NCT00788658

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration for not_applicable

Status
completed

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

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
20 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

2 years

First QC Date

November 10, 2008

Last Update Submit

April 12, 2016

Conditions

Keywords

Obstructed constipationQuality of life

Outcome Measures

Primary Outcomes (1)

  • Symptom score

    3 months

Secondary Outcomes (1)

  • Quality of life assessment

    3 months

Study Arms (2)

Diet modifications

PLACEBO COMPARATOR

Diet consultation and life style modifications for 6 sessions

Behavioral: Diet modifications

Cognitive therapy

ACTIVE COMPARATOR

6 sessions of cognitive behavioral therapy

Behavioral: Cognitive behavioral therapy

Interventions

Diet consultation

Also known as: Diet
Diet modifications

Cognitive behavioral therapy

Also known as: CBT
Cognitive therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Irritable Bowel SyndromeConstipationAbdominal PainDepression

Interventions

Diet TherapyDietCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeuticsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ram Dickman, MD

    RMC

    PRINCIPAL INVESTIGATOR

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