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Use of Expressive Writing in Irritable Bowel Syndrome (IBS)

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01192672
First received: August 12, 2010
Last updated: March 14, 2017
Last verified: March 2017
  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: Participant
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 ]
    IBSQOL is a measure of IBS - specific quality of life.


Secondary Outcome Measures:
  • CT3 [ Time Frame: 3 months ]
    Measure of health-related cognition (catastrophizing or maladaptive coping,and patients' perceived ability to control symptoms)

  • Health care Utilization (HCU) [ Time Frame: 3 months ]
    HCU is a measure of frequency and type of health care received for IBS

  • IBSSS [ Time Frame: 3 months ]
    IBSSS provides a disease severity measure

  • Demographics (DEM-MED) [ Time Frame: Baseline ]
    Demographic information

  • Cognitive Scale for Functional Bowel Disorders (CGFBD) [ Time Frame: 3 months ]
    Measure of IBS related cognitions.

  • Writing Evaluation Questionnaire (WEQ) [ Time Frame: 3 months ]
    The WEQ measure obtains subjects' reflections about their writing experience.


Enrollment: 197
Actual Study Start Date: September 2008
Study Completion Date: November 2010
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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01192672     History of Changes
Other Study ID Numbers: 4764-8
Study First Received: August 12, 2010
Last Updated: March 14, 2017
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on June 26, 2017