Effectiveness of Internet Delivered Cognitive Behavior Therapy (CBT) for Irritable Bowel Syndrome (IBS)

Irritable Bowel Syndrome Clinical Trial

Official title:

Study of the Effectiveness of Internet Delivered Cognitive Behavior Therapy in a Sample of Consecutively Recruited Patients Diagnosed With Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844961
• Other study ID #: IBS-K
• Status: Completed
• Phase: N/A
• First received: February 13, 2009
• Last updated: November 8, 2011
• Start date: November 2008
• Est. completion date: February 2011

Study information

• Verified date: February 2009
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The study will recruit 80 out-patients diagnosed with Irritable Bowel Syndrome from a gastroenterological clinic. The recruitment will be consecutive with all patients receiving the diagnosis being offered to participate. After recruitment and 3 week baseline measure of IBS symptoms they will be randomised to either 10 weeks of internet delivered CBT or waiting list. After treatment IBS-symptoms are measured again to assess treatment effectiveness. All patients on waiting list are offered the same treatment as patients randomised to treatment.

All patients are assessed 12 months after completion of treatment.

Patients in treatment condition are hypothesized to experience significant reduction IBS symptoms and quality of life compared to patients on waiting list.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Irritable Bowel Syndrome according to Rome III criteria

Exclusion Criteria:

• History of inflammatory bowel disease (IBD)

• Symptom debut after age of 50

• Ongoing severe mental illness (psychosis, severe depression, suicidal ideation, bipolar disease)

• Inability to participate in internet delivered treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• Internet delivered cognitive behavior therapy
10 weeks of internet delivered cognitive behavior therapy targeted at reducing experience of IBS symptoms and improving quality of life. Patients are offered guidance via email by a therapist.

Locations

Country	Name	City	State
Sweden	Internetpsykatrienheten, M57, Psykiatri sydväst	Stockholm

Sponsors (5)

Lead Sponsor	Collaborator
Karolinska Institutet	Aleris Helse, Allmänna arvsfonden, Königska-Söderströmska sjukhemmet, Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)		Before treatment	No
Primary	The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)		After treatment	No
Primary	The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)		12 months after treatment	No