NCT00248742

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 6, 2011

Status Verified

March 1, 2009

Enrollment Period

5.8 years

First QC Date

November 3, 2005

Last Update Submit

July 3, 2011

Conditions

Inflammatory Bowel Disease

Keywords

IBD, psychological, stress management

Outcome Measures

Primary Outcomes (1)

  • Improvement in activity index.

    18 months

Secondary Outcomes (4)

  • Reduction of inflammatory parameters.

    18 months

  • Reduction in number of relapses.

    18 months

  • Quality of life improvement

    18 months

  • Psychobiological factors related to improvement

    18 months

Interventions

Psychological behavioral interventionBEHAVIORAL

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

Also known as: stress management

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Ulcerous colitis and Crohn's disease verified by histology and endoscope Relapse last 18 months or enduring activity Activity index≥4 PSQ≥60

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

RRHF

Oslo, 0027, Norway

Location

Related Publications (1)

  • Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

    PMID: 40243391DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Georg Høyer, MD

    Psychological behavioral intervention based on cognitive behavioral methods

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 4, 2005

Study Start

February 1, 2001

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

July 6, 2011

Record last verified: 2009-03

Locations

NO(1)