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

February 3, 2014 updated by: Anil Batra, University Hospital Tuebingen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72070
        • University Hospital of Tuebingen Smoking Cessation Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • hypnosis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Study Director: Anil Batra, Prof., University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

May 24, 2010

First Posted (Estimate)

May 25, 2010

Study Record Updates

Last Update Posted (Estimate)

February 4, 2014

Last Update Submitted That Met QC Criteria

February 3, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DKH-Studie VT-HT
  • 108368 (Other Grant/Funding Number: Deutsche Krebshilfe e.V.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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