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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
  Purpose
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.

Condition Intervention
Smoking Cessation Behavioral: Cognitive-Behavioral Therapy Behavioral: Hypnotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparative Efficacy of Cognitive-Behavioral Therapy (CBT) and Hypnotherapy (HT) for Smoking Cessation.

Resource links provided by NLM:


Further study details as provided by Anil Batra, University Hospital Tuebingen:

Primary Outcome Measures:
  • 12-months continuous smoking abstinence according to the Russell Standard (RS; West et al. 2005) [ Time Frame: 12-months follow-up ]

Secondary Outcome Measures:
  • 7-day point-prevalence smoking abstinence rates at 6- and 12-months follow-up [ Time Frame: 12-months follow-up ]

Enrollment: 360
Study Start Date: September 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive-Behavioral Therapy Behavioral: Cognitive-Behavioral Therapy
a cognitive-behavioral smoking cessation program; 6, weekly-held, group sessions (90 min each)
Experimental: Hypnotherapy Behavioral: Hypnotherapy
hypnotherapeutic smoking cessation program; 6, weekly-held, group sessions (90 min each)
Other Name: hypnosis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129999


Locations
Germany
University Hospital of Tuebingen Smoking Cessation Research Group
Tuebingen, Germany, 72070
Sponsors and Collaborators
University Hospital Tuebingen
Universitätsklinikum Hamburg-Eppendorf
Investigators
Study Director: Anil Batra, Prof. University Hospital Tuebingen
  More Information

Responsible Party: Anil Batra, Prof. Dr., University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01129999     History of Changes
Other Study ID Numbers: DKH-Studie VT-HT
108368 ( Other Grant/Funding Number: Deutsche Krebshilfe e.V. )
First Submitted: May 24, 2010
First Posted: May 25, 2010
Last Update Posted: February 4, 2014
Last Verified: February 2014

Keywords provided by Anil Batra, University Hospital Tuebingen:
smoking cessation, CBT, hypnotherapy