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
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
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
NCT ID
NCT01178593
First Posted
August 9, 2010
Last Updated
December 11, 2011
Sponsor
Medical University of Vienna
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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