Cognitive Behaviour Therapy for Patients With IBS (EFI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00788658
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : April 13, 2016
Information provided by (Responsible Party):
Ram Dickman, Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Constipation Abdominal Pain Depression Behavioral: Diet modifications Behavioral: Cognitive behavioral therapy Not Applicable

Detailed Description:
Symptomatic treatment of patients would not be modified

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Behavior Therapy (CBT) as Compared With Standard Therapy for Patients With IBS and Other Functional Gastrointestinal Disorders
Study Start Date : December 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Placebo Comparator: Diet modifications
Diet consultation and life style modifications for 6 sessions
Behavioral: Diet modifications
Diet consultation
Other Name: Diet

Active Comparator: Cognitive therapy
6 sessions of cognitive behavioral therapy
Behavioral: Cognitive behavioral therapy
Cognitive behavioral therapy
Other Name: CBT

Primary Outcome Measures :
  1. Symptom score [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Quality of life assessment [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-75
  • IBS

Exclusion Criteria:

  • Malignancy
  • Known psychiatric disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00788658

Sponsors and Collaborators
Rabin Medical Center
Principal Investigator: Ram Dickman, MD RMC

Responsible Party: Ram Dickman, MD, Rabin Medical Center Identifier: NCT00788658     History of Changes
Other Study ID Numbers: RMC 5139
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016

Keywords provided by Ram Dickman, Rabin Medical Center:
Obstructed constipation
Quality of life

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Abdominal Pain
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Nervous System Diseases