Use of Expressive Writing in Irritable Bowel Syndrome (IBS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Boston University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT01192672
First received: August 12, 2010
Last updated: August 31, 2010
Last verified: August 2010
  Purpose

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


Condition Intervention
Irritable Bowel Syndrome
Behavioral: Expressive Writing
Behavioral: Control Writing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Use of Expressive Writing in Irritable Bowel Syndrome (IBS)

Further study details as provided by Boston University:

Primary Outcome Measures:
  • IBS-Specific Quality of Life (IBS-QOL) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    IBSQOL is a measure of IBS - specific quality of life.


Secondary Outcome Measures:
  • CT3 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measure of health-related cognition (catastrophizing or maladaptive coping,and patients' perceived ability to control symptoms)

  • Health care Utilization (HCU) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    HCU is a measure of frequency and type of health care received for IBS

  • IBSSS [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    IBSSS provides a disease severity measure

  • Demographics (DEM-MED) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Demographic information

  • Cognitive Scale for Functional Bowel Disorders (CGFBD) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measure of IBS related cognitions.

  • Writing Evaluation Questionnaire (WEQ) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The WEQ measure obtains subjects' reflections about their writing experience.


Estimated Enrollment: 383
Study Start Date: September 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Expressive Writing
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.
Behavioral: Expressive Writing
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.
Active Comparator: Control Writing
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.
Behavioral: Control Writing
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.
No Intervention: Usual Care
Subjects in this group did not receive an intervention. They filled out measures at baseline, 1 month, and 3 month follow-up time periods.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Irritable Bowel syndrome

Exclusion Criteria:

  • Non-English Speakers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192672

Sponsors and Collaborators
Boston University
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: Albena Halpert, MD Boston University
  More Information

No publications provided

Responsible Party: Albena Halpert, MD Principal Investigator, Boston University School of Medicine
ClinicalTrials.gov Identifier: NCT01192672     History of Changes
Other Study ID Numbers: 4764-8
Study First Received: August 12, 2010
Last Updated: August 31, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014