Post Acute Coronary Event Smoking Study

Smoking Cessation Clinical Trial

— PACES  

Official title:

Integrated Smoking Cessation and Mood Management for Cardiac Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964898
• Other study ID #: 5K23HL107391
• Status: Completed
• Phase: N/A
• First received: October 15, 2013
• Last updated: January 10, 2017
• Start date: October 2013
• Est. completion date: April 2015

Study information

• Verified date: January 2017
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Smoking Cessation

Intervention

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.
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Primary	Continuous Abstinence From Smoking Since Discharge	Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.	6 months	No
Primary	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.	6 months	No
Primary	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.	6 months	No
Secondary	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.	Baseline to 6 months	No
Secondary	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.	Baseline to 6 months	No
Secondary	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	Baseline to 6 months	No
Secondary	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.	Baseline to 6 months	No