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Completed

NCT Number: NCT01051973

Cognitive Behavior Therapy (CBT) Compared to Stress Management for Irritable Bowel Syndrome

The study aims to compare two manualized treatments. They are based on cognitive behavior therapy or stress management. Both treatments are delivered via an internet application and the patients' work with the treatments is supported through online contact with a therapist. The treatments last for 10 weeks.

Approximately 200 patients will be included in the study and randomized to either condition.

The study hypothesis is that CBT will be superior to stress management on the main outcome measure, which is IBS symptom severity measured over 4 weeks.

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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, M57, Psykiatri sydväst

Stockholm, 181 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

Cognitive Behavior Therapy

Behavioral

A 10-week treatment based on exposure to symptoms and related feelings.

Stress Management

Behavioral

A 10-week stress management treatment including applied relaxation and dietary advice.

Primary outcomes

  1. Level of IBS symptoms

    Time frame: During 4 consecutive weeks before randomization

    The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.

  2. Level of IBS symptoms

    Time frame: During 4 consecutive weeks after treatment completion (10 weeks after randomization)

    The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.

  3. Level of IBS symptoms

    Time frame: During 4 consecutive weeks 6 months after treatment completion

    The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.

Secondary outcomes

  1. Quality of life

    Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion

    The Irritable Bowel Syndrome Quality of Life Instrument

  2. Use of health care resources and societal production loss because of illness

    Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion

    Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry

  3. Level of IBS-symptoms

    Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion

    IBS-Severity Scoring System

  4. Anxiety related to gastrointestinal symptoms

    Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion

    Visceral Sensitivity Index

  5. Level of daily stress

    Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion

    Perceived stress scale

  6. Subjective relief of IBS-symptoms

    Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion

    One question: "In the past week, have you had adequate relief from IBS pain or discomfort?"

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Internet-delivered Cognitive Behavior Therapy Compared to Stress Management in the Treatment of Irritable Bowel Syndrome - A Randomized Controlled Study.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 20, 2010
Registry last updated
Jan 5, 2012

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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