Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation
Background: Pharmacological strategies to improve smoking cessation have been largely studied. The efficacy of cognitive behavior therapy associated to nicotine replacement in tobacco cessation has not yet been demonstrated.
Objective: Evaluate if cognitive behavior therapy during six weeks associated to nicotine replacement for twelve weeks is able to contribute to tobacco cessation at the end of 52 weeks.
Methods: Multicentre, open-label, and pragmatic randomized controlled trial will include 334 patients. Analysis will follow intention-to-treat principle.
Patients older than 18 years old and who had smoked at least 5 cigarettes in the past year before randomization will be included.
All of them will receive nicotine replacement therapy with patches and gum. They will be randomized 1:1 ratio to attend or not cognitive behavior therapy once a week for the first six weeks of the treatment. Every two weeks all of the patients will be evaluated by a physician in order to access any adverse effects from the nicotine replacement.
All patients will have carbon monoxide levels accessed at baseline and after 6 weeks. Telephonic interview will be done at 16, 28, and 52 weeks to access the rates of tobacco cessation, relapses episodes and abstinence maintenance.
Behavioral: Cognitive behavioral therapy in group
Drug: Nicotine replacement
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy of Cognitive Behaviour Therapy Associated to Nicotine Replacement in Tobacco Cessation: a Randomised Open Label Clinical Trial|
- Smoking cessation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Levels of anxiety [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Evaluated by the State-Trait Anxiety Inventory
- Levels of depression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Evaluated by Beck Depression Inventory
- Smoking Relapse rates [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Study Completion Date:||November 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Cognitive behavior therapy
Cognitive behavior therapy for 6 weeks associated to nicotine replacement for 12 weeks
|Behavioral: Cognitive behavioral therapy in group Drug: Nicotine replacement|
Nicotine replacement for 12 weeks
|Drug: Nicotine replacement|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734330
|Instituto de Medicina Integral Professor Fernando Figueira - IMIP|
|Recife, Pernanbuco, Brazil, 50070-550|
|Hospital do Coração|
|São Paulo, SP, Brazil, 04005000|
|Study Chair:||Silvia Ismael||Hospital do Coração|