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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.

ABSTRACT: OBJECTIVE:To evaluate exercise as a treatment for stimulant use disorders. METHODS: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. RESULTS: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). CONCLUSIONS: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. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT01141608.

SUBMITTER: Trivedi MH

PROVIDER: S-EPMC5683711 | biostudies-literature | 2017 Sep/Oct

REPOSITORIES: biostudies-literature

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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.

Trivedi Madhukar H MH Greer Tracy L TL Rethorst Chad D CD Carmody Thomas T Grannemann Bruce D BD Walker Robrina R Warden Diane D Shores-Wilson Kathy K Stoutenberg Mark M Oden Neal N Silverstein Meredith M Hodgkins Candace C Love Lee L Seamans Cindy C Stotts Angela A Causey Trey T Szucs-Reed Regina P RP Rinaldi Paul P Myrick Hugh H Straus Michele M Liu David D Lindblad Robert R Church Timothy T Blair Steven N SN Nunes Edward V EV

The Journal of clinical psychiatry 20170901 8

<h4>Objective</h4>To evaluate exercise as a treatment for stimulant use disorders.<h4>Methods</h4>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 ...[more]

PMID: 28199070

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Project description:There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study.STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI) or Health Education Intervention Augmentation (HEI). Both groups will receive TAU (i.e., usual care). The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions, although other participants may be exercising at the same time. Following the 12-week acute phase, participants will begin a 6-month continuation phase during which time they will attend one weekly supervised DEI or HEI session.ClinicalTrials.gov, NCT01141608 http://clinicaltrials.gov/ct2/show/NCT01141608?term=Stimulant+Reduction+Intervention+using+Dosed+Exercise&rank=1.

Project description:OBJECTIVE:The self-report Concise Associated Symptoms Tracking Scale (CAST-SR) was developed to track mania, irritability, anxiety, panic, and insomnia symptoms among depressed outpatients receiving antidepressant medication. Given the overlap between these domains, depression, and stimulant use disorders, we reexamined CAST-SR psychometrics in a novel sample: individuals with stimulant use disorder receiving aerobic exercise or health education interventions. METHODS:Using the subsample of stimulant-dependent (following DSM-IV criteria) individuals prescribed antidepressants (N = 124) from the multisite Stimulant Reduction Intervention Using Dosed Exercise (CTN-0037) trial (total sample N = 302), conducted July 2010 to February 2013, we analyzed CAST-SR data collected at the first assessment after participant's discharge from residential treatment. We also evaluated the convergent/discriminant validity of the CAST-SR with several self-report questionnaires. RESULTS:Confirmatory factor analysis revealed a 12-item measure composed of 4 factors: irritability, anxiety, panic, and insomnia. This factor structure loaded only in participants prescribed antidepressant medication, not in those who were not prescribed antidepressants. These results replicate the original CAST-SR factor structure, except for the mania factor, which failed to load. Internal consistency was high (? = 0.92 for total scale and ? = 0.78-0.89 for the 4 factors), and convergent validity was established, especially for the insomnia and irritability factors, alongside the total score with depressive symptoms, insomnia, quality of life, suicide risk, and physical health measures. CONCLUSIONS:These results demonstrate the factor structure, reliability, and validity of the CAST-SR in a novel population of only individuals with stimulant use disorders receiving both exercise/health education interventions and antidepressant medication. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT01141608.

Project description:BackgroundMore than half of the women of reproductive age (aged 15-49 years) are anemic in India. The uptake of and adherence to iron folic acid (IFA) supplements remain low despite sustained efforts to increase their use. With India's burgeoning digital environment, mobile phones offer a potential medium for increasing their uptake, especially when combined with interactive voice messages that deliver entertaining stories infused with norms-based educational messages.ObjectiveThis study aims to investigate whether a norms-based entertainment education mobile health intervention can increase self-efficacy for IFA adherence among women of reproductive age in Odisha, India.MethodsMobile reduction in anemia through normative innovations (mRANI) is a randomized 2-arm study that includes assessments before and after the intervention. All study participants will be recruited from the intervention arm of the parent reduction in anemia through normative innovations trial only. Although the usual practice is to randomize participants either to a treatment arm or a usual care control arm, we will assign the mRANI control group to another entertainment education-based treatment group that is designed to improve bystander intervention to reduce violence against women. Data collection for the mRANI study is embedded in the parent trial and will include baseline and end line assessments. The primary outcomes are self-efficacy for IFA adherence and violence against women-related bystander intervention. The inclusion criteria for the mRANI study are participation in the parent trial and phone ownership. Women (approximately n=400) who meet the mRANI inclusion criteria will be randomly assigned to the IFA arm or the bystander arm. Ordinary least squares regression with robust SEs will be conducted to assess between-group comparisons at the end line. A mediation analysis will be conducted to examine whether social norms and interactivity mediate the relationship between intervention exposure and primary outcomes in both arms. Real-time monitoring data will offer insights into intervention receptivity and audience engagement.ResultsData collection for the mRANI study is integrated within the parent trial. Household surveys were conducted between February and March of 2021. Responses on the mRANI study's primary and secondary outcomes were collected from 381 participants. The data analysis is expected to be completed by October 2021.ConclusionsThis study will provide evidence on whether a mobile health norms-based entertainment education intervention can increase self-efficacy for IFA adherence and violence against women-related bystander intervention.International registered report identifier (irrid)PRR1-10.2196/26252.

Dataset Information

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.

Publications

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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