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

NCT ID: NCT02424188

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-07
• Study Completion Date: 2020-03-31

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.

Conditions

Mental Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TRIUMPH intervention

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

Group Type: EXPERIMENTAL

TRIIUMPH Intervention

Intervention Type: OTHER

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 as Usual

referral to quit line

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TRIIUMPH Intervention

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gail L Daumit, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

A. Eden Evins, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachussetts General Hospital

Locations

Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

References

Daumit GL, Evins AE, Cather C, Dalcin AT, Dickerson FB, Miller ER 3rd, Appel LJ, Jerome GJ, McCann U, Ford DE, Charleston JB, Young DR, Gennusa JV 3rd, Goldsholl S, Cook C, Fink T, Wang NY. Effect of a Tobacco Cessation Intervention Incorporating Weight Management for Adults With Serious Mental Illness: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Sep 1;80(9):895-904. doi: 10.1001/jamapsychiatry.2023.1691.

Reference Type: DERIVED

PMID: 37378972 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01MH104553

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00072510

Identifier Type: -

Identifier Source: org_study_id