Irritable Bowel Syndrome Hypnotherapy
Outcome Effectiveness Predictors of Irritable Bowel Syndrome Hypnotherapy
1 other identifier
interventional
89
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 22, 2010
CompletedFirst Posted
Study publicly available on registry
November 25, 2010
CompletedResults Posted
Study results publicly available
January 6, 2011
CompletedJanuary 6, 2011
January 1, 2011
4.3 years
November 22, 2010
November 24, 2010
January 5, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
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
one year
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.
One year after termination of treatment
Secondary Outcomes (1)
Outcome Predictors
one year
Interventions
7 session hypnotherapy protocol designed for irritable bowel syndrome
Eligibility Criteria
You may qualify if:
- Diagnosis of irritable bowel syndrome by Rome II criteria, age 20 and older
You may not qualify if:
- Age below 20
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mind Body Digestive Center
New York, New York, 10023, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Subjects who dropped out did so for reasons of inconvenience of scheduling attendance.
Results Point of Contact
- Title
- Charles D. Gerson, M.D.
- Organization
- Mind-Body Digestive Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 22, 2010
First Posted
November 25, 2010
Study Start
September 1, 2005
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
January 6, 2011
Results First Posted
January 6, 2011
Record last verified: 2011-01