Use of Expressive Writing in Irritable Bowel Syndrome (IBS)

NCT ID: NCT01192672

Last Updated: 2017-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-11-30

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Expressive Writing

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Control Writing

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of Irritable Bowel syndrome

Exclusion Criteria

• Non-English Speakers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda Pharmaceuticals North America, Inc.

INDUSTRY

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albena Halpert, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Other Identifiers

4764-8

Identifier Type: -

Identifier Source: org_study_id