Integrated Smoking Cessation and Mood Management for ACS Patients

Not Applicable

Withdrawn

• Conditions: Acute Coronary Syndrome; Tobacco Use
• Interventions: Behavioral: Smoking cessation plus Health and Wellness

• 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

Study Timeline

• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-24
• Study Start: 2017-02-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29
• Primary Completion: 2017-10-01
• Study Completion: 2017-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. hospital inpatients with an ACS diagnosis documented in medical record,
2. smoked 1 or more cigarettes per day before being hospitalized,
3. age of 18-75,
4. English fluency,
5. lives within a 1 hour drive of the admitting hospital and has no plans to move away from the area for 1 year,
6. willing to consider quitting smoking at discharge,
7. has telephone, and
8. willing to consent to all study procedures.

Exclusion Criteria

1. limited mental competency (i.e., Mini Mental Status Exam score ≤ 23);
2. presence of severe mental illness that would interfere with participation (e.g., schizophrenia) or suicidality;
3. expected discharge to hospice; and
4. currently attending counseling for depression or smoking cessation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smoking cessation and Health and Wellness	Smoking cessation plus Health and Wellness	Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared.

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)

Trial Locations

Locations (1)

The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States