Internet-delivered CBT for Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Behavioral: Internet-delivered CBT; Behavioral: Therapist support

• Registration Number: NCT01171053
• Lead Sponsor: Karolinska Institutet

Brief Summary

The aim of this study is to investigate the efficacy of a 10 week Internet-delivered CBT treatment for patients diagnosed with IBS. The patients' work with the treatment and is supported through online contact with a therapist.

Approximately 86 patients will be included in the study and randomized to either condition.

All included patients are assessed one week before the treatment starts. After 10 weeks (post treatment). Follow-up assessments are conducted at 3 and 12 months follow-up after treatment.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-07
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-07-27
• Last Update Submitted: 2010-07-27
• Study First Posted: 2010-07-28
• Last Update Posted: 2010-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet CBT	Internet-delivered CBT	Internet-delivered cognitive behavioral therapy with therapist support
Attention control	Therapist support	Weekly support from therapist without CBT-interventions

Primary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms	One year after the treatment ended	Gastrointestinal Symptom rating scale (GSRS)

Secondary Outcome Measures

Name	Time	Method
Health economic data	One year after the treatment ended	"Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry". In this questionnaire, patients register their monthly health care consumption (e.g. GP visits) as well as time spent in informal health enhancing activities (e.g. self-help groups and informal care from friends). In addition, work loss and work cutback both at work and in the domestic realm is measured.
Quality of life	One year after the treatment ended	The Irritable Bowel Syndrome Quality of Life Instrument
Gastrointestinal symptom-specific anxiety	One year after the treatment ended	Visceral Sensitivity Index
Functional impairments in work, social and family life	One year after the treatment ended	Sheenan Disability Scale (DSD)
Depressive symptoms	One year after the treatment ended	The Montgomery Åsberg Depression Rating Scale

Trial Locations

Locations (1)

Internetpsykatrienheten, M46, Psykiatri sydväst; 🇸🇪 Stockholm, Sweden