Cognitive-behavioral treatment with behavioral activation for smokers with depressive symptomatology: study protocol of a randomized controlled trial

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 registration ClinicalTrials.gov: NCT02844595. Retrospectively registered 19th July, 2016. The study started in January 2016, and the recruitment is ongoing.

Cognitive-behavioral treatment with behavioral activation for smoking cessation: Randomized controlled trial

“…A full description of the protocol and session-by-session treatment components has been published [48]. Treatment conditions were exclusively cognitive-behavioral-based interventions, and pharmacotherapy was not used.…”

Treatment completion and anxiety sensitivity effects on smoking cessation outcomes

“…Participants were 210 smokers enrolled in a smoking-cessation cognitive-behavioral treatment conducted in Spain. The data of this study are derived from a more extensive investigation of a randomized clinical trial for smoking cessation (NCT Identifier02844595), which has been published previously (Becoña et al, 2017;Martínez-Vispo et al, 2019). The total sample of the main trial was composed of 275 treatment-seeking smokers but for the aims of the present study, only those participants who received active smoking-cessation treatment and who had attended at least the first session were included.…”

“…These interventions were conducted by two trained therapists (Master's level in Counseling Psychology) with experience in the application of smoking-cessation interventions. The detailed trial rationale and protocol have been published previously (Becoña et al, 2017).…”

Specific Relapse Predictors: Could Cognitive-Behavioral Treatment for Smoking Cessation Be Improved?

“…For the purpose of this study, we selected those participants who achieved abstinence at the end of the intervention (n = 130). The present study is a post hoc analysis of this trial, and a complete description was previously published [27,28]. To be included in the study, participants had to be 18 years of age or older, be current daily smokers (at least 8 cigarettes per day), wish to participate in the treatment program, and provide written informed consent.…”