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

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



Sponsors


Source

Sykehuset Innlandet HF

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Completed

Start Date

2016-02-01

Completion Date

2018-02-07

Primary Completion Date

2017-12-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Reduction of alcohol consumption
baseline + 12 months

Secondary Outcome

Measure

Time Frame

Level of mental distress
baseline + 12 months

Enrollment

31

Condition


Intervention

Intervention Type

Behavioral

Intervention Name


Description

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

Arm Group Label

Hypnotherapy group

Other Name

Motivational interviewing


Intervention Type

Other

Intervention Name


Description

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

Arm Group Label

Motivational interviewing group



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.

Gender

All

Minimum Age

N/A

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Jørgen G Bramness, Ph.D.
Study Director
Hospital Innlandet/ University of Tromso

Verification Date

2018-06-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Hypnotherapy group

Arm Group Type

Experimental

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 Group Label

Motivational interviewing group

Arm Group Type

Active Comparator

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.



Firstreceived Results Date

N/A

Reference

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.

PMID

5963138


Citation

Hartman BJ. Hypnotherapeutic approaches to the treatment of alcoholism. J Natl Med Assoc. 1976 Mar;68(2):101-3, 147.

PMID

1263266


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.

PMID

15190730


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. Review.

PMID

25563299


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. Review.

PMID

9881538



Patient Data

Sharing Ipd

Undecided


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Intervention 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).

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

May 29, 2018

Study First Submitted Qc

June 28, 2018

Study First Posted

July 11, 2018

Last Update Submitted

June 28, 2018

Last Update Submitted Qc

June 28, 2018

Last Update Posted

July 11, 2018


ClinicalTrials.gov processed this data on August 22, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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