BACKGROUND: Smoking cessation following hospitalization for Acute Coronary Syndrome (ACS) significantly reduces subsequent mortality. Depressed mood is a major barrier to cessation post-ACS. Although existing counseling treatments address smoking and depression independently in ACS patients, no integrated treatment addresses both. We developed an integrated treatment combining gold standard cessation counseling with behavioral activation-based mood management; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS). The purpose of this pilot randomized controlled trial was to test feasibility, acceptability, and preliminary efficacy of BAT-CS vs. Standard of Care (SC).
METHODS: Participants were recruited during hospitalization for ACS and were randomly assigned to BAT-CS or SC. The nicotine patch was offered in both conditions. Smoking, mood, and stress outcomes were collected at end-of-treatment and 24-week follow-up.
RESULTS: Fifty-nine participants (28 BAT-CS, 31 SC) were recruited over 42 weeks, and assessment completion was above 80% in both conditions. Treatment acceptability and fidelity were high. At 24 week follow-up adjusted odds ratios favoring BAT-CS were 1.27 (95% CI: 0.41-3.93) for 7-day point prevalence abstinence and 1.27 (95% CI: 0.42-3.82) for continuous abstinence. Time to first smoking lapse was significantly longer in BAT-CS (62.4 vs. 31.8 days, p = 0.03). At 24-weeks, effect sizes for mood and stress outcomes ranged from eta2partial of.07-.11, with significant between treatment effects for positive affect, negative affect, and stress.
CONCLUSIONS: The design of this study proved feasible and acceptable. Results provide preliminary evidence that combining behavioral activation with standard smoking cessation counseling could be efficacious for this high risk population. A larger trial with longer follow-up is warranted.
TRIAL REGISTRATION: NCT01964898. First received by clinicaltrials.gov October 15, 2013.
- Acute coronary syndrome,
- Behavioral activation,
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