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Cognitive Behavior Therapy (CBT) Compared to Stress Management for Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Cognitive behavior therapy

Stress management

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Cognitive behavior therapy, exposure, stress management

Eligibility Criteria

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

Inclusion Criteria:

Diagnosis of IBS given by physician
At screening fulfilling Rome III-criteria for IBS

Exclusion Criteria:

Severe depression
Suicidal ideation
Presence of unexplained IBS alarm symptoms

Sites / Locations

Internetpsykatrienheten, M57, Psykiatri sydväst

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive behavior therapy

Stress management

Arm Description

Outcomes

Primary Outcome Measures

Level of IBS symptoms

The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.

Level of IBS symptoms

The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.

Level of IBS symptoms

The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.

Secondary Outcome Measures

Quality of life

The Irritable Bowel Syndrome Quality of Life Instrument

Use of health care resources and societal production loss because of illness

Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry

Level of IBS-symptoms

IBS-Severity Scoring System

Anxiety related to gastrointestinal symptoms

Visceral Sensitivity Index

Level of daily stress

Perceived stress scale

Subjective relief of IBS-symptoms

One question: "In the past week, have you had adequate relief from IBS pain or discomfort?"

Full Information

NCT ID

NCT01051973

First Posted

January 19, 2010

Last Updated

January 3, 2012

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

1. Study Identification

Unique Protocol Identification Number

NCT01051973

Brief Title

Cognitive Behavior Therapy (CBT) Compared to Stress Management for Irritable Bowel Syndrome

Official Title

Internet-delivered Cognitive Behavior Therapy Compared to Stress Management in the Treatment of Irritable Bowel Syndrome - A Randomized Controlled Study.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

October 2009 (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

Karolinska Institutet

Collaborators

Region Stockholm

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study aims to compare two manualized treatments. They are based on cognitive behavior therapy or stress management. Both treatments are delivered via an internet application and the patients' work with the treatments is supported through online contact with a therapist. The treatments last for 10 weeks. Approximately 200 patients will be included in the study and randomized to either condition. The study hypothesis is that CBT will be superior to stress management on the main outcome measure, which is IBS symptom severity measured over 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

Cognitive behavior therapy, exposure, stress management

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cognitive behavior therapy

Arm Type

Experimental

Arm Title

Stress management

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Cognitive behavior therapy

Intervention Description

A 10-week treatment based on exposure to symptoms and related feelings.

Intervention Type

Behavioral

Intervention Name(s)

Stress management

Intervention Description

A 10-week stress management treatment including applied relaxation and dietary advice.

Primary Outcome Measure Information:

Title

Level of IBS symptoms

Description

The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.

Time Frame

During 4 consecutive weeks before randomization

Title

Level of IBS symptoms

Description

The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.

Time Frame

During 4 consecutive weeks after treatment completion (10 weeks after randomization)

Title

Level of IBS symptoms

Description

The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.

Time Frame

During 4 consecutive weeks 6 months after treatment completion

Secondary Outcome Measure Information:

Title

Quality of life

Description

The Irritable Bowel Syndrome Quality of Life Instrument

Time Frame