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

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypnotherapy
Motivational Interviewing
Sponsored by
Sykehuset Innlandet HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Hypnotherapy group

    Motivational interviewing group

    Arm Description

    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 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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    May 29, 2018
    Last Updated
    June 28, 2018
    Sponsor
    Sykehuset Innlandet HF
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03583788
    Brief Title
    Effect of Hypnotherapy in Alcohol Use Disorder Compared to Motivational Interviewing.
    Official Title
    Effect of Hypnotherapy in Alcohol Use Disorder Compared to Motivational Interviewing. A Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2016 (Actual)
    Primary Completion Date
    December 1, 2017 (Actual)
    Study Completion Date
    February 7, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sykehuset Innlandet HF

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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). 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypnotherapy group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Motivational interviewing group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Hypnotherapy
    Other Intervention Name(s)
    Motivational interviewing
    Intervention Description
    The intervention consisted of hypnotherapy given as five one-hour sessions over 5 weeks as individual therapy instead of motivational interviewing.
    Intervention Type
    Other
    Intervention Name(s)
    Motivational Interviewing
    Intervention Description
    The intervention consisted of Motivational Interviewing given as five one-hour sessions over 5 weeks as individual therapy instead of hypnotherapy.
    Primary Outcome Measure Information:
    Title
    Reduction of alcohol consumption
    Description
    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.
    Time Frame
    baseline + 12 months
    Secondary Outcome Measure Information:
    Title
    Level of mental distress
    Description
    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
    Time Frame
    baseline + 12 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jørgen G Bramness, Ph.D.
    Organizational Affiliation
    Hospital Innlandet/ University of Tromso
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    5963138
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    1263266
    Citation
    Hartman BJ. Hypnotherapeutic approaches to the treatment of alcoholism. J Natl Med Assoc. 1976 Mar;68(2):101-3, 147. No abstract available.
    Results Reference
    background
    PubMed Identifier
    15190730
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25563299
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9881538
    Citation
    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.
    Results Reference
    background

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

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