Internet-delivered CBT for Irritable Bowel Syndrome

Internet-delivered Exposure and Mindfulness Based Therapy for Irritable Bowel Syndrome - A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Behavioral: Therapist support; Behavioral: Internet-delivered CBT

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 141 86
    • Internetpsykatrienheten, M46, Psykiatri sydväst

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Attention control; Weekly support from therapist without CBT-interventions	Behavioral: Therapist support; Weekly therapist support without CBT-interventions
Experimental: Internet CBT; Internet-delivered cognitive behavioral therapy with therapist support	Behavioral: Internet-delivered CBT; Internet-delivered cognitive behavioral therapy with therapist support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal symptoms	Gastrointestinal Symptom rating scale (GSRS)	One week before the treatment starts
Gastrointestinal symptoms	Gastrointestinal Symptom rating scale (GSRS)	10 weeks after the treatment started
Gastrointestinal symptoms	Gastrointestinal Symptom rating scale (GSRS)	3 months after the treatment ended
Gastrointestinal symptoms	Gastrointestinal Symptom rating scale (GSRS)	One year after the treatment ended

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health economic data	"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.	One week before the treatment starts
Health economic data	"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.	10 weeks after the treatment started
Health economic data	"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.	3 months after the treatment ended
Health economic data	"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.	One year after the treatment ended
Quality of life	The Irritable Bowel Syndrome Quality of Life Instrument	One week before the treatment starts
Quality of life	The Irritable Bowel Syndrome Quality of Life Instrument	10 weeks after the treatment started
Quality of life	The Irritable Bowel Syndrome Quality of Life Instrument	3 months after the treatment ended
Quality of life	The Irritable Bowel Syndrome Quality of Life Instrument	One year after the treatment ended
Gastrointestinal symptom-specific anxiety	Visceral Sensitivity Index	One week before the treatment starts
Gastrointestinal symptom-specific anxiety	Visceral Sensitivity Index	10 weeks after the treatment started
Gastrointestinal symptom-specific anxiety	Visceral Sensitivity Index	3 months after the treatment ended
Gastrointestinal symptom-specific anxiety	Visceral Sensitivity Index	One year after the treatment ended
Depressive symptoms	The Montgomery Åsberg Depression Rating Scale	One week before the treatment starts
Depressive symptoms	The Montgomery Åsberg Depression Rating Scale	10 weeks after the treatment started
Depressive symptoms	The Montgomery Åsberg Depression Rating Scale	3 months after the treatment ended
Depressive symptoms	The Montgomery Åsberg Depression Rating Scale	One year after the treatment ended
Functional impairments in work, social and family life	Sheenan Disability Scale (DSD)	One week before the treatment starts
Functional impairments in work, social and family life	Sheenan Disability Scale (DSD)	10 weeks after the treatment started
Functional impairments in work, social and family life	Sheenan Disability Scale (DSD)	3 months after the treatment ended
Functional impairments in work, social and family life	Sheenan Disability Scale (DSD)	One year after the treatment ended

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Publications and helpful links

General Publications

• Ljotsson B, Falk L, Vesterlund AW, Hedman E, Lindfors P, Ruck C, Hursti T, Andreewitch S, Jansson L, Lindefors N, Andersson G. Internet-delivered exposure and mindfulness based therapy for irritable bowel syndrome--a randomized controlled trial. Behav Res Ther. 2010 Jun;48(6):531-9. doi: 10.1016/j.brat.2010.03.003. Epub 2010 Mar 16.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 27, 2010
• First Posted (Estimate): July 28, 2010

Study Record Updates

• Last Update Posted (Estimate): July 28, 2010
• Last Update Submitted That Met QC Criteria: July 27, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Cognitive behavior therapy; Cost-effectiveness; Internet; Irritable bowel syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: IBS-S