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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
History of Changes
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248742

Locations
Norway
RRHF
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Aker
Haukeland University Hospital
University of Bergen
Lübeck University Clinic
University Hospital, Akershus
Investigators
Study Director: Georg Høyer, MD Psychological behavioral intervention based on cognitive behavioral methods
  More Information

No publications provided

Responsible Party: Birgitte Boye MD PhD, Rikshsoptialet University Hospital
ClinicalTrials.gov 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
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013