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Group Hypnosis for Irritable Bowel Syndrome (IBS)

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ClinicalTrials.gov Identifier: NCT01178593
Recruitment Status : Completed
First Posted : August 10, 2010
Last Update Posted : December 13, 2011
Sponsor:
Information provided by (Responsible Party):
Gabriele Moser, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE August 9, 2010
First Posted Date  ICMJE August 10, 2010
Last Update Posted Date December 13, 2011
Study Start Date  ICMJE April 2008
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2011)
Irritable Bowel Syndrome - Impact Scale, IBS-IS [ Time Frame: May 2008-September 2010 ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2010)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2011)
Short-Form 36 (SF-36) [ Time Frame: May 2008-September 2010 ]
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Group Hypnosis for Irritable Bowel Syndrome
Official Title  ICMJE GUT-FOCUSED GROUP HYPNOSIS FOR TREATMENT OF IRRITABLE BOWEL SYNDROME - A RANDOMISED CONTROLLED TRIAL
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE Other: Gut-focused hypnotherapy in group sessions
weekly session (45 min) of gut focused hypnotherapy (10 sessions within 12 weeks)
Other Names:
  • hypnosis
  • gut directed hypnosis
  • gut directed hypnotherapy
  • gut focused hypnosis
Study Arms  ICMJE
  • No Intervention: Standard Medical Therapy (SMT)
    standard medical treatment (care as usual) with supportive talks
  • Active Comparator: Gut focused hypnotherapy
    weekly sessions of gut focused hypnotherapy in groups (10 sessions within 12 weeks)
    Intervention: Other: Gut-focused hypnotherapy in group sessions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2011)
100
Original Actual Enrollment  ICMJE
 (submitted: August 9, 2010)
40
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01178593
Other Study ID Numbers  ICMJE FA716E0126
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gabriele Moser, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gabriele Moser, ao. Prof. Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP