Irritable Bowel Syndrome Hypnotherapy

Irritable Bowel Syndrome Clinical Trial

Official title:

Outcome Effectiveness Predictors of Irritable Bowel Syndrome Hypnotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248013
• Other study ID #: 05-0575
• Status: Completed
• Phase: N/A
• First received: November 22, 2010
• Last updated: January 5, 2011
• Start date: September 2005
• Est. completion date: December 2009

Study information

• Verified date: January 2011
• Source: Mind-Body Digestive Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age below 20

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• gut focused hypnotherapy
7 session hypnotherapy protocol designed for irritable bowel syndrome

Locations

Country	Name	City	State
United States	Mind Body Digestive Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Mind-Body Digestive Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Outcome Predictors	to determine whether relationship quality, or attribution of symptoms to physical or emotional causation correlated with result	one year	No