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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02844595
• Date of registration: 19/07/2016
• Prospective Registration: No
• Primary sponsor: University of Santiago de Compostela
• Public title: Behavioural Activation Treatment for Smoking Cessation and Depressive Symptomatology: a Randomized Controlled Trial
• Scientific title: Behavioural Activation Treatment for Smoking Cessation and Depressive Symptomatology: a Randomized Controlled Trial
• Date of first enrolment: January 2016
• Target sample size: 275
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02844595
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Elisardo Becoña
• Affiliation: University of Santiago de Compostela

Key inclusion & exclusion criteria

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.)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Smoking

Intervention(s)

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

Behavioral: Standard cognitive-behavioural smoking cessation treatment

Primary Outcome(s)

Point-prevalence abstinence [Time Frame: 1 year]

Change from baseline in depressive symptoms on the Beck Depression Inventory-II (BDI-II) [Time Frame: 1 year]

Change from baseline in depressive symptoms on the Hamilton Depression Rating Scale [Time Frame: 1 year]

Secondary Outcome(s)

Reduction of cigarette consumption [Time Frame: 1 year]

Continuous abstinence [Time Frame: 1 year]

Change from baseline in the Environmental Reward Observation Scale (EROS) scores [Time Frame: 1 year]

Change from baseline in the Behavioural Activation for Depression Scale (BADS) scores [Time Frame: 1 year]

Secondary ID(s)

PSI2015-66755-R (MINECO/FEDER)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors