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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Smoking Abstinence	measured at 18 months	7-day point prevalence, biochemically validated

Secondary Outcome Measures

Name	Time	Method
Smoking Abstinence - 3 Months	from 15 to 18 months	Participants with 3 month smoking abstinence
Health Status as Assessed by the Short Form -12 (SF-12) Index	6 and 18 months	SF-12 Mental Health Index and Physical Composite (scores range from 0-100), the higher the score means a better outcome
Smoking Abstinence	measured at 6 and 12 months	7-day point prevalence, biochemically validated
Psychiatric Symptoms Assessed by the Brief Psychiatric Rating Scale	Baseline	Brief Psychiatric Rating Scale. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.
12 Months Continuous Smoking Abstinence	measured from 6 months to 18 months	participants who reported smoking abstinence continuously from 6 months 18 months
Weight	Baseline, 6 and 18 months	weight in kilograms
Body Mass Index	Baseline, 18 months
Six Minute Walk	18 months
Framingham Stroke Risk Profile Score	18 months	The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke