Clinical trial NCT03413423: Post Acute Cardiac Event Smoking (PACES) Study
Official title: Secondary Prevention Following Acute Coronary Syndrome Using Integrated Smoking Cessation and Mood Management
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome
Tobacco Use
Keywords: smoking
depression
Behavioral Activation
Mood management
Secondary Prevention
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Minneapolis Heart Institute Foundation
name: The Miriam Hospital
name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Minnesota
First posted: 2018-01-29
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 7-day point prevalence abstinence from smoking
timeFrame: 12 Months
measure: Depression Symptoms
timeFrame: 12 Months
Secondary outcomes:
measure: Continuous Abstinence From Smoking Since Hospital Discharge
timeFrame: 12 Months
measure: Time to Smoking Relapse
timeFrame: 12 Months
measure: Time to Smoking Lapse
timeFrame: 12 Months
measure: Depressed mood
timeFrame: The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms.
measure: Positive Affect
timeFrame: 12 Months
measure: Negative Affect
timeFrame: 12 Months
measure: Systolic and Diastolic Blood Pressure
timeFrame: 12 Months
measure: Blood Bio-markers
timeFrame: 12 Months
measure: Major adverse cardiac events (MACE) and all cause mortality
timeFrame: 5 years
measure: Health Related Quality of Life
timeFrame: 12 Months
measure: Treatment Acceptability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Senior Investigator
name: Andrew Busch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.