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Psychobiology in Inflammatory Bowel Disease(IBD)

The Impact of Psychobiological Factors in Inflammatory Bowel Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00248742
Acronym
INSPIRE
Enrollment
114
Registered
2005-11-04
Start date
2001-02-28
Completion date
2006-12-31
Last updated
2011-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Keywords

IBD, psychological, stress management

Brief 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.

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.

Interventions

BEHAVIORALPsychological behavioral intervention

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

Sponsors

University Hospital, Aker
CollaboratorOTHER
Haukeland University Hospital
CollaboratorOTHER
University of Bergen
CollaboratorOTHER
Lübeck University Clinic
CollaboratorOTHER
University Hospital, Akershus
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Improvement in activity index.18 months

Secondary

MeasureTime frame
Reduction of inflammatory parameters.18 months
Reduction in number of relapses.18 months
Quality of life improvement18 months
Psychobiological factors related to improvement18 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026