Integrated Treatment for Smoking Cessation After Acute Coronary Syndrome

Recruiting in Palo Alto (17 mi)

Overseen by Andrew Busch, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Hennepin Healthcare Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Andrew Busch, PhD

Principal Investigator

Senior Investigator

Eligibility Criteria

This trial is for hospital inpatients aged 18-75 who had an acute coronary syndrome (ACS) event within the last month, smoke at least one cigarette daily before hospitalization, speak English, are considering quitting smoking after discharge, and can use a phone. It's not for those with severe mental illness or high risk of dying within six months.

Inclusion Criteria

Willing to consent to all study procedures

I am open to quitting smoking after leaving the hospital.

I have access to a phone or am willing to use one provided by the study.

Exclusion Criteria

I am currently in counseling for depression or to quit smoking.

You are not expected to live for more than 6 months, based on a risk calculator.

I have some difficulties making decisions due to my mental health.

Treatment Details

Interventions

• BAT-CS (Behavioural Intervention)
• Smoking Cessation and Health & Wellness (Behavioural Intervention)

Trial Overview The PACES study tests BAT-CS, an integrated treatment targeting both depression and smoking cessation post-ACS. The goal is to see if this combined approach can effectively reduce mortality by addressing mood issues that may hinder quitting smoking.

Participant Groups

Group I: BAT-CS Experimental Treatment 1 Intervention

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

Group II: Smoking Cessation and Health & Wellness Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Hennepin Healthcare Research Institute

Lead Sponsor

Trials

94

Recruited

77,100+

Jennifer DeCubellis

Hennepin Healthcare Research Institute

Chief Executive Officer since 2020

M.A. from the Illinois School of Professional Psychology, B.A. from the University of Wisconsin-Madison

Dr. Eric W. Ling

Hennepin Healthcare Research Institute

Chief Medical Officer since 2024

MD from Northwestern Feinberg School of Medicine, MBA from the University of St. Thomas

Minneapolis Heart Institute Foundation

Collaborator

Trials

32

Recruited

15,700+

The Miriam Hospital

Collaborator

Trials

252

Recruited

39,200+

Maria Ducharme

The Miriam Hospital

Chief Executive Officer since 2021

Doctor of Nursing Practice from Massachusetts General Hospital Institute of Health Professions, MS in Nursing from University of Rhode Island, BS in Nursing from Rhode Island College

Mark A. Deitch

The Miriam Hospital

Chief Medical Officer

MD, MBA

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Shashank Priya

University of Minnesota

Chief Executive Officer since 2023

PhD in Materials Engineering from Penn State

Charles Semba

University of Minnesota

Chief Medical Officer since 2021

MD from the University of Minnesota Medical School