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

July 26, 2010
July 27, 2010
June 2008
June 2010   (final data collection date for primary outcome measure)
  • 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)
Same as current
Complete list of historical versions of study NCT01171053 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Internet-delivered CBT for Irritable Bowel Syndrome
Internet-delivered Exposure and Mindfulness Based Therapy for Irritable Bowel Syndrome - A Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Irritable Bowel Syndrome
  • Behavioral: Internet-delivered CBT
    Internet-delivered cognitive behavioral therapy with therapist support.
  • Behavioral: Therapist support
    Weekly therapist support without CBT-interventions
  • Placebo Comparator: Attention control
    Weekly support from therapist without CBT-interventions
    Intervention: Behavioral: Therapist support
  • Experimental: Internet CBT
    Internet-delivered cognitive behavioral therapy with therapist support
    Intervention: Behavioral: Internet-delivered CBT
Ljótsson B, Falk L, Vesterlund AW, Hedman E, Lindfors P, Rück C, Hursti T, Andréewitch S, Jansson L, Lindefors N, Andersson G. Internet-delivered exposure and mindfulness based therapy for irritable bowel syndrome--a randomized controlled trial. Behav Res Ther. 2010 Jun;48(6):531-9. doi: 10.1016/j.brat.2010.03.003. Epub 2010 Mar 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01171053
IBS-S
No
Nils Lindefors, Psykiatri Sydväst
Karolinska Institutet
Stockholm County Council, Sweden
Principal Investigator: Nils Lindefors, PhD Karolinska Institutet, Sweden
Karolinska Institutet
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP