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Integrated Treatment for Smoking Cessation After Acute Coronary Syndrome

N/A

Waitlist Available

Led By Andrew Busch, PhD

Research Sponsored by Hennepin Healthcare Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospital inpatients with an ACS diagnosis documented in medical record within the past 30 days

Age of 18-75 years

Must not have

Limited mental competency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a single, integrated treatment that targets both depressed mood and smoking is more effective than usual care in reducing post-acute coronary syndrome mortality.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed for Behavioral Activation Treatment (BAT), potential risks may include discomfort discussing personal issues during therapy sessions and emotional distress related to behavior changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was hospitalized for acute coronary syndrome (ACS) within the last 30 days.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

7-day point prevalence abstinence from smoking

Depression Symptoms

Secondary study objectives

Blood Bio-markers

Continuous Abstinence From Smoking Since Hospital Discharge

Depressed mood

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BAT-CSExperimental Treatment1 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 & WellnessActive Control1 Intervention

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

0 / 3Eligibility criteria met