search
Back to results

Cognitive Behaviour Therapy for Patients With IBS (EFI)

Primary Purpose

Irritable Bowel Syndrome, Constipation, Abdominal Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diet modifications
Cognitive behavioral therapy
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Obstructed constipation, Quality of life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-75
  • IBS

Exclusion Criteria:

  • Malignancy
  • Known psychiatric disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Diet modifications

    Cognitive therapy

    Arm Description

    Diet consultation and life style modifications for 6 sessions

    6 sessions of cognitive behavioral therapy

    Outcomes

    Primary Outcome Measures

    Symptom score

    Secondary Outcome Measures

    Quality of life assessment

    Full Information

    First Posted
    November 10, 2008
    Last Updated
    April 12, 2016
    Sponsor
    Rabin Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00788658
    Brief Title
    Cognitive Behaviour Therapy for Patients With IBS
    Acronym
    EFI
    Official Title
    Cognitive Behavior Therapy (CBT) as Compared With Standard Therapy for Patients With IBS and Other Functional Gastrointestinal Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2008 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rabin Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Symptomatic treatment of patients would not be modified

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome, Constipation, Abdominal Pain, Depression
    Keywords
    Obstructed constipation, Quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diet modifications
    Arm Type
    Placebo Comparator
    Arm Description
    Diet consultation and life style modifications for 6 sessions
    Arm Title
    Cognitive therapy
    Arm Type
    Active Comparator
    Arm Description
    6 sessions of cognitive behavioral therapy
    Intervention Type
    Behavioral
    Intervention Name(s)
    Diet modifications
    Other Intervention Name(s)
    Diet
    Intervention Description
    Diet consultation
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive behavioral therapy
    Other Intervention Name(s)
    CBT
    Intervention Description
    Cognitive behavioral therapy
    Primary Outcome Measure Information:
    Title
    Symptom score
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Quality of life assessment
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-75 IBS Exclusion Criteria: Malignancy Known psychiatric disorders
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ram Dickman, MD
    Organizational Affiliation
    RMC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Cognitive Behaviour Therapy for Patients With IBS

    We'll reach out to this number within 24 hrs