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Post Acute Coronary Event Smoking Study (PACES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01964898
Recruitment Status : Completed
First Posted : October 17, 2013
Results First Posted : January 12, 2017
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Andrew Busch, The Miriam Hospital

Tracking Information
First Submitted Date  ICMJE October 15, 2013
First Posted Date  ICMJE October 17, 2013
Results First Submitted Date  ICMJE October 5, 2016
Results First Posted Date  ICMJE January 12, 2017
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE October 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
  • Smoking Cessation: 7 Day Point Prevalence Abstinence [ Time Frame: 6 months ]
    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 [ Time Frame: 6 months ]
    Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
  • Time to Smoking Relapse [ Time Frame: 6 months ]
    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 Frame: 6 months ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2013)
Smoking Cessation [ Time Frame: 6 months ]
7 day point prevalence abstinence (no smoking, not even a puff, for 7 days; verified by carbon monoxide measurement), continuous abstinence, and time to relapse will be assessed.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
  • Depression: 9 Item Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline to 6 months ]
    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) [ Time Frame: Baseline to 6 months ]
    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 [ Time Frame: Baseline to 6 months ]
    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 [ Time Frame: Baseline to 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2013)
  • Depression [ Time Frame: 6 months ]
    As measured by the 10 item CESD and the 9 item Patient Health Questionnaire (PHQ-9)
  • Positive Affect [ Time Frame: 6 months ]
    As measured by the 10 item Positive Affect Negative Affect Scales (PANAS).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post Acute Coronary Event Smoking Study
Official Title  ICMJE Integrated Smoking Cessation and Mood Management for Cardiac Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Smoking Cessation
  • Acute Coronary Syndrome
Intervention  ICMJE
  • Behavioral: Behavioral Activation (BA)
    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.
  • Behavioral: Standard Smoking Cessation Counseling
    1 hour of in hospital counseling based on clinical guidelines
  • Drug: Nicotine patch
    An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
  • Other: Printed Self-help materials for Smoking Cessation
Study Arms  ICMJE
  • Experimental: BA for cardiac patients who smoke
    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.
    Interventions:
    • Behavioral: Behavioral Activation (BA)
    • Behavioral: Standard Smoking Cessation Counseling
    • Drug: Nicotine patch
  • Active Comparator: Standard Care
    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.
    Interventions:
    • Behavioral: Standard Smoking Cessation Counseling
    • Drug: Nicotine patch
    • Other: Printed Self-help materials for Smoking Cessation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2016)
65
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2013)
72
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01964898
Other Study ID Numbers  ICMJE 5K23HL107391( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew Busch, The Miriam Hospital
Study Sponsor  ICMJE The Miriam Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew M Busch, Ph.D The Miriam Hospital Centers for Behavioral and Preventive Medicine
PRS Account The Miriam Hospital
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP