Condition category
Mental and Behavioural Disorders
Date applied
15/08/2011
Date assigned
26/08/2011
Last edited
04/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Schaub

ORCID ID

Contact details

Konradstrasse 32
Zurich
8031
Switzerland
michael.schaub@isgf.uzh.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10.005768

Study information

Scientific title

Smoking cessation through group hypnosis: a randomised controlled trial

Acronym

Study hypothesis

A 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

Cantonal Ethical Committee of Zurich, 25/08/2010

Study design

Single-centre randomised controlled double-blind study with repeated measurements

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient 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]

Condition

Public health, smoking, hypnosis, smoking cessation

Intervention

Two 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. 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 measures

1. 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 trial start date

20/04/2011

Overall trial end date

01/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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®)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

172

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

20/04/2011

Recruitment end date

01/06/2012

Locations

Countries of recruitment

Switzerland

Trial participating centre

Konradstrasse 32
Zurich
8031
Switzerland

Sponsor information

Organisation

Tobacco Control Fund (Switzerland)

Sponsor details

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

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Tobacco Control Fund (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24365274

Publication citations

  1. Results

    Dickson-Spillmann M, Haug S, Schaub MP, Group hypnosis vs. relaxation for smoking cessation in adults: a cluster-randomised controlled trial., BMC Public Health, 2013, 13, 1227, doi: 10.1186/1471-2458-13-1227.

Additional files

Editorial Notes