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Irritable Bowel Syndrome Hypnotherapy

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
gut focused hypnotherapy
Sponsored by
Mind-Body Digestive Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Age below 20

Sites / Locations

  • Mind Body Digestive Center

Outcomes

Primary Outcome Measures

Effectiveness of Group Hypnotherapy in Irritable Bowel Syndrome
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.
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
to determine whether relationship quality, or attribution of symptoms to physical or emotional causation correlated with result

Full Information

First Posted
November 22, 2010
Last Updated
January 5, 2011
Sponsor
Mind-Body Digestive Center
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1. Study Identification

Unique Protocol Identification Number
NCT01248013
Brief Title
Irritable Bowel Syndrome Hypnotherapy
Official Title
Outcome Effectiveness Predictors of Irritable Bowel Syndrome Hypnotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mind-Body Digestive Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
gut focused hypnotherapy
Intervention Description
7 session hypnotherapy protocol designed for irritable bowel syndrome
Primary Outcome Measure Information:
Title
Effectiveness of Group Hypnotherapy in Irritable Bowel Syndrome
Description
assessed by symptom severity scale given before treatment began and after 7 bi-weekly sessions, at 3 months, 6 months and 12 months
Time Frame
one year
Title
Percentage of Patients With Significant Reduction in Their IBS Symptom Severity Score One Year After Completion of Therapy.
Description
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.
Time Frame
One year after termination of treatment
Secondary Outcome Measure Information:
Title
Outcome Predictors
Description
to determine whether relationship quality, or attribution of symptoms to physical or emotional causation correlated with result
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of irritable bowel syndrome by Rome II criteria, age 20 and older Exclusion Criteria: Age below 20
Facility Information:
Facility Name
Mind Body Digestive Center
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States

12. IPD Sharing Statement

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Irritable Bowel Syndrome Hypnotherapy

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