Internet-delivered CBT for Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01171053
First received: July 26, 2010
Last updated: July 27, 2010
Last verified: July 2010
  Purpose

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 Intervention
Irritable Bowel Syndrome
Behavioral: Internet-delivered CBT
Behavioral: Therapist support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internet-delivered Exposure and Mindfulness Based Therapy for Irritable Bowel Syndrome - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Gastrointestinal symptoms [ Time Frame: One week before the treatment starts ] [ Designated as safety issue: No ]
    Gastrointestinal Symptom rating scale (GSRS)

  • Gastrointestinal symptoms [ Time Frame: 10 weeks after the treatment started ] [ Designated as safety issue: No ]
    Gastrointestinal Symptom rating scale (GSRS)

  • Gastrointestinal symptoms [ Time Frame: 3 months after the treatment ended ] [ Designated as safety issue: No ]
    Gastrointestinal Symptom rating scale (GSRS)

  • Gastrointestinal symptoms [ Time Frame: One year after the treatment ended ] [ Designated as safety issue: No ]
    Gastrointestinal Symptom rating scale (GSRS)


Secondary Outcome Measures:
  • Health economic data [ Time Frame: One week before the treatment starts ] [ Designated as safety issue: No ]
    "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.

  • Health economic data [ Time Frame: 10 weeks after the treatment started ] [ Designated as safety issue: No ]
    "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.

  • Health economic data [ Time Frame: 3 months after the treatment ended ] [ Designated as safety issue: No ]
    "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.

  • Health economic data [ Time Frame: One year after the treatment ended ] [ Designated as safety issue: No ]
    "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.

  • Quality of life [ Time Frame: One week before the treatment starts ] [ Designated as safety issue: No ]
    The Irritable Bowel Syndrome Quality of Life Instrument

  • Quality of life [ Time Frame: 10 weeks after the treatment started ] [ Designated as safety issue: No ]
    The Irritable Bowel Syndrome Quality of Life Instrument

  • Quality of life [ Time Frame: 3 months after the treatment ended ] [ Designated as safety issue: No ]
    The Irritable Bowel Syndrome Quality of Life Instrument

  • Quality of life [ Time Frame: One year after the treatment ended ] [ Designated as safety issue: No ]
    The Irritable Bowel Syndrome Quality of Life Instrument

  • Gastrointestinal symptom-specific anxiety [ Time Frame: One week before the treatment starts ] [ Designated as safety issue: No ]
    Visceral Sensitivity Index

  • Gastrointestinal symptom-specific anxiety [ Time Frame: 10 weeks after the treatment started ] [ Designated as safety issue: No ]
    Visceral Sensitivity Index

  • Gastrointestinal symptom-specific anxiety [ Time Frame: 3 months after the treatment ended ] [ Designated as safety issue: No ]
    Visceral Sensitivity Index

  • Gastrointestinal symptom-specific anxiety [ Time Frame: One year after the treatment ended ] [ Designated as safety issue: No ]
    Visceral Sensitivity Index

  • Depressive symptoms [ Time Frame: One week before the treatment starts ] [ Designated as safety issue: No ]
    The Montgomery Åsberg Depression Rating Scale

  • Depressive symptoms [ Time Frame: 10 weeks after the treatment started ] [ Designated as safety issue: No ]
    The Montgomery Åsberg Depression Rating Scale

  • Depressive symptoms [ Time Frame: 3 months after the treatment ended ] [ Designated as safety issue: No ]
    The Montgomery Åsberg Depression Rating Scale

  • Depressive symptoms [ Time Frame: One year after the treatment ended ] [ Designated as safety issue: No ]
    The Montgomery Åsberg Depression Rating Scale

  • Functional impairments in work, social and family life [ Time Frame: One week before the treatment starts ] [ Designated as safety issue: No ]
    Sheenan Disability Scale (DSD)

  • Functional impairments in work, social and family life [ Time Frame: 10 weeks after the treatment started ] [ Designated as safety issue: No ]
    Sheenan Disability Scale (DSD)

  • Functional impairments in work, social and family life [ Time Frame: 3 months after the treatment ended ] [ Designated as safety issue: No ]
    Sheenan Disability Scale (DSD)

  • Functional impairments in work, social and family life [ Time Frame: One year after the treatment ended ] [ Designated as safety issue: No ]
    Sheenan Disability Scale (DSD)


Enrollment: 86
Study Start Date: June 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Sweden
  More Information

Publications:
Responsible Party: Nils Lindefors, Psykiatri Sydväst
ClinicalTrials.gov Identifier: NCT01171053     History of Changes
Other Study ID Numbers: IBS-S
Study First Received: July 26, 2010
Last Updated: July 27, 2010
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on August 20, 2014