Use of Expressive Writing in Irritable Bowel Syndrome (IBS)
1 other identifier
interventional
197
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2008
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 12, 2010
CompletedFirst Posted
Study publicly available on registry
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedMarch 15, 2017
March 1, 2017
2 years
August 12, 2010
March 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
IBS-Specific Quality of Life (IBS-QOL)
IBSQOL is a measure of IBS - specific quality of life.
3 months
Secondary Outcomes (6)
CT3
3 months
Health care Utilization (HCU)
3 months
IBSSS
3 months
Demographics (DEM-MED)
Baseline
Cognitive Scale for Functional Bowel Disorders (CGFBD)
3 months
- +1 more secondary outcomes
Study Arms (3)
Expressive Writing
EXPERIMENTALSubjects 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
ACTIVE COMPARATORThe 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.
Usual Care
NO INTERVENTIONSubjects in this group did not receive an intervention. They filled out measures at baseline, 1 month, and 3 month follow-up time periods.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Irritable Bowel syndrome
You may not qualify if:
- Non-English Speakers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Universitylead
- Takeda Pharmaceuticals North America, Inc.collaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Albena Halpert, MD
Boston University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2010
First Posted
September 1, 2010
Study Start
September 1, 2008
Primary Completion
September 1, 2010
Study Completion
November 1, 2010
Last Updated
March 15, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share