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Randomized controlled trial of contingency management for stimulant use in community mental health patients with serious mental illness.

ABSTRACT: The primary objective of this study was to determine whether contingency management was associated with increased abstinence from stimulant drug use in stimulant-dependent patients with serious mental illness treated in a community mental health center. Secondary objectives were to determine whether contingency management was associated with reductions in use of other substances, psychiatric symptoms, HIV risk behavior, and inpatient service utilization.A randomized controlled design was used to compare outcomes of 176 outpatients with serious mental illness and stimulant dependence. Participants were randomly assigned to receive 3 months of contingency management for stimulant abstinence plus treatment as usual or treatment as usual with reinforcement for study participation only. Urine drug tests and self report, clinician-report, and service utilization outcomes were assessed during the 3-month treatment period and the 3-month follow-up period.Although participants in the contingency management condition were significantly less likely to complete the treatment period than those assigned to the control condition (42% compared with 65%), they were 2.4 times (95% CI=1.9–3.0)more likely to submit a stimulant-negative urine test during treatment. Compared with participants in the control condition,they had significantly lower levels of alcohol use, injection drug use, and psychiatric symptoms and were one-fifth as likely as those assigned to the control condition to be admitted for psychiatric hospitalization during treatment. They also reported significantly fewer days of stimulant drug use during the 3-month follow-up.When added to treatment as usual, contingency management is associated with large reductions in stimulant,injection drug, and alcohol use.Reductions in psychiatric symptoms and hospitalizations are important secondary benefits.

SUBMITTER: McDonell MG

PROVIDER: S-EPMC4242089 | biostudies-literature | 2013 Jan

REPOSITORIES: biostudies-literature

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Randomized controlled trial of contingency management for stimulant use in community mental health patients with serious mental illness.

McDonell Michael G MG Srebnik Debra D Angelo Frank F McPherson Sterling S Lowe Jessica M JM Sugar Andrea A Short Robert A RA Roll John M JM Ries Richard K RK

The American journal of psychiatry 20130101 1

<h4>Objective</h4>The primary objective of this study was to determine whether contingency management was associated with increased abstinence from stimulant drug use in stimulant-dependent patients with serious mental illness treated in a community mental health center. Secondary objectives were to determine whether contingency management was associated with reductions in use of other substances, psychiatric symptoms, HIV risk behavior, and inpatient service utilization.<h4>Method</h4>A randomi ...[more]

PMID: 23138961

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Project description:BackgroundPeople with serious mental illness (SMI) have significant unmet mental health needs. Development and testing of digital interventions that can alleviate the suffering of people with SMI is a public health priority.ObjectiveThe aim of this study is to conduct a fully remote randomized waitlist-controlled trial of CORE, a smartphone intervention that comprises daily exercises designed to promote reassessment of dysfunctional beliefs in multiple domains.MethodsIndividuals were recruited via the web using Google and Facebook advertisements. Enrolled participants were randomized into either active intervention or waitlist control groups. Participants completed the Beck Depression Inventory-Second Edition (BDI-II), Generalized Anxiety Disorder-7 (GAD-7), Hamilton Program for Schizophrenia Voices, Green Paranoid Thought Scale, Recovery Assessment Scale (RAS), Rosenberg Self-Esteem Scale (RSES), Friendship Scale, and Sheehan Disability Scale (SDS) at baseline (T1), 30-day (T2), and 60-day (T3) assessment points. Participants in the active group used CORE from T1 to T2, and participants in the waitlist group used CORE from T2 to T3. Both groups completed usability and accessibility measures after they concluded their intervention periods.ResultsOverall, 315 individuals from 45 states participated in this study. The sample comprised individuals with self-reported bipolar disorder (111/315, 35.2%), major depressive disorder (136/315, 43.2%), and schizophrenia or schizoaffective disorder (68/315, 21.6%) who displayed moderate to severe symptoms and disability levels at baseline. Participants rated CORE as highly usable and acceptable. Intent-to-treat analyses showed significant treatment×time interactions for the BDI-II (F1,313=13.38; P<.001), GAD-7 (F1,313=5.87; P=.01), RAS (F1,313=23.42; P<.001), RSES (F1,313=19.28; P<.001), and SDS (F1,313=10.73; P=.001). Large effects were observed for the BDI-II (d=0.58), RAS (d=0.61), and RSES (d=0.64); a moderate effect size was observed for the SDS (d=0.44), and a small effect size was observed for the GAD-7 (d=0.20). Similar changes in outcome measures were later observed in the waitlist control group participants following crossover after they received CORE (T2 to T3). Approximately 41.5% (64/154) of participants in the active group and 60.2% (97/161) of participants in the waitlist group were retained at T2, and 33.1% (51/154) of participants in the active group and 40.3% (65/161) of participants in the waitlist group were retained at T3.ConclusionsWe successfully recruited, screened, randomized, treated, and assessed a geographically dispersed sample of participants with SMI entirely via the web, demonstrating that fully remote clinical trials are feasible in this population; however, study retention remains challenging. CORE showed promise as a usable, acceptable, and effective tool for reducing the severity of psychiatric symptoms and disability while improving recovery and self-esteem. Rapid adoption and real-world dissemination of evidence-based mobile health interventions such as CORE are needed if we are to shorten the science-to-service gap and address the significant unmet mental health needs of people with SMI during the COVID-19 pandemic and beyond.Trial registrationClinicalTrials.gov NCT04068467; https://clinicaltrials.gov/ct2/show/NCT04068467.

