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Completed

NCT Number: NCT01171053

Internet-delivered CBT for Irritable Bowel Syndrome

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.

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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

Primary location

Internetpsykatrienheten, M46, Psykiatri sydväst

Stockholm, 141 86, Sweden

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Internet-delivered CBT

Behavioral

Internet-delivered cognitive behavioral therapy with therapist support.

Therapist support

Behavioral

Weekly therapist support without CBT-interventions

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Internet-delivered Exposure and Mindfulness Based Therapy for Irritable Bowel Syndrome - A Randomized Controlled Trial

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 28, 2010
Registry last updated
Jul 28, 2010

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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