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Active, Not Recruiting

NCT Number: NCT03413423

Post Acute Cardiac Event Smoking (PACES) Study

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acute Coronary Syndrome Behavior Behavioral Symptoms Cardiovascular Diseases Depression Heart Diseases Myocardial Ischemia Smoking Tobacco Use Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BAT-CS

Behavioral

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

Smoking Cessation and Health & Wellness

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.

Primary outcomes

  1. 7-day point prevalence abstinence from smoking

    Time frame: 12 Months

    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

  2. Depression Symptoms

    Time frame: 12 Months

    The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms.

Secondary outcomes

  1. Continuous Abstinence From Smoking Since Hospital Discharge

    Time frame: 12 Months

    No smoking, not even a puff, since hospital discharge

  2. Time to Smoking Relapse

    Time frame: 12 Months

    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.

  3. Time to Smoking Lapse

    Time frame: 12 Months

    Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing.

  4. Depressed mood

    Time frame: The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms.

    10 Item Center for Epidemiologic Studies Depression Scale (CESD)

  5. Positive Affect

    Time frame: 12 Months

    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.

  6. Negative Affect

    Time frame: 12 Months

    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.

  7. Systolic and Diastolic Blood Pressure

    Time frame: 12 Months

    Resting Systolic and Diastolic Blood Pressure

  8. Blood Bio-markers

    Time frame: 12 Months

    HDL, LDL, High Sensitivity C-reactive protein, and Fibrinogen

  9. Major adverse cardiac events (MACE) and all cause mortality

    Time frame: 5 years

    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.

  10. Health Related Quality of Life

    Time frame: 12 Months

    12-Item Short Form Health Survey (SF-12)

  11. Treatment Acceptability

    Time frame: 12 weeks

    Client Satisfaction Questionnaire

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Collaborators

  • Minneapolis Heart Institute Foundation
  • National Heart, Lung, and Blood Institute (NHLBI)
  • The Miriam Hospital
  • University of Minnesota

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2026
First posted
Jan 29, 2018
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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