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Completed

NCT Number: NCT02424188

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

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.

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Key information

Conditions

Mental Illness Behavior Mental Disorders Motor Activity Smoking Tobacco Smoking Tobacco Use

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TRIIUMPH Intervention

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

Primary outcomes

  1. Number of Participants With Smoking Abstinence

    Time frame: measured at 18 months

    7-day point prevalence, biochemically validated

Secondary outcomes

  1. Smoking Abstinence - 3 Months

    Time frame: from 15 to 18 months

    Participants with 3 month smoking abstinence

  2. Smoking Abstinence

    Time frame: measured at 6 and 12 months

    7-day point prevalence, biochemically validated

  3. 12 Months Continuous Smoking Abstinence

    Time frame: measured from 6 months to 18 months

    participants who reported smoking abstinence continuously from 6 months 18 months

  4. Weight

    Time frame: Baseline, 6 and 18 months

    weight in kilograms

  5. Body Mass Index

    Time frame: Baseline, 18 months

  6. Six Minute Walk

    Time frame: 18 months

  7. Framingham Stroke Risk Profile Score

    Time frame: 18 months

    The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke

  8. Health Status as Assessed by the Short Form -12 (SF-12) Index

    Time frame: 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

  9. Psychiatric Symptoms Assessed by the Brief Psychiatric Rating Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Massachusetts General Hospital
  • National Institute of Mental Health (NIMH)

Registry information

Acronym: TRIUMPH

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2015
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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