Psychobiology in Inflammatory Bowel Disease(IBD)
- Conditions
- Inflammatory Bowel Disease
- Registration Number
- NCT00248742
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
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.
- Detailed Description
The study includes distressed patients with ulcerous colitis and Crohn's disease with relapse or enduring activity last 18 months and an simple activity index ≥4, on stable medication last 4 weeks. All patients were followed by a gastroenterologist at baseline, 3, 6, 12 and 18 months follow up and a psychiatrist or clinical psychologist at 18 months. Half of the patients received additional psychosocial intervention (education, relaxation, supportive psychotherapy with stress management). Assessments include gastrointestinal assessments; blood tests; psychiatric evaluations and psychometric evaluations.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Improvement in activity index. 18 months
- Secondary Outcome Measures
Name Time Method Reduction of inflammatory parameters. 18 months Reduction in number of relapses. 18 months Quality of life improvement 18 months Psychobiological factors related to improvement 18 months
Trial Locations
- Locations (1)
RRHF
🇳🇴Oslo, Norway