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Completed

NCT Number: NCT00844961

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Internetpsykatrienheten, M57, Psykiatri sydväst

Stockholm, 181 86, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet delivered cognitive behavior therapy

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.

Other names: CBT

Primary outcomes

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

    Time frame: Before treatment

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

    Time frame: After treatment

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

    Time frame: 12 months after treatment

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 16, 2009
Registry last updated
Nov 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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