Overview

This trial is active, not recruiting.

Condition irritable bowel syndrome
Treatments expressive writing, control writing
Sponsor Boston University
Collaborator Takeda Pharmaceuticals North America, Inc.
Start date September 2008
End date September 2010
Trial size 383 participants
Trial identifier NCT01192672, 4764-8

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
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.
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)
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.
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)
Subjects in this group did not receive an intervention. They filled out measures at baseline, 1 month, and 3 month follow-up time periods.

Primary Outcomes

Measure
IBS-Specific Quality of Life (IBS-QOL)
time frame: 3 months

Secondary Outcomes

Measure
CT3
time frame: 3 months
Health care Utilization (HCU)
time frame: 3 months
IBSSS
time frame: 3 months
Demographics (DEM-MED)
time frame: Baseline
Cognitive Scale for Functional Bowel Disorders (CGFBD)
time frame: 3 months
Writing Evaluation Questionnaire (WEQ)
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Clinical diagnosis of Irritable Bowel syndrome Exclusion Criteria: - Non-English Speakers

Additional Information

Official title Use of Expressive Writing in Irritable Bowel Syndrome (IBS)
Principal investigator Albena Halpert, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by Boston University.