gov (United States)

Bucur, Roxana C; Reid, Lauren S; Hamilton, Celeste J; Cummings, Steven R; Jamal, Sophie A

2013-09-08

Organic nitrates uncouple bone turnover, improve bone mineral density, and improve trabecular and cortical components of bone. These changes in turnover, strength and geometry may translate into an important reduction in fractures. However, before proceeding with a large fracture trial, there is a need to identify the nitrate formulation that has both the greatest efficacy (with regards to bone turnover markers) and gives the fewest headaches. Ascertaining which nitrate formulation this may be is the purpose of the current study. This will be an open-label randomized, controlled trial conducted at Women's College Hospital comparing five formulations of nitrates for their effects on bone turnover markers and headache. We will recruit postmenopausal women age 50 years or older with no contraindications to nitroglycerin. Our trial will consist of a run-in phase and a treatment phase. We will enroll 420 women in the run-in phase, each to receive all of the 5 potential treatments in random order for 2 days, each with a 2-day washout period between treatments. Those who tolerate all formulations will enter the 12-week treatment phase and be randomly assigned to one of five groups: 0.3 mg sublingual nitroglycerin tablet, 0.6 mg of the sublingual tablet, a 20 mg tablet of isosorbide mononitrate, a 160 mg nitroglycerin transdermal patch (used for 8 h), and 15 mg of nitroglycerin ointment as used in a previous trial by our group. We will continue enrolment until we have randomized 210 women or 35 women per group. Concentrations of bone formation (bone-specific alkaline phosphatase and procollagen type I N-terminal propeptide) and bone resorption (C-telopeptides of collagen crosslinks and N-terminal crosslinks of collagen) agents will be measured in samples taken at study entry (the start of the run in phase) and 12 weeks. Subjects will record the frequency and severity of headaches daily during the run-in phase and then monthly after that. We will use the 'multiple

Recruitment of black and Latina women to a randomized controlled trial.

Science.gov (United States)

Martin, Anika; Negron, Rennie; Balbierz, Amy; Bickell, Nina; Howell, Elizabeth A

2013-08-01

Minority women are often not adequately represented in randomized controlled trials, limiting the generalizability of research trial results. We implemented a recruitment strategy for a postpartum depression prevention trial that utilized patient feedback to identify and understand the recruitment barriers of black and Latina postpartum women. Feedback on patients' reasons for trial refusal informed adaptations to the recruitment process. We calculated weekly recruitment rates and analyzed qualitative and quantitative data from patient refusals. Of the 668 women who were approached and completed the consent process, 540 enrolled in the trial and 128 declined participation. Over 52-weeks of recruitment, refusal rates decreased from 40% to 19%. A taxonomy of eight reasons for refusal derived from patient responses identified barriers to recruitment and generated targeted revisions to the recruitment message. A recruitment strategy designed to incorporate and respond to patient feedback improved recruitment of Black and Latina women to a clinical trial.

Yoga for High‑Risk Pregnancy: A Randomized Controlled Trial ...

African Journals Online (AJOL)

The study was a single‑blind randomized controlled clinical trial. Perceived stress scale (PSS) was measured during the 12th, 20th, and 28th weeks of pregnancy. SPSS version 16.0 (Chicago, IL, USA) was used for all data analysis. When the data were found to be normally distributed,the RMANOVA were used to assess ...

Using WhatsApp and Facebook Online Social Groups for Smoking Relapse Prevention for Recent Quitters: A Pilot Pragmatic Cluster Randomized Controlled Trial.

Science.gov (United States)

Cheung, Yee Tak Derek; Chan, Ching Han Helen; Lai, Chi-Keung Jonah; Chan, Wai Fung Vivian; Wang, Man Ping; Li, Ho Cheung William; Chan, Sophia Siu Chee; Lam, Tai-Hing

2015-10-22

Quit attempters often have episodes of smoking relapse before they eventually quit. Interactive text messaging through mobile phones has been shown to increase abstinence. This service can be potentially applied on the platform of a social networking service to help quitters maintain abstinence. Our aim was to determine if the group discussion and reminders via the WhatsApp or Facebook social group were effective to prevent smoking relapse in quitters who had stopped smoking recently. This was a single-blinded, parallel, 3-arm pilot cluster randomized controlled trial allocating recent quitters, who had completed an 8-week treatment and reported abstinence for at least 7 days, to WhatsApp (n=42), Facebook (n=40), and a control group (n=54). The 2 intervention groups participated in a 2-month online group discussion with either WhatsApp or Facebook moderated by a trained smoking cessation counselor and received a self-help booklet on smoking cessation. The control group only received the booklet. The primary outcome was the 2- and 6-month relapse rates, defined as the proportion of participants who smoked at least 5 cigarettes in 3 consecutive days. Fewer participants in the WhatsApp group (17%, 7/42) reported relapse than the control group (42.6%, 23/54) at 2-month (OR 0.27, 95% CI 0.10-0.71) and 6-month (40.5%, 17/42 vs 61.1%, 33/54; OR 0.43, 95% CI 0.19-0.99) follow-ups. The Facebook group (30.0%, 12/40) had an insignificantly lower relapse rate than the control group (42.6%, 23/54) at 2-month (OR 0.58, 95% CI 0.24-1.37) and 6-month (52.5%, 13/40 vs 61.1%, 33/54; OR 0.70, 95% CI 0.31-1.61) follow-ups. The WhatsApp social groups had more moderators' posts (median 60, IQR 25 vs median 32, IQR 7; P=.05) and participants' posts (median 35, IQR 50 vs median 6, IQR 9; P=.07) than their Facebook counterparts, but the difference was insignificant. The intervention via the WhatsApp social group was effective in reducing relapse probably because of enhanced discussion and

A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

Science.gov (United States)

Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

2014-01-01

Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y, Shapiro S, Wyatt JK. A randomized controlled trial of mindfulness meditation for chronic insomnia. SLEEP 2014;37(9):1553-1563. PMID:25142566

Exposure to and Views of Information about Sexual Abstinence among Older Teens

Science.gov (United States)

Jones, Rachel K.; Biddlecom, Ann E.

2011-01-01

There is scant research of adolescents' understanding of abstinence. We conducted interviews with a sample of 58 teens to find out their exposure to abstinence information from a range of sources. Most teens had received abstinence information or messages from school, family members, and friends. For many teens, information about abstinence, or…

A prospective randomized trial of Kotase ® (Bromelain + Trypsin) in ...

African Journals Online (AJOL)

International Journal of Medicine and Health Development. Journal Home · ABOUT THIS ... A prospective randomized trial of Kotase® (Bromelain + Trypsin) in the management of post-operative abdominal wounds at the University of Nigeria Teaching Hospital Enugu, Nigeria. Emmanuel R Ezeome, Aloy E Aghaji ...

Recruitment barriers in a randomized controlled trial from the physicians' perspective – A postal survey

Directory of Open Access Journals (Sweden)

Karrer Werner

2009-03-01

Full Text Available Abstract Background The feasibility of randomized trials often depends on successful patient recruitment. Although numerous recruitment barriers have been identified it is unclear which of them complicate recruitment most. Also, most surveys have focused on the patients' perspective of recruitment barriers whereas the perspective of recruiting physicians has received less attention. Therefore, our aim was to conduct a postal survey among recruiting physicians of a multi-center trial to weigh barriers according to their impact on recruitment. Methods We identified any potential recruitment barriers from the literature and from our own experience with a multi-center trial of respiratory rehabilitation in patients with chronic obstructive pulmonary disease. We developed and pilot-tested a self-administered questionnaire where recruiting physicians were asked to express their agreement with statements about recruitment barriers on a Likert-type scale from 1 (full agreement with statement = very substantial recruitment barrier to 7 (no agreement with statement = no recruitment barrier. Results 38 of 55 recruiting physicians returned questionnaires (69% response rate, of which 35 could be analyzed (64% useable response rate. Recruiting physicians reported that "time constraints" (median agreement of 3, interquartile range 2–5 had the most negative impact on recruitment followed by "difficulties including identified eligible patients" (median agreement of 5, IQR 3–6. Other barriers such as "trial design barriers", "lack of access to treatment", "individual barriers of recruiting physicians" or "insufficient training of recruiting physicians" were perceived to have little or no impact on patient recruitment. Conclusion Physicians perceived time constraints as the most relevant recruitment barrier in a randomized trial. To overcome recruitment barriers interventions, that are affordable for both industry- and investigator-driven trials, need to be

A randomized controlled trial of an electronic informed consent process.

Science.gov (United States)

Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

2014-12-01

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

A randomized controlled trial of a smoking cessation self-help intervention for dual users of tobacco cigarettes and E-cigarettes: Intervention development and research design.

Science.gov (United States)

Meltzer, Lauren R; Simmons, Vani N; Sutton, Steven K; Drobes, David J; Quinn, Gwendolyn P; Meade, Cathy D; Unrod, Marina; Brandon, Karen O; Harrell, Paul T; Eissenberg, Thomas; Bullen, Christopher R; Brandon, Thomas H

2017-09-01

Electronic Nicotine Delivery Systems, also called electronic cigarettes or e-cigarettes, have been available for over a decade and use has been increasing dramatically. The primary reported reasons for use are to aid smoking cessation or reduction, yet a significant proportion appear to be long-term users of both products ("dual users"). Dual users may be motivated to quit smoking and might benefit from a behavioral intervention for smoking cessation. This paper describes the intervention development, as well as the design, methods, and data analysis plans for an ongoing randomized controlled trial (RCT). Formative research and learner verification were conducted to create a usable, understandable, and acceptable self-help intervention targeting dual users. The efficacy is being tested in an RCT with current dual users (N=2900) recruited nationally and randomized to one of three conditions. The Assessment Only (ASSESS) group only completes assessments. The Generic Self-Help (GENERIC) group receives non-targeted smoking cessation booklets and supplemental materials sent monthly over 18months. The e-cigarette Targeted Self-Help (eTARGET) group receives the newly developed intervention (targeted booklets and supplemental materials) sent over the same period. All participants complete self-report surveys every 3months over 2years. The primary study outcome is self-reported 7-day point prevalence abstinence. Cost-effectiveness metrics for the GENERIC and eTARGET interventions will also be calculated. Copyright © 2017 Elsevier Inc. All rights reserved.

Design and analysis of group-randomized trials in cancer: A review of current practices.

Science.gov (United States)

Murray, David M; Pals, Sherri L; George, Stephanie M; Kuzmichev, Andrey; Lai, Gabriel Y; Lee, Jocelyn A; Myles, Ranell L; Nelson, Shakira M

2018-06-01

The purpose of this paper is to summarize current practices for the design and analysis of group-randomized trials involving cancer-related risk factors or outcomes and to offer recommendations to improve future trials. We searched for group-randomized trials involving cancer-related risk factors or outcomes that were published or online in peer-reviewed journals in 2011-15. During 2016-17, in Bethesda MD, we reviewed 123 articles from 76 journals to characterize their design and their methods for sample size estimation and data analysis. Only 66 (53.7%) of the articles reported appropriate methods for sample size estimation. Only 63 (51.2%) reported exclusively appropriate methods for analysis. These findings suggest that many investigators do not adequately attend to the methodological challenges inherent in group-randomized trials. These practices can lead to underpowered studies, to an inflated type 1 error rate, and to inferences that mislead readers. Investigators should work with biostatisticians or other methodologists familiar with these issues. Funders and editors should ensure careful methodological review of applications and manuscripts. Reviewers should ensure that studies are properly planned and analyzed. These steps are needed to improve the rigor and reproducibility of group-randomized trials. The Office of Disease Prevention (ODP) at the National Institutes of Health (NIH) has taken several steps to address these issues. ODP offers an online course on the design and analysis of group-randomized trials. ODP is working to increase the number of methodologists who serve on grant review panels. ODP has developed standard language for the Application Guide and the Review Criteria to draw investigators' attention to these issues. Finally, ODP has created a new Research Methods Resources website to help investigators, reviewers, and NIH staff better understand these issues. Published by Elsevier Inc.

