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
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2008
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2008
CompletedFirst Posted
Study publicly available on registry
November 11, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedApril 13, 2016
April 1, 2016
2 years
November 10, 2008
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptom score
3 months
Secondary Outcomes (1)
Quality of life assessment
3 months
Study Arms (2)
Diet modifications
PLACEBO COMPARATORDiet consultation and life style modifications for 6 sessions
Cognitive therapy
ACTIVE COMPARATOR6 sessions of cognitive behavioral therapy
Interventions
Cognitive behavioral therapy
Eligibility Criteria
You may qualify if:
- Age 18-75
- IBS
You may not qualify if:
- Malignancy
- Known psychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ram Dickman, MD
RMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 10, 2008
First Posted
November 11, 2008
Study Start
December 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
April 13, 2016
Record last verified: 2016-04