Use of Expressive Writing in Irritable Bowel Syndrome (IBS)

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

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Behavioral: Expressive Writing; Behavioral: Control Writing

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 Type: Interventional
• Enrollment (Actual): 197
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of Irritable Bowel syndrome

Exclusion Criteria:

• Non-English Speakers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS-Specific Quality of Life (IBS-QOL)	IBSQOL is a measure of IBS - specific quality of life.	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Takeda Pharmaceuticals North America, Inc.
• Investigators: Principal Investigator: Albena Halpert, MD, Boston University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2008
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: August 12, 2010
• First Submitted That Met QC Criteria: August 31, 2010
• First Posted (Estimate): September 1, 2010

Study Record Updates

• Last Update Posted (Actual): March 15, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 4764-8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO