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Completed

NCT Number: NCT00248742

Psychobiology in Inflammatory Bowel Disease(IBD)

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.

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Key information

Conditions

Inflammatory Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RRHF

Oslo, 0027, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychological behavioral intervention

Behavioral

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

Other names: stress management

Primary outcomes

  1. Improvement in activity index.

    Time frame: 18 months

Secondary outcomes

  1. Reduction of inflammatory parameters.

    Time frame: 18 months

  2. Reduction in number of relapses.

    Time frame: 18 months

  3. Quality of life improvement

    Time frame: 18 months

  4. Psychobiological factors related to improvement

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Haukeland University Hospital
  • Lübeck University Clinic
  • University Hospital, Aker
  • University Hospital, Akershus
  • University of Bergen

Registry information

Official study title

The Impact of Psychobiological Factors in Inflammatory Bowel Disease

Acronym: INSPIRE

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Nov 4, 2005
Registry last updated
Jul 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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