Use of Expressive Writing in Irritable Bowel Syndrome (IBS)

Irritable Bowel Syndrome Clinical Trial

Official title:

Use of Expressive Writing in Irritable Bowel Syndrome (IBS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192672
• Other study ID #: 4764-8
• Status: Completed
• Phase: N/A
• First received: August 12, 2010
• Last updated: March 14, 2017
• Start date: September 2008
• Est. completion date: November 2010

Study information

• Verified date: March 2017
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Irritable Bowel syndrome

Exclusion Criteria:

• Non-English Speakers

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	Takeda Pharmaceuticals North America, Inc.

Outcome

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