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

Johns Hopkins University

Status: Completed

Conditions: Mental Illness

Treatments: Other: TRIIUMPH Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02424188

R01MH104553 (U.S. NIH Grant/Contract)

IRB00072510

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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192 participants in 2 patient groups

TRIUMPH intervention

Experimental group

Description:

Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support

Treatment:

Other: TRIIUMPH Intervention

Treatment as Usual

No Intervention group

Description:

referral to quit line