Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248742
Status:
COMPLETED
Last Update Posted:
2011-07-06
First Post:
2005-11-03
Brief Title:
Psychobiology in Inflammatory Bowel DiseaseIBD
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
The Impact of Psychobiological Factors in Inflammatory Bowel Disease
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSPIRE
Brief Summary:
Patients with ulcerous colitis and Crohns 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 Crohns 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005188-2 FBB- | None | None | None |