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Completed

NCT Number: NCT01192672

Use of Expressive Writing in Irritable Bowel Syndrome (IBS)

The purpose of this study is to test whether disease-related expressive writing is effective in the treatment of Irritable Bowel Syndrome (IBS).

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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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Expressive writing involves writing about traumatic, stressful or emotional events. Expressive writing, for as little as 3-5 sessions of 20 minutes, has been found to improve both physical and psychological health based on health outcome measures such as number of doctor's visits and hospital days, blood pressure control, lung and immune function, and pain. Given its simplicity, and obvious advantages in terms of cost efficiency, expressive writing appears to have great potential as a therapeutic tool or as a means of self-help, either alone or as an adjunct to traditional therapies. This modality has not been studied in irritable bowel syndrome (IBS), a common gastrointestinal condition, which is lacking well-defined etiology or treatments and is best understood in a biopsychosocial context.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of Irritable Bowel syndrome

Exclusion criteria

  • Non-English Speakers

Treatment and study plan

Expressive writing

Behavioral

Subjects in the Intervention were instructed to write for 30-minute intervals for 4 consecutive days about their deepest thoughts and feelings related to their Irritable Bowel Syndrome.

Control Writing

Behavioral

Subjects were asked to write about the actions they performed during the last 24 hours. They were asked not to write about their feelings or thoughts related to these actions.

Primary outcomes

  1. IBS-Specific Quality of Life (IBS-QOL)

    Time frame: 3 months

    IBSQOL is a measure of IBS - specific quality of life.

Secondary outcomes

  1. CT3

    Time frame: 3 months

    Measure of health-related cognition (catastrophizing or maladaptive coping,and patients' perceived ability to control symptoms)

  2. Health care Utilization (HCU)

    Time frame: 3 months

    HCU is a measure of frequency and type of health care received for IBS

  3. IBSSS

    Time frame: 3 months

    IBSSS provides a disease severity measure

  4. Demographics (DEM-MED)

    Time frame: Baseline

    Demographic information

  5. Cognitive Scale for Functional Bowel Disorders (CGFBD)

    Time frame: 3 months

    Measure of IBS related cognitions.

  6. Writing Evaluation Questionnaire (WEQ)

    Time frame: 3 months

    The WEQ measure obtains subjects' reflections about their writing experience.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Takeda Pharmaceuticals North America, Inc.

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 1, 2010
Registry last updated
Mar 15, 2017

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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