Integrated Smoking Cessation and Mood Management for ACS Patients
- Conditions
- Acute Coronary SyndromeTobacco Use
- Registration Number
- NCT03029923
- Lead Sponsor
- The Miriam Hospital
- Brief Summary
Quitting smoking following acute coronary syndrome can reduce mortality up to 50%. However, depression and smoking are highly co-morbid and depressed mood may interfere with cessation and independently predicts mortality. Thus, a single, integrated treatment for both smoking and depression could be highly effective in reducing post-acute coronary syndrome mortality. Behavioral Activation (BA) is a well established treatment for depression and has recently shown promise as a treatment for smoking cessation. The investigators systematically developed an intervention integrating gold standard smoking cessation counseling with existing BA based mood management techniques for post-ACS smokers; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS).
Objective: For this R56 the investigators will conduct a vanguard trial to pilot all methods, materials, and systems for the later fully powered BAT-CS vs. attention control trial. The investigators will enroll up to 36 smokers with ACS and randomize them to 12 weeks of BAT-CS or an attention control (Health and Wellness Education). Both groups will be offered the nicotine patch if medically safe.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- hospital inpatients with an ACS diagnosis documented in medical record,
- smoked 1 or more cigarettes per day before being hospitalized,
- age of 18-75,
- English fluency,
- lives within a 1 hour drive of the admitting hospital and has no plans to move away from the area for 1 year,
- willing to consider quitting smoking at discharge,
- has telephone, and
- willing to consent to all study procedures.
- limited mental competency (i.e., Mini Mental Status Exam score ≤ 23);
- presence of severe mental illness that would interfere with participation (e.g., schizophrenia) or suicidality;
- expected discharge to hospice; and
- currently attending counseling for depression or smoking cessation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Treatment Acceptability 12 weeks post-Discharge Treatment Acceptability as measured by the Client Satisfaction Questionnaire
- Secondary Outcome Measures
Name Time Method Smoking Cessation 12 weeks post-Discharge 7 day point-prevalence abstinence. Biochemically verified.
Depression Symptoms 12 weeks post-Discharge Depression Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Related Research Topics
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Trial Locations
- Locations (1)
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
The Miriam Hospital🇺🇸Providence, Rhode Island, United States