Irritable Bowel Syndrome Hypnotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01248013
Recruitment Status : Completed
First Posted : November 25, 2010
Results First Posted : January 6, 2011
Last Update Posted : January 6, 2011
Information provided by:
Mind-Body Digestive Center

Brief Summary:
The primary goal of the study was whether gut focused hypnotherapy, in a group format, was successful in reduction of symptoms in patients with irritable bowel syndrome. The secondary goal was to see if any outcome predictors could be determined.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Behavioral: gut focused hypnotherapy Not Applicable

Detailed Description:

Patients with Irritable Bowel Syndrome entering a group hypnotherapy program are asked to complete a series of questionnaires at the outset, and repeat a symptom severity scale at intervals over the one year period after termination of treatment. Eligibility was limited to patients with age greater than 20.

Outcome measures were improvement in symptom score. Outcome predictors studied included quality of relationships, measured with a Quality of Relationship Inventory and attribution of IBS to physical or emotional cause, measured with a Mind-Body IBS Questionnaire, both administered before onset of hypnotherapy.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcome Effectiveness Predictors of Irritable Bowel Syndrome Hypnotherapy
Study Start Date : September 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Intervention Details:
    Behavioral: gut focused hypnotherapy
    7 session hypnotherapy protocol designed for irritable bowel syndrome

Primary Outcome Measures :
  1. Effectiveness of Group Hypnotherapy in Irritable Bowel Syndrome [ Time Frame: one year ]
    assessed by symptom severity scale given before treatment began and after 7 bi-weekly sessions, at 3 months, 6 months and 12 months

  2. Percentage of Patients With Significant Reduction in Their IBS Symptom Severity Score One Year After Completion of Therapy. [ Time Frame: One year after termination of treatment ]
    The IBS Symptom Severity Scale has four components, severity of abdominal pain, number of days with pain in past 10 days, abdominal distension, bowel habit and interference with life in general. Maximum score is 500, minimum score is 0. The lower the score, the lower the symptom severity. Participants are considered clinically improved if they have a reduction in score of 50 points or greater.

Secondary Outcome Measures :
  1. Outcome Predictors [ Time Frame: one year ]
    to determine whether relationship quality, or attribution of symptoms to physical or emotional causation correlated with result

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of irritable bowel syndrome by Rome II criteria, age 20 and older

Exclusion Criteria:

  • Age below 20

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01248013

United States, New York
Mind Body Digestive Center
New York, New York, United States, 10023
Sponsors and Collaborators
Mind-Body Digestive Center

Responsible Party: Charles D. Gerson, M.D., Mind-Body Digestive Center Identifier: NCT01248013     History of Changes
Other Study ID Numbers: 05-0575
First Posted: November 25, 2010    Key Record Dates
Results First Posted: January 6, 2011
Last Update Posted: January 6, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases