Use of Expressive Writing in Irritable Bowel Syndrome (IBS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Expressive Writing in Irritable Bowel Syndrome (IBS)

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: Expressive Writing
* Behavioral: Control Writing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Irritable Bowel syndrome Exclusion Criteria: Non-English Speakers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expressive Writing<br>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<br>* 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.<br>|
| Active Comparator: Control Writing<br>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<br>* 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.<br>|
| No Intervention: Usual Care<br>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?
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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 |