- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00248742
Psychobiology in Inflammatory Bowel Disease(IBD) (INSPIRE)
July 3, 2011 updated by: Oslo University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Oslo, Norway, 0027
- RRHF
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Ulcerous colitis and Crohn's disease verified by histology and endoscope Relapse last 18 months or enduring activity Activity index≥4 PSQ≥60
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in activity index.
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of inflammatory parameters.
Time Frame: 18 months
|
18 months
|
Reduction in number of relapses.
Time Frame: 18 months
|
18 months
|
Quality of life improvement
Time Frame: 18 months
|
18 months
|
Psychobiological factors related to improvement
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Georg Høyer, MD, Psychological behavioral intervention based on cognitive behavioral methods
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2001
Primary Completion (ACTUAL)
December 1, 2006
Study Completion (ACTUAL)
December 1, 2006
Study Registration Dates
First Submitted
November 3, 2005
First Submitted That Met QC Criteria
November 3, 2005
First Posted (ESTIMATE)
November 4, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
July 6, 2011
Last Update Submitted That Met QC Criteria
July 3, 2011
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-00093
- 2005/188-2 FBB/-
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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