Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Number of Participants With Smoking Abstinence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Number of Participants With Smoking Abstinence
时间窗: measured at 18 months
7-day point prevalence, biochemically validated
次要结局
- Smoking Abstinence - 3 Months(from 15 to 18 months)
- Smoking Abstinence(measured at 6 and 12 months)
- 12 Months Continuous Smoking Abstinence(measured from 6 months to 18 months)
- Weight(Baseline, 6 and 18 months)
- Body Mass Index(Baseline, 18 months)
- Six Minute Walk(18 months)
- Framingham Stroke Risk Profile Score(18 months)
- Health Status as Assessed by the Short Form -12 (SF-12) Index(6 and 18 months)
- Psychiatric Symptoms Assessed by the Brief Psychiatric Rating Scale(Baseline)