Internet-delivered CBT for Irritable Bowel Syndrome

This study has been completed.

Sponsor:

Collaborator:

Stockholm County Council, Sweden

Information provided by:

Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT01171053

First received: July 26, 2010

Last updated: July 27, 2010

Last verified: July 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 26, 2010

Last Updated Date

July 27, 2010

Start Date ^ICMJE

June 2008

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Gastrointestinal symptoms [ Time Frame: One week before the treatment starts ] [ Designated as safety issue: No ]
Gastrointestinal Symptom rating scale (GSRS)
Gastrointestinal symptoms [ Time Frame: 10 weeks after the treatment started ] [ Designated as safety issue: No ]
Gastrointestinal Symptom rating scale (GSRS)
Gastrointestinal symptoms [ Time Frame: 3 months after the treatment ended ] [ Designated as safety issue: No ]
Gastrointestinal Symptom rating scale (GSRS)
Gastrointestinal symptoms [ Time Frame: One year after the treatment ended ] [ Designated as safety issue: No ]
Gastrointestinal Symptom rating scale (GSRS)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01171053 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Health economic data [ Time Frame: One week before the treatment starts ] [ Designated as safety issue: No ]
"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.
Health economic data [ Time Frame: 10 weeks after the treatment started ] [ Designated as safety issue: No ]
"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.
Health economic data [ Time Frame: 3 months after the treatment ended ] [ Designated as safety issue: No ]
"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.
Health economic data [ Time Frame: One year after the treatment ended ] [ Designated as safety issue: No ]
"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 [ Time Frame: One week before the treatment starts ] [ Designated as safety issue: No ]
The Irritable Bowel Syndrome Quality of Life Instrument
Quality of life [ Time Frame: 10 weeks after the treatment started ] [ Designated as safety issue: No ]
The Irritable Bowel Syndrome Quality of Life Instrument
Quality of life [ Time Frame: 3 months after the treatment ended ] [ Designated as safety issue: No ]
The Irritable Bowel Syndrome Quality of Life Instrument
Quality of life [ Time Frame: One year after the treatment ended ] [ Designated as safety issue: No ]
The Irritable Bowel Syndrome Quality of Life Instrument
Gastrointestinal symptom-specific anxiety [ Time Frame: One week before the treatment starts ] [ Designated as safety issue: No ]
Visceral Sensitivity Index
Gastrointestinal symptom-specific anxiety [ Time Frame: 10 weeks after the treatment started ] [ Designated as safety issue: No ]
Visceral Sensitivity Index
Gastrointestinal symptom-specific anxiety [ Time Frame: 3 months after the treatment ended ] [ Designated as safety issue: No ]
Visceral Sensitivity Index
Gastrointestinal symptom-specific anxiety [ Time Frame: One year after the treatment ended ] [ Designated as safety issue: No ]
Visceral Sensitivity Index
Depressive symptoms [ Time Frame: One week before the treatment starts ] [ Designated as safety issue: No ]
The Montgomery Åsberg Depression Rating Scale
Depressive symptoms [ Time Frame: 10 weeks after the treatment started ] [ Designated as safety issue: No ]
The Montgomery Åsberg Depression Rating Scale
Depressive symptoms [ Time Frame: 3 months after the treatment ended ] [ Designated as safety issue: No ]
The Montgomery Åsberg Depression Rating Scale
Depressive symptoms [ Time Frame: One year after the treatment ended ] [ Designated as safety issue: No ]
The Montgomery Åsberg Depression Rating Scale
Functional impairments in work, social and family life [ Time Frame: One week before the treatment starts ] [ Designated as safety issue: No ]
Sheenan Disability Scale (DSD)
Functional impairments in work, social and family life [ Time Frame: 10 weeks after the treatment started ] [ Designated as safety issue: No ]
Sheenan Disability Scale (DSD)
Functional impairments in work, social and family life [ Time Frame: 3 months after the treatment ended ] [ Designated as safety issue: No ]
Sheenan Disability Scale (DSD)
Functional impairments in work, social and family life [ Time Frame: One year after the treatment ended ] [ Designated as safety issue: No ]
Sheenan Disability Scale (DSD)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Internet-delivered CBT for Irritable Bowel Syndrome

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Irritable Bowel Syndrome

Intervention ^ICMJE

Behavioral: Internet-delivered CBT
Internet-delivered cognitive behavioral therapy with therapist support.
Behavioral: Therapist support
Weekly therapist support without CBT-interventions

Study Arm (s)

Placebo Comparator: Attention control
Weekly support from therapist without CBT-interventions

Intervention: Behavioral: Therapist support
Experimental: Internet CBT
Internet-delivered cognitive behavioral therapy with therapist support

Intervention: Behavioral: Internet-delivered CBT

Publications *

Ljótsson B, Falk L, Vesterlund AW, Hedman E, Lindfors P, Rück C, Hursti T, Andréewitch 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. Epub 2010 Mar 16.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2010

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT01171053

Other Study ID Numbers ^ICMJE

IBS-S

Has Data Monitoring Committee

Responsible Party

Nils Lindefors, Psykiatri Sydväst

Study Sponsor ^ICMJE

Karolinska Institutet

Collaborators ^ICMJE

Stockholm County Council, Sweden

Investigators ^ICMJE

Principal Investigator:

Nils Lindefors, PhD

Karolinska Institutet, Sweden

Information Provided By

Karolinska Institutet

Verification Date

July 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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