Integrated Smoking Cessation and Mood Management for ACS Patients (PACES)

Lifespan

Status: Withdrawn

Conditions: Acute Coronary Syndrome; Tobacco Use

Treatments: Behavioral: Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS); Behavioral: Smoking cessation plus Health and Wellness

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03029923

214016

R56HL131711-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 2 patient groups

Smoking Cessation and Mood Management

Experimental group

Description:

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

Treatment:

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

Smoking cessation and Health and Wellness

Active Comparator group

Description:

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

Treatment:

Behavioral: Smoking cessation plus Health and Wellness