Promoting healthful family meals to prevent obesity: HOME Plus, a randomized controlled trial

OpenAIRE

Fulkerson, Jayne A.; Friend, Sarah; Flattum, Colleen; Horning, Melissa; Draxten, Michelle; Neumark-Sztainer, Dianne; Gurvich, Olga; Story, Mary; Garwick, Ann; Kubik, Martha Y.

2015-01-01

Background Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. Methods Families (n?=?160 8-12-yea...

Efficacy of a Nurse-Delivered Intervention to Prevent and Delay Postpartum Return to Smoking: The Quit for Two Trial.

Science.gov (United States)

Pollak, Kathryn I; Fish, Laura J; Lyna, Pauline; Peterson, Bercedis L; Myers, Evan R; Gao, Xiaomei; Swamy, Geeta K; Brown-Johnson, Angela; Whitecar, Paul; Bilheimer, Alicia K; Pletsch, Pamela K

2016-10-01

Most pregnant women who quit smoking return to smoking postpartum. Trials to prevent this return have been unsuccessful. We tested the efficacy of a nurse-delivered intervention in maintaining smoking abstinence after delivery among pregnant women who quit smoking that was tailored on their high risk of relapse (eg, had strong intentions to return). We recruited 382 English-speaking spontaneous pregnant quitters from 14 prenatal clinics and randomized them to receive either a smoking abstinence booklet plus newsletters about parenting and stress (control) or a nurse-delivered smoking abstinence intervention that differed in intensity for the high and low risk groups. Our primary outcome was smoking abstinence at 12 months postpartum. Using intent-to-treat analyses, there was a high rate of biochemically validated smoking abstinence at 12 months postpartum but no arm differences ( 36% [95% confidence interval [CI]: 29-43] vs. 35% [95% CI: 28-43], P = .81). Among women at low risk of returning to smoking, the crude abstinence rate was significantly higher in the control arm (46%) than in the intervention arm (33%); among women at high risk of returning to smoking, the crude abstinence rate was slightly lower but not different in the control arm (31%) than in the intervention arm (37%). Low-risk women fared better with a minimal intervention that focused on parenting skills and stress than when they received an intensive smoking abstinence intervention. The opposite was true for women who were at high risk of returning to smoking. Clinicians might need to tailor their approach based on whether women are at high or low risk of returning to smoking. Results suggest that high-risk and low-risk women might benefit from different types of smoking relapse interventions. Those who are lower risk of returning to smoking might benefit from stress reduction that is devoid of smoking content, whereas those who are higher risk might benefit from smoking relapse prevention. © The

The Danish randomized lung cancer CT screening trial

DEFF Research Database (Denmark)

Pedersen, Jesper H; Ashraf, Haseem; Dirksen, Asger

2009-01-01

INTRODUCTION: Lung cancer screening with low dose computed tomography (CT) has not yet been evaluated in randomized clinical trials, although several are underway. METHODS: In The Danish Lung Cancer Screening Trial, 4104 smokers and previous smokers from 2004 to 2006 were randomized to either...... lung cancer. Ten of these had stage I disease. Eleven of 17 lung cancers at baseline were treated surgically, eight of these by video assisted thoracic surgery resection. CONCLUSIONS: Screening may facilitate minimal invasive treatment and can be performed with a relatively low rate of false......-positive screen results compared with previous studies on lung cancer screening....

Two controlled trials to increase participant retention in a randomized controlled trial of mobile phone-based smoking cessation support in the United Kingdom.

Science.gov (United States)

Severi, Ettore; Free, Caroline; Knight, Rosemary; Robertson, Steven; Edwards, Philip; Hoile, Elizabeth

2011-10-01

Loss to follow-up of trial participants represents a threat to research validity. To date, interventions designed to increase participants' awareness of benefits to society of completing follow-up, and the impact of a telephone call from a senior female clinician and researcher requesting follow-up have not been evaluated robustly. Trial 1 aimed to evaluate the effect on trial follow-up of written information regarding the benefits of participation to society. Trial 2 aimed to evaluate the effect on trial follow-up of a telephone call from a senior female clinician and researcher. Two single-blind randomized controlled trials were nested within a larger trial, Txt2stop. In Trial 1, participants were allocated using minimization to receive a refrigerator magnet and a text message emphasizing the benefits to society of completing follow-up, or to a control group receiving a simple reminder regarding follow-up. In Trial 2, participants were randomly allocated to receive a telephone call from a senior female clinician and researcher, or to a control group receiving standard Txt2stop follow-up procedures. Trial 1: 33.5% (327 of 976) of the intervention group and 33.8% (329 of 974) of the control group returned the questionnaire within 26 weeks of randomization, risk ratio (RR) 0.99; 95% confidence interval (CI) 0.88-1.12. In all, 83.3% (813 of 976) of the intervention group and 82.2% (801 of/974) of the control group sent back the questionnaire within 30 weeks of randomization, RR 1.01; 95% CI 0.97, 1.05. Trial 2: 31% (20 of 65) of the intervention group and 32% (20 of 62) of the control group completed trial follow-up, RR 0.93; 95%CI 0.44, 1.98. In presence of other methods to increase follow-up neither experimental method (refrigerator magnet and text message emphasizing participation's benefits to society nor a telephone call from study's principal investigator) increased participant follow-up in the Txt2stop trial.

Platelet-rich fibrin versus albumin in surgical wound repair: a randomized trial with paired design

DEFF Research Database (Denmark)

Danielsen, Patricia L; Ågren, Sven Per Magnus; Jørgensen, Lars Nannestad

2010-01-01

To study the effects of autologous platelet-rich fibrin (PRF) versus human albumin on incisional wound breaking strength and subcutaneous collagen deposition in patients undergoing laparoscopic cholecystectomy in a randomized trial.......To study the effects of autologous platelet-rich fibrin (PRF) versus human albumin on incisional wound breaking strength and subcutaneous collagen deposition in patients undergoing laparoscopic cholecystectomy in a randomized trial....

SPIRIT: A seamless phase I/II randomized design for immunotherapy trials.

Science.gov (United States)

Guo, Beibei; Li, Daniel; Yuan, Ying

2018-06-07

Immunotherapy-treatments that enlist the immune system to battle tumors-has received widespread attention in cancer research. Due to its unique features and mechanisms for treating cancer, immunotherapy requires novel clinical trial designs. We propose a Bayesian seamless phase I/II randomized design for immunotherapy trials (SPIRIT) to find the optimal biological dose (OBD) defined in terms of the restricted mean survival time. We jointly model progression-free survival and the immune response. Progression-free survival is used as the primary endpoint to determine the OBD, and the immune response is used as an ancillary endpoint to quickly screen out futile doses. Toxicity is monitored throughout the trial. The design consists of two seamlessly connected stages. The first stage identifies a set of safe doses. The second stage adaptively randomizes patients to the safe doses identified and uses their progression-free survival and immune response to find the OBD. The simulation study shows that the SPIRIT has desirable operating characteristics and outperforms the conventional design. Copyright © 2018 John Wiley & Sons, Ltd.

From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology

Science.gov (United States)

Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C.; Hobbs, Brian P.; Berry, Donald A.; Pentz, Rebecca D.; Tam, Alda; Hong, Waun K.; Ellis, Lee M.; Abbruzzese, James; Overman, Michael J.

2015-01-01

Purpose The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. Methods We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. Results A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007). Conclusion Despite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting. PMID:26304898

Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study

Directory of Open Access Journals (Sweden)

Chaudhry Shazia H

2009-07-01

Full Text Available Abstract Background Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities – rather than individual themselves – are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1 identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2 understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK; (3 elicit the views and experiences of trial participants and cluster representatives; (4 develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5 disseminate the guidelines to researchers, research ethics boards (REBs, journal editors, and research funders. Methods We will use a mixed-methods (qualitative and quantitative approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An

A randomized trial of female-specific cognitive behavior therapy for alcohol dependent women.

Science.gov (United States)

Epstein, Elizabeth E; McCrady, Barbara S; Hallgren, Kevin A; Cook, Sharon; Jensen, Noelle K; Hildebrandt, Thomas

2018-02-01

This study compared Female-Specific Cognitive Behavioral Therapy (FS-CBT) to evidence-based, gender-neutral CBT (GN-CBT; Epstein & McCrady, 2009) for women with alcohol use disorder (AUD). Women (N = 99) with AUD, mean age 48, were randomly assigned to 12 outpatient manual-guided sessions of FS-CBT (n = 44) or GN-CBT (n = 55). Women were assessed at baseline and 3, 9 and 15 months after baseline for drinking and for specific issues common among women with AUD. A FS-CBT protocol was developed that was discriminable on treatment integrity ratings from GN-CBT. No treatment condition differences were found in treatment engagement, changes in drinking, alcohol-related coping, abstinence self-efficacy, motivation to change, or constructs directly targeted in FS-CBT (sociotropy, autonomy, depression, anxiety). Women in both conditions were highly engaged and satisfied with treatment, and reported significant reductions in drinking and changes in desired directions for all other variables except social support for abstinence. In the year following treatment, women in the FS-CBT but not in the CBT condition reported an increase in percentage of abstainers in their social networks (0.69% per month, SE = 0.21, p = .002). The value and appeal of female-specific programming in AUD treatment has been established in the wider literature (Epstein & Menges, 2013), and the current study provides support for the use of the Female-Specific Cognitive Behavioral Therapy (FS-CBT) manual as an option that may yield outcomes similar to standard gender-neutral CBT for women with AUD. Future research should examine whether FS-CBT enhances treatment utilization for women. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Encouraging GPs to undertake screening and a brief intervention in order to reduce problem drinking: a randomized controlled trial

DEFF Research Database (Denmark)

Hansen, Lars Jørgen; Olivarius, Niels de Fine; Beich, Anders

1999-01-01

intervention, problem drinking, randomized controlled trial, family practice, marketing of health services......intervention, problem drinking, randomized controlled trial, family practice, marketing of health services...

Personalized Genetic Risk Counseling to Motivate Diabetes Prevention: A randomized trial

OpenAIRE

Grant, Richard W.; O’Brien, Kelsey E.; Waxler, Jessica L.; Vassy, Jason L.; Delahanty, Linda M.; Bissett, Laurie G.; Green, Robert C.; Stember, Katherine G.; Guiducci, Candace; Park, Elyse R.; Florez, Jose C.; Meigs, James B.

2013-01-01

OBJECTIVE To examine whether diabetes genetic risk testing and counseling can improve diabetes prevention behaviors. RESEARCH DESIGN AND METHODS We conducted a randomized trial of diabetes genetic risk counseling among overweight patients at increased phenotypic risk for type 2 diabetes. Participants were randomly allocated to genetic testing versus no testing. Genetic risk was calculated by summing 36 single nucleotide polymorphisms associated with type 2 diabetes. Participants in the top an...

Randomized clinical trials in orthodontics are rarely registered a priori and often published late or not at all.

Science.gov (United States)

Papageorgiou, Spyridon N; Antonoglou, Georgios N; Sándor, George K; Eliades, Theodore

2017-01-01

A priori registration of randomized clinical trials is crucial to the transparency and credibility of their findings. Aim of this study was to assess the frequency with which registered and completed randomized trials in orthodontics are published. We searched ClinicalTrials.gov and ISRCTN for registered randomized clinical trials in orthodontics that had been completed up to January 2017 and judged the publication status and date of registered trials using a systematic protocol. Statistical analysis included descriptive statistics, chi-square or Fisher exact tests, and Kaplan-Meier survival estimates. From the 266 orthodontic trials registered up to January 2017, 80 trials had been completed and included in the present study. Among these 80 included trials, the majority (76%) were registered retrospectively, while only 33 (41%) were published at the time. The median time from completion to publication was 20.1 months (interquartile range: 9.1 to 31.6 months), while survival analysis indicated that less than 10% of the trials were published after 5 years from their completion. Finally, 22 (28%) of completed trials remain unpublished even after 5 years from their completion. Publication rates of registered randomized trials in orthodontics remained low, even 5 years after their completion date.

Young South Africans’ views on, and perceptions of, abstinence and faithfulness

Directory of Open Access Journals (Sweden)

Keitshepile G. Setswe

2010-09-01

Full Text Available The goals of the Abstinence and Be Faithful Among Youth (ABY project were to enhance local responses among the youth in South Africa to prevent HIV infection through encouraging abstinence,faithfulness and avoidance of unhealthy sexual behaviour among youths over a five-year period. A quantitative baseline evaluation of the ABY project was conducted in five cities in South Africa. Data were collected from learners and youths just before the ABY intervention started at nine randomly selected sites in Johannesburg, Cape Town, Durban, Port Elizabeth and Mthatha using a three-stage cluster sampling design. In total, nine sites were randomly selected from a possible eighteen. At each of the data-collection points, data were collected from 60 participants. In total there were 27 data-collection points and 1620 respondents. Young people have strong views on abstaining from sexual intercourse, as 83% said that it was possible not to have sex for as long as you can. There was also strong support for abstinence, as 78.5% said that not having sex was the best way of preventing infection with HIV. In total, 68.1% of the youths said that the media had a positive influence on encouraging abstinence and 72.1% said role models could help them not to have sex, while 84.3% said that leadership and life skills workshops were helpful in encouraging them to abstain from sex. In total, 68.7% of young people said that the media encouraged faithfulness in relationships and 84.6% said that life skills workshops were helpful in encouraging them to remain faithful to one partner. Young people have strong views on and support for abstinence. They also have strong views on and perceptions of remaining faithful to one partner. These findings are a valuable guide to the views and perceptions of young people with respect to abstinence and faithfulness before interventions are implemented. Opsomming Die doel van die Abstinence and Be Faithful for Youth (ABY projek was om die

Generalizing Evidence From Randomized Clinical Trials to Target Populations

Science.gov (United States)

Cole, Stephen R.; Stuart, Elizabeth A.

2010-01-01

Properly planned and conducted randomized clinical trials remain susceptible to a lack of external validity. The authors illustrate a model-based method to standardize observed trial results to a specified target population using a seminal human immunodeficiency virus (HIV) treatment trial, and they provide Monte Carlo simulation evidence supporting the method. The example trial enrolled 1,156 HIV-infected adult men and women in the United States in 1996, randomly assigned 577 to a highly active antiretroviral therapy and 579 to a largely ineffective combination therapy, and followed participants for 52 weeks. The target population was US people infected with HIV in 2006, as estimated by the Centers for Disease Control and Prevention. Results from the trial apply, albeit muted by 12%, to the target population, under the assumption that the authors have measured and correctly modeled the determinants of selection that reflect heterogeneity in the treatment effect. In simulations with a heterogeneous treatment effect, a conventional intent-to-treat estimate was biased with poor confidence limit coverage, but the proposed estimate was largely unbiased with appropriate confidence limit coverage. The proposed method standardizes observed trial results to a specified target population and thereby provides information regarding the generalizability of trial results. PMID:20547574

Review of Recent Methodological Developments in Group-Randomized Trials: Part 2-Analysis.

Science.gov (United States)

Turner, Elizabeth L; Prague, Melanie; Gallis, John A; Li, Fan; Murray, David M

2017-07-01

In 2004, Murray et al. reviewed methodological developments in the design and analysis of group-randomized trials (GRTs). We have updated that review with developments in analysis of the past 13 years, with a companion article to focus on developments in design. We discuss developments in the topics of the earlier review (e.g., methods for parallel-arm GRTs, individually randomized group-treatment trials, and missing data) and in new topics, including methods to account for multiple-level clustering and alternative estimation methods (e.g., augmented generalized estimating equations, targeted maximum likelihood, and quadratic inference functions). In addition, we describe developments in analysis of alternative group designs (including stepped-wedge GRTs, network-randomized trials, and pseudocluster randomized trials), which require clustering to be accounted for in their design and analysis.

Depressive Symptoms, Friend and Partner Relationship Quality, and Posttreatment Abstinence*

Science.gov (United States)

McKee, Laura G.; Bonn-Miller, Marcel O.; Moos, Rudolf H.

2011-01-01

Objective: This study employed a prospective design to examine the role of friend and partner relationship quality 1 year following substance use disorder treatment in the association between depressive symptoms at discharge from treatment and abstinence from substance use 2 years after treatment. Method: The sample consisted of 1,453 male veterans who used alcohol and at least one other substance in the 3 months before treatment admission, who completed treatment, and who were abstinent from substances during the 2 weeks before discharge. Results: Fewer depressive symptoms at treatment discharge predicted better relationship quality with friends and a partner at 1 -year follow-up, as well as abstinence from substance use at 2-year follow-up. Furthermore, friend and partner relationship quality at 1 year predicted abstinence from substance use at 2 years. Friend relationship quality at 1 year mediated part of the association between fewer depressive symptoms at treatment discharge and abstinence at 2-year follow-up. Conclusions: A stronger focus in treatment on reducing depressive symptoms and enhancing the quality of patients' relationships with their friends and partner may increase the likelihood of long-term abstinence. PMID:21138721

A Prospective, Randomized, Double-blind Clinical Trial of One Nano ...

African Journals Online (AJOL)

2015-12-16

Dec 16, 2015 ... prospective randomized clinical trial that evaluated the clinical performance of one high‑viscosity bulk‑fill composite resin in Class II cavities of posterior teeth. .... amount of glass ionomer needed was used to cover the calcium ...

Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE: a randomized controlled trial protocol

Directory of Open Access Journals (Sweden)

Winstein Carolee J

2013-01-01

Full Text Available Abstract Background Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting. The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP, compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC. Two secondary objectives are to compare ASAP to a true (active monitoring only usual and customary (UCC therapy group and to compare DEUCC and UCC. Methods/design Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS hand domain is a secondary outcome measure. The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary

Setting up a randomized clinical trial in the UK: approvals and process.

Science.gov (United States)

Greene, Louise Eleanor; Bearn, David R

2013-06-01

Randomized clinical trials are considered the 'gold standard' in primary research for healthcare interventions. However, they can be expensive and time-consuming to set up and require many approvals to be in place before they can begin. This paper outlines how to determine what approvals are required for a trial, the background of each approval and the process for obtaining them.

Acupuncture for sequelae of Bell's palsy: a randomized controlled trial protocol

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Kim Yong-Suk

2011-03-01

Full Text Available Abstract Objective Incomplete recovery from facial palsy has a long-term impact on the quality of life, and medical options for the sequelae of Bell's palsy are limited. Invasive treatments and physiotherapy have been employed to relieve symptoms, but there is limited clinical evidence for their effectiveness. Acupuncture is widely used on Bell's palsy patients in East Asia, but there is insufficient evidence for its effectiveness on Bell's palsy sequelae. The objective is to evaluate the efficacy and safety of acupuncture in patients with sequelae of Bell's palsy. Method/Design This study consists of a randomized controlled trial with two parallel arms: an acupuncture group and a waitlist group. The acupuncture group will receive acupuncture treatment three times per week for a total of 24 sessions over 8 weeks. Participants in the waitlist group will not receive any acupuncture treatments during this 8 week period, but they will participate in the evaluations of symptoms at the start of the study, at 5 weeks and at 8 weeks after randomization, at which point the same treatment as the acupuncture group will be provided. The primary outcome will be analyzed by the change in the Facial Disability Index (FDI from baseline to week eight. The secondary outcome measures will include FDI from baseline to week five, House-Brackmann Grade, lip mobility, and stiffness scales. Trial registration Current Controlled-Trials ISRCTN43104115; registration date: 06 July 2010; the date of the first patient's randomization: 04 August 2010

Acupuncture for sequelae of Bell's palsy: a randomized controlled trial protocol

Science.gov (United States)

2011-01-01

Objective Incomplete recovery from facial palsy has a long-term impact on the quality of life, and medical options for the sequelae of Bell's palsy are limited. Invasive treatments and physiotherapy have been employed to relieve symptoms, but there is limited clinical evidence for their effectiveness. Acupuncture is widely used on Bell's palsy patients in East Asia, but there is insufficient evidence for its effectiveness on Bell's palsy sequelae. The objective is to evaluate the efficacy and safety of acupuncture in patients with sequelae of Bell's palsy. Method/Design This study consists of a randomized controlled trial with two parallel arms: an acupuncture group and a waitlist group. The acupuncture group will receive acupuncture treatment three times per week for a total of 24 sessions over 8 weeks. Participants in the waitlist group will not receive any acupuncture treatments during this 8 week period, but they will participate in the evaluations of symptoms at the start of the study, at 5 weeks and at 8 weeks after randomization, at which point the same treatment as the acupuncture group will be provided. The primary outcome will be analyzed by the change in the Facial Disability Index (FDI) from baseline to week eight. The secondary outcome measures will include FDI from baseline to week five, House-Brackmann Grade, lip mobility, and stiffness scales. Trial registration Current Controlled-Trials ISRCTN43104115; registration date: 06 July 2010; the date of the first patient's randomization: 04 August 2010 PMID:21388554

A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation

Science.gov (United States)

Acosta, Joie D.; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S.

2016-01-01

Restorative practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this article describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI)…

A randomized trial evaluating a block-replacement regimen during radioiodine therapy

DEFF Research Database (Denmark)

Bonnema, Steen J; Grupe, Peter; Boel-Jørgensen, Henrik

2011-01-01

Eur J Clin Invest 2010 ABSTRACT: Background  Lack of consensus regarding the antithyroid drug regimen in relation to radioiodine ((131) I) therapy of hyperthyroidism prompted this randomized trial comparing two strategies. Design  Patients with Graves' disease (GD, n = 51) or toxic nodular goitre...

Trajectories of abstinence-induced Internet gaming withdrawal symptoms: A prospective pilot study

Directory of Open Access Journals (Sweden)

Dean Kaptsis

2016-12-01

Full Text Available Internet Gaming Disorder (IGD is positioned in the appendix of the DSM-5 as a condition requiring further study. The IGD criteria refer to withdrawal symptoms, including irritability, anxiety, or sadness, that follow cessation of Internet gaming (APA, 2013. The aim of this study was to prospectively examine the nature of Internet gaming withdrawal symptoms, if they occur, under gaming abstinence conditions. This study employed a repeated-measures protocol to examine the cognitive-affective reactions of participants undertaking an 84-h Internet gaming abstinence period. The sample included individuals who met the IGD criteria as well as those who regularly played Internet games but did not meet the IGD criteria. Outcome variables included affect (positive and negative, psychological distress (depression, anxiety, stress, and Internet gaming withdrawal symptoms (craving/urge, thoughts about gaming, inability to resist gaming. A total of 24 participants (Mage = 24.6 years, SD = 5.8 were recruited from online gaming communities, and completed a series of online surveys before, during, and after abstaining from Massively Multiplayer Online (MMO games. Both the IGD group and the non-IGD group experienced an abstinence-induced decline in withdrawal symptomatology, negative affect, and psychological distress. The IGD group experienced its largest decline in withdrawal symptomatology within the first 24 h of abstinence. These preliminary data suggest that gaming withdrawal symptoms may follow, at least initially, negative linear and quadratic trends. Further prospective work in larger samples involving longer periods of abstinence is required to verify and expand upon these observations.

Trajectories of abstinence-induced Internet gaming withdrawal symptoms: A prospective pilot study.

Science.gov (United States)

Kaptsis, Dean; King, Daniel L; Delfabbro, Paul H; Gradisar, Michael

2016-12-01

Internet Gaming Disorder (IGD) is positioned in the appendix of the DSM-5 as a condition requiring further study. The IGD criteria refer to withdrawal symptoms, including irritability, anxiety, or sadness, that follow cessation of Internet gaming (APA, 2013). The aim of this study was to prospectively examine the nature of Internet gaming withdrawal symptoms, if they occur, under gaming abstinence conditions. This study employed a repeated-measures protocol to examine the cognitive-affective reactions of participants undertaking an 84-h Internet gaming abstinence period. The sample included individuals who met the IGD criteria as well as those who regularly played Internet games but did not meet the IGD criteria. Outcome variables included affect (positive and negative), psychological distress (depression, anxiety, stress), and Internet gaming withdrawal symptoms (craving/urge, thoughts about gaming, inability to resist gaming). A total of 24 participants ( M age  = 24.6 years, SD  = 5.8) were recruited from online gaming communities, and completed a series of online surveys before, during, and after abstaining from Massively Multiplayer Online (MMO) games. Both the IGD group and the non-IGD group experienced an abstinence-induced decline in withdrawal symptomatology, negative affect, and psychological distress. The IGD group experienced its largest decline in withdrawal symptomatology within the first 24 h of abstinence. These preliminary data suggest that gaming withdrawal symptoms may follow, at least initially, negative linear and quadratic trends. Further prospective work in larger samples involving longer periods of abstinence is required to verify and expand upon these observations.

A quality assessment of randomized controlled trial reports in endodontics.

Science.gov (United States)

Lucena, C; Souza, E M; Voinea, G C; Pulgar, R; Valderrama, M J; De-Deus, G

2017-03-01

To assess the quality of the randomized clinical trial (RCT) reports published in Endodontics between 1997 and 2012. Retrieval of RCTs in Endodontics was based on a search of the Thomson Reuters Web of Science (WoS) database (March 2013). Quality evaluation was performed using a checklist based on the Jadad criteria, CONSORT (Consolidated Standards of Reporting Trials) statement and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials). Descriptive statistics were used for frequency distribution of data. Student's t-test and Welch test were used to identify the influence of certain trial characteristics upon report quality (α = 0.05). A total of 89 RCTs were evaluated, and several methodological flaws were found: only 45% had random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, and 19% were nonblinded designs. Regarding statistics, only 55% of the RCTs performed adequate sample size estimations, only 16% presented confidence intervals, and 25% did not provide the exact P-value. Also, 2% of the articles used no statistical tests, and in 87% of the RCTs, the information provided was insufficient to determine whether the statistical methodology applied was appropriate or not. Significantly higher scores were observed for multicentre trials (P = 0.023), RCTs signed by more than 5 authors (P = 0.03), articles belonging to journals ranked above the JCR median (P = 0.03), and articles complying with the CONSORT guidelines (P = 0.000). The quality of RCT reports in key areas for internal validity of the study was poor. Several measures, such as compliance with the CONSORT guidelines, are important in order to raise the quality of RCTs in Endodontics. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

Fractional Nonablative 1540 nm Laser Resurfacing for Thermal Burn Scars: A Randomized Controlled Trial

DEFF Research Database (Denmark)

Haedersdal, M.; Moreau, K.E.R.; Beyer, D.M.

2009-01-01

Background and Objective: Burn scars cause permanent and disfiguring problems for many patients and limited treatments are available. Nonablative fractional lasers induce a wound healing response, which may lead to remodeling of burn sear texture. This randomized trial evaluates efficacy and adve......Background and Objective: Burn scars cause permanent and disfiguring problems for many patients and limited treatments are available. Nonablative fractional lasers induce a wound healing response, which may lead to remodeling of burn sear texture. This randomized trial evaluates efficacy...

A cluster randomized pilot trial of a tailored worksite smoking cessation intervention targeting Hispanic/Latino construction workers: Intervention development and research design.

Science.gov (United States)

Asfar, Taghrid; Caban-Martinez, Alberto J; McClure, Laura A; Ruano-Herreria, Estefania C; Sierra, Danielle; Gilford Clark, G; Samano, Daniel; Dietz, Noella A; Ward, Kenneth D; Arheart, Kristopher L; Lee, David J

2018-04-01

Construction workers have the highest smoking rate among all occupations (39%). Hispanic/Latino workers constitute a large and increasing group in the US construction industry (over 2.6 million; 23% of all workers). These minority workers have lower cessation rates compared to other groups due to their limited access to cessation services, and lack of smoking cessation interventions adapted to their culture and work/life circumstances. Formative research was conducted to create an intervention targeting Hispanic/Latino construction workers. This paper describes the intervention development and the design, methods, and data analysis plans for an ongoing cluster pilot two-arm randomized controlled trial comparing an Enhanced Care worksite cessation program to Standard Care. Fourteen construction sites will be randomized to either Enhanced Care or Standard Care and 126 participants (63/arm) will be recruited. In both arms, recruitment and intervention delivery occur around "food trucks" that regularly visit the construction sites. Participants at Enhanced Care sites will receive the developed intervention consisting of a single face-to-face group counseling session, 2 phone calls, and a fax referral to Florida tobacco quitline (QL). Participants at Standard Care sites will receive a fax referral to the QL. Both groups will receive eight weeks of nicotine replacement treatment and two follow-up assessments at three and six months. Feasibility outcomes are estimated recruitment yield, barriers to delivering the intervention onsite, and rates of adherence/compliance to the intervention, follow-ups, and QL enrollment. Efficacy outcomes are point-prevalence and prolonged abstinence rates at six month follow-up confirmed by saliva cotinine <15 ng/ml. Copyright © 2018. Published by Elsevier Inc.

Multimodal Neuroimaging Differences in Nicotine Abstinent vs. Satiated Smokers.

Science.gov (United States)

Chaarani, Bader; Spechler, Philip A; Ivanciu, Alexandra; Snowe, Mitchell; Nickerson, Joshua P; Higgins, Stephen T; Garavan, Hugh

2018-04-06

Research on cigarette smokers suggests cognitive and behavioral impairments. However, much remains unclear how the functional neurobiology of smokers is influenced by nicotine state. Therefore, we sought to determine which state, be it acute nicotine abstinence or satiety, would yield the most robust differences compared to non-smokers when assessing neurobiological markers of nicotine dependence. Smokers(N=15) and sociodemographically matched non-smokers(N=15) were scanned twice using a repeated-measures design. Smokers were scanned after a 24-hour nicotine abstinence, and immediately after smoking their usual brand cigarette. The neuroimaging battery included a stop-signal task of response inhibition and pseudo-continuous arterial spin labeling to measure cerebral blood flow (CBF). Whole brain voxel-wise ANCOVAs were carried out on stop success and stop fail SST contrasts and CBF maps to assess differences among non-, abstinent and satiated smokers. Cluster-correction was performed using AFNI's 3dClustSim to achieve a significance of pSmokers exhibited higher brain activation in bilateral inferior frontal gyrus (IFG), a brain region known to be involved in inhibitory control, during successful response inhibitions relative to non-smokers. This effect was significantly higher during nicotine abstinence relative to satiety. Smokers also exhibited lower CBF in the bilateral IFG than non-smokers. These hypo-perfusions were not different between abstinence and satiety. These findings converge on alterations in smokers in prefrontal circuits known to be critical for inhibitory control. These effects are present, even when smokers are satiated, but the neural activity required to achieve performance equal to controls is increased when smokers are in acute abstinence. Our multi-modal neuroimaging study gives neurobiological insights into the cognitive demands of maintaining abstinence and suggest targets for assessing the efficacy of therapeutic interventions.

Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

Directory of Open Access Journals (Sweden)

Peter Magnusson

2017-04-01

Full Text Available BackgroundA pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket.MethodsIn October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device.ConclusionsPOCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

Directory of Open Access Journals (Sweden)

Peter Magnusson

2017-04-01

Full Text Available Background: A pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket. Methods: In October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device. Conclusions: POCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

A randomized, controlled clinical trial: the effect of mindfulness-based cognitive therapy on generalized anxiety disorder among Chinese community patients: protocol for a randomized trial

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Wong Samuel YS

2011-11-01

Full Text Available Abstract Background Research suggests that an eight-week Mindfulness-Based Cognitive Therapy (MBCT program may be effective in the treatment of generalized anxiety disorders. Our objective is to compare the clinical effectiveness of the MBCT program with a psycho-education programme and usual care in reducing anxiety symptoms in people suffering from generalized anxiety disorder. Methods A three armed randomized, controlled clinical trial including 9-month post-treatment follow-up is proposed. Participants screened positive using the Structure Clinical Interview for DSM-IV (SCID for general anxiety disorder will be recruited from community-based clinics. 228 participants will be randomly allocated to the MBCT program plus usual care, psycho-education program plus usual care or the usual care group. Validated Chinese version of instruments measuring anxiety and worry symptoms, depression, quality of life and health service utilization will be used. Our primary end point is the change of anxiety and worry score (Beck Anxiety Inventory and Penn State Worry Scale from baseline to the end of intervention. For primary analyses, treatment outcomes will be assessed by ANCOVA, with change in anxiety score as the baseline variable, while the baseline anxiety score and other baseline characteristics that significantly differ between groups will serve as covariates. Conclusions This is a first randomized controlled trial that compare the effectiveness of MBCT with an active control, findings will advance current knowledge in the management of GAD and the way that group intervention can be delivered and inform future research. Unique Trail Number (assigned by Centre for Clinical Trails, Clinical Trials registry, The Chinese University of Hong Kong: CUHK_CCT00267

Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review

OpenAIRE

Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

2009-01-01

Luke Perraton, Zuzana Machotka, Saravana KumarInternational Centre for Allied Health Evidence, University of South Australia, Adelaide, South Australia, AustraliaAim: Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials.Method: A systematic review of randomized controlled trials was conducted. Onl...

Randomization in clinical trials: stratification or minimization? The HERMES free simulation software.

Science.gov (United States)

Fron Chabouis, Hélène; Chabouis, Francis; Gillaizeau, Florence; Durieux, Pierre; Chatellier, Gilles; Ruse, N Dorin; Attal, Jean-Pierre

2014-01-01

Operative clinical trials are often small and open-label. Randomization is therefore very important. Stratification and minimization are two randomization options in such trials. The first aim of this study was to compare stratification and minimization in terms of predictability and balance in order to help investigators choose the most appropriate allocation method. Our second aim was to evaluate the influence of various parameters on the performance of these techniques. The created software generated patients according to chosen trial parameters (e.g., number of important prognostic factors, number of operators or centers, etc.) and computed predictability and balance indicators for several stratification and minimization methods over a given number of simulations. Block size and proportion of random allocations could be chosen. A reference trial was chosen (50 patients, 1 prognostic factor, and 2 operators) and eight other trials derived from this reference trial were modeled. Predictability and balance indicators were calculated from 10,000 simulations per trial. Minimization performed better with complex trials (e.g., smaller sample size, increasing number of prognostic factors, and operators); stratification imbalance increased when the number of strata increased. An inverse correlation between imbalance and predictability was observed. A compromise between predictability and imbalance still has to be found by the investigator but our software (HERMES) gives concrete reasons for choosing between stratification and minimization; it can be downloaded free of charge. This software will help investigators choose the appropriate randomization method in future two-arm trials.

