Cognitive Behaviour Therapy for Patients With IBS (EFI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ram Dickman, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00788658
First received: November 10, 2008
Last updated: April 12, 2016
Last verified: April 2016
  Purpose

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 Intervention
Irritable Bowel Syndrome
Constipation
Abdominal Pain
Depression
Behavioral: Diet modifications
Behavioral: Cognitive behavioral therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Symptom score [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life assessment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: December 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Symptomatic treatment of patients would not be modified
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-75
  • IBS

Exclusion Criteria:

  • Malignancy
  • Known psychiatric disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788658

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

Responsible Party: Ram Dickman, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00788658     History of Changes
Other Study ID Numbers: RMC 5139 
Study First Received: November 10, 2008
Last Updated: April 12, 2016
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

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

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

ClinicalTrials.gov processed this record on August 29, 2016