CClinicalTrials.gg
CompletedNCT01129999CBT-HTUpdated Feb 4, 2014

Cognitive-Behavioral Therapy and Hypnotherapy for Smoking Cessation

An interventional study of Cognitive-Behavioral Therapy and Hypnotherapy in Smoking Cessation, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-04.

Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Smoking Cessation

Keywords

  • smoking cessation, CBT, hypnotherapy
03

In context

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • women: planned or current pregnancy or breast-feeding
  • participation in a smoking cessation program within the last 6 months
  • severe mental illness
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
360 participants (actual)

Study arms

  • Experimental
    Cognitive-Behavioral Therapy

    Behavioral: Cognitive-Behavioral Therapy

  • Experimental
    Hypnotherapy

    Behavioral: Hypnotherapy

Interventions

  • BehavioralCognitive-Behavioral Therapy

    a cognitive-behavioral smoking cessation program; 6, weekly-held, group sessions (90 min each)

  • BehavioralHypnotherapy

    hypnotherapeutic smoking cessation program; 6, weekly-held, group sessions (90 min each)

    Also known as: hypnosis

06

What researchers measure

Primary outcomes

  1. 12-months continuous smoking abstinence according to the Russell Standard (RS; West et al. 2005)

    Time frame: 12-months follow-up

Secondary outcomes

  1. 7-day point-prevalence smoking abstinence rates at 6- and 12-months follow-up

    Time frame: 12-months follow-up

07

Study locations

1 site
  • University Hospital of Tuebingen Smoking Cessation Research Group
    Tuebingen, 72070, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01129999
Lead sponsor
University Hospital Tuebingen
Collaborators
Universitätsklinikum Hamburg-Eppendorf
Responsible party
Anil Batra (Prof. Dr., University Hospital Tuebingen) — Principal investigator
First posted
May 25, 2010
Start date
Sep 2010
Primary completion
Apr 2013
Completion
Apr 2013
Last update
Feb 4, 2014

Study contacts

Anil Batra, Prof.
study director · University Hospital Tuebingen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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