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

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: Smoking Cessation
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Therapy; Behavioral: Hypnotherapy

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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	12-months follow-up

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Study Director: Anil Batra, Prof., University Hospital Tuebingen

Study record dates

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: smoking cessation, CBT, hypnotherapy
• Other Study ID Numbers: DKH-Studie VT-HT; 108368 (Other Grant/Funding Number: Deutsche Krebshilfe e.V.)