The efficacy of group hypnosis and relaxation in smoking cessation

ISRCTN ISRCTN72839675
DOI https://doi.org/10.1186/ISRCTN72839675
Secondary identifying numbers 10.005768
Submission date
15/08/2011
Registration date
26/08/2011
Last edited
04/09/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Scientists believe that hypnosis may help people stop smoking, but studies show unclear results. At the same time, people who want to give up smoking are not always able and willing to attend several sessions of therapy or to use medication. Therefore, we are investigating whether a single hypnosis session helps smokers quit smoking.

Who can participate?
You are invited to participate in the study if you are older than 18 years, if you smoke at least five cigarettes per day, if you want to quit and if you are not trying to give up smoking in any other way.

What does the study involve?
You will attend a 40-minutes session of motivational training then you will be randomly allocated to attend a 40-minute group session of either hypnosis or relaxation. You will attend the session together with 10-15 other people. A trained hypnotherapist and relaxation instructor will lead the session.

What are the possible benefits and risks of participating?
There are no risks for you because hypnosis has hardly any side effects in healthy people. The results will provide information to tobacco prevention organisations in Switzerland on whether or not to recommend hypnosis as a method to stop smoking.

Where is the study run from?
Institut für Sucht- und Gesundheitsforschung (ISGF) (Switzerland).

When is the study starting and how long is it expected to run for?
The study ran from April 2011 to June 2012.

Who is funding the study?
Tobacco Control Fund (Switzerland).

Who is the main contact?
Dr Michael Schaub
michael.schaub@isgf.uzh.ch

Contact information

Dr Michael Schaub
Scientific

Konradstrasse 32
Zurich
8031
Switzerland

Email michael.schaub@isgf.uzh.ch

Study information

Study designSingle-centre randomised controlled double-blind study with repeated measurements
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Patient information can be found at http://www.isgf.ch/index.php?id=94&no_cache=1&tx_ttnews[tt_news]=27&tx_ttnews[backPid]=9&cHash=859b89b6fa6ac5bd25fa181c4e58ae97%20 [German]
Scientific titleSmoking cessation through group hypnosis: a randomised controlled trial
Study objectivesA one-time session consisting of mental preparation followed by hypnosis or relaxation in a group setting helps smokers quit smoking. We hypothesise that 6 months following the intervention, at least 30% of participants in the hypnosis group and at least 18% of participants in the relaxation group will be abstinent.
Ethics approval(s)Cantonal Ethical Committee of Zurich, 25/08/2010
Health condition(s) or problem(s) studiedPublic health, smoking, hypnosis, smoking cessation
InterventionTwo groups to be compared:
1. Participants receive 40 minutes of motivational training followed by 40 minutes of hypnosis in a group session (8 to 15 participants)
2. Participants receive 40 minutes of motivational training followed by 40 minutes of relaxation in a group session (8 to 15 participants)

Motivational training: the intention of the participants to quit smoking is reinforced in an oral presentation given by a trained instructor. The presentation focuses on participants’ life after smoking cessation.

Group hypnosis: deep relaxation is induced through repetitive statements and soft background music. During the hypnosis, suggestions reinforcing cigarette abstinence are made by a trained instructor.

Group relaxation: relaxation is induced through soft music. During the relaxation, suggestions reinforcing cigarette abstinence are made by a trained instructor.

All participants are contacted 2 weeks and 6 months following the intervention in order to check their smoking status, mental and physical health.
Intervention typeOther
Primary outcome measure1. Number of participants smoking 2 weeks after each intervention (smoking defined as 5 or more cigarettes per day) (inter-subject design)
2. Number of participants smoking 6 months after each intervention (inter-subject design)
3. Changes in the number of daily cigarettes smoked from baseline to 2 weeks after the intervention (intra-subject design)
4. Changes in the number of daily cigarettes smoked from baseline to 6 months after the intervention (intra-subject design)
5. Changes in salivary cotinine levels from baseline to 6 months after the intervention (intra-subject design)
Secondary outcome measures1. Depression (BDI-V, Schmitt et al. 2003; 2006) at baseline, 2 weeks and 6 months after the intervention
2. Anxiety (BAI, Beck et al. 1988, German version by Margraf & Ehlers) at baseline, 2 weeks and 6 months after the intervention
3. Expected self-efficacy in situations of high smoking temptation (Tönjes et al., 2007) at baseline and 2 weeks after the intervention
4. Adverse events (headache, insomnia, gastrointestinal problems etc.) 2 weeks and 6 months after the intervention
Overall study start date20/04/2011
Completion date01/06/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants172
Key inclusion criteria1. Aged between 18 and 65 years
2. Smoking five or more cigarettes per day
3. Not taking any medication or following another program for smoking cessation
4. Willing to stop smoking
5. Not suffering from alcohol dependence or psychotic disorders
6. No intake of stimulating medication such as methylphenidate (Ritalin) or venlafaxine (Effexor®)
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment20/04/2011
Date of final enrolment01/06/2012

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Konradstrasse 32
Zurich
8031
Switzerland

Sponsor information

Tobacco Control Fund (Switzerland)
Government

c/o Mr Peter Blatter
Hessstrasse 27E
Bern
3003
Switzerland

ROR logo "ROR" https://ror.org/01qtc5416

Funders

Funder type

Government

Tobacco Control Fund (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 23/12/2013 Yes No