Post Acute Cardiac Event Smoking (PACES) Study
Secondary Prevention Following Acute Coronary Syndrome Using Integrated Smoking Cessation and Mood Management
2 other identifiers
interventional
233
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2018
CompletedFirst Posted
Study publicly available on registry
January 29, 2018
CompletedStudy Start
First participant enrolled
January 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
ExpectedSeptember 15, 2025
September 1, 2025
6.3 years
January 19, 2018
September 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (11)
Continuous Abstinence From Smoking Since Hospital Discharge
12 Months
Time to Smoking Relapse
12 Months
Time to Smoking Lapse
12 Months
Depressed mood
The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms.
Positive Affect
12 Months
- +6 more secondary outcomes
Study Arms (2)
BAT-CS
EXPERIMENTALParticipants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared.
Smoking Cessation and Health & Wellness
ACTIVE COMPARATORParticipants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hennepin Healthcare Research Institutelead
- Minneapolis Heart Institute Foundationcollaborator
- The Miriam Hospitalcollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- University of Minnesotacollaborator
Study Sites (1)
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Related Publications (1)
Adkins-Hempel M, Japuntich SJ, Chrastek M, Dunsiger S, Breault CE, Ayenew W, Everson-Rose SA, Nijjar PS, Bock BC, Wu WC, Miedema MD, Carlson BM, Busch AM. Integrated smoking cessation and mood management following acute coronary syndrome: Protocol for the post-acute cardiac event smoking (PACES) trial. Addict Sci Clin Pract. 2023 May 12;18(1):29. doi: 10.1186/s13722-023-00388-9.
PMID: 37173792BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Busch, PhD
Senior Investigator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Investigator
Study Record Dates
First Submitted
January 19, 2018
First Posted
January 29, 2018
Study Start
January 29, 2018
Primary Completion
May 8, 2024
Study Completion (Estimated)
May 30, 2026
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
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.