Irritable Bowel Syndrome Hypnotherapy

This study has been completed.
Sponsor:
Information provided by:
Mind-Body Digestive Center
ClinicalTrials.gov Identifier:
NCT01248013
First received: November 22, 2010
Last updated: January 5, 2011
Last verified: January 2011
  Purpose

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 Intervention
Irritable Bowel Syndrome
Behavioral: gut focused hypnotherapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outcome Effectiveness Predictors of Irritable Bowel Syndrome Hypnotherapy

Further study details as provided by Mind-Body Digestive Center:

Primary Outcome Measures:
  • Effectiveness of Group Hypnotherapy in Irritable Bowel Syndrome [ Time Frame: one year ] [ Designated as safety issue: No ]
    assessed by symptom severity scale given before treatment began and after 7 bi-weekly sessions, at 3 months, 6 months and 12 months

  • 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 ] [ Designated as safety issue: No ]
    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:
  • Outcome Predictors [ Time Frame: one year ] [ Designated as safety issue: No ]
    to determine whether relationship quality, or attribution of symptoms to physical or emotional causation correlated with result


Enrollment: 89
Study Start Date: September 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: gut focused hypnotherapy
    7 session hypnotherapy protocol designed for irritable bowel syndrome
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age below 20
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248013

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

No publications provided

Responsible Party: Charles D. Gerson, M.D., Mind-Body Digestive Center
ClinicalTrials.gov Identifier: NCT01248013     History of Changes
Other Study ID Numbers: 05-0575
Study First Received: November 22, 2010
Results First Received: November 24, 2010
Last Updated: January 5, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014