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Use of Expressive Writing in Irritable Bowel Syndrome (IBS)

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Expressive Writing
Control Writing
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of Irritable Bowel syndrome

Exclusion Criteria:

  • Non-English Speakers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Expressive Writing

    Control Writing

    Usual Care

    Arm Description

    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.

    The participants were instructed to write for 30-minute intervals for 4 consecutive days about all of the actions they performed that day for a 24 hour period. The subjects were asked not to write about their feelings or thoughts related to these actions.

    Subjects in this group did not receive an intervention. They filled out measures at baseline, 1 month, and 3 month follow-up time periods.

    Outcomes

    Primary Outcome Measures

    IBS-Specific Quality of Life (IBS-QOL)
    IBSQOL is a measure of IBS - specific quality of life.

    Secondary Outcome Measures

    CT3
    Measure of health-related cognition (catastrophizing or maladaptive coping,and patients' perceived ability to control symptoms)
    Health care Utilization (HCU)
    HCU is a measure of frequency and type of health care received for IBS
    IBSSS
    IBSSS provides a disease severity measure
    Demographics (DEM-MED)
    Demographic information
    Cognitive Scale for Functional Bowel Disorders (CGFBD)
    Measure of IBS related cognitions.
    Writing Evaluation Questionnaire (WEQ)
    The WEQ measure obtains subjects' reflections about their writing experience.

    Full Information

    First Posted
    August 12, 2010
    Last Updated
    March 14, 2017
    Sponsor
    Boston University
    Collaborators
    Takeda Pharmaceuticals North America, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01192672
    Brief Title
    Use of Expressive Writing in Irritable Bowel Syndrome (IBS)
    Official Title
    Use of Expressive Writing in Irritable Bowel Syndrome (IBS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2008 (Actual)
    Primary Completion Date
    September 2010 (Actual)
    Study Completion Date
    November 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boston University
    Collaborators
    Takeda Pharmaceuticals North America, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    197 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Expressive Writing
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Writing
    Arm Type
    Active Comparator
    Arm Description
    The participants were instructed to write for 30-minute intervals for 4 consecutive days about all of the actions they performed that day for a 24 hour period. The subjects were asked not to write about their feelings or thoughts related to these actions.
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    Subjects in this group did not receive an intervention. They filled out measures at baseline, 1 month, and 3 month follow-up time periods.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Expressive Writing
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control Writing
    Intervention Description
    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 Outcome Measure Information:
    Title
    IBS-Specific Quality of Life (IBS-QOL)
    Description
    IBSQOL is a measure of IBS - specific quality of life.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    CT3
    Description
    Measure of health-related cognition (catastrophizing or maladaptive coping,and patients' perceived ability to control symptoms)
    Time Frame
    3 months
    Title
    Health care Utilization (HCU)
    Description
    HCU is a measure of frequency and type of health care received for IBS
    Time Frame
    3 months
    Title
    IBSSS
    Description
    IBSSS provides a disease severity measure
    Time Frame
    3 months
    Title
    Demographics (DEM-MED)
    Description
    Demographic information
    Time Frame
    Baseline
    Title
    Cognitive Scale for Functional Bowel Disorders (CGFBD)
    Description
    Measure of IBS related cognitions.
    Time Frame
    3 months
    Title
    Writing Evaluation Questionnaire (WEQ)
    Description
    The WEQ measure obtains subjects' reflections about their writing experience.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of Irritable Bowel syndrome Exclusion Criteria: Non-English Speakers
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Albena Halpert, MD
    Organizational Affiliation
    Boston University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Use of Expressive Writing in Irritable Bowel Syndrome (IBS)

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