Psychobiology in Inflammatory Bowel Disease(IBD) (INSPIRE)

July 3, 2011 updated by: Oslo University Hospital

The Impact of Psychobiological Factors in Inflammatory Bowel Disease

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.

Study Overview

Status

Completed

Conditions

Inflammatory Bowel Disease

Intervention / Treatment

Behavioral: Psychological behavioral intervention

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.

Study Type

Interventional

Enrollment (Actual)

114

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Norway
- - Oslo, Norway, 0027
    - RRHF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in activity index. Time Frame: 18 months	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction of inflammatory parameters. Time Frame: 18 months	18 months
Reduction in number of relapses. Time Frame: 18 months	18 months
Quality of life improvement Time Frame: 18 months	18 months
Psychobiological factors related to improvement Time Frame: 18 months	18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Bergen

Haukeland University Hospital

University Hospital, Akershus

University Hospital, Aker

Lübeck University Clinic

Investigators

Study Director: Georg Høyer, MD, Psychological behavioral intervention based on cognitive behavioral methods

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)