Irritable Bowel Syndrome Hypnotherapy

This study has been completed.
Sponsor:
Information provided by:
Mind-Body Digestive Center
ClinicalTrials.gov Identifier:
NCT01248013
First received: November 22, 2010
Last updated: January 5, 2011
Last verified: January 2011

November 22, 2010
January 5, 2011
September 2005
December 2009   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01248013 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Irritable Bowel Syndrome Hypnotherapy
Outcome Effectiveness Predictors of Irritable Bowel Syndrome Hypnotherapy

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Irritable Bowel Syndrome
Behavioral: gut focused hypnotherapy
7 session hypnotherapy protocol designed for irritable bowel syndrome
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Age below 20
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01248013
05-0575
No
Charles D. Gerson, M.D., Mind-Body Digestive Center
Mind-Body Digestive Center
Not Provided
Not Provided
Mind-Body Digestive Center
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP