We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive-Behavioral Therapy and Hypnotherapy for Smoking Cessation (CBT-HT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01129999
First Posted: May 25, 2010
Last Update Posted: February 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Anil Batra, University Hospital Tuebingen
May 24, 2010
May 25, 2010
February 4, 2014
September 2010
April 2013   (Final data collection date for primary outcome measure)
12-months continuous smoking abstinence according to the Russell Standard (RS; West et al. 2005) [ Time Frame: 12-months follow-up ]
Same as current
Complete list of historical versions of study NCT01129999 on ClinicalTrials.gov Archive Site
7-day point-prevalence smoking abstinence rates at 6- and 12-months follow-up [ Time Frame: 12-months follow-up ]
Same as current
Not Provided
Not Provided
 
Cognitive-Behavioral Therapy and Hypnotherapy for Smoking Cessation
The Comparative Efficacy of Cognitive-Behavioral Therapy (CBT) and Hypnotherapy (HT) for Smoking Cessation.
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Smoking Cessation
  • Behavioral: Cognitive-Behavioral Therapy
    a cognitive-behavioral smoking cessation program; 6, weekly-held, group sessions (90 min each)
  • Behavioral: Hypnotherapy
    hypnotherapeutic smoking cessation program; 6, weekly-held, group sessions (90 min each)
    Other Name: hypnosis
  • Experimental: Cognitive-Behavioral Therapy
    Intervention: Behavioral: Cognitive-Behavioral Therapy
  • Experimental: Hypnotherapy
    Intervention: Behavioral: Hypnotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
April 2013
April 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01129999
DKH-Studie VT-HT
108368 ( Other Grant/Funding Number: Deutsche Krebshilfe e.V. )
Yes
Not Provided
Not Provided
Anil Batra, University Hospital Tuebingen
University Hospital Tuebingen
Universitätsklinikum Hamburg-Eppendorf
Study Director: Anil Batra, Prof. University Hospital Tuebingen
University Hospital Tuebingen
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP