Integrated Smoking Cessation and Mood Management for ACS Patients (PACES)
Primary Purpose
Acute Coronary Syndrome, Tobacco Use
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)
Smoking cessation plus Health and Wellness
Sponsored by
About this trial
This is an interventional other trial for Acute Coronary Syndrome focused on measuring smoking, depression, Behavioral Activation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- The Miriam Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Smoking Cessation and Mood Management
Smoking cessation and Health and Wellness
Arm Description
Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared.
Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared.
Outcomes
Primary Outcome Measures
Treatment Acceptability
Treatment Acceptability as measured by the Client Satisfaction Questionnaire
Secondary Outcome Measures
Smoking Cessation
7 day point-prevalence abstinence. Biochemically verified.
Depression Symptoms
Depression Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Full Information
NCT ID
NCT03029923
First Posted
January 20, 2017
Last Updated
August 28, 2017
Sponsor
The Miriam Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT03029923
Brief Title
Integrated Smoking Cessation and Mood Management for ACS Patients
Acronym
PACES
Official Title
Integrated Smoking Cessation and Mood Management for ACS Patients (PACES Phase IV Vanguard R56 Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Funding for this pilot transitioned into funding for a fully powered study.
Study Start Date
February 1, 2017 (Anticipated)
Primary Completion Date
October 1, 2017 (Anticipated)
Study Completion Date
December 1, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Tobacco Use
Keywords
smoking, depression, Behavioral Activation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smoking Cessation and Mood Management
Arm Type
Experimental
Arm Description
Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared.
Arm Title
Smoking cessation and Health and Wellness
Arm Type
Active Comparator
Arm Description
Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared.
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation plus Health and Wellness
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Acceptability
Description
Treatment Acceptability as measured by the Client Satisfaction Questionnaire
Time Frame
12 weeks post-Discharge
Secondary Outcome Measure Information:
Title
Smoking Cessation
Description
7 day point-prevalence abstinence. Biochemically verified.
Time Frame
12 weeks post-Discharge
Title
Depression Symptoms
Description
Depression Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Time Frame
12 weeks post-Discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Integrated Smoking Cessation and Mood Management for ACS Patients
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