Project description:IntroductionHigh rates of tobacco use among people with serious mental illness (SMI), along with their unique needs, suggest the importance of developing tailored smoking cessation interventions for this group. Previous early-phase work empirically validated the design and content of Learn to Quit, a theory-based app designed for this population.MethodsIn a pilot randomized controlled trial, we compared the feasibility, acceptability, and preliminary efficacy of Learn to Quit versus QuitGuide, an app designed for the general population. All participants received nicotine replacement therapy and technical assistance. Daily smokers with SMI (N = 62) participated in the trial with outcomes assessed at weeks 4, 8, 12, and 16.ResultsCompared to QuitGuide, Learn to Quit participants had similar number of days of app use (34 vs. 32, p = .754), but larger number of app interactions (335 vs. 205; p = .001), longer durations of app use (4.24 hrs. vs. 2.14 hrs; p = .044), and higher usability scores (85 vs. 79, p = .046). At week 16, Learn to Quit led to greater reductions in cigarettes per day (12.3 vs. 5.9 for QuitGuide; p = 0.10). Thirty-day point prevalence abstinence was verified in 12% of Learn to Quit participants versus 3% of QuitGuide participants (odds ratio = 3.86, confidence interval = 0.41 to 36, p = .239). Changes in psychiatric symptoms and adverse events were not clinically significant between conditions.ConclusionsThis pilot trial provides strong evidence of Learn to Quit's usability, feasibility, and safety. Preliminary evidence suggests the app may be efficacious. A randomized controlled efficacy trial is needed to test the app in a larger sample of smokers with SMI.ImplicationsThis study suggests that the Learn to Quit app is a feasible approach to deliver smoking cessation treatment in patients with co-occurring tobacco use disorder and SMI. This means that, if found efficacious, this technology could be used to deploy smoking cessation treatment to larger segments of this population, hence improving public health. Therefore, a randomized controlled trial should be conducted to examine the efficacy of this digital intervention.

Project description:BackgroundTransition-age youth have elevated rates of mental disorders, and they often do not receive services. This is a serious public health concern, as mental health conditions persist into adulthood. Continuing to engage this population has been a pervasive challenge for the mental health care system worldwide. Few mental health interventions have been developed for transition-age youth, and even fewer have been found to be effective over the transition to adulthood. Cornerstone, a theoretically guided intervention has shown promise for addressing the mental health and psychosocial needs of this population as they emerge into adulthood. Cornerstone provides case management, trauma-focused cognitive behavioral therapy, mentoring/peer support, community-based in vivo practice, and groups to address stigma, mistrust, and practical skill development to improve the transition to independence among transition-age youth with serious mental health conditions.Methods/designThis study utilizes a hybrid research design and focuses on examining feasibility, acceptability and preliminary impact, along with factors that influence implementation, to maximize new knowledge. The study combines qualitative methods and a randomized controlled trial, using data to inform and refine protocols and manuals, while testing the preliminary impact of the intervention, compared to best available services (treatment as usual, TAU) at a partnering outpatient mental health clinic (n = 60). Contributors to the intervention development research (n = 20) are national experts on mental health services, clinic administrators and staff and young adults with direct experience. The intervention involves intensive staff training and 18 months of ongoing service provision, monitoring and supervision. Quantitative survey data will be collected at baseline, 3 months, 6 months, and 9 months measuring mental health and practical life outcomes via self-report measures. Medical records will be used to triangulate self-report data (i.e., primary diagnosis, treatment planning and attendance). Qualitative data focuses on the intervention development process and implementation research and will use constant comparison coding techniques. In this intention-to-treat analysis, we will conduct basic omnibus analyses to examine whether Cornerstone leads to improved outcomes relative to TAU utilizing t tests across treatment conditions for each outcome measure specified. We will likewise examine whether changes in the proposed mediating variables differ across groups.DiscussionThe aim of this study is to refine Cornerstone through an intensive preliminary trial, learning through collaboration with clinic staff, project team members, and leaders in New York State and nationwide on how to best serve transition-age youth with serious mental health conditions. Cornerstone has the potential to fill a large gap in the service system for transition-age youth with serious mental health conditions, and may enhance the menu of care options for those who have been recently diagnosed with a serious mental health condition, and yet, have a long life to live. The program is recovery-oriented, builds on the best evidence to date, and is in line with both local and national health care reform efforts.Trial registrationThis trial was registered with ClinicalTrials.gov (Identifier: NCT02696109 ) on 22 April 16 as Protocol Record R34-MH102525-01A1MRM, as New York University, Cornerstone program for transition-age youth with serious mental illness: study protocol for a randomized controlled trial.

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Randomized controlled trial of contingency management for stimulant use in community mental health patients with serious mental illness.

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Randomized controlled trial of contingency management for stimulant use in community mental health patients with serious mental illness.

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