Post Acute Cardiac Event Smoking (PACES) Study

Secondary Prevention Following Acute Coronary Syndrome Using Integrated Smoking Cessation and Mood Management

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Tobacco Use; Acute Coronary Syndrome
• Intervention / Treatment: Behavioral: BAT-CS; Behavioral: Smoking Cessation and Health & Wellness

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Busch, PhD; Phone Number: 612-873-6681; Email: andrew.busch@hcmed.org
• Study Contact Backup: Name: Michelle L Chrastek, MPH; Phone Number: 612-873-5364; Email: michelle.chrastek@hcmed.org

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAT-CS; Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared.	Behavioral: BAT-CS; All participants will receive one hour 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.; Other Names: Smoking Cessation and Mood Management
Active Comparator: Smoking Cessation and Health & Wellness; Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared.	Behavioral: Smoking Cessation and Health & 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7-day point prevalence abstinence from smoking	Self-report of no smoking, not even a puff, for 7 days; then Bio-chemically confirmed with saliva cotinine or by carbon monoxide in a breath sample	12 Months
Depression Symptoms	The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous Abstinence From Smoking Since Hospital Discharge	No smoking, not even a puff, since hospital discharge	12 Months
Time to Smoking Relapse	Time in days to first relapse (i.e., smoking on 7 consecutive days or smoking in 2 consecutive 7 day periods), which were determined through timeline follow back interviewing.	12 Months
Time to Smoking Lapse	Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing.	12 Months
Depressed mood	10 Item Center for Epidemiologic Studies Depression Scale (CESD)	The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms.
Positive Affect	As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect.	12 Months
Negative Affect	As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect.	12 Months
Systolic and Diastolic Blood Pressure	Resting Systolic and Diastolic Blood Pressure	12 Months
Blood Bio-markers	HDL, LDL, High Sensitivity C-reactive protein, and Fibrinogen	12 Months
Major adverse cardiac events (MACE) and all cause mortality	Time in days to MACE or all cause mortality. MACE = non-fatal myocardial infarction (using standard American Heart Association definitions), hospitalization for unstable angina, or urgent coronary revascularization.	5 years
Health Related Quality of Life	12-Item Short Form Health Survey (SF-12)	12 Months
Treatment Acceptability	Client Satisfaction Questionnaire	12 weeks

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); The Miriam Hospital; University of Minnesota; Minneapolis Heart Institute Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2018
• Primary Completion (Anticipated): May 30, 2024
• Study Completion (Anticipated): May 30, 2026

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Behavioral Activation; depression; smoking; Secondary Prevention; Mood management
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: 17-4375; 1R01HL136327 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Completely de-identified data (i.e.,data that has been cleaned of all 18 types of HIPAA identifiers) will be available to other qualified researchers. Within 18 months of study completion, we will make datasets available to interested investigators who submit a written request to the PI. The only contingency on the use of the data will be that ethical guidelines be followed (e.g., only individuals who have completed a research ethics training course will have access to the data, the data will be stored securely). The NIH will be notified of transmissions of the data to interested investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No