Internet-delivered CBT for Irritable Bowel Syndrome

NCT ID: NCT01171053

Last Updated: 2010-07-28

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

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-06-30

Brief Summary

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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

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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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Attention control

Weekly support from therapist without CBT-interventions

Group Type PLACEBO_COMPARATOR

Therapist support

Intervention Type BEHAVIORAL

Weekly therapist support without CBT-interventions

Internet CBT

Internet-delivered cognitive behavioral therapy with therapist support

Group Type EXPERIMENTAL

Internet-delivered CBT

Intervention Type BEHAVIORAL

Internet-delivered cognitive behavioral therapy with therapist support.

Interventions

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Internet-delivered CBT

Internet-delivered cognitive behavioral therapy with therapist support.

Intervention Type BEHAVIORAL

Therapist support

Weekly therapist support without CBT-interventions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Psykiatri Sydväst

Principal Investigators

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Nils Lindefors, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Internetpsykatrienheten, M46, Psykiatri sydväst

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT
PMID: 20362976 (View on PubMed)

Other Identifiers

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IBS-S

Identifier Type: -

Identifier Source: org_study_id

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