NCT00844961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

November 9, 2011

Status Verified

February 1, 2009

Enrollment Period

2.3 years

First QC Date

February 13, 2009

Last Update Submit

November 8, 2011

Conditions

Irritable Bowel Syndrome

Keywords

IBSCBTInternet treatmentCognitive behavior therapy

Outcome Measures

Primary Outcomes (3)

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

    Before treatment

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

    After treatment

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

    12 months after treatment

Study Arms (2)

Internet CBT

EXPERIMENTAL

10 weeks of internet delivered cognitive behaviour therapy

Behavioral: Internet delivered cognitive behavior therapy

Waiting list

NO INTERVENTION

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

Interventions

Internet delivered cognitive behavior therapyBEHAVIORAL

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.

Also known as: CBT
Internet CBT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Irritable Bowel Syndrome according to Rome III criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internetpsykatrienheten, M57, Psykiatri sydväst

Stockholm, 181 86, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 21992655DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Nils Lindefors, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2009

First Posted

February 16, 2009

Study Start

November 1, 2008

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

November 9, 2011

Record last verified: 2009-02

Locations

SE(1)