Cognitive Behaviour Therapy for Patients With IBS | NCT00788658

Studies
Cognitive Behaviour Therapy for Patients With IBS

NCT00788658

Sponsor

Rabin Medical Center

Status

Completed

Last Update Posted

Apr 13, 2016Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Irritable Bowel Syndrome
Constipation
Abdominal Pain
Depression

Interventions

Diet modifications
Cognitive behavioral therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Nov 10, 2008

First Submission Date that Met QC Criteria

Nov 10, 2008

First Posted Date

Nov 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2016

Last Update Posted Date

Apr 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Diet modifications	Behavioral	Diet consultation	Diet modifications

Measure	Description	Time Frame
Symptom score		3 months

Measure	Description	Time Frame
Quality of life assessment		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-75
IBS

Exclusion Criteria:

Malignancy
Known psychiatric disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ram Dickman, MD	RMC	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome
D003248	Constipation
D015746	Abdominal Pain
D003863	Depression

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004035	Diet Therapy
D004032	Diet
D015928	Cognitive Behavioral Therapy

Ancestor Terms

ID	Term
D044623	Nutrition Therapy
D013812	Therapeutics
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition

Browse Leaves

Not provided

Browse Branches

Not provided