Smoking Clinical Trial
Official title:
Behavioural Activation Treatment for Smoking Cessation and Depressive Symptomatology: a Randomized Controlled Trial
Verified date | October 2018 |
Source | University of Santiago de Compostela |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 275 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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.) |
Country | Name | City | State |
---|---|---|---|
Spain | Smoking Cessation and Addictive Disorders Unit, Faculty of Psychology, University of Santiago de Compostela | Santiago de Compostela | A Coruña |
Lead Sponsor | Collaborator |
---|---|
University of Santiago de Compostela |
Spain,
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Change from baseline in depressive symptoms on the Beck Depression Inventory-II (BDI-II) | 1 year | ||
Primary | Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale | 1 year | ||
Secondary | Continuous abstinence | 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 | 1 year | |
Secondary | Reduction of cigarette consumption | 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. | 1 year | |
Secondary | Change from baseline in the Environmental Reward Observation Scale (EROS) scores | 1 year | ||
Secondary | Change from baseline in the Behavioural Activation for Depression Scale (BADS) scores | 1 year |
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