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Group Hypnosis for Irritable Bowel Syndrome (IBS)

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gut-focused hypnotherapy in group sessions
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS, RCT, psychology, hypnosis, psychotherapy, group therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with IBS, fulfilling Rome III criteria, and aged between 18 and 70, The time for patients to reach the hospital should not to be longer than one hour

Exclusion Criteria:

pregnancy, bowel surgery, mental retardation, insufficient knowledge of German, a concomitant severe organic and/or psychiatric disease, recently indicated treatment with anti-depressants.-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Standard Medical Therapy (SMT)

    Gut focused hypnotherapy

    Arm Description

    standard medical treatment (care as usual) with supportive talks

    weekly sessions of gut focused hypnotherapy in groups (10 sessions within 12 weeks)

    Outcomes

    Primary Outcome Measures

    Irritable Bowel Syndrome - Impact Scale, IBS-IS
    the IBS-Impact-Scale (IBS-IS). The IBS-IS is a disease-specific documentation of the impact of IBS on patients' lives and was developed and validated for use in clinical trials

    Secondary Outcome Measures

    Short-Form 36 (SF-36)
    conveys eight dimensions of Quality of life (QOL): limitations in physical functioning, role limitation due to physical health problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional limitations and mental health (higher scores indicating higher QOL). Validity and reliability have been proven extensively for diverse patient groups

    Full Information

    First Posted
    August 9, 2010
    Last Updated
    December 11, 2011
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01178593
    Brief Title
    Group Hypnosis for Irritable Bowel Syndrome
    Acronym
    IBS
    Official Title
    GUT-FOCUSED GROUP HYPNOSIS FOR TREATMENT OF IRRITABLE BOWEL SYNDROME - A RANDOMISED CONTROLLED TRIAL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2008 (undefined)
    Primary Completion Date
    September 2010 (Actual)
    Study Completion Date
    July 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Vienna

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This randomised controlled trial (RCT) aimed at assessing the efficacy of hypnotherapy in group sessions (GHT) with a 12-months follow-up.
    Detailed Description
    Method:Patients with IBS, fulfilling Rome III criteria, and aged between 18 and 70, were recruited from the University Hospital of Vienna, from primary care physicians and the Austrian IBS patients' organisation by an information letter with an invitation to participate in this RCT. Patients were invited for an interview at the University hospital to confirm the IBS diagnosis according to the guidelines. Exclusion criteria were: pregnancy, bowel surgery, mental retardation, insufficient knowledge of German, a concomitant severe organic and/or psychiatric disease, and recently indicated treatment with anti-depressants. Anti-depressants at a stable dose for longer than three months were allowed for admission to the study. The time for patients to reach the hospital was not to be longer than one hour. Patients with lactose and fructose intolerance as diagnosed by breath tests were not excluded if they had had an adequate diet over a period of more than three weeks without any change of their IBS symptoms. Randomisation and therapy If 12 patients fulfilled all inclusion criteria they were randomly assigned to one of the two study arms at a 1:1 ratio. Randomisation was done by using permutated blocks of four in order to provide a balanced allocation. The investigator who generated the randomisation schedule was independent of the rest of the trial (blinded). Randomisation was either to supportive talks and symptomatic (standard) medical treatment (SMT, IBS-symptom-related) according to the guidelines (15-17) or to GHT with SMT. The GHT protocol used was the Manchester protocol of gut-directed hypnotherapy ( ) and consisted of 10 weekly sessions (45 minutes) with six patients per group over a treatment period of 12 weeks. GHT was performed at the University Hospital by two experienced physicians, trained in Manchester (UK). At the first session patients were informed about effects of hypnosis and at the third session subjects were given a compact disc (created by hypnotherapists) for practicing at home on a daily basis (practicing was documented). After an induction of hypnosis by closing the eyes a combination of standard deepening procedures followed. Then suggestions for ego-strengthening, power of self-control and gut-specific relaxation were made with hands on abdomen and visualization of slow, rhythmic waves (water, sea, or river) in pleasant, relaxing situations. The final phase involved imagery to increase one's sense of control and self-efficacy over IBS symptoms. GHT patients received also SMT. For control patients the same frequency and duration (45 minutes, SMT) of doctor's visits were offered at the University Hospital provided by a physician with additional qualification in psychosomatic medicine. No kind of relaxation techniques was allowed for control patients during the study. Psychotherapies and (changes of) symptomatic medication were allowed for all patients if indicated. If anti-depressants were taken at a stable dose at baseline, no dose reduction or increase was allowed until the six-month follow-up. All data were collected by study coordinators not involved in the treatment. Data were entered into SPSS 17.0 and analysed by an independent person with no information about patients' randomisation (blinded).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome
    Keywords
    IBS, RCT, psychology, hypnosis, psychotherapy, group therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Medical Therapy (SMT)
    Arm Type
    No Intervention
    Arm Description
    standard medical treatment (care as usual) with supportive talks
    Arm Title
    Gut focused hypnotherapy
    Arm Type
    Active Comparator
    Arm Description
    weekly sessions of gut focused hypnotherapy in groups (10 sessions within 12 weeks)
    Intervention Type
    Other
    Intervention Name(s)
    Gut-focused hypnotherapy in group sessions
    Other Intervention Name(s)
    hypnosis, gut directed hypnosis, gut directed hypnotherapy, gut focused hypnosis
    Intervention Description
    weekly session (45 min) of gut focused hypnotherapy (10 sessions within 12 weeks)
    Primary Outcome Measure Information:
    Title
    Irritable Bowel Syndrome - Impact Scale, IBS-IS
    Description
    the IBS-Impact-Scale (IBS-IS). The IBS-IS is a disease-specific documentation of the impact of IBS on patients' lives and was developed and validated for use in clinical trials
    Time Frame
    May 2008-September 2010
    Secondary Outcome Measure Information:
    Title
    Short-Form 36 (SF-36)
    Description
    conveys eight dimensions of Quality of life (QOL): limitations in physical functioning, role limitation due to physical health problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional limitations and mental health (higher scores indicating higher QOL). Validity and reliability have been proven extensively for diverse patient groups
    Time Frame
    May 2008-September 2010

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with IBS, fulfilling Rome III criteria, and aged between 18 and 70, The time for patients to reach the hospital should not to be longer than one hour Exclusion Criteria: pregnancy, bowel surgery, mental retardation, insufficient knowledge of German, a concomitant severe organic and/or psychiatric disease, recently indicated treatment with anti-depressants.-
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gabriele Moser, ao. Prof.
    Organizational Affiliation
    Medical University of Vienna
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Group Hypnosis for Irritable Bowel Syndrome

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