Cognitive Behaviour Therapy for Patients With IBS

NCT ID: NCT00788658

Last Updated: 2016-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Symptomatic treatment of patients would not be modified

Conditions

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Irritable Bowel Syndrome Constipation Abdominal Pain Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diet modifications

Diet consultation and life style modifications for 6 sessions

Group Type PLACEBO_COMPARATOR

Diet modifications

Intervention Type BEHAVIORAL

Diet consultation

Cognitive therapy

6 sessions of cognitive behavioral therapy

Group Type ACTIVE_COMPARATOR

Cognitive behavioral therapy

Intervention Type BEHAVIORAL

Cognitive behavioral therapy

Interventions

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Diet modifications

Diet consultation

Intervention Type BEHAVIORAL

Cognitive behavioral therapy

Cognitive behavioral therapy

Intervention Type BEHAVIORAL

Other Intervention Names

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Diet CBT

Eligibility Criteria

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Inclusion Criteria

* Age 18-75
* IBS

Exclusion Criteria

* Malignancy
* Known psychiatric disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ram Dickman

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ram Dickman, MD

Role: PRINCIPAL_INVESTIGATOR

RMC

Other Identifiers

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RMC 5139

Identifier Type: -

Identifier Source: org_study_id

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