Integrated Smoking Cessation and Mood Management for ACS Patients

NCT ID: NCT03029923

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2017-12-01

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.

Conditions

Acute Coronary Syndrome; Tobacco Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Smoking Cessation and Mood Management

Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared.

Group Type: EXPERIMENTAL

Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)

Intervention Type: BEHAVIORAL

All participants will receive one hour of standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to BAT-CS condition will receive 5 more counseling sessions over the 12 weeks after discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur by phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and mood management using behavioral activation techniques. Participants will be offered the nicotine patch if medically cleared.

Smoking cessation and Health and Wellness

Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared.

Group Type: ACTIVE_COMPARATOR

Smoking cessation plus Health and Wellness

Intervention Type: BEHAVIORAL

All participants will receive one hour of standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to the Smoking cessation plus Health and Wellness condition will receive 5 more counseling sessions over the 12 weeks after hospital discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur over the phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and didactic health and wellness education. Participants will be offered the nicotine patch if medically cleared.

Interventions

Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)

All participants will receive one hour of standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to BAT-CS condition will receive 5 more counseling sessions over the 12 weeks after discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur by phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and mood management using behavioral activation techniques. Participants will be offered the nicotine patch if medically cleared.

Intervention Type: BEHAVIORAL

Smoking cessation plus Health and Wellness

All participants will receive one hour of standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to the Smoking cessation plus Health and Wellness condition will receive 5 more counseling sessions over the 12 weeks after hospital discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur over the phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and didactic health and wellness education. Participants will be offered the nicotine patch if medically cleared.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Andrew Busch

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

R56HL131711-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

214016

Identifier Type: -

Identifier Source: org_study_id