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

This study has been completed.
Sponsor:
Collaborator:
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Anil Batra, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01129999
First received: May 24, 2010
Last updated: February 3, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 7-day point-prevalence smoking abstinence rates at 6- and 12-months follow-up [ Time Frame: 12-months follow-up ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 24, 2010
Last Updated: February 3, 2014
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on July 22, 2014