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Completed

NCT Number: NCT01529567

Cognitive Behavioral Therapy With Our Without Exposure Therapy for Irritable Bowel Syndrome

Patients with a diagnosis of irritable bowel syndrome (IBS) are recruited by self-referral. They are randomized to two 10 weeks of internet-delivered cognitive behavioral programs. Both programs include mindfulness training, education about how excessive avoidant and control behaviors maintain IBS symptoms, and changing of these behaviors to live a richer life. One of the programs also includes instructions on how to perform systematic exposure. The hypothesis of the study is while both groups will show improvement in terms of IBS symptom severity and quality of life, the addition of systematic exposure will lead to more improvement in symptoms.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Fluency in Swedish
  • IBS-diagnosis established by physician
  • Fulfillment of Rome III criteria for IBS

Exclusion criteria

  • Diarrhea predominance with no colonoscopy performed
  • Blood in stool without benign medical explanation
  • Rapid weight loss without benign medical explanation
  • Ongoing alcohol or drug abuse
  • Suicidal ideation

Treatment and study plan

Cognitive Behavioral Therapy without exposure

Behavioral

10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, and guided behavioral change aiming to increase quality of life and flexibility.

Cognitive Behavioral Therapy with exposure

Behavioral

10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, guided behavioral change aiming to increase quality of life and flexibility, and systematic exposure to IBS symptoms and aversive situations.

Primary outcomes

  1. Gastrointestinal symptom rating scale

    Time frame: 1 week before randomization

  2. Gastrointestinal symptom rating scale

    Time frame: 10 weeks after randomization (i.e. after conclusion of treatment)

  3. Gastrointestinal symptom rating scale

    Time frame: 36 weeks after randomization (i.e. 6 months after conclusion of treatment)

Secondary outcomes

  1. Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)

    Time frame: 1 week before randomization

  2. Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)

    Time frame: 10 weeks after randomization (i.e. after conclusion of treatment)

  3. Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)

    Time frame: 36 weeks after randomization (i.e. 6 months after conclusion of treatment)

  4. Visceral Sensitivity Index (VSI)

    Time frame: 1 week before randomization

  5. Visceral Sensitivity Index (VSI)

    Time frame: 10 weeks after randomization (i.e. after conclusion of treatment)

  6. Visceral Sensitivity Index (VSI)

    Time frame: 36 weeks after randomization (i.e. 6 months after conclusion of treatment)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 9, 2012
Registry last updated
Feb 15, 2013

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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