Group hypnotherapy versus group relaxation for smoking cessation: an RCT study protocol

Abstract

BackgroundA significant number of smokers would like to stop smoking. Despite the demonstrated efficacy of pharmacological smoking cessation treatments, many smokers are unwilling to use them; however, they are inclined to try alternative methods. Hypnosis has a long-standing reputation in smoking cessation therapy, but its efficacy has not been scientifically proven. We designed this randomised controlled trial to evaluate the effects of group hypnosis as a method for smoking cessation, and we will compare the results of group hypnosis with group relaxation.Methods/DesignThis is a randomised controlled trial (RCT) to compare the efficacy of a single session of hypnosis with that of relaxation performed in groups of 8-15 smokers. We intend to include at least 220 participants in our trial. The inclusion criteria include smoking at least 5 cigarettes per day, not using other cessation methods and being willing to quit smoking. The intervention is performed by a trained hypnotist/relaxation therapist. Both groups first receive 40 min of mental preparation that is based on motivational interviewing. Then, a state of deep relaxation is induced in the hypnosis condition, and superficial relaxation is induced in the control condition. Suggestions are made in the hypnosis condition that aim to switch the mental self-image of the participants from that of smokers to that of non-smokers. Each intervention lasts for 40 min. The participants also complete questionnaires that assess their smoking status and symptoms of depression and anxiety at baseline, 2 weeks and 6 months post-intervention. In addition, saliva samples are collected to assess cotinine levels at baseline and at 6 months post-intervention. We also assess nicotine withdrawal symptoms at 2 weeks post-intervention.DiscussionTo the best of our knowledge, this RCT is the first to test the efficacy of group hypnosis versus group relaxation. Issues requiring discussion in the outcome paper include the lack of standardisation of hypnotic interventions in smoking cessation, the debriefing of the participants, the effects of group dynamics and the reasons for dropouts.Trial registrationCurrent Controlled Trials, ISRCTN72839675.

Group hypnosis vs. relaxation for smoking cessation in adults: a cluster-randomised controlled trial

“…The protocol for this study has been previously published [ 34 ]. Regarding the trial design, a divergence between the protocol and the present article should be noted.…”

“…The cluster-randomized design of this trial required a recalculation of the sample size compared to the study protocol [ 34 ]. We recalculated sample size on the basis of group hypnosis studies that did not use nicotine replacement therapy.…”

“…Secondary outcomes were analysed using linear and ordinal regression analysis. We did not use generalised estimating equations (GEE) as originally intended [ 34 ] since this procedure was less suitable to the present outcomes than logistic regression analysis. STATA 12 SE (College Station, Texas, USA) was used for the regression analyses.…”

Effectiveness of Text Messaging for the Management of Psychological and Somatic Distress in Depressed and Anxious Outpatients

“…Some relaxation based cognitive behavioral approaches have also some efficacy across a range of clinical conditions, including anxiety [17] and depression [18,19]. CBT for depression and anxiety can easily be applied in group settings, which may prove more cost-effective [19,20].…”