Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH

Study Overview
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Brief Summary
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This study will determine whether an 18-month practical tobacco smoking cessation program integrating weight management counseling and exercise will be superior to treatment as usual in achieving prolonged smoking abstinence in persons with serious mental illness.

Detailed Description
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The objective of this study is to perform a randomized clinical trial (TRIUMPH) in persons with serious mental illness to test the hypothesis that intervention participants will have higher rates of smoking abstinence at 18 months than participants in the treatment as usual arm. The intervention includes group and individual smoking cessation and weight management counseling tailored by a participant's readiness to quit, pharmacotherapy with either varenicline or buproprion plus nicotine replacement therapy prescribed in the community clinic, exercise, and text messaging supporting health behavior change.

Official Title
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Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH

Conditions
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Mental Illness

Intervention / Treatment
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* Other: TRIIUMPH Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or recurrent major depression meeting criteria for serious mental illness Fagerstrom Test for Nicotine Dependence of ≥3 and daily cigarette smoking for at least the past 6 months (on days that cigarettes were available) On stable psychotropic medication for mental illness for at least 30 days (i.e., antipsychotic medication for those with schizophrenia spectrum illness, mood stabilizer for those with bipolar disorder) Competent and willing to give informed consent Completion of baseline data collection Willing to participate in smoking cessation intervention that includes combination of evidence-based behavioral (group and individual sessions) and pharmacotherapeutic smoking cessation aids Exclusion Criteria: Serious cardiovascular event (e.g. myocardial infarction, stroke) within the past 6 months Serious unstable medical condition that limits life expectancy Pregnant, breastfeeding, or planning a pregnancy during study period. Alcohol or illicit substance use disorder if not sober/abstinent for ≥ 30 days Planning to leave mental health program or move out of geographic area within 18 months Review by treating psychiatrist required for those with inpatient psychiatric hospitalization within six months of enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRIUMPH intervention<br>Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support | Other: TRIIUMPH Intervention<br>* Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support<br>|
| No Intervention: Treatment as Usual<br>referral to quit line | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking abstinence | 7-day point prevalence, biochemically validated | measured at 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking abstinence - 3 months | 3 month smoking abstinence | from 15 to 18 months | 
| smoking abstinence | 7-day point prevalence, biochemically validated | measured at 6 and 12 months | 
| continuous smoking abstinence - 12 months | 12 month smoking abstinence | measured at 18 months | 
| Weight | weight in pounds | 6 and 18 months | 
| Body Mass Index |  | 6 and 18 months | 
| Six Minute Walk |  | 6 and 18 months | 
| Framingham Risk Score | global Framingham Risk Score | 18 months | 
| Health Status | measured by SF-12 | 6 and 18 months | 
| Psychiatric Symptoms | Brief Psychiatric Rating Scale | 6 and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight management, physical activity, Tobacco smoking, Serious mental illness