- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03583788
Effect of Hypnotherapy in Alcohol Use Disorder Compared to Motivational Interviewing.
Effect of Hypnotherapy in Alcohol Use Disorder Compared to Motivational Interviewing. A Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was designed as a parallel study, where two groups were compared: one receiving treatment as usual (motivational interviewing) and the intervention (hypnotherapy group). With difference in treatment effect as great as 40% we would have needed 46 participants to achieve p=0.05. We had initially planned to recruit as many as 50 individuals, but many were sceptical to the novel treatment. Four persons withdrew from the hypnotherapy group either before or after first treatment because of uncertainty. This did not affect randomization and they are not represented in the results.
Participants in the study were recruited from patients admitted to a six week long inpatient treatment programme at Vangseter Clinic in Norway in 2016. Only individuals who suffered from AUD were included in this study. The treatment programme consisted of the following elements: 5 hours of group therapy 5 days a week, a 2-3 day long family visit, where a family therapy session was also included, some obligatory group activities, like trips to museums or walks in nature, and lastly, informal activities, such as barbecues, watching movies together or discussions in the hall. All this was thought to contribute to the therapy of the patients. From the second week of the program the patients were expected to have one hour of additional individual therapy a week. It was conducted as motivational interviewing (MI), totaling five hours. MI is one of the most popular and effective modern treatments. As a brief intervention, MI appears to be at least as effective as, and possibly more effective than, other treatment methods. As an alternative to the MI sessions the patients enrolled in the study could receive five individual hour-long sessions of hypnotherapy.
Patients were informed about the study, were given time to consider, and if they volunteered to participate then signed a consent form. Thirty-one individuals, who took part in this randomized controlled trial (RCT), were assigned at random to receive either hypnotherapy (N=16) or to be in the control group (N=15).
At the beginning of the second week of treatment (baseline) all the participants were administered Mini International Neuro-psychiatric Interview (MINI) psychiatric interview to be able to diagnose mental problems other than AUD. Exclusion criteria were having psychotic episodes, a recent severe other psychiatric diagnosis or recent drug abuse other than alcohol.
In addition, all patients filled in the Alcohol Use Identification Test (AUDIT) and a Time-line-follow-back (TLFB) for registration of number of standardized alcohol units consumed and alcohol-related problems during the previous month. They also filled in the Hopkins Symptoms Check List (HSCL-25) to measure their level of mental distress. Mental distress was given as a global average of the HSCL-25 denoted Global Severity Index (GSI). The Traumatic Life Events Questionnaire was used to register traumatic life experiences. AUDIT, TLFB and HSCL-25 were re-administered one year later as a follow-up.
The intervention consisted of hypnotherapy given as five one-hour sessions over 5 weeks as individual therapy instead of motivational interviewing. The treatment method was Erickson's (permissive) hypnosis. Each treatment session began with a conversation about the patient's past life events, present situation, alcohol problem and his or her thoughts about it. To be able to use visualisation, patients were always asked when and where they bought alcohol, and how it was consumed. During the first part of the treatment session the theme of the hypnotic intervention was formulated, and then hypnotic trance was induced. The induction method was mostly a combination of relaxation and breathing exercises with mental pictures of a peaceful place. Once the trance was induced, the patient was asked to visualize mastery of a selected situation. This situation was tailored according to the patient's needs. It could include, for example, abstaining from alcohol at a party, passing an alcohol shop without going inside, or mastering another problematic issue, such as staying relaxed and calm in the presence of other people. When indicated, the events of the past were a subject of hypnotic intervention as well.
Data were analysed using Statistical Package for the Social Sciences (SPSS; IBM statistics) version 25, using simple bivariate analysis (Student's T-test or chi-square test), comparing the intervention group and the control group. Level of significance was set to p < 0.05, but even higher values were considered as the risk of type II statistical errors would be substantial in the small randomized controlled trial.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Only individuals who suffered from AUD were included in this study.
Exclusion Criteria:
- Exclusion criteria were having psychotic episodes, a recent severe other psychiatric diagnosis or recent drug abuse other than alcohol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hypnotherapy group
The intervention consisted of individual hypnotherapy of 5 hourly sessions (60 minutes) over 5 weeks, a total of five hours.
The hypnotherapy treatment method was Erickson's (permissive) hypnosis (17).
It began with a conversation about patient's past life events, present situation, alcohol problem and his or her thoughts about it.
The hypnotherapy Group did not receive any treatment of motivational interviewing.
|
The intervention consisted of hypnotherapy given as five one-hour sessions over 5 weeks as individual therapy instead of motivational interviewing.
Other Names:
|
|
Active Comparator: Motivational interviewing group
The comparator patient group received individual therapy as motivational interviewing (MI) for 5 hourly sessions over 5 weeks, a total of five hours.
The patients in the experimental group did not receive this.
|
The intervention consisted of Motivational Interviewing given as five one-hour sessions over 5 weeks as individual therapy instead of hypnotherapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction of alcohol consumption
Time Frame: baseline + 12 months
|
Alcohol consumption was measured at the entry to the study and at follow-up one year later using Alcohol Use Identification Test (AUDIT) registration of number of standardized alcohol units consumed and alcohol-related problems during the previous month.
|
baseline + 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of mental distress
Time Frame: baseline + 12 months
|
Mental distress was given as a global average of the HSCL-25 denoted Global Severity Index (GSI).
HSCL-25 was administered at the entry to the study and at follow-up one year later
|
baseline + 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jørgen G Bramness, Ph.D., Hospital Innlandet/ University of Tromso
Publications and helpful links
General Publications
- Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
- Edwards G. Hypnosis in treatment of alcohol addiction. Controlled trial, with analysis of factors affecting outcome. Q J Stud Alcohol. 1966 Jun;27(2):221-41. No abstract available.
- Hartman BJ. Hypnotherapeutic approaches to the treatment of alcoholism. J Natl Med Assoc. 1976 Mar;68(2):101-3, 147. No abstract available.
- Pekala RJ, Maurer R, Kumar VK, Elliott NC, Masten E, Moon E, Salinger M. Self-hypnosis relapse prevention training with chronic drug/alcohol users: effects on self-esteem, affect, and relapse. Am J Clin Hypn. 2004 Apr;46(4):281-97. doi: 10.1080/00029157.2004.10403613.
- Kohler S, Hofmann A. Can motivational interviewing in emergency care reduce alcohol consumption in young people? A systematic review and meta-analysis. Alcohol Alcohol. 2015 Mar;50(2):107-17. doi: 10.1093/alcalc/agu098. Epub 2015 Jan 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HypnotherapyAUD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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