Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Psychiatric |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 2/22/2019 |
| Start Date: | March 26, 2016 |
| End Date: | June 2019 |
| Contact: | Gail L Daumit, MD, MHS |
| Email: | gdaumit@jhmi.edu |
| Phone: | 410 614 6460 |
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.
integrating weight management counseling and exercise will be superior to treatment as usual
in achieving prolonged smoking abstinence in persons with serious mental illness.
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.
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.
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.
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