N/A
Completed N=192
Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH
Source: ClinicalTrials.gov NCT02424188 ↗Enrolled (actual)
192
Serious AEs
28.1%
Results posted
Jun 2025
Primary outcomePrimary: Number of Participants With Smoking Abstinence — 27; 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Smoking Abstinence |
27; 6 | — |
| SECONDARY Smoking Abstinence - 3 Months |
14; 4 | — |
| SECONDARY Smoking Abstinence |
13; 3; 84; 92; 18; 2 | — |
| SECONDARY 12 Months Continuous Smoking Abstinence |
6; 0; 91; 95 | — |
| SECONDARY Weight |
92.1; 89.8; 92.2; 89.6; 92.2; 88.4 | — |
| SECONDARY Body Mass Index |
32.1; 32; 32.3; 31.3 | — |
| SECONDARY Six Minute Walk |
1000.7; 943.8; 953.6; 942.4 | — |
| SECONDARY Framingham Stroke Risk Profile Score |
9.5; 11.1; 9.3; 11.6 | — |
| SECONDARY Health Status as Assessed by the Short Form -12 (SF-12) Index |
45.0; 43.2; 45.5; 42.5; 45.8; 43.1 | — |
| SECONDARY Psychiatric Symptoms Assessed by the Brief Psychiatric Rating Scale |
42.0; 41.0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02424188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.