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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00248742
Other study ID # S-00093
Secondary ID 2005/188-2 FBB/-
Status Completed
Phase N/A
First received November 3, 2005
Last updated July 3, 2011
Start date February 2001
Est. completion date December 2006

Study information

Verified date March 2009
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research EthicsNorway: Data Protection Authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Ulcerous colitis and Crohn's disease verified by histology and endoscope Relapse last 18 months or enduring activity Activity index=4 PSQ=60

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Psychological behavioral intervention
3x3 hours group intervention followed by 6-9 hours individual psychotherapy based on cognitive behavioral methods

Locations

Country Name City State
Norway RRHF Oslo

Sponsors (6)

Lead Sponsor Collaborator
Oslo University Hospital Haukeland University Hospital, Lübeck University Clinic, University Hospital, Aker, University Hospital, Akershus, University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in activity index. 18 months No
Secondary Reduction of inflammatory parameters. 18 months No
Secondary Reduction in number of relapses. 18 months No
Secondary Quality of life improvement 18 months No
Secondary Psychobiological factors related to improvement 18 months No
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