Smokers
Conditions
Keywords
behavior cognitive therapy, Smokers, randomized clinical trial
Brief summary
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.
Interventions
BEHAVIORALCognitive behavioral therapy in group
Sponsors
Ministry of Health, Brazil
Hospital do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Smokers (≥ 5 cigarettes/day during the previous year) who had not had a period of abstinence greater than 3 months before randomization * Age ≥ 18 years \< 75 years; * Capable of reading and understanding Portuguese; * Willing to quit smoking.
Exclusion criteria
* Dementia; * Alcoholism; * Regular use of illicit drugs; * Panic disorders; * Psychosis; * Current pregnancy; * History of bipolar disturbance; * Contraindication to nicotine patches; * Prior use of bupropion and/or varenicline in the previous 12 months before randomization; * Patients who refused to provide informed consent;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Smoking cessation | 52 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of anxiety | 6 weeks | Evaluated by the State-Trait Anxiety Inventory |
| Levels of depression | 6 weeks | Evaluated by Beck Depression Inventory |
| Smoking Relapse rates | 52 weeks | — |
Countries
Brazil
Outcome results
None listed