Post Acute Cardiac Event Smoking (PACES) Study

Hennepin Healthcare

Status: Active, not recruiting

Conditions: Acute Coronary Syndrome; Tobacco Use

Treatments: Behavioral: BAT-CS; Behavioral: Smoking Cessation and Health & Wellness

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03413423

17-4375

1R01HL136327 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Summary of the Project :

Quitting smoking following acute coronary syndrome (ACS) 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 R01 the investigators will evaluate the efficacy of using a single, integrated treatment that targets both depressed mood and smoking (BAT-CS).

Full description

This project will implement a fully powered efficacy trial enrolling 324 smokers with ACS and randomize them to 12 weeks of either Behavioral Activation Treatment for Cardiac Smokers (BAT-CS) or control condition (including contact match). BAT-CS interventions will focus on smoking cessation and mood management, while the control condition will focus on smoking cessation and general health education. Both groups will be offered the nicotine patch if medically safe. Follow-up assessments will be conducted at end-of-treatment (12 weeks post-discharge for index event), and 6, 9, and 12 months after hospital discharge. The occurrence of major adverse cardiac events and all-cause mortality will be tracked for up to 60 months post discharge.

Enrollment: 233 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hospital inpatients with an ACS diagnosis documented in medical record within the past 30 days
• smoked equal or greater than 1 cigarette per day before being hospitalized
• age of 18-75 years
• English fluency
• willing to consider quitting smoking at discharge
• has a telephone or is willing to use a study issued cell phone
• willing to consent to all study procedures.

Exclusion criteria

• limited mental competency
• presence of severe mental illness that would interfere with participation or suicidality
• expected discharge to hospice or greater than 50% chance of 6 month mortality per risk calculator
• currently attending counseling for depression or smoking cessation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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233 participants in 2 patient groups

BAT-CS

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: BAT-CS

Smoking Cessation and Health & 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 and Health & Wellness