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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

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Acute Coronary Syndrome Behavioral: Behavioral Activation (BA) Behavioral: Standard Smoking Cessation Counseling Drug: Nicotine patch Other: Printed Self-help materials for Smoking Cessation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrated Smoking Cessation and Mood Management for Cardiac Patients
Study Start Date : October 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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



Primary Outcome Measures :
  1. 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.

  2. Continuous Abstinence From Smoking Since Discharge [ Time Frame: 6 months ]
    Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964898


Locations
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United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
Investigators
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Principal Investigator: Andrew M Busch, Ph.D The Miriam Hospital Centers for Behavioral and Preventive Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrew Busch, Research Scientist, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01964898    
Other Study ID Numbers: 5K23HL107391 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2013    Key Record Dates
Results First Posted: January 12, 2017
Last Update Posted: January 12, 2017
Last Verified: January 2017
Keywords provided by Andrew Busch, The Miriam Hospital:
Smoking
Mood Management
Depression
Behavioral Activation
Acute Coronary Syndrome
Myocardial Infarction
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action