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
Results First Received: November 24, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Irritable Bowel Syndrome
Intervention: Behavioral: gut focused hypnotherapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited at their initial visit to an IBS treatment center, on a purely voluntary basis into a group hypnotherapy program, from 2005 to 2009. 75 patients were entered into the study. Another 14 filled out initial questionnaires but then declined to enter treatment or dropped out after 1 or 2 sessions.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was no control group assignment in this preliminary study which was designed to see if hypnotherapy, already proven effective in individual treatment was effective when using a group format.

Reporting Groups
  Description
Group Hypnotherapy for Irritable Bowel Syndrome IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.

Participant Flow:   Overall Study
    Group Hypnotherapy for Irritable Bowel Syndrome  
STARTED     89  
Irritable Bowel Syndrome Hypnotherapy     75  
COMPLETED     75  
NOT COMPLETED     14  
Withdrawal by Subject                 14  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group Hypnotherapy for Irritable Bowel Syndrome IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.

Baseline Measures
    Group Hypnotherapy for Irritable Bowel Syndrome  
Number of Participants  
[units: participants]
  89  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     80  
>=65 years     9  
Age  
[units: years]
Mean ± Standard Deviation
  45.9  ± 14.4  
Gender  
[units: participants]
 
Female     56  
Male     33  
Region of Enrollment  
[units: participants]
 
United States     89  



  Outcome Measures

1.  Primary:   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 ]

2.  Primary:   Effectiveness of Group Hypnotherapy in Irritable Bowel Syndrome   [ Time Frame: one year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Outcome Predictors   [ Time Frame: one year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Subjects who dropped out did so for reasons of inconvenience of scheduling attendance.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Charles D. Gerson, M.D.
Organization: Mind-Body Digestive Center
phone: 212 496 6161
e-mail: cgerson@yahoo.com


No publications provided


Responsible Party: Charles D. Gerson, M.D., Mind-Body Digestive Center
ClinicalTrials.gov Identifier: NCT01248013     History of Changes
Other Study ID Numbers: 05-0575
Study First Received: November 22, 2010
Results First Received: November 24, 2010
Last Updated: January 5, 2011
Health Authority: United States: Institutional Review Board