Inflammatory Bowel Disease Clinical Trial
— INSPIREOfficial title:
The Impact of Psychobiological Factors in Inflammatory Bowel Disease
Patients with ulcerous colitis and Crohn's disease, age 18-60, with a relapse within the last 18 months and an activity index ≥4, with a long time stress level ≥60 on the perceived stress questionnaire (PSQ) were randomized to a stress management intervention program or treatment as usual and followed up for 18 months.
Status | Completed |
Enrollment | 114 |
Est. completion date | December 2006 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility | Ulcerous colitis and Crohn's disease verified by histology and endoscope Relapse last 18 months or enduring activity Activity index=4 PSQ=60 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | RRHF | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Haukeland University Hospital, Lübeck University Clinic, University Hospital, Aker, University Hospital, Akershus, University of Bergen |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in activity index. | 18 months | No | |
Secondary | Reduction of inflammatory parameters. | 18 months | No | |
Secondary | Reduction in number of relapses. | 18 months | No | |
Secondary | Quality of life improvement | 18 months | No | |
Secondary | Psychobiological factors related to improvement | 18 months | No |
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