Irritable Bowel Syndrome Hypnotherapy

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT01248013
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-09
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-11-24
• Results First Submitted: 2010-11-24
• Study First Posted: 2010-11-25
• Status Verified: 2011-01
• Results First Submitted QC: 2011-01-05
• Last Update Submitted: 2011-01-05
• Results First Posted: 2011-01-06
• Last Update Posted: 2011-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

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

Exclusion Criteria

• Age below 20

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Effectiveness of Group Hypnotherapy in Irritable Bowel Syndrome	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
Percentage of Patients With Significant Reduction in Their IBS Symptom Severity Score One Year After Completion of Therapy.	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

Name	Time	Method
Outcome Predictors	one year	to determine whether relationship quality, or attribution of symptoms to physical or emotional causation correlated with result

Trial Locations

Locations (1)

Mind Body Digestive Center; 🇺🇸 New York, New York, United States