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

NCT ID: NCT00844961

Last Updated: 2011-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Internet CBT

10 weeks of internet delivered cognitive behaviour therapy

Group Type EXPERIMENTAL

Internet delivered cognitive behavior therapy

Intervention Type BEHAVIORAL

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.

Waiting list

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allmänna arvsfonden

UNKNOWN

Sponsor Role collaborator

Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Königska-Söderströmska sjukhemmet

UNKNOWN

Sponsor Role collaborator

Aleris Helse

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Psykiatri Sydväst, Stockholms läns landsting

Principal Investigators

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Nils Lindefors, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Internetpsykatrienheten, M57, Psykiatri sydväst

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 21992655 (View on PubMed)

Other Identifiers

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IBS-K

Identifier Type: -

Identifier Source: org_study_id