Integrated Smoking Cessation and Mood Management for ACS Patients

Acute Coronary Syndrome Clinical Trial

— PACES  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03029923
• Other study ID #: 214016
• Secondary ID: R56HL131711-01A1
• Status: Withdrawn
• Phase: N/A
• First received: January 20, 2017
• Last updated: August 28, 2017
• Start date: February 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: August 2017
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Tobacco Use

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Acceptability	Treatment Acceptability as measured by the Client Satisfaction Questionnaire	12 weeks post-Discharge
Secondary	Smoking Cessation	7 day point-prevalence abstinence. Biochemically verified.	12 weeks post-Discharge
Secondary	Depression Symptoms	Depression Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)	12 weeks post-Discharge