Cognitive-Behavioral Therapy and Hypnotherapy for Smoking Cessation

Smoking Cessation Clinical Trial

— CBT-HT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129999
• Other study ID #: DKH-Studie VT-HT
• Secondary ID: 108368
• Status: Completed
• Phase: N/A
• First received: May 24, 2010
• Last updated: February 3, 2014
• Start date: September 2010
• Est. completion date: April 2013

Study information

• Verified date: February 2014
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Cognitive-Behavioral Therapy
a cognitive-behavioral smoking cessation program; 6, weekly-held, group sessions (90 min each)
• Hypnotherapy
hypnotherapeutic smoking cessation program; 6, weekly-held, group sessions (90 min each)

Locations

Country	Name	City	State
Germany	University Hospital of Tuebingen Smoking Cessation Research Group	Tuebingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-months continuous smoking abstinence according to the Russell Standard (RS; West et al. 2005)		12-months follow-up	No
Secondary	7-day point-prevalence smoking abstinence rates at 6- and 12-months follow-up		12-months follow-up	No