Integrated Smoking Cessation and Mood Management for ACS Patients

NCT03029923 | Withdrawn

• 2 other identifiers: 214016R56HL131711-01A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome; Tobacco Use

Keywords

smoking; depression; Behavioral Activation

Outcome Measures

Primary Outcomes (1)

• Treatment Acceptability

  Treatment Acceptability as measured by the Client Satisfaction Questionnaire

  12 weeks post-Discharge

Secondary Outcomes (2)

• Smoking Cessation

  12 weeks post-Discharge

• Depression Symptoms

  12 weeks post-Discharge

Study Arms (2)

Smoking Cessation and Mood Management

EXPERIMENTAL

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)

Smoking cessation and Health and Wellness

ACTIVE COMPARATOR

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

Interventions

Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS) BEHAVIORAL

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.

Smoking Cessation and Mood Management

Smoking cessation plus Health and Wellness BEHAVIORAL

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.

Smoking cessation and Health and Wellness

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Tobacco Use; Smoking; Depression

Interventions

Health

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 24, 2017
• Study Start: February 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 29, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)