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

Primary Purpose

Irritable Bowel Syndrome

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Internet delivered cognitive behavior therapy

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS, CBT, Internet treatment, Cognitive behavior therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Internetpsykatrienheten, M57, Psykiatri sydväst

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet CBT

Waiting list

Arm Description

10 weeks of internet delivered cognitive behaviour therapy

Waiting list which is offered treatment after completion of post intervention assessments

Outcomes

Primary Outcome Measures

The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)

Secondary Outcome Measures

Full Information

NCT ID

NCT00844961

First Posted

February 13, 2009

Last Updated

November 8, 2011

Sponsor

Karolinska Institutet

Collaborators

Allmänna arvsfonden, Region Stockholm, Königska-Söderströmska sjukhemmet, Aleris Helse

1. Study Identification

Unique Protocol Identification Number

NCT00844961

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Karolinska Institutet

Collaborators

Allmänna arvsfonden, Region Stockholm, Königska-Söderströmska sjukhemmet, Aleris Helse

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

IBS, CBT, Internet treatment, Cognitive behavior therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Internet CBT

Arm Type

Experimental

Arm Description

10 weeks of internet delivered cognitive behaviour therapy

Arm Title

Waiting list

Arm Type

No Intervention

Arm Description

Waiting list which is offered treatment after completion of post intervention assessments

Intervention Type

Behavioral

Intervention Name(s)

Internet delivered cognitive behavior therapy

Other Intervention Name(s)

CBT

Intervention Description

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.

Primary Outcome Measure Information:

Title

The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)

Time Frame

Before treatment

Title

The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)

Time Frame

After treatment

Title

The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)

Time Frame

12 months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nils Lindefors, PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Internetpsykatrienheten, M57, Psykiatri sydväst

City

Stockholm

ZIP/Postal Code

181 86

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

21992655

Citation

Ljotsson B, Andersson G, Andersson E, Hedman E, Lindfors P, Andreewitch S, Ruck C, Lindefors N. Acceptability, effectiveness, and cost-effectiveness of internet-based exposure treatment for irritable bowel syndrome in a clinical sample: a randomized controlled trial. BMC Gastroenterol. 2011 Oct 12;11:110. doi: 10.1186/1471-230X-11-110.

Results Reference

derived

Learn more about this trial

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

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