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Internet-delivered CBT for Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT01171053
Recruitment Status : Completed
First Posted : July 28, 2010
Last Update Posted : July 28, 2010
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by:
Karolinska Institutet

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Behavioral: Internet-delivered CBT Behavioral: Therapist support Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-delivered Exposure and Mindfulness Based Therapy for Irritable Bowel Syndrome - A Randomized Controlled Trial
Study Start Date : June 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Placebo Comparator: Attention control
Weekly support from therapist without CBT-interventions
Behavioral: Therapist support
Weekly therapist support without CBT-interventions

Experimental: Internet CBT
Internet-delivered cognitive behavioral therapy with therapist support
Behavioral: Internet-delivered CBT
Internet-delivered cognitive behavioral therapy with therapist support.




Primary Outcome Measures :
  1. Gastrointestinal symptoms [ Time Frame: One week before the treatment starts ]
    Gastrointestinal Symptom rating scale (GSRS)

  2. Gastrointestinal symptoms [ Time Frame: 10 weeks after the treatment started ]
    Gastrointestinal Symptom rating scale (GSRS)

  3. Gastrointestinal symptoms [ Time Frame: 3 months after the treatment ended ]
    Gastrointestinal Symptom rating scale (GSRS)

  4. Gastrointestinal symptoms [ Time Frame: One year after the treatment ended ]
    Gastrointestinal Symptom rating scale (GSRS)


Secondary Outcome Measures :
  1. Health economic data [ Time Frame: One week before the treatment starts ]
    "Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry". In this questionnaire, patients register their monthly health care consumption (e.g. GP visits) as well as time spent in informal health enhancing activities (e.g. self-help groups and informal care from friends). In addition, work loss and work cutback both at work and in the domestic realm is measured.

  2. Health economic data [ Time Frame: 10 weeks after the treatment started ]
    "Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry". In this questionnaire, patients register their monthly health care consumption (e.g. GP visits) as well as time spent in informal health enhancing activities (e.g. self-help groups and informal care from friends). In addition, work loss and work cutback both at work and in the domestic realm is measured.

  3. Health economic data [ Time Frame: 3 months after the treatment ended ]
    "Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry". In this questionnaire, patients register their monthly health care consumption (e.g. GP visits) as well as time spent in informal health enhancing activities (e.g. self-help groups and informal care from friends). In addition, work loss and work cutback both at work and in the domestic realm is measured.

  4. Health economic data [ Time Frame: One year after the treatment ended ]
    "Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry". In this questionnaire, patients register their monthly health care consumption (e.g. GP visits) as well as time spent in informal health enhancing activities (e.g. self-help groups and informal care from friends). In addition, work loss and work cutback both at work and in the domestic realm is measured.

  5. Quality of life [ Time Frame: One week before the treatment starts ]
    The Irritable Bowel Syndrome Quality of Life Instrument

  6. Quality of life [ Time Frame: 10 weeks after the treatment started ]
    The Irritable Bowel Syndrome Quality of Life Instrument

  7. Quality of life [ Time Frame: 3 months after the treatment ended ]
    The Irritable Bowel Syndrome Quality of Life Instrument

  8. Quality of life [ Time Frame: One year after the treatment ended ]
    The Irritable Bowel Syndrome Quality of Life Instrument

  9. Gastrointestinal symptom-specific anxiety [ Time Frame: One week before the treatment starts ]
    Visceral Sensitivity Index

  10. Gastrointestinal symptom-specific anxiety [ Time Frame: 10 weeks after the treatment started ]
    Visceral Sensitivity Index

  11. Gastrointestinal symptom-specific anxiety [ Time Frame: 3 months after the treatment ended ]
    Visceral Sensitivity Index

  12. Gastrointestinal symptom-specific anxiety [ Time Frame: One year after the treatment ended ]
    Visceral Sensitivity Index

  13. Depressive symptoms [ Time Frame: One week before the treatment starts ]
    The Montgomery Åsberg Depression Rating Scale

  14. Depressive symptoms [ Time Frame: 10 weeks after the treatment started ]
    The Montgomery Åsberg Depression Rating Scale

  15. Depressive symptoms [ Time Frame: 3 months after the treatment ended ]
    The Montgomery Åsberg Depression Rating Scale

  16. Depressive symptoms [ Time Frame: One year after the treatment ended ]
    The Montgomery Åsberg Depression Rating Scale

  17. Functional impairments in work, social and family life [ Time Frame: One week before the treatment starts ]
    Sheenan Disability Scale (DSD)

  18. Functional impairments in work, social and family life [ Time Frame: 10 weeks after the treatment started ]
    Sheenan Disability Scale (DSD)

  19. Functional impairments in work, social and family life [ Time Frame: 3 months after the treatment ended ]
    Sheenan Disability Scale (DSD)

  20. Functional impairments in work, social and family life [ Time Frame: One year after the treatment ended ]
    Sheenan Disability Scale (DSD)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171053


Locations
Sweden
Internetpsykatrienheten, M46, Psykiatri sydväst
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Investigators
Principal Investigator: Nils Lindefors, PhD Karolinska Institutet

Publications of Results:
Responsible Party: Nils Lindefors, Psykiatri Sydväst
ClinicalTrials.gov Identifier: NCT01171053     History of Changes
Other Study ID Numbers: IBS-S
First Posted: July 28, 2010    Key Record Dates
Last Update Posted: July 28, 2010
Last Verified: July 2010

Keywords provided by Karolinska Institutet:
Cognitive behavior therapy
Internet
Cost-effectiveness
Irritable bowel syndrome

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases