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Psychobiology in Inflammatory Bowel Disease(IBD) (INSPIRE)

This study has been completed.
Sponsor:
Collaborators:
University Hospital, Aker
Haukeland University Hospital
University of Bergen
Lübeck University Clinic
University Hospital, Akershus
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00248742
First received: November 3, 2005
Last updated: July 3, 2011
Last verified: March 2009

November 3, 2005
July 3, 2011
February 2001
December 2006   (final data collection date for primary outcome measure)
Improvement in activity index. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Improvement in activity index.
Complete list of historical versions of study NCT00248742 on ClinicalTrials.gov Archive Site
  • Reduction of inflammatory parameters. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Reduction in number of relapses. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Quality of life improvement [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Psychobiological factors related to improvement [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Reduction of inflammatory parameters.
  • Reduction in number of relapses.
  • Quality of life improvement
  • Medication changes
  • Psychobiological factors related to improvement
Not Provided
Not Provided
 
Psychobiology in Inflammatory Bowel Disease(IBD)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Inflammatory Bowel Disease
Behavioral: Psychological behavioral intervention
3x3 hours group intervention followed by 6-9 hours individual psychotherapy based on cognitive behavioral methods
Other Name: stress management
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
December 2006
December 2006   (final data collection date for primary outcome measure)

Ulcerous colitis and Crohn's disease verified by histology and endoscope Relapse last 18 months or enduring activity Activity index≥4 PSQ≥60

Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00248742
S-00093, 2005/188-2 FBB/-
No
Birgitte Boye MD PhD, Rikshsoptialet University Hospital
Oslo University Hospital
  • University Hospital, Aker
  • Haukeland University Hospital
  • University of Bergen
  • Lübeck University Clinic
  • University Hospital, Akershus
Study Director: Georg Høyer, MD Psychological behavioral intervention based on cognitive behavioral methods
Oslo University Hospital
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP