Back to resultsPsychobiology in Inflammatory Bowel Disease(IBD) (INSPIRE)
Primary Purpose
Inflammatory Bowel Disease
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Psychological behavioral intervention
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring IBD, psychological, stress management
Eligibility Criteria
Ulcerous colitis and Crohn's disease verified by histology and endoscope Relapse last 18 months or enduring activity Activity index≥4 PSQ≥60
Sites / Locations
- RRHF
Outcomes
Primary Outcome Measures
Improvement in activity index.
Secondary Outcome Measures
Reduction of inflammatory parameters.
Reduction in number of relapses.
Quality of life improvement
Psychobiological factors related to improvement
Full Information
NCT ID
NCT00248742
First Posted
November 3, 2005
Last Updated
July 3, 2011
Sponsor
Oslo University Hospital
Collaborators
University Hospital, Aker, Haukeland University Hospital, University of Bergen, Lübeck University Clinic, University Hospital, Akershus
1. Study Identification
Unique Protocol Identification Number
NCT00248742
Brief Title
Psychobiology in Inflammatory Bowel Disease(IBD)
Acronym
INSPIRE
Official Title
The Impact of Psychobiological Factors in Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Oslo University Hospital
Collaborators
University Hospital, Aker, Haukeland University Hospital, University of Bergen, Lübeck University Clinic, University Hospital, Akershus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
IBD, psychological, stress management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Psychological behavioral intervention
Other Intervention Name(s)
stress management
Intervention Description
3x3 hours group intervention followed by 6-9 hours individual psychotherapy based on cognitive behavioral methods
Primary Outcome Measure Information:
Title
Improvement in activity index.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Reduction of inflammatory parameters.
Time Frame
18 months
Title
Reduction in number of relapses.
Time Frame
18 months
Title
Quality of life improvement
Time Frame
18 months
Title
Psychobiological factors related to improvement
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Ulcerous colitis and Crohn's disease verified by histology and endoscope Relapse last 18 months or enduring activity Activity index≥4 PSQ≥60
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Høyer, MD
Organizational Affiliation
Psychological behavioral intervention based on cognitive behavioral methods
Official's Role
Study Director
Facility Information:
Facility Name
RRHF
City
Oslo
ZIP/Postal Code
0027
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Psychobiology in Inflammatory Bowel Disease(IBD)
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