Psychobiology in Inflammatory Bowel Disease(IBD)

Inflammatory Bowel Disease Clinical Trial

— INSPIRE  

Official title:

The Impact of Psychobiological Factors in Inflammatory Bowel Disease

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

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

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