A randomized trial of specialized versus standard neck physiotherapy in cervical dystonia.

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Counsell, Carl; Sinclair, Hazel; Fowlie, Jillian; Tyrrell, Elaine; Derry, Natalie; Meager, Peter; Norrie, John; Grosset, Donald

2016-02-01

Anecdotal reports suggested that a specialized physiotherapy technique developed in France (the Bleton technique) improved primary cervical dystonia. We evaluated the technique in a randomized trial. A parallel-group, single-blind, two-centre randomized trial compared the specialized outpatient physiotherapy programme given by trained physiotherapists up to once a week for 24 weeks with standard physiotherapy advice for neck problems. Randomization was by a central telephone service. The primary outcome was the change in the total Toronto Western Spasmodic Torticollis Rating (TWSTR) scale, measured before any botulinum injections that were due, between baseline and 24 weeks evaluated by a clinician masked to treatment. Analysis was by intention-to-treat. 110 patients were randomized (55 in each group) with 24 week outcomes available for 84. Most (92%) were receiving botulinum toxin injections. Physiotherapy adherence was good. There was no difference between the groups in the change in TWSTR score over 24 weeks (mean adjusted difference 1.44 [95% CI -3.63, 6.51]) or 52 weeks (mean adjusted difference 2.47 [-2.72, 7.65]) nor in any of the secondary outcome measures (Cervical Dystonia Impact Profile-58, clinician and patient-rated global impression of change, mean botulinum toxin dose). Both groups showed large sustained improvements compared to baseline in the TWSTR, most of which occurred in the first four weeks. There were no major adverse events. Subgroup analysis suggested a centre effect. There was no statistically or clinically significant benefit from the specialized physiotherapy compared to standard neck physiotherapy advice but further trials are warranted. Copyright © 2015 Elsevier Ltd. All rights reserved.

Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review.

Science.gov (United States)

Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

2009-11-30

Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials. A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery) were analyzed. Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery. Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%-80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes.

RARtool: A MATLAB Software Package for Designing Response-Adaptive Randomized Clinical Trials with Time-to-Event Outcomes.

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Ryeznik, Yevgen; Sverdlov, Oleksandr; Wong, Weng Kee

2015-08-01

Response-adaptive randomization designs are becoming increasingly popular in clinical trial practice. In this paper, we present RARtool , a user interface software developed in MATLAB for designing response-adaptive randomized comparative clinical trials with censored time-to-event outcomes. The RARtool software can compute different types of optimal treatment allocation designs, and it can simulate response-adaptive randomization procedures targeting selected optimal allocations. Through simulations, an investigator can assess design characteristics under a variety of experimental scenarios and select the best procedure for practical implementation. We illustrate the utility of our RARtool software by redesigning a survival trial from the literature.

The effect of hormone replacement therapy on serum homocysteine levels in perimenopausal women : a randomized controlled trial

NARCIS (Netherlands)

Hak, AE; Bak, AAA; Lindemans, J; Planellas, J; Bennink, HJTC; Hofman, A; Grobbee, DE; Witteman, JCM

2001-01-01

Serum homocysteine levels may be lowered by hormone replacement therapy, but randomized controlled trial data are scarce. We performed a single center randomized placebo-controlled trial to assess the 6 months effect of hormone replacement therapy compared with placebo on fasting serum homocysteine

Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial

Science.gov (United States)

Sung, Vivian W.; Borello-France, Diane; Dunivan, Gena; Gantz, Marie; Lukacz, Emily S.; Moalli, Pamela; Newman, Diane K.; Richter, Holly E.; Ridgeway, Beri; Smith, Ariana L.; Weidner, Alison C.; Meikle, Susan

2016-01-01

Introduction Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months. Methods ESTEEM is a multi-site, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient-centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure and need for additional treatment. Results The final study design was implemented in November 2013 across 8 clinical sites in the Pelvic Floor Disorders Network. As of February 27, 2016, 433 total /472 targeted participants have been randomized. Conclusions We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision-making. PMID:27287818

Understanding the prevalence of lifetime abstinence from alcohol: An ecological study.

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Probst, Charlotte; Manthey, Jakob; Rehm, Jürgen

2017-09-01

The level of alcohol consumption and related burden in a country are strongly impacted by the prevalence of abstinence from alcohol use. The objective of this study was to characterize the association of lifetime abstinence from alcohol use with economic wealth (as measured in the gross domestic product [GDP]) and Muslim religion on a country level. An ecological study was performed using aggregate data of 183 countries for the year 2010. Lifetime abstinence among men and women was predicted using fractional response regression models with the natural logarithm of GDP-PPP (purchasing power parity) and the proportion of Muslim population as predictors. The models were further adjusted by the country's median age and World Health Organization region. Precision of prediction was investigated. Descriptive analyses showed a strong negative association between GDP-PPP and lifetime abstinence in countries without a Muslim majority and a GDP-PPP up to 20,000 international dollars. Regression models confirmed the negative association with GDP-PPP and showed a strong positive association between lifetime abstinence and the proportion of Muslim population. Stratified sensitivity analyses showed that in countries without a Muslim majority only GDP-PPP showed a statistically significant association whereas in Muslim majority countries only the proportion of Muslims was associated with the prevalence of lifetime abstinence. Particularly in countries with a lower GDP and without Muslim majority the prevalence of lifetime abstinence from alcohol use is strongly negatively associated with GDP-PPP. Future research should analyze the accordance in trends of GDP and lifetime abstinence over time. Copyright © 2017 Elsevier B.V. All rights reserved.

Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT study: study protocol for a randomized controlled trial

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Dregan Alex

2012-10-01

Full Text Available Abstract Background The purpose of this research is to develop and evaluate methods for conducting pragmatic cluster randomized trials in a primary care electronic database. The proposal describes one application, in a less frequent chronic condition of public health importance, secondary prevention of stroke. A related protocol in antibiotic prescribing was reported previously. Methods/Design The study aims to implement a cluster randomized trial (CRT using the electronic patient records of the General Practice Research Database (GPRD as a sampling frame and data source. The specific objective of the trial is to evaluate the effectiveness of a computer-delivered intervention at enhancing the delivery of stroke secondary prevention in primary care. GPRD family practices will be allocated to the intervention or usual care. The intervention promotes the use of electronic prompts to support adherence with the recommendations of the UK Intercollegiate Stroke Working Party and NICE guidelines for the secondary prevention of stroke in primary care. Primary outcome measure will be the difference in systolic blood pressure between intervention and control trial arms at 12-month follow-up. Secondary outcomes will be differences in serum cholesterol, prescribing of antihypertensive drugs, statins, and antiplatelet therapy. The intervention will continue for 12 months. Information on the utilization of the decision-support tools will also be analyzed. Discussion The CRT will investigate the effectiveness of using a computer-delivered intervention to reduce the risk of stroke recurrence following a first stroke event. The study will provide methodological guidance on the implementation of CRTs in electronic databases in primary care. Trial registration Current Controlled Trials ISRCTN35701810

Blinding in randomized clinical trials: imposed impartiality

DEFF Research Database (Denmark)

Hróbjartsson, A; Boutron, I

2011-01-01

Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...

Random forests of interaction trees for estimating individualized treatment effects in randomized trials.

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Su, Xiaogang; Peña, Annette T; Liu, Lei; Levine, Richard A

2018-04-29

Assessing heterogeneous treatment effects is a growing interest in advancing precision medicine. Individualized treatment effects (ITEs) play a critical role in such an endeavor. Concerning experimental data collected from randomized trials, we put forward a method, termed random forests of interaction trees (RFIT), for estimating ITE on the basis of interaction trees. To this end, we propose a smooth sigmoid surrogate method, as an alternative to greedy search, to speed up tree construction. The RFIT outperforms the "separate regression" approach in estimating ITE. Furthermore, standard errors for the estimated ITE via RFIT are obtained with the infinitesimal jackknife method. We assess and illustrate the use of RFIT via both simulation and the analysis of data from an acupuncture headache trial. Copyright © 2018 John Wiley & Sons, Ltd.

Participants' Understanding of Informed Consent in a Randomized Controlled Trial for Chronic Knee Pain.

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Guillemin, Marilys; Barnard, Emma; Walker, Hannah; Bennell, Kim; Hinman, Rana; Gillam, Lynn

2015-12-01

This study explored participants' experiences of randomized controlled trial (RCT) participation to examine their understanding of the trial design and whether their consent was indeed informed. A nested qualitative interview study was conducted with 38 participants from a sample of 282 who participated in a complex RCT evaluating the effectiveness of laser compared with needle acupuncture for chronic knee pain. Overall participants had a good understanding of the RCT, and concepts such as randomization and placebo. Their experiences of being in the trial were largely positive, even if they did not experience any knee pain improvement. Their responses to unblinding at the end of the study were accepting. Participants had a good functional understanding of the RCT, sufficient for valid informed consent. © The Author(s) 2015.

Glutamatergic neurometabolites during early abstinence from chronic methamphetamine abuse.

Science.gov (United States)

O'Neill, Joseph; Tobias, Marc C; Hudkins, Matthew; London, Edythe D

2014-10-31

The acute phase of abstinence from methamphetamine abuse is critical for rehabilitation success. Proton magnetic resonance spectroscopy has detected below-normal levels of glutamate+glutamine in anterior middle cingulate of chronic methamphetamine abusers during early abstinence, attributed to abstinence-induced downregulation of the glutamatergic systems in the brain. This study further explored this phenomenon. We measured glutamate+glutamine in additional cortical regions (midline posterior cingulate, midline precuneus, and bilateral inferior frontal cortex) putatively affected by methamphetamine. We examined the relationship between glutamate+glutamine in each region with duration of methamphetamine abuse as well as the depressive symptoms of early abstinence. Magnetic resonance spectroscopic imaging was acquired at 1.5 T from a methamphetamine group of 44 adults who had chronically abused methamphetamine and a control group of 23 age-, sex-, and tobacco smoking-matched healthy volunteers. Participants in the methamphetamine group were studied as inpatients during the first week of abstinence from the drug and were not receiving treatment. In the methamphetamine group, small but significant (5-15%, Pright inferior frontal cortex; glutamate+glutamine in posterior cingulate was negatively correlated (Pabuse. The Beck Depression Inventory score was negatively correlated (Pright inferior frontal cortex. Our findings support the idea that glutamatergic metabolism is downregulated in early abstinence in multiple cortical regions. The extent of downregulation may vary with length of abuse and may be associated with severity of depressive symptoms emergent in early recovery. © The Author 2015. Published by Oxford University Press on behalf of CINP.

Quality of reporting of randomized controlled trials of pharmacologic treatment of bipolar disorders: a systematic review.

