Irritable Bowel Syndrome Hypnotherapy
|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|
- 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.
- 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
|Study Start Date:||September 2005|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Behavioral: gut focused hypnotherapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248013
|United States, New York|
|Mind Body Digestive Center|
|New York, New York, United States, 10023|