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Alcohol Use DisorderNCT03583788

Effect of Hypnotherapy in Alcohol Use Disorder Compared to Motivational Interviewing.

A study testing Hypnotherapy and Motivational Interviewing in people with Alcohol Use Disorder, run by Sykehuset Innlandet HF.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was carried out at an inpatient clinic in Norway. A six- week long treatment programme included intensive group therapy, but also five hours of individual therapy, given as motivational interviewing (MI). Read more about this study

Who is it for?
Any age
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Hypnotherapy and Motivational Interviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
No sites listed yet
Study dates
1 Feb 2016to 7 Feb 2018
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Only individuals who suffered from AUD were included in this study.

Who cannot join

  • Exclusion criteria were having psychotic episodes, a recent severe other psychiatric diagnosis or recent drug abuse other than alcohol.

About this study

Official title: Effect of Hypnotherapy in Alcohol Use Disorder Compared to Motivational Interviewing. A Randomised Controlled Trial

This study was carried out at an inpatient clinic in Norway. A six- week long treatment programme included intensive group therapy, but also five hours of individual therapy, given as motivational interviewing (MI). Thirty-one patients were randomized either to receive five individual sessions of hypnotherapy instead of MI (N=16) or to be in the control group (N=15). The treatment method for the hypnotherapy group was Erickson's (permissive) hypnosis. At baseline all the participants were diagnosed using a psychiatric interview and filled in the Alcohol Use Identification Test (AUDIT), Time-line-follow-back (TLFB) for alcohol use, Hopkins Symptoms Check List (HSCL-25) for monitoring mental distress and Traumatic Life Events Questionnaire. AUDIT, TLFB and HSCL-25 were re-administered at follow-up after one year.

Read the 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.

Being tested
Hypnotherapy, Motivational Interviewing
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HypnotherapyBehavioural

    Also called Motivational interviewing

    The intervention consisted of hypnotherapy given as five one-hour sessions over 5 weeks as individual therapy instead of motivational interviewing.

  • Motivational InterviewingOther

    The intervention consisted of Motivational Interviewing given as five one-hour sessions over 5 weeks as individual therapy instead of hypnotherapy.

Study groups in NCT03583788
Study groupRoleWhat they receive
Hypnotherapy groupExperimentalThe 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.
Receives: Behavioral: Hypnotherapy
Motivational interviewing groupActive comparatorThe 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.
Receives: Other: Motivational Interviewing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of alcohol consumption

    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.

    Measured: baseline + 12 months

Secondary outcomes (1)
  1. Level of mental distress

    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

    Measured: baseline + 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2018
  2. Study start1 Feb 2016
  3. Primary completion1 Dec 2017
  4. Study completion7 Feb 2018

Resources

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
Model 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).
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03583788
Sponsor's protocol ID
HypnotherapyAUD
Status last verified
Jun 2018
First submitted
29 May 2018
Last updated
11 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 5963138
  • Hartman BJ. Hypnotherapeutic approaches to the treatment of alcoholism. J Natl Med Assoc. 1976 Mar;68(2):101-3, 147. No abstract available.

    PubMed 1263266
  • 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.

    PubMed 15190730
  • 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.

    PubMed 25563299
  • 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.

    PubMed 9881538

Questions about this trial

What is this clinical trial studying?

A study testing Hypnotherapy and Motivational Interviewing in people with Alcohol Use Disorder, run by Sykehuset Innlandet HF.

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 1 inclusion and 1 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 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Reduction of alcohol consumption (time frame: baseline + 12 months). 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 NCT03583788, which also lists 5 linked publications.

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 11 Jul 2018.

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