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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
192
Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support
Johns Hopkins
Baltimore, Maryland, United States
Number of Participants With Smoking Abstinence
7-day point prevalence, biochemically validated
Time frame: measured at 18 months
Smoking Abstinence - 3 Months
Participants with 3 month smoking abstinence
Time frame: from 15 to 18 months
Smoking Abstinence
7-day point prevalence, biochemically validated
Time frame: measured at 6 and 12 months
12 Months Continuous Smoking Abstinence
participants who reported smoking abstinence continuously from 6 months 18 months
Time frame: measured from 6 months to 18 months
Weight
weight in kilograms
Time frame: Baseline, 6 and 18 months
Body Mass Index
Time frame: Baseline, 18 months
Six Minute Walk
Time frame: 18 months
Framingham Stroke Risk Profile Score
The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke
Time frame: 18 months
Health Status as Assessed by the Short Form -12 (SF-12) Index
SF-12 Mental Health Index and Physical Composite (scores range from 0-100), the higher the score means a better outcome
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Time frame: 6 and 18 months
Psychiatric Symptoms Assessed by the Brief Psychiatric Rating Scale
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.
Time frame: Baseline