- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02844595
Behavioural Activation Treatment for Smoking Cessation and Depressive Symptomatology: a Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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A Coruña
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Santiago de Compostela, A Coruña, Spain, 15782
- Smoking Cessation and Addictive Disorders Unit, Faculty of Psychology, University of Santiago de Compostela
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 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
Exclusion Criteria:
- 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.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard cognitive-behavioural smoking cessation treatment
|
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. |
Active Comparator: Standard smoking cessation treatment and behavioral activation
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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. |
No Intervention: Control group
It will be a delayed treatment control group for a period of 3 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Point-prevalence abstinence
Time Frame: 1 year
|
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.
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1 year
|
Change from baseline in depressive symptoms on the Beck Depression Inventory-II (BDI-II)
Time Frame: 1 year
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1 year
|
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Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Continuous abstinence
Time Frame: 1 year
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According to the Russell Standard (West et al., 2005), participants will be considered abstinent if they report abstinence, have smoke not more than five cigarettes from the start of the abstinence period, and have an expired carbon monoxide reading of ≤10 parts per million
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1 year
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Reduction of cigarette consumption
Time Frame: 1 year
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Reduction of cigarette consumption by 50% or more between baseline and each follow-up will be calculated from the number of cigarettes smoked in the past 7 days at the end of treatment (week 8 since beginning treatment) and at 3 months follow-up.
At 6-, and 12-months follow-ups it will be calculated from the number of cigarettes smoked in the past 30 days.
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1 year
|
Change from baseline in the Environmental Reward Observation Scale (EROS) scores
Time Frame: 1 year
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1 year
|
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Change from baseline in the Behavioural Activation for Depression Scale (BADS) scores
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Elisardo Becoña, University of Santiago de Compostela
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PSI2015-66755-R (MINECO/FEDER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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