Cognitive-Behavioral Therapy and Hypnotherapy for Smoking Cessation

Study Overview
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Brief Summary
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Intensive cognitive-behaviour interventions (CBT) combined with pharmacotherapy for smoking cessation are well established and have been proved to be efficacious. Nevertheless, they yield only long-term abstinence rates about 35%. Considering the high interest of smokers in alternative medicine, the availability of a broad range of treatment methods, of which smokers choose an intervention according to their preferences, might contribute to improve treatment outcome. While hypnotherapy (HT) is an already widely promoted alternative method for aiding cessation, considerable methodological shortcomings of studies on this topic limit the interpretability of the results. In 2006, the German Academic Advisory Committee for Psychotherapy released new guidelines that included HT as an acceptable treatment for smoking cessation. The committee conceded, however, that conclusions concerning its efficacy are restricted due to the heterogeneity of findings. Hence, further well-designed studies are required to better test the efficacy of HT in comparison to accepted treatments. This randomised, controlled trial aims to compare the efficacy of CBT and HT for smoking cessation. Further, the influence of moderating variables will be investigated. It is hypothesized that 1) participants receiving CBT will evince higher abstinence rates than those receiving HT, 2) levels of nicotine dependence, self-efficacy and motivation to change will moderate the intervention effects and 3) participants with high levels of suggestibility will evince higher abstinence rates in the HT-intervention compared to participants with low levels of suggestibility. 220 adult healthy smokers will be randomized to receive either CBT or HT. Both programmes will be conducted in 6, weekly, 90-minute group sessions. Participants will be followed up at 1, 3, 6, 9 und 12 month post-treatment. Generalized estimating equation models will be conducted to analyse group differences on abstinence rates. The models will include the above mentioned moderator variables.

Official Title
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The Comparative Efficacy of Cognitive-Behavioral Therapy (CBT) and Hypnotherapy (HT) for Smoking Cessation.

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Cognitive-Behavioral Therapy
* Behavioral: Hypnotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years of age smoking at least 10 cigarettes per day smoking at least for the past two years fluency in German language willing and able to give written informed consent Exclusion Criteria: women: planned or current pregnancy or breast-feeding participation in a smoking cessation program within the last 6 months severe mental illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-Behavioral Therapy<br> | Behavioral: Cognitive-Behavioral Therapy<br>* a cognitive-behavioral smoking cessation program; 6, weekly-held, group sessions (90 min each)<br>|
| Experimental: Hypnotherapy<br> | Behavioral: Hypnotherapy<br>* hypnotherapeutic smoking cessation program; 6, weekly-held, group sessions (90 min each)<br>* Other names: hypnosis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-months continuous smoking abstinence according to the Russell Standard (RS; West et al. 2005) |  | 12-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point-prevalence smoking abstinence rates at 6- and 12-months follow-up |  | 12-months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, CBT, hypnotherapy