Behavioural Activation Treatment for Smoking Cessation and Depressive Symptomatology: a Randomized Controlled Trial

NCT02844595 | Completed

• 1 other identifier: PSI2015-66755-R (MINECO/FEDER)
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief Summary

The number of people who smoke, have concurrent depression and that seek treatment for smoking cessation has increased in recent years. This implies the need to design intensive and specific interventions that target this issue. In depression treatment, behavioural activation is one of the psychological interventions whose characteristics of brevity, flexibility and efficiency make it an ideal candidate to be included as part of smoking cessation treatment, especially when smokers have depressive symptoms. The aims of the present trial are: 1) to assess the efficacy (abstinence rates) of a psychological smoking cessation treatment with elements from behavioural activation for managing depressed mood (a randomized control trial with three groups: standard cognitive-behavioural smoking cessation treatment, standard cognitive-behavioural smoking cessation treatment plus behavioural activation, and a control group of delayed treatment) at the end of treatment, and at 3-, 6-, and 12-months follow-ups; and 2) to assess whether the applied cognitive-behavioural smoking cessation treatment plus behavioural activation improves depressed mood at the end of treatment and 3-, 6, 12-months follow-ups.

Conditions

Smoking

Keywords

Smoking, psychological treatment, depression

Outcome Measures

Primary Outcomes (3)

• Point-prevalence abstinence

  Participants will be considered abstinent if they report abstinence, not even a puff of a cigarette, for ≥24 hours at the end of treatment (week 8 since beginning treatment), and for ≥7 days prior to follow up day at 3 months follow-up and have an expired carbon monoxide reading of ≤10 parts per million. At 6-, and 12-months follow-ups, participants will be considered abstinent if they report abstinence, not even a puff of a cigarette, for ≥30 days prior to follow up day and have an expired carbon monoxide reading of ≤10 parts per million.

  1 year

• Change from baseline in depressive symptoms on the Beck Depression Inventory-II (BDI-II)

  1 year

• Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale

  1 year

Secondary Outcomes (4)

• Continuous abstinence

  1 year

• Reduction of cigarette consumption

  1 year

• Change from baseline in the Environmental Reward Observation Scale (EROS) scores

  1 year

• Change from baseline in the Behavioural Activation for Depression Scale (BADS) scores

  1 year

Study Arms (3)

Standard cognitive-behavioural smoking cessation treatment

ACTIVE COMPARATOR

Behavioral: Standard cognitive-behavioural smoking cessation treatment

Standard smoking cessation treatment and behavioral activation

ACTIVE COMPARATOR

Behavioral: Standard cognitive-behavioural smoking cessation treatment and behavioural activation

Control group

NO INTERVENTION

It will be a delayed treatment control group for a period of 3 months.

Interventions

Standard cognitive-behavioural smoking cessation treatment BEHAVIORAL

Standard cognitive-behavioural smoking cessation treatment is an effective treatment for tobacco dependence. The treatment elements are: treatment contract, self-report and graphic representation of cigarette consumption, information about tobacco, stimulus control, activities for the avoidance of withdrawal syndrome, physiological feedback (CO in expired air) on cigarette consumption, nicotine fading (change of cigarette brands each week progressively decreasing the intake of nicotine and tar), and relapse-prevention strategies (assertion training, problem solving training, change tobacco related misconceptions, management of anxiety and anger, exercise, weight control, self-reinforcing, and changing irrational beliefs). Treatment will be delivered in eight 60-minute sessions over 8 consecutive weeks.

Standard cognitive-behavioural smoking cessation treatment

Standard cognitive-behavioural smoking cessation treatment and behavioural activation BEHAVIORAL

Behavioural activation will be applied along with standard cognitive-behavioural smoking cessation treatment. The treatment elements are: those present in the standard cognitive-behavioural smoking cessation treatment, plus analysis of the relationship between behaviour and mood, identification of situations and behaviours that decrease mood, identifying avoidance behaviours, and identifying thoughts of rumination and worry, self-report of pleasant daily activities, pleasant activity scheduling to increase engagement in rewarding activities, and to reduce patterns of behavioural avoidance. Treatment will be delivered in eight 60-minute sessions over 8 consecutive weeks.

Standard smoking cessation treatment and behavioral activation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older who smoke at least 10 cigarettes per day
• Desire to participate voluntarily in the treatment offered to quit smoking
• Correctly fill out all the pretreatment assessment questionnaires
• Be able to provide written informed consent

You may not qualify if:

• To have a diagnosis of a severe mental disorder (bipolar disorder and / or psychotic disorder)
• To have a substance use disorder (alcohol, cannabis, cocaine, heroin), different from a tobacco use disorder
• To smoke rolling snuff, cigars, little cigars or other tobacco products
• To have participated in an effective psychological treatment to quit smoking during the previous 12 months
• To have received other effective pharmacological treatment to quit smoking in the previous 12 months (nicotine gum or patches, bupropion, varenicline)
• To have a physical pathology involving life threatening risks for the person who would require immediate intervention in individual format (eg. Recent myocardial infarction, pneumothorax, etc.)

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (1)

Smoking Cessation and Addictive Disorders Unit, Faculty of Psychology, University of Santiago de Compostela

Santiago de Compostela, A Coruña, 15782, Spain

Location

Related Publications (8)

• Cook JW, Piper ME, Leventhal AM, Schlam TR, Fiore MC, Baker TB. Anhedonia as a component of the tobacco withdrawal syndrome. J Abnorm Psychol. 2015 Feb;124(1):215-25. doi: 10.1037/abn0000016. Epub 2014 Nov 10.

  PMID: 25384069 BACKGROUND

• Gierisch JM, Bastian LA, Calhoun PS, McDuffie JR, Williams JW Jr. Smoking cessation interventions for patients with depression: a systematic review and meta-analysis. J Gen Intern Med. 2012 Mar;27(3):351-60. doi: 10.1007/s11606-011-1915-2. Epub 2011 Oct 26.

  PMID: 22038468 BACKGROUND

• Hitsman B, Papandonatos GD, McChargue DE, DeMott A, Herrera MJ, Spring B, Borrelli B, Niaura R. Past major depression and smoking cessation outcome: a systematic review and meta-analysis update. Addiction. 2013 Feb;108(2):294-306. doi: 10.1111/add.12009.

  PMID: 23072580 BACKGROUND

• MacPherson L, Tull MT, Matusiewicz AK, Rodman S, Strong DR, Kahler CW, Hopko DR, Zvolensky MJ, Brown RA, Lejuez CW. Randomized controlled trial of behavioral activation smoking cessation treatment for smokers with elevated depressive symptoms. J Consult Clin Psychol. 2010 Feb;78(1):55-61. doi: 10.1037/a0017939.

  PMID: 20099950 BACKGROUND

• Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

  PMID: 39868569 DERIVED

• Lopez-Duran A, Martinez-Vispo C, Barroso-Hurtado M, Suarez-Castro D, Becona E. Incorporating technology in smoking cessation interventions: In-person vs. Video-call formats. Int J Med Inform. 2025 Mar;195:105774. doi: 10.1016/j.ijmedinf.2024.105774. Epub 2024 Dec 24.

  PMID: 39742855 DERIVED

• Martinez-Vispo C, Rodriguez-Cano R, Lopez-Duran A, Senra C, Fernandez Del Rio E, Becona E. Cognitive-behavioral treatment with behavioral activation for smoking cessation: Randomized controlled trial. PLoS One. 2019 Apr 8;14(4):e0214252. doi: 10.1371/journal.pone.0214252. eCollection 2019.

  PMID: 30958831 DERIVED

• Becona E, Martinez-Vispo C, Senra C, Lopez-Duran A, Rodriguez-Cano R, Fernandez Del Rio E. Cognitive-behavioral treatment with behavioral activation for smokers with depressive symptomatology: study protocol of a randomized controlled trial. BMC Psychiatry. 2017 Apr 8;17(1):134. doi: 10.1186/s12888-017-1301-7.

  PMID: 28390417 DERIVED

MeSH Terms

Conditions

Smoking; Depression

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms

Study Officials

• Elisardo Becoña

  University of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Elisardo Becoña

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 26, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 10, 2018

Record last verified: 2018-10

Locations

ES (1)