Clinical trial NCT02424188: Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH
Official title: Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Illness
Keywords: weight management
physical activity
Tobacco smoking
Serious mental illness
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: National Institute of Mental Health (NIMH)
First posted: 2015-04-22
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: smoking abstinence
timeFrame: measured at 18 months
Secondary outcomes:
measure: smoking abstinence - 3 months
timeFrame: from 15 to 18 months
measure: smoking abstinence
timeFrame: measured at 6 and 12 months
measure: continuous smoking abstinence - 12 months
timeFrame: measured at 18 months
measure: Weight
timeFrame: 6 and 18 months
measure: Body Mass Index
timeFrame: 6 and 18 months
measure: Six Minute Walk
timeFrame: 6 and 18 months
measure: Framingham Risk Score
timeFrame: 18 months
measure: Health Status
timeFrame: 6 and 18 months
measure: Psychiatric Symptoms
timeFrame: 6 and 18 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Gail L Daumit, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachussetts General Hospital
name: A. Eden Evins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: