Integrated Smoking Cessation and Mood Management for ACS Patients (PACES)

Integrated Smoking Cessation and Mood Management for ACS Patients (PACES Phase IV Vanguard R56 Trial)

Quitting smoking following acute coronary syndrome 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 R56 the investigators will conduct a vanguard trial to pilot all methods, materials, and systems for the later fully powered BAT-CS vs. attention control trial. The investigators will enroll up to 36 smokers with ACS and randomize them to 12 weeks of BAT-CS or an attention control (Health and Wellness Education). Both groups will be offered the nicotine patch if medically safe.

Study Overview

• Status: Withdrawn
• Conditions: Tobacco Use; Acute Coronary Syndrome
• Intervention / Treatment: Behavioral: Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS); Behavioral: Smoking cessation plus Health and Wellness

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • The Miriam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. hospital inpatients with an ACS diagnosis documented in medical record,
2. smoked 1 or more cigarettes per day before being hospitalized,
3. age of 18-75,
4. English fluency,
5. lives within a 1 hour drive of the admitting hospital and has no plans to move away from the area for 1 year,
6. willing to consider quitting smoking at discharge,
7. has telephone, and
8. willing to consent to all study procedures.

Exclusion Criteria:

1. limited mental competency (i.e., Mini Mental Status Exam score ≤ 23);
2. presence of severe mental illness that would interfere with participation (e.g., schizophrenia) or suicidality;
3. expected discharge to hospice; and
4. currently attending counseling for depression or smoking cessation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smoking Cessation and Mood Management; Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared.	Behavioral: Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS); 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 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.
Active Comparator: Smoking cessation and Health and Wellness; Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared.	Behavioral: Smoking cessation plus Health and Wellness; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Acceptability	Treatment Acceptability as measured by the Client Satisfaction Questionnaire	12 weeks post-Discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Cessation	7 day point-prevalence abstinence. Biochemically verified.	12 weeks post-Discharge
Depression Symptoms	Depression Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)	12 weeks post-Discharge

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2017
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: January 20, 2017
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (Estimate): January 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Behavioral Activation; depression; smoking
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: 214016; R56HL131711-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No