- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00788658
Cognitive Behaviour Therapy for Patients With IBS (EFI)
Cognitive Behavior Therapy (CBT) as Compared With Standard Therapy for Patients With IBS and Other Functional Gastrointestinal Disorders
Irritable bowel syndrome (IBS) affects approximately 10-15% of the adult population. This condition is characterized by abdominal pain, altered bowel habit, abdominal bloating and reduced quality of life. Options for treating IBS include pharmacotherapy, psychotherapy, hypnotherapy and cognitive behavior therapy (CBT). Available data on the effectiveness of CBT in IBS patients in Israel are scarce.
The aim of the present study is to assess effectiveness of CBT as compared with standard therapy for IBS patients in Israel The course of CBT consisted of up to six 40 min sessions, and included education about IBS and techniques to reduce focusing on symptoms and to manage stress.Standard therapy includs life style modifications.
The primary outcome measure was the score on a symptom-severity scale specific to IBS.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-75
- IBS
Exclusion Criteria:
- Malignancy
- Known psychiatric disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Diet modifications
Diet consultation and life style modifications for 6 sessions
|
Diet consultation
Other Names:
|
ACTIVE_COMPARATOR: Cognitive therapy
6 sessions of cognitive behavioral therapy
|
Cognitive behavioral therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Symptom score
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life assessment
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ram Dickman, MD, RMC
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RMC 5139
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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