Psychobiology in Inflammatory Bowel Disease(IBD) (INSPIRE)

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

Condition Intervention
Inflammatory Bowel Disease
Behavioral: Psychological behavioral intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Psychobiological Factors in Inflammatory Bowel Disease

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Improvement in activity index. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 114
Study Start Date: February 2001
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Psychological behavioral intervention
    3x3 hours group intervention followed by 6-9 hours individual psychotherapy based on cognitive behavioral methods
    Other Name: stress management
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.

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Ulcerous colitis and Crohn's disease verified by histology and endoscope Relapse last 18 months or enduring activity Activity index≥4 PSQ≥60
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Please refer to this study by its identifier: NCT00248742

Oslo, Norway, 0027
Sponsors and Collaborators
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
  More Information

Responsible Party: Birgitte Boye MD PhD, Rikshsoptialet University Hospital Identifier: NCT00248742     History of Changes
Other Study ID Numbers: S-00093  2005/188-2 FBB/- 
Study First Received: November 3, 2005
Last Updated: July 3, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Data Protection Authority

Keywords provided by Oslo University Hospital:
IBD, psychological, stress management

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases processed this record on April 27, 2016