Science.gov (United States)

Strech, Daniel; Soltmann, Bettina; Weikert, Beate; Bauer, Michael; Pfennig, Andrea

2011-09-01

This study aimed to assess (1) the quality of reporting of randomized controlled trials of pharmacologic treatment of bipolar disorder, (2) the potential improvement in quality of reporting over time, and (3) differences in quality of reporting between journals that endorse or do not endorse the Uniform Requirements for Manuscripts Submitted to Biomedical Journals developed by the International Committee of Medical Journal Editors. A systematic literature search was done to identify all randomized controlled trials published between 2000 and 2008 relevant to the pharmacologic treatment of bipolar disorder. The search strategy of the published National Institute for Health and Clinical Excellence guideline for management of bipolar disorders was used and adapted. All included and excluded clinical trials mentioned in the guideline and published from 2000 onward were reviewed for eligibility. For an update search from July 2004 through December 2008, an adapted search strategy was used in MEDLINE, EMBASE, PsycINFO, CINAHL, Ovid, and Cochrane Central Register of Controlled Trials. Titles and abstracts were scanned for relevance, and full texts were ordered in case of uncertainty to maximize sensitivity. Reference lists of retrieved systematic reviews were checked. All full texts were checked for eligibility. Only relevant randomized controlled trials published between 2000 and 2008 were included. Abstracts, randomized controlled trials published before 2000, nonrandomized clinical studies, pooled analyses, editorials, reviews, case reports, observational studies, and unpublished reports were excluded. A checklist based on the Consolidated Standards of Reporting Trials (CONSORT) statement was used to assess quality of reporting of all included studies. A total of 105 randomized controlled trials were included in the analysis. Of the 72 applicable checklist items, 42% were generally reported adequately and 25% inadequately. Reporting was especially poor for

Micro-Randomized Trials: An Experimental Design for Developing Just-in-Time Adaptive Interventions

Science.gov (United States)

Klasnja, Predrag; Hekler, Eric B.; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A.

2015-01-01

Objective This paper presents an experimental design, the micro-randomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals’ health behaviors. Micro-randomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. Methods The paper describes the micro-randomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Results Micro-randomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Conclusions Micro-randomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions’ effects, enabling creation of more effective JITAIs. PMID:26651463

Person mobility in the design and analysis of cluster-randomized cohort prevention trials.

Science.gov (United States)

Vuchinich, Sam; Flay, Brian R; Aber, Lawrence; Bickman, Leonard

2012-06-01

Person mobility is an inescapable fact of life for most cluster-randomized (e.g., schools, hospitals, clinic, cities, state) cohort prevention trials. Mobility rates are an important substantive consideration in estimating the effects of an intervention. In cluster-randomized trials, mobility rates are often correlated with ethnicity, poverty and other variables associated with disparity. This raises the possibility that estimated intervention effects may generalize to only the least mobile segments of a population and, thus, create a threat to external validity. Such mobility can also create threats to the internal validity of conclusions from randomized trials. Researchers must decide how to deal with persons who leave study clusters during a trial (dropouts), persons and clusters that do not comply with an assigned intervention, and persons who enter clusters during a trial (late entrants), in addition to the persons who remain for the duration of a trial (stayers). Statistical techniques alone cannot solve the key issues of internal and external validity raised by the phenomenon of person mobility. This commentary presents a systematic, Campbellian-type analysis of person mobility in cluster-randomized cohort prevention trials. It describes four approaches for dealing with dropouts, late entrants and stayers with respect to data collection, analysis and generalizability. The questions at issue are: 1) From whom should data be collected at each wave of data collection? 2) Which cases should be included in the analyses of an intervention effect? and 3) To what populations can trial results be generalized? The conclusions lead to recommendations for the design and analysis of future cluster-randomized cohort prevention trials.

Imipramine and Pregabalin Combination for Painful Polyneuropathy. A Randomized Controlled Trial

DEFF Research Database (Denmark)

Holbech, Jakob V; Bach, Flemming W; Finnerup, Nanna B

2015-01-01

Monotherapy with first-line drugs for neuropathic pain often fails to provide sufficient pain relief or has unacceptable side effects because of the need for high doses. The aim of this trial was to test whether the combination of imipramine and pregabalin in moderate doses would relieve pain more...... effectively than monotherapy with either of the drugs. This was a randomized, double-blind, placebo-controlled, crossover, multicenter trial consisting of four 5-week treatment periods in patients with painful polyneuropathy. Treatment arms were imipramine 75 mg/d vs pregabalin 300 mg/d vs combination therapy...... randomized, and 69 patients were included in the data analysis. The effect on average pain in comparison with placebo was: combination (-1.67 NRS points, P pregabalin (-0.48 NRS points, P = 0.03). The combination therapy had significantly lower pain...

Anxiety, depression and tobacco abstinence.

Science.gov (United States)

Almadana Pacheco, Virginia; Gómez-Bastero Fernández, Ana Paulina; Valido Morales, Agustín; Luque Crespo, Estefanía; Monserrat, Soledad; Montemayor Rubio, Teodoro

2017-09-29

There is evidence of the relationship between mental illness and smoking and increased risk of depressive episodes after quitting smoking, even with specific treatments for abstinence. To assess the influence of a cessation program on the emotional state of patients by measuring levels of anxiety / depression and differences depending on the presence of psychiatric history. A prospective observational study of patients taking part in a combined program (pharmacological and cognitive-behavioral) for giving up smoking. Anxiety (A) and depression (D) were measured using the HADS questionnaire at baseline, first and third month of abstinence. Anxiety and depression showed significant and progressive improvement during treatment (A: baseline 9.2 ± 4.5, 5.9 ± 3.6 1 month, 3 months 4.5 ± 3.1, p.

Quality of radiotherapy reporting in randomized controlled trials of prostate cancer.

Science.gov (United States)

Soon, Yu Yang; Chen, Desiree; Tan, Teng Hwee; Tey, Jeremy

2018-06-07

Good radiotherapy reporting in clinical trials of prostate radiotherapy is important because it will allow accurate reproducibility of radiotherapy treatment and minimize treatment variations that can affect patient outcomes. The aim of our study is to assess the quality of prostate radiotherapy (RT) treatment reporting in randomized controlled trials in prostate cancer. We searched MEDLINE for randomized trials of prostate cancer, published from 1996 to 2016 and included prostate RT as one of the intervention arms. We assessed if the investigators reported the ten criteria adequately in the trial reports: RT dose prescription method; RT dose-planning procedures; organs at risk (OAR) dose constraints; target volume definition, simulation procedures; treatment verification procedures; total RT dose; fractionation schedule; conduct of quality assurance (QA) as well as presence or absence of deviations in RT treatment planning and delivery. We performed multivariate logistic regression to determine the factors that may influence the quality of reporting. We found 59 eligible trials. There was significant variability in the quality of reporting. Target volume definition, total RT dose and fractionation schedule were reported adequately in 97% of included trials. OAR constraints, simulation procedures and presence or absence of deviations in RT treatment planning and delivery were reported adequately in 30% of included trials. Twenty-four trials (40%) reported seven criteria or more adequately. Multivariable logistic analysis showed that trials that published their quality assurance results and cooperative group trials were more likely to have adequate quality in reporting in at least seven criteria. There is significant variability in the quality of reporting on prostate radiotherapy treatment in randomized trials of prostate cancer. We need to have consensus guidelines to standardize the reporting of radiotherapy treatment in randomized trials.

A pilot test of the new Swiss regulatory procedure for categorizing clinical trials by risk: A randomized controlled trial.

Science.gov (United States)

Cevallos, Myriam; Züllig, Stephanie; Christen, Andri; Meier, Brigitte E; Goetz, Martin; Coslovsky, Michael; Trelle, Sven

2015-12-01

Several countries are working to adapt clinical trial regulations to align the approval process to the level of risk for trial participants. The optimal framework to categorize clinical trials according to risk remains unclear, however. Switzerland is the first European country to adopt a risk-based categorization procedure in January 2014. We assessed how accurately and consistently clinical trials are categorized using two different approaches: an approach using criteria set forth in the new law (concept) or an intuitive approach (ad hoc). This was a randomized controlled trial with a method-comparison study nested in each arm. We used clinical trial protocols from eight Swiss ethics committees approved between 2010 and 2011. Protocols were randomly assigned to be categorized in one of three risk categories using the concept or the ad hoc approach. Each protocol was independently categorized by the trial's sponsor, a group of experts and the approving ethics committee. The primary outcome was the difference in categorization agreement between the expert group and sponsors across arms. Linear weighted kappa was used to quantify agreements, with the difference between kappas being the primary effect measure. We included 142 of 231 protocols in the final analysis (concept=78; ad hoc=64). Raw agreement between the expert group and sponsors was 0.74 in the concept and 0.78 in the ad hoc arm. Chance-corrected agreement was higher in the ad hoc (kappa: 0.34 (95% confidence interval=0.10-0.58)) than in the concept arm (0.27 (0.06-0.50)), but the difference was not significant (p=0.67). The main limitation was the large number of protocols excluded from the analysis mostly because they did not fit with the clinical trial definition of the new law. A structured risk categorization approach was not better than an ad hoc approach. Laws introducing risk-based approaches should provide guidelines, examples and templates to ensure correct application. © The Author(s) 2015.

Improving tobacco dependence treatment outcomes for smokers of lower socioeconomic status: A randomized clinical trial.

Science.gov (United States)

Sheffer, Christine E; Bickel, Warren K; Franck, Christopher T; Panissidi, Luana; Pittman, Jami C; Stayna, Helen; Evans, Shenell

2017-12-01

Evidence-based treatments for tobacco dependence are significantly less effective for smokers of lower socioeconomic status which contributes to socioeconomic disparities in smoking prevalence rates and health. We aimed to reduce the socioeconomic gradient in treatment outcomes by systematically adapting evidence-based, cognitive-behavioral treatment for tobacco dependence for diverse lower socioeconomic smokers. Participants were randomized to adapted or standard treatment, received six 1-h group treatment sessions, and were followed for six months. We examined the effectiveness of the adapted treatment to improve treatment outcomes for lower socioeconomic groups. Participants (n=227) were ethnically, racially, and socioeconomically diverse. The adapted treatment significantly reduced the days to relapse for the two lowest socioeconomic groups: SES1: M=76.6 (SD 72.9) vs. 38.3 (SD 60.1) days to relapse (RR=0.63 95% CI, 0.45, 0.88, p=0.0013); SES2: M=88.2 (SD 67.3) vs. 40.1 (SD 62.6 days to relapse (RR=0.57 95% CI, 0.18, 0.70, p=0.0024). Interactions between socioeconomic status and condition were significant for initial abstinence (OR=1.26, 95% CI 1.09, 1.46, p=0.002), approached significance for 3-month abstinence (OR=0.90, 95% CI 0.80, 1.01, psocioeconomic smokers and reduce inequities in days to relapse. Novel methods of providing targeted extended support are needed to improve long-term outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.

Rain dance: the role of randomization in clinical trials

Directory of Open Access Journals (Sweden)

Diniz JB

2016-07-01

Full Text Available Juliana Belo Diniz,1 Victor Fossaluza,2 Carlos Alberto de Bragança Pereira,1,2 Sergio Wechsler2 1Institute of Psychiatry, Clinics Hospital University of São Paulo Medical School, 2Department of Statistics, Institute of Mathematics and Statistics, University of São Paulo, São Paulo, Brazil Abstract: Randomized clinical trials are the gold standard for testing efficacy of treatment interventions. However, although randomization protects against deliberately biased samples, it does not guarantee random imbalances will not occur. Methods of intentional allocation that can overcome such deficiency of randomization have been developed, but are less frequently applied than randomization. Initially, we introduce a fictitious case example to revise and discuss the reasons of researchers' resistance to intentionally allocate instead of simply randomizing. We then introduce a real case example to evaluate the performance of an intentional protocol for allocation based on compositional data balance. A real case of allocation of 50 patients in two arms was compared with an optimal allocation of global instead of sequential arrivals. Performance was measured by a weighted average of Aitchison distances, between arms, of prognostic factors. To compare the intentional allocation with simple random allocation, 50,000 arrival orderings of 50 patients were simulated. To each one of the orders, both kinds of allocations into two arms were considered. Intentional allocation performed as well as optimal allocation in the case considered. In addition, out of the 50,000 simulated orders, 61% of them performed better with intentional allocation than random allocation. Hence, we conclude that intentional allocation should be encouraged in the design of future interventional clinical trials as a way to prevent unbalanced samples. Our sequential method is a viable alternative to overcome technical difficulties for study designs that require sequential inclusion of

Abstinence And Faithfulness Programmes For Prevention Of Hiv ...

