Use of Expressive Writing in Irritable Bowel Syndrome (IBS)

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT01192672
• Lead Sponsor: Boston University

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2010-08-12
• Study First Submitted QC: 2010-08-31
• Primary Completion: 2010-09
• Study First Posted: 2010-09-01
• Study Completion: 2010-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

Inclusion Criteria

• Clinical diagnosis of Irritable Bowel syndrome

Exclusion Criteria

• Non-English Speakers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
IBS-Specific Quality of Life (IBS-QOL)	3 months	IBSQOL is a measure of IBS - specific quality of life.

Secondary Outcome Measures

Name	Time	Method
Health care Utilization (HCU)	3 months	HCU is a measure of frequency and type of health care received for IBS
IBSSS	3 months	IBSSS provides a disease severity measure
CT3	3 months	Measure of health-related cognition (catastrophizing or maladaptive coping,and patients' perceived ability to control symptoms)
Demographics (DEM-MED)	Baseline	Demographic information
Cognitive Scale for Functional Bowel Disorders (CGFBD)	3 months	Measure of IBS related cognitions.
Writing Evaluation Questionnaire (WEQ)	3 months	The WEQ measure obtains subjects' reflections about their writing experience.