Abstract
BackgroundSmoking is an important risk factor for mental health-related problems. Numerous studies have supported a bi-directional association between cigarette smoking and depression. Despite the advances in understanding the comorbidity between both problems, the most effective psychological treatment that simultaneously targets smoking and depressive symptomatology remains unclear. The objective of this study is to assess the effectiveness of a cognitive-behavioral intervention for smoking cessation with components of behavioral activation for managing depressed mood.MethodA single blind, three-arm, superiority randomized controlled trial is proposed. Participants will be smokers over 18 years old, who smoke at least 8 cigarettes per day. Participants will be randomized to one of three conditions, using a 2:2:1 allocation ratio: 1) standard cognitive-behavioral smoking cessation treatment; 2) standard cognitive-behavioral smoking cessation treatment plus behavioral activation; or 3) a three-month delayed treatment control group. The primary outcome measures will be biochemically verified point-prevalence abstinence (carbon monoxide in expired air) and significant change from baseline in depressive symptoms to the end of treatment, and at the 3-, 6-, and 12-month follow-up.DiscussionThis study aims to assess the efficacy of a cognitive-behavioral intervention with behavioral activation components for smoking cessation and depressive symptoms, compared to a standard cognitive-behavioral intervention to quit smoking. As the relation between depressive symptoms, even at subclinical levels, and quitting smoking difficulties is well known, we expect that such intervention will allow obtaining higher abstinence rates, lower relapse rates, and mood improvement.Trial registrationClinicalTrials.gov: NCT02844595. Retrospectively registered 19th July, 2016. The study started in January 2016, and the recruitment is ongoing.
Highlights
Smoking is an important risk factor for mental health-related problems
This study aims to assess the efficacy of a cognitive-behavioral intervention with behavioral activation components for smoking cessation and depressive symptoms, compared to a standard cognitive-behavioral intervention to quit smoking
As the relation between depressive symptoms, even at subclinical levels, and quitting smoking difficulties is well known, we expect that such intervention will allow obtaining higher abstinence rates, lower relapse rates, and mood improvement
Summary
This is the first randomized controlled trial conducted evaluating the efficacy of a cognitive-behavioral smoking cessation intervention (CBSCI) with components of Behavioral Activation (BA). This study has significant strengths: (1) to date, it will be the largest trial to address the clinical-effectiveness of BA integrated into a cognitive-behavioral smoking cessation treatment; (2) follow-up assessments will be carried out at 3-, 6- and 12-month post-treatment in both active groups (CBSCI vs CBSCI + BA), which will provide an opportunity to evaluate the long-term treatment effects on abstinence rates and mood; and (3) participants will be included regardless of current depressive symptom level, which will allow us to investigate the influence of subclinical depressive symptomatology in treatment outcomes.
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