African Journals Online (AJOL)

Questions have been raised on whether abstinence and faithfulness programs work, particularly for young people. Research is needed for evidence-based documentation of the effectiveness or otherwise of abstinence and faithfulness programmes in young people. This review was conducted in three stages: identification ...

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

Science.gov (United States)

Ahlen, Johan; Lenhard, Fabian; Ghaderi, Ata

2015-12-01

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

Very brief physician advice and supplemental proactive telephone calls to promote smoking reduction and cessation in Chinese male smokers with no intention to quit: a randomized trial.

Science.gov (United States)

Wu, Lei; He, Yao; Jiang, Bin; Zhang, Di; Tian, Hui; Zuo, Fang; Lam, Tai Hing

2017-11-01

There is inconsistent evidence that behavioural support to promote smoking reduction is effective at increasing smoking cessation. We examined the effectiveness of brief physician advice together with four very brief telephone calls in promoting smoking cessation among Chinese men via reduction compared with equivalent advice on diet and exercise. A two-group pragmatic randomized controlled trial. Male patients attending the Endocrinology and Acupuncture out-patient clinics of a general hospital in Beijing, China. Physicians advised participants allocated to the smoking-reduction intervention (SRI, n = 181) group to reduce smoking to at least half of their current consumption within 1 month at baseline. At follow-up, a telephone counsellor repeated this advice if the participant had not reduced their cigarette consumption. Participants who had reduced consumption were encouraged to quit smoking. Physicians gave participants in the exercise and diet advice (EDA, n = 188) control group brief advice about physical activity and healthy diet at baseline, and a telephone counsellor reinforced this at each follow-up interview. Both groups had one face-to-face interview at baseline plus five telephone interviews and interventions (approximately 1 minute each) at 1 week and 1-, 3-, 6- and 12-month follow-up. The primary outcome was self-reported 6-month prolonged abstinence rate at 12-month follow-up interview. By intention-to-treat, the self-reported 6-month prolonged abstinence rate at 12-month follow-up in the SRI groups (19 quitters, 15.7%) was higher, but not significantly, than the EDA control group (10 quitters, 7.8%), and the adjusted odds ratio (OR) and 95% confidence interval (CI) was 2.26 (0.97-5.26), P = 0.062. The self-reported 7-day point prevalence quit rate (secondary outcome) in the SRI group was significantly higher than the control group at each follow-up interview (at 12-month follow-up: 13.3 versus 6.9%, OR (95% CI) = 2.09 (1.01, 4.34), P = 0

Intention-to-treat analysis and accounting for missing data in orthopaedic randomized clinical trials.

Science.gov (United States)

Herman, Amir; Botser, Itamar Busheri; Tenenbaum, Shay; Chechick, Ahron

2009-09-01

The intention-to-treat principle implies that all patients who are randomized in a clinical trial should be analyzed according to their original allocation. This means that patients crossing over to another treatment group and patients lost to follow-up should be included in the analysis as a part of their original group. This principle is important for preserving the randomization scheme, which is the basis for correct inference in any randomized trial. In this study, we examined the use of the intention-to-treat principle in recently published orthopaedic clinical trials. We surveyed eight leading orthopaedic journals for randomized clinical trials published between January 2005 and August 2008. We determined whether the intention-to-treat principle was implemented and, if so, how it was used in each trial. Specifically, we ascertained which methods were used to account for missing data. Our search yielded 274 randomized clinical trials, and the intention-to-treat principle was used in ninety-six (35%) of them. There were significant differences among the journals with regard to the use of the intention-to-treat principle. The relative number of trials in which the principle was used increased each year. The authors adhered to the strict definition of the intention-to-treat principle in forty-five of the ninety-six studies in which it was claimed that this principle had been used. In forty-four randomized trials, patients who had been lost to follow-up were excluded from the final analysis; this practice was most notable in studies of surgical interventions. The most popular method of adjusting for missing data was the "last observation carried forward" technique. In most of the randomized clinical trials published in the orthopaedic literature, the investigators did not adhere to the stringent use of the intention-to-treat principle, with the most conspicuous problem being a lack of accounting for patients lost to follow-up. This omission might introduce bias to

Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study.

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Johnson, Anna M; Jones, Sara B; Duncan, Pamela W; Bushnell, Cheryl D; Coleman, Sylvia W; Mettam, Laurie H; Kucharska-Newton, Anna M; Sissine, Mysha E; Rosamond, Wayne D

2018-01-26

Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study. The COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies. We successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board

Randomized controlled trials in children's heart surgery in the 21st century: a systematic review.

Science.gov (United States)

Drury, Nigel E; Patel, Akshay J; Oswald, Nicola K; Chong, Cher-Rin; Stickley, John; Barron, David J; Jones, Timothy J

2018-04-01

Randomized controlled trials are the gold standard for evaluating health care interventions, yet are uncommon in children's heart surgery. We conducted a systematic review of clinical trials in paediatric cardiac surgery to evaluate the scope and quality of the current international literature. We searched MEDLINE, CENTRAL and LILACS, and manually screened retrieved references and systematic reviews to identify all randomized controlled trials reporting the effect of any intervention on the conduct or outcomes of heart surgery in children published in any language since January 2000; secondary publications and those reporting inseparable adult data were excluded. Two reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases. We identified 333 trials from 34 countries randomizing 23 902 children. Most were early phase (313, 94.0%), recruiting few patients (median 45, interquartile range 28-82), and only 11 (3.3%) directly evaluated a surgical intervention. One hundred and nine (32.7%) trials calculated a sample size, 52 (15.6%) reported a CONSORT diagram, 51 (15.3%) were publicly registered and 25 (7.5%) had a Data Monitoring Committee. The overall risk of bias was low in 22 (6.6%), high in 69 (20.7%) and unclear in 242 (72.7%). The recent literature in children's heart surgery contains few late-phase clinical trials. Most trials did not conform to the accepted standards of reporting, and the overall risk of bias was low in few studies. There is a need for high-quality, multicentre clinical trials to provide a robust evidence base for contemporary paediatric cardiac surgical practice.

Ipsilateral transversus abdominis plane block provides effective analgesia after appendectomy in children: a randomized controlled trial.

LENUS (Irish Health Repository)

Carney, John

2010-10-01

The transversus abdominis plane (TAP) block provides effective postoperative analgesia in adults undergoing major abdominal surgery. Its efficacy in children remains unclear, with no randomized clinical trials in this population. In this study, we evaluated its analgesic efficacy over the first 48 postoperative hours after appendectomy performed through an open abdominal incision, in a randomized, controlled, double-blind clinical trial.

A Systematic Review of Surgical Randomized Controlled Trials: Part 2. Funding Source, Conflict of Interest, and Sample Size in Plastic Surgery.

Science.gov (United States)

Voineskos, Sophocles H; Coroneos, Christopher J; Ziolkowski, Natalia I; Kaur, Manraj N; Banfield, Laura; Meade, Maureen O; Chung, Kevin C; Thoma, Achilleas; Bhandari, Mohit

2016-02-01

The authors examined industry support, conflict of interest, and sample size in plastic surgery randomized controlled trials that compared surgical interventions. They hypothesized that industry-funded trials demonstrate statistically significant outcomes more often, and randomized controlled trials with small sample sizes report statistically significant results more frequently. An electronic search identified randomized controlled trials published between 2000 and 2013. Independent reviewers assessed manuscripts and performed data extraction. Funding source, conflict of interest, primary outcome direction, and sample size were examined. Chi-squared and independent-samples t tests were used in the analysis. The search identified 173 randomized controlled trials, of which 100 (58 percent) did not acknowledge funding status. A relationship between funding source and trial outcome direction was not observed. Both funding status and conflict of interest reporting improved over time. Only 24 percent (six of 25) of industry-funded randomized controlled trials reported authors to have independent control of data and manuscript contents. The mean number of patients randomized was 73 per trial (median, 43, minimum, 3, maximum, 936). Small trials were not found to be positive more often than large trials (p = 0.87). Randomized controlled trials with small sample size were common; however, this provides great opportunity for the field to engage in further collaboration and produce larger, more definitive trials. Reporting of trial funding and conflict of interest is historically poor, but it greatly improved over the study period. Underreporting at author and journal levels remains a limitation when assessing the relationship between funding source and trial outcomes. Improved reporting and manuscript control should be goals that both authors and journals can actively achieve.

Characterizing Durations of Heroin Abstinence in the California Civil Addict Program: Results From a 33-Year Observational Cohort Study

Science.gov (United States)

Nosyk, Bohdan; Anglin, M. Douglas; Brecht, Mary-Lynn; Lima, Viviane Dias; Hser, Yih-Ing

2013-01-01

In accordance with the chronic disease model of opioid dependence, cessation is often observed as a longitudinal process rather than a discrete endpoint. We aimed to characterize and identify predictors of periods of heroin abstinence in the natural history of recovery from opioid dependence. Data were collected on participants from California who were enrolled in the Civil Addict Program from 1962 onward by use of a natural history interview. Multivariate regression using proportional hazards frailty models was applied to identify independent predictors and correlates of repeated abstinence episode durations. Among 471 heroin-dependent males, 387 (82.2%) reported 932 abstinence episodes, 60.3% of which lasted at least 1 year. Multivariate analysis revealed several important findings. First, demographic factors such as age and ethnicity did not explain variation in durations of abstinence episodes. However, employment and lower drug use severity predicted longer episodes. Second, abstinence durations were longer following sustained treatment versus incarceration. Third, individuals with multiple abstinence episodes remained abstinent for longer durations in successive episodes. Finally, abstinence episodes initiated >10 and ≤20 years after first use lasted longer than others. Public policy facilitating engagement of opioid-dependent individuals in maintenance-oriented drug treatment and employment is recommended to achieve and sustain opioid abstinence. PMID:23445901

Home medicines reviews following acute coronary syndrome: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Bernal Daniel DL

2012-04-01

Full Text Available Abstract Background Despite continual improvements in the management of acute coronary syndromes, adherence to guideline-based medications remains suboptimal. We aim to improve adherence with guideline-based therapy following acute coronary syndrome using an existing service that is provided by specifically trained pharmacists, called a Home Medicines Review. We have made two minor adjustments to target the focus of the existing service including an acute coronary syndrome specific referral letter and a training package for the pharmacists providing the service. Methods/Design We will be conducting a randomized controlled trial to compare the directed home medicines review service to usual care following acute coronary syndromes. All patients aged 18 to 80 years and with a working diagnosis of acute coronary syndrome, who are admitted to two public, acute care hospitals, will be screened for enrolment into the trial. Exclusion criteria will include: not being discharged home, documented cognitive decline, non-Medicare eligibility, and presence of a terminal malignancy. Randomization concealment and sequence generation will occur through a centrally-monitored computer program. Patients randomized to the control group will receive usual post-discharge care. Patients randomized to receive the intervention will be offered usual post-discharge care and a directed home medicines review at two months post-discharge. The study endpoints will be six and twelve months post-discharge. The primary outcome will be the proportion of patients who are adherent to a complete, guideline-based medication regimen. Secondary outcomes will include hospital readmission rates, length of hospital stays, changes in quality of life, smoking cessation rates, cardiac rehabilitation completion rates, and mortality. Discussion As the trial is closely based on an existing service, any improvements observed should be highly translatable into regular practice. Possible

Methadone dose and neonatal abstinence syndrome-systematic review and meta-analysis.

