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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy without exposure
Cognitive Behavioral Therapy with exposure
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    CBT without exposure

    CBT with exposure

    Arm Description

    Outcomes

    Primary Outcome Measures

    Gastrointestinal symptom rating scale
    Gastrointestinal symptom rating scale
    Gastrointestinal symptom rating scale

    Secondary Outcome Measures

    Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
    Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
    Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
    Visceral Sensitivity Index (VSI)
    Visceral Sensitivity Index (VSI)
    Visceral Sensitivity Index (VSI)

    Full Information

    First Posted
    February 6, 2012
    Last Updated
    February 14, 2013
    Sponsor
    Karolinska Institutet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01529567
    Brief Title
    Cognitive Behavioral Therapy With Our Without Exposure Therapy for Irritable Bowel Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska Institutet

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    311 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CBT without exposure
    Arm Type
    Active Comparator
    Arm Title
    CBT with exposure
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Behavioral Therapy without exposure
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Behavioral Therapy with exposure
    Intervention Description
    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 Outcome Measure Information:
    Title
    Gastrointestinal symptom rating scale
    Time Frame
    1 week before randomization
    Title
    Gastrointestinal symptom rating scale
    Time Frame
    10 weeks after randomization (i.e. after conclusion of treatment)
    Title
    Gastrointestinal symptom rating scale
    Time Frame
    36 weeks after randomization (i.e. 6 months after conclusion of treatment)
    Secondary Outcome Measure Information:
    Title
    Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
    Time Frame
    1 week before randomization
    Title
    Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
    Time Frame
    10 weeks after randomization (i.e. after conclusion of treatment)
    Title
    Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
    Time Frame
    36 weeks after randomization (i.e. 6 months after conclusion of treatment)
    Title
    Visceral Sensitivity Index (VSI)
    Time Frame
    1 week before randomization
    Title
    Visceral Sensitivity Index (VSI)
    Time Frame
    10 weeks after randomization (i.e. after conclusion of treatment)
    Title
    Visceral Sensitivity Index (VSI)
    Time Frame
    36 weeks after randomization (i.e. 6 months after conclusion of treatment)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brjánn Ljótsson, PhD
    Organizational Affiliation
    Karolinska Institutet
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34256715
    Citation
    Wallen H, Lindfors P, Andersson E, Hedman-Lagerlof E, Hesser H, Lindefors N, Svanborg C, Ljotsson B. Return on investment of internet delivered exposure therapy for irritable bowel syndrome: a randomized controlled trial. BMC Gastroenterol. 2021 Jul 13;21(1):289. doi: 10.1186/s12876-021-01867-6.
    Results Reference
    derived

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

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