title: Cognitive-behavioral treatment with behavioral activation for smokers with depressive symptomatology: study protocol of a randomized controlled trial.
abstract: Smoking 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.
  
  
  
  A 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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov : NCT02844595 . Retrospectively registered 19th July, 2016. The study started in January 2016, and the recruitment is ongoing.
authors.affiliation: Smoking Cessation and Addictive Disorders Unit, Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Santiago de Compostela, 15782, Santiago de Compostela, Galicia, Spain. elisardo.becona@usc.es.
authors.forename: Elisardo
authors.initials: E
authors.lastname: Becoña
authors.affiliation: Smoking Cessation and Addictive Disorders Unit, Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Santiago de Compostela, 15782, Santiago de Compostela, Galicia, Spain.
authors.forename: Carmela
authors.initials: C
authors.lastname: Martínez-Vispo
authors.affiliation: Smoking Cessation and Addictive Disorders Unit, Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Santiago de Compostela, 15782, Santiago de Compostela, Galicia, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Senra
authors.affiliation: Smoking Cessation and Addictive Disorders Unit, Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Santiago de Compostela, 15782, Santiago de Compostela, Galicia, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: López-Durán
authors.affiliation: Smoking Cessation and Addictive Disorders Unit, Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Santiago de Compostela, 15782, Santiago de Compostela, Galicia, Spain.
authors.forename: Rubén
authors.initials: R
authors.lastname: Rodríguez-Cano
authors.affiliation: Department of Psychology and Sociology, University of Zaragoza, 50009, Zaragoza, Spain.
authors.forename: Elena
authors.initials: E
authors.lastname: Fernández Del Río
mesh_terms: D000328:Adult; D003071:Cognition; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003863:Depression / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D012907:Smoking / Q000523:psychology; D016540:Smoking Cessation / Q000379:methods; D000074606:Smoking Prevention; D014029:Tobacco Use Disorder / Q000523:psychology / Q000628:therapy*; D016896:Treatment Outcome
keywords: Behavioral activation; Depressive symptoms; Randomized controlled trial; Smoking cessation