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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01051973

Enrollment

200

Registered

2010-01-20

Start date

2009-10-31

Completion date

2010-12-31

Last updated

2012-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Cognitive behavior therapy, exposure, stress management

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.

Interventions

BEHAVIORALCognitive behavior therapy

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

BEHAVIORALStress management

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Level of IBS symptoms	During 4 consecutive weeks before randomization	The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.

Secondary

Measure	Time frame	Description
Use of health care resources and societal production loss because of illness	Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion	Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry
Level of IBS-symptoms	Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion	IBS-Severity Scoring System
Quality of life	Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion	The Irritable Bowel Syndrome Quality of Life Instrument
Level of daily stress	Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion	Perceived stress scale
Subjective relief of IBS-symptoms	Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion	One question: In the past week, have you had adequate relief from IBS pain or discomfort?
Anxiety related to gastrointestinal symptoms	Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion	Visceral Sensitivity Index

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026