LENUS (Irish Health Repository)

Cleary, Brian J

2012-02-01

AIM: To determine if there is a relationship between maternal methadone dose in pregnancy and the diagnosis or medical treatment of neonatal abstinence syndrome (NAS). METHODS: PubMed, EMBASE, the Cochrane Library and PsychINFO were searched for studies reporting on methadone use in pregnancy and NAS (1966-2009). The relative risk (RR) of NAS was compared for methadone doses above versus below a range of cut-off points. Summary RRs and 95% confidence intervals (CI) were estimated using random effects meta-analysis. Sensitivity analyses explored the impact of limiting meta-analyses to prospective studies or studies using an objective scoring system to diagnose NAS. RESULTS: A total of 67 studies met inclusion criteria for the systematic review; 29 were included in the meta-analysis. Any differences in the incidence of NAS in infants of women on higher compared with lower doses were statistically non-significant in analyses restricted to prospective studies or to those using an objective scoring system to diagnose NAS. CONCLUSIONS: Severity of the neonatal abstinence syndrome does not appear to differ according to whether mothers are on high- or low-dose methadone maintenance therapy.

HEART: heart exercise and remote technologies: A randomized controlled trial study protocol

Directory of Open Access Journals (Sweden)

Kira Geoffrey

2011-05-01

Full Text Available Abstract Background Cardiovascular disease (CVD is the leading cause of death worldwide. Cardiac rehabilitation (CR is aimed at improving health behaviors to slow or reverse the progression of CVD disease. Exercise is a central element of CR. Technologies such as mobile phones and the Internet (mHealth offer potential to overcome many of the psychological, physical, and geographical barriers that have been associated with lack of participation in exercise-based CR. We aim to trial the effectiveness of a mobile phone delivered exercise-based CR program to increase exercise capacity and functional outcomes compared with usual CR care in adults with CVD. This paper outlines the rationale and methods of the trial. Methods A single-blinded parallel two-arm randomized controlled trial is being conducted. A total of 170 people will be randomized at 1:1 ratio either to receive a mHealth CR program or usual care. Participants are identified by CR nurses from two metropolitan hospitals in Auckland, New Zealand through outpatient clinics and existing databases. Consenting participants are contacted to attend a baseline assessment. The intervention consists of a theory-based, personalized, automated package of text and video message components via participants' mobile phones and the Internet to increase exercise behavior, delivered over six months. The control group will continue with usual CR. Data collection occurs at baseline and 24 weeks (post-intervention. The primary outcome is change in maximal oxygen uptake from baseline to 24 weeks. Secondary outcomes include post-intervention measures on self-reported physical activity (IPAQ, cardiovascular risk factors (systolic blood pressure, weight, and waist to hip ratio, health related quality of life (SF-36, and cost-effectiveness. Discussion This manuscript presents the protocol for a randomized controlled trial of a mHealth exercise-based CR program. Results of this trial will provide much needed

Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Krüger Matthias

2011-02-01

Full Text Available Abstract Background Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents complications like anastomotic failure and meanwhile is the standard procedure. Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy. The best surgical technique for closure of loop ileostomy has not been defined yet. Methods/Design A study protocol was developed on the basis of the only randomized controlled mono-center trial to solve clinical equipoise concerning the optimal surgical technique for closure of loop ileostomy after low anterior resection due to rectal cancer. The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy. It will include 334 randomized patients undergoing closure of loop ileostomy after low anterior resection with protective ileostomy due to rectal cancer in approximately 20 centers consisting of German hospitals of all level of health care. The primary endpoint is the rate of bowel obstruction within 30 days after ileostomy closure. In addition, a set of surgical and general variables including quality of life will be analyzed with a follow-up of 12 months. An investigators meeting with a practical session will help to minimize performance bias and enforce protocol adherence. Centers are monitored centrally as well as on-site before and during recruitment phase to assure inclusion, treatment and follow up according to the protocol. Discussion Aim of the HASTA trial is to evaluate the efficacy of hand-suture versus stapling for

A prospective, randomized, double-blind clinical trial of one nano ...

African Journals Online (AJOL)

Abstract. Background: Recently, manufacturers have introduced bulk‑fill composite resins that reportedly can be placed in increments of 4 mm or greater. Objective: The purpose of this article was to report the results of 12 months prospective randomized clinical trial that evaluated the clinical performance of one ...

Gaze-Contingent Music Reward Therapy for Social Anxiety Disorder: A Randomized Controlled Trial.

Science.gov (United States)

Lazarov, Amit; Pine, Daniel S; Bar-Haim, Yair

2017-07-01

Patients with social anxiety disorder exhibit increased attentional dwelling on social threats, providing a viable target for therapeutics. This randomized controlled trial examined the efficacy of a novel gaze-contingent music reward therapy for social anxiety disorder designed to reduce attention dwelling on threats. Forty patients with social anxiety disorder were randomly assigned to eight sessions of either gaze-contingent music reward therapy, designed to divert patients' gaze toward neutral stimuli rather than threat stimuli, or to a control condition. Clinician and self-report measures of social anxiety were acquired pretreatment, posttreatment, and at 3-month follow-up. Dwell time on socially threatening faces was assessed during the training sessions and at pre- and posttreatment. Gaze-contingent music reward therapy yielded greater reductions of symptoms of social anxiety disorder than the control condition on both clinician-rated and self-reported measures. Therapeutic effects were maintained at follow-up. Gaze-contingent music reward therapy, but not the control condition, also reduced dwell time on threat, which partially mediated clinical effects. Finally, gaze-contingent music reward therapy, but not the control condition, also altered dwell time on socially threatening faces not used in training, reflecting near-transfer training generalization. This is the first randomized controlled trial to examine a gaze-contingent intervention in social anxiety disorder. The results demonstrate target engagement and clinical effects. This study sets the stage for larger randomized controlled trials and testing in other emotional disorders.

A randomized trial comparing primary angioplasty versus stent placement for symptomatic intracranial stenosis

Science.gov (United States)

Qureshi, Adnan I; Chaudhry, Saqib A; Siddiq, Farhan; Majidi, Shahram; Rodriguez, Gustavo J; Suri, M Fareed K

2013-01-01

Background: Both primary angioplasty alone and angioplasty with a self-expanding stent have been compared in non-randomized concurrent clinical studies that suggest equivalent results. However, there is no randomized trial that has compared the two procedures in patients with symptomatic high grade intracranial stenosis. Objective: The primary aim of the randomized trial was to compare the clinical and angiographic efficacy of primary angioplasty and angioplasty followed by stent placement in preventing restenosis, stroke, requirement for second treatment, and death in patients with symptomatic intracranial stenosis. Methods: The study prospectively evaluated efficacy and safety of the two existing neurointerventional techniques for treatment of moderate intracranial stenosis (stenosis ≥ 50%) with documented failure of medical treatment or severe stenosis (≥70%) with or without failure of medical treatment. Results: A total of 18 patients were recruited in the study (mean age [±SD] was 64.7 ± 15.1 years); out of these, 12 were men. Of these 18, 10 were treated with primary angioplasty and 8 were treated with angioplasty followed by self-expanding stent. The technical success rates of intracranial angioplasty and stent placements defined as ability to achieve <30% residual stenosis when assessed by immediate post-procedure angiography was 5 of 10 and 5 of 8 patients, respectively. The total fluoroscopic time (mean [±SD]) was lower in patients undergoing primary angioplasty 37 [±11] min versus those undergoing angioplasty followed by self-expanding stent 42 [±15] min, P = 0.4321. The stroke and death rate within 1 month was very low in both patient groups (1 of 10 versus 0 of 8 patients). One patient randomized to stent placement continued to have recurrent ischemic symptoms requiring another angioplasty in the vertebral artery on post-procedure Day 2. Conclusions: The trial suggests that a randomized trial comparing primary angioplasty to angioplasty

Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.

Directory of Open Access Journals (Sweden)

Humam Saltaji

Full Text Available To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time.We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics.Sequence generation was assessed to be inadequate (at unclear or high risk of bias in 68% (n = 367 of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%. Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154 and 40.5% (n = 219 of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427 of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95 of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%, while the method of blinding was appropriate in 53% (n = 286 of the trials. We identified a significant decrease over time (1955-2013 in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05 in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias.The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent

Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review.

Science.gov (United States)

Taljaard, Monica; Hemming, Karla; Shah, Lena; Giraudeau, Bruno; Grimshaw, Jeremy M; Weijer, Charles

2017-08-01

Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants-yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28

Shared Care in Monitoring Stable Glaucoma Patients: A Randomized Controlled Trial

NARCIS (Netherlands)

Holtzer-Goor, Kim M.; van Vliet, Ellen J.; van Sprundel, Esther; Plochg, Thomas; Koopmanschap, Marc A.; Klazinga, Niek S.; Lemij, Hans G.

2016-01-01

Comparing the quality of care provided by a hospital-based shared care glaucoma follow-up unit with care as usual. This randomized controlled trial included stable glaucoma patients and patients at risk for developing glaucoma. Patients in the Usual Care group (n=410) were seen by glaucoma

Randomized trials, generalizability, and meta-analysis: Graphical insights for binary outcomes

Directory of Open Access Journals (Sweden)

Kramer Barnett S

2003-06-01

Full Text Available Abstract Background Randomized trials stochastically answer the question. "What would be the effect of treatment on outcome if one turned back the clock and switched treatments in the given population?" Generalizations to other subjects are reliable only if the particular trial is performed on a random sample of the target population. By considering an unobserved binary variable, we graphically investigate how randomized trials can also stochastically answer the question, "What would be the effect of treatment on outcome in a population with a possibly different distribution of an unobserved binary baseline variable that does not interact with treatment in its effect on outcome?" Method For three different outcome measures, absolute difference (DIF, relative risk (RR, and odds ratio (OR, we constructed a modified BK-Plot under the assumption that treatment has the same effect on outcome if either all or no subjects had a given level of the unobserved binary variable. (A BK-Plot shows the effect of an unobserved binary covariate on a binary outcome in two treatment groups; it was originally developed to explain Simpsons's paradox. Results For DIF and RR, but not OR, the BK-Plot shows that the estimated treatment effect is invariant to the fraction of subjects with an unobserved binary variable at a given level. Conclusion The BK-Plot provides a simple method to understand generalizability in randomized trials. Meta-analyses of randomized trials with a binary outcome that are based on DIF or RR, but not OR, will avoid bias from an unobserved covariate that does not interact with treatment in its effect on outcome.

Experiences of randomization: interviews with patients and clinicians in the SPCG-IV trial.

Science.gov (United States)

Bill-Axelson, Anna; Christensson, Anna; Carlsson, Marianne; Norlén, Bo Johan; Holmberg, Lars

2008-01-01

Recruitment of both patients and clinicians to randomized trials is difficult. Low participation carries the risk of terminating studies early and making them invalid owing to insufficient statistical power. This study investigated patients' and clinicians' experiences of randomization with the aim of facilitating trial participation in the future. This was a qualitative study using content analysis. Patients offered to participate in a randomized trial and randomizing clinicians were interviewed. Five participants, four non-participants and five randomizing clinicians were interviewed, 2-8 years from randomization. Clinicians used strategies in interaction with the patients to facilitate decision making. Patients' attitudes differed and experiences of relatives or friends were often stated as reasons for treatment preferences. Patients described that letting chance decide treatment was a difficult barrier to overcome for randomization. The clinicians used a number of different strategies perceived to make randomization more acceptable to their patients. The clinicians' own motivation for randomizing patients for trials depended on the medical relevance of the study question and the clinicians' major obstacle was to maintain equipoise over time. Regular meetings with the study group helped to maintain equipoise and motivation. To establish a good platform for randomization the clinician needs to know about the patient's treatment preferences and the patient's attitude concerning the role of the clinician to facilitate decision making. The strategies used by the clinicians were perceived as helpful and could be tested in an intervention study.