Smoking CessationCBT-HTNCT01129999
Cognitive-Behavioral Therapy and Hypnotherapy for Smoking Cessation
A study testing Cognitive-Behavioral Therapy and Hypnotherapy in people with Smoking Cessation, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Cognitive-Behavioral Therapy and Hypnotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- women: planned or current pregnancy or breast-feeding
- participation in a smoking cessation program within the last 6 months
- severe mental illness
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Tuebingen Smoking Cessation Research Group
Tübingen, 72070
About this study
Official title: 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.
- Conditions
- Smoking Cessation
- Being tested
- Cognitive-Behavioral Therapy, Hypnotherapy
- Keywords
- smoking cessation, CBT, hypnotherapy
- Medical subject headings
- Smoking Cessation, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral TherapyBehavioural
a cognitive-behavioral smoking cessation program; 6, weekly-held, group sessions (90 min each)
HypnotherapyBehavioural
Also called hypnosis
hypnotherapeutic smoking cessation program; 6, weekly-held, group sessions (90 min each)
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | Not described Receives: Behavioral: Cognitive-Behavioral Therapy |
| Hypnotherapy | Experimental | Not described Receives: Behavioral: Hypnotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-months continuous smoking abstinence according to the Russell Standard (RS; West et al. 2005)
Measured: 12-months follow-up
Secondary outcomes (1)
7-day point-prevalence smoking abstinence rates at 6- and 12-months follow-up
Measured: 12-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Principal investigator, Anil Batra, University Hospital Tuebingen
- Investigators
- Anil Batra, Prof., Study director, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129999
- Sponsor's protocol ID
- DKH-Studie VT-HT
- Other IDs
- 108368
- Acronym
- CBT-HT
- Status last verified
- Feb 2014
- First submitted
- 24 May 2010
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Batra A, Eck S, Riegel B, Friedrich S, Fuhr K, Torchalla I, Tonnies S. Hypnotherapy compared to cognitive-behavioral therapy for smoking cessation in a randomized controlled trial. Front Psychol. 2024 Feb 27;15:1330362. doi: 10.3389/fpsyg.2024.1330362. eCollection 2024.
PubMed 38476396
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Efficacy of Cognitive-Behavioral Therapy (CBT) and Hypnotherapy (HT) for Smoking Cessation.
- ClinicalTrials.gov ID
- NCT01129999
- Acronym / sponsor ID
- CBT-HT / DKH-Studie VT-HT
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, CBT, hypnotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Study start
- Sep 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 25 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | Behavioral: Cognitive-Behavioral Therapy |
| Hypnotherapy | Experimental | Behavioral: Hypnotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- women: planned or current pregnancy or breast-feeding
- participation in a smoking cessation program within the last 6 months
- severe mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioral Therapya cognitive-behavioral smoking cessation program; 6, weekly-held, group sessions (90 min each) | Behavioural | Cognitive-Behavioral Therapy |
| HypnotherapyAlso: hypnosishypnotherapeutic smoking cessation program; 6, weekly-held, group sessions (90 min each) | Behavioural | Hypnotherapy |
Primary outcome
12-months continuous smoking abstinence according to the Russell Standard (RS; West et al. 2005)
Time frame: 12-months follow-up
1 secondary outcome
7-day point-prevalence smoking abstinence rates at 6- and 12-months follow-up
Time frame: 12-months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
- Derived from this study: PubMed 38476396Batra A, Eck S, Riegel B, Friedrich S, Fuhr K, Torchalla I, Tonnies S. Hypnotherapy compared to cognitive-behavioral therapy for smoking cessation in a randomized controlled trial. Front Psychol. 2024 Feb 27;15:1330362. doi: 10.3389/fpsyg.2024.1330362. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil Batra, Prof. study director
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy and Hypnotherapy in people with Smoking Cessation, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-months continuous smoking abstinence according to the Russell Standard (RS; West et al. 2005) (time frame: 12-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01129999, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014; AzTrials last refreshed its copy on 31 Oct 2026.