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Post Acute Coronary Event Smoking Study (PACES)

Primary Purpose

Smoking Cessation, Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation (BA)
Standard Smoking Cessation Counseling
Nicotine patch
Printed Self-help materials for Smoking Cessation
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring Smoking, Mood Management, Depression, Behavioral Activation, Acute Coronary Syndrome, Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ACS diagnosis documented in medical record
  • smoked 3 or more cigarettes per day before being hospitalized
  • between the ages of 18-75
  • fluent in English
  • regular access to a telephone
  • lives in the Providence, RI area
  • willing to "strongly consider" an attempt to quit smoking at discharge

Exclusion criteria:

  • limited mental competency (i.e., Mini-Mental Status exam < 20)
  • presence of current psychosis, serious mental illness, or suicidality, expectation that patient will not live through 6 month study period
  • currently regularly attending counseling for depression or smoking cessation and plans to continue after discharge

Sites / Locations

  • The Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BA for cardiac patients who smoke

Standard Care

Arm Description

Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Outcomes

Primary Outcome Measures

Smoking Cessation: 7 Day Point Prevalence Abstinence
No smoking, not even a puff, for 7 days; verified by carbon monoxide measurement. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Continuous Abstinence From Smoking Since Discharge
Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time to Smoking Relapse
Time in days to first relapse (i.e., smoking on 7 consecutive days or smoking in 2 consecutive 7 day periods), which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time to Smoking Lapse
Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.

Secondary Outcome Measures

Depression: 9 Item Patient Health Questionnaire (PHQ-9)
The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)
The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
Positive Affect
As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance
Negative Affect
As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.

Full Information

First Posted
October 15, 2013
Last Updated
January 10, 2017
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01964898
Brief Title
Post Acute Coronary Event Smoking Study
Acronym
PACES
Official Title
Integrated Smoking Cessation and Mood Management for Cardiac Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Smoking and depressed mood are both predictive of mortality following Acute Coronary Syndrome. However, to date, no counseling treatment has been designed to target smoking cessation and manage mood in this population. This trial will test such a treatment based on Behavioral Activation, an approach that has shown promise as an integrated treatment for smoking and mood management in other populations.
Detailed Description
The occurrence of Acute Coronary Syndrome (ACS; unstable angina, ST and non-ST elevation myocardial infarction) can be conceptualized as a "teachable moment," whereby patients may be more receptive to smoking cessation messages. Continued smoking following ACS is an independent predictor of mortality. Depressed mood post-ACS is also predictive of mortality, and smokers with depressed mood are less likely to abstain from smoking following an ACS hospitalization. Thus, a single, integrated treatment that targets both depressed mood and smoking could be highly effective in reducing post-ACS mortality. Behavioral Activation (BA) may be an ideal treatment for this population as BA can easily integrate both mood and smoking cessation related goals and it focuses on addressing restriction of valued activities, which is common in the post-ACS population. Thus, the overall aim of the current study is test a BA treatment manual that integrates smoking cessation and mood management for post-ACS smokers (Behavioral Activation Treatment for cardiac patients who smoke; BAT-CS). We will conduct an RCT (N=72) comparing BAT-CS (1 in-hospital session and 5-9 post-discharge sessions) to Standard Care (SC; 1 in-hospital session and 5 mailed packets of printed self-help materials). Differences in smoking cessation, depressed mood, and positive affect will be compared between conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Acute Coronary Syndrome
Keywords
Smoking, Mood Management, Depression, Behavioral Activation, Acute Coronary Syndrome, Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BA for cardiac patients who smoke
Arm Type
Experimental
Arm Description
Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation (BA)
Intervention Description
5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.
Intervention Type
Behavioral
Intervention Name(s)
Standard Smoking Cessation Counseling
Intervention Description
1 hour of in hospital counseling based on clinical guidelines
Intervention Type
Drug
Intervention Name(s)
Nicotine patch
Intervention Description
An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Intervention Type
Other
Intervention Name(s)
Printed Self-help materials for Smoking Cessation
Primary Outcome Measure Information:
Title
Smoking Cessation: 7 Day Point Prevalence Abstinence
Description
No smoking, not even a puff, for 7 days; verified by carbon monoxide measurement. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time Frame
6 months
Title
Continuous Abstinence From Smoking Since Discharge
Description
Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time Frame
6 months
Title
Time to Smoking Relapse
Description
Time in days to first relapse (i.e., smoking on 7 consecutive days or smoking in 2 consecutive 7 day periods), which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time Frame
6 months
Title
Time to Smoking Lapse
Description
Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Depression: 9 Item Patient Health Questionnaire (PHQ-9)
Description
The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
Time Frame
Baseline to 6 months
Title
Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)
Description
The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
Time Frame
Baseline to 6 months
Title
Positive Affect
Description
As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance
Time Frame
Baseline to 6 months
Title
Negative Affect
Description
As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
Time Frame
Baseline to 6 months

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: ACS diagnosis documented in medical record smoked 3 or more cigarettes per day before being hospitalized between the ages of 18-75 fluent in English regular access to a telephone lives in the Providence, RI area willing to "strongly consider" an attempt to quit smoking at discharge Exclusion criteria: limited mental competency (i.e., Mini-Mental Status exam < 20) presence of current psychosis, serious mental illness, or suicidality, expectation that patient will not live through 6 month study period currently regularly attending counseling for depression or smoking cessation and plans to continue after discharge
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew M Busch, Ph.D
Organizational Affiliation
The Miriam Hospital Centers for Behavioral and Preventive Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28415979
Citation
Busch AM, Tooley EM, Dunsiger S, Chattillion EA, Srour JF, Pagoto SL, Kahler CW, Borrelli B. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial. BMC Public Health. 2017 Apr 17;17(1):323. doi: 10.1186/s12889-017-4250-7.
Results Reference
derived

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Post Acute Coronary Event Smoking Study

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