Irritable Bowel Syndrome
Conditions
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.
Interventions
BEHAVIORALExpressive 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.
BEHAVIORALControl 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.
Sponsors
Takeda Pharmaceuticals North America, Inc.
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Irritable Bowel syndrome
Exclusion criteria
* Non-English Speakers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IBS-Specific Quality of Life (IBS-QOL) | 3 months | IBSQOL is a measure of IBS - specific quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health care Utilization (HCU) | 3 months | HCU is a measure of frequency and type of health care received for IBS |
| IBSSS | 3 months | IBSSS provides a disease severity measure |
| CT3 | 3 months | Measure of health-related cognition (catastrophizing or maladaptive coping,and patients' perceived ability to control symptoms) |
| Cognitive Scale for Functional Bowel Disorders (CGFBD) | 3 months | Measure of IBS related cognitions. |
| Writing Evaluation Questionnaire (WEQ) | 3 months | The WEQ measure obtains subjects' reflections about their writing experience. |
| Demographics (DEM-MED) | Baseline | Demographic information |
Outcome results
None listed