- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01989728
Prevalence and Effect of Detecting Common Mental Disorders in Long-term Sickness Absence (PRW)
November 14, 2013 updated by: Hans Joergen Soegaard, Region MidtJylland Denmark
The hypothesis was that a large fraction of individuals with common mental disorders were undetected in long-term sickness and that detection of the disorders by screening, a psychiatric diagnostic examination and feedback to the individuals, primary care, and rehabilitation officers improved return to work, improved quality of life and reduced psychological distress.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1121
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
-
-
-
Herning, Denmark, 7400
- Psychiatric Research Unit West, Regional Psychiatric Services West
-
-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- First sick-listing between August 30, 2004 and August 29, 2005 in six municipalities (118,000 inhabitants)
Exclusion Criteria:
- Unable to understand Danish and absence due to pregnancy
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: care as usual
|
|
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Experimental: psychiatric examination and feedback
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
duration until return to work
Time Frame: 1-2 years
|
Included individuals were followed until payment of sickness absence compensation was ended
|
1-2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological distress by subscales of Hopkins Symptom Checklist Revised (SCL-90-R)
Time Frame: 1 year
|
At baseline when entering long-term sickness absence (eight weeks of continuous sickness absence) the psychological distress was measured
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life by means of Social Functioning) SF-36
Time Frame: 1 year
|
At baseline when entering long-term sickness absence (eight weeks of continuous sickness absence) the quality of life was measured
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sogaard HJ, Bech P. Psychiatric disorders in long-term sickness absence -- a population-based cross-sectional study. Scand J Public Health. 2009 Sep;37(7):682-9. doi: 10.1177/1403494809344357. Epub 2009 Aug 21.
- Sogaard HJ, Bech P. Psychometric analysis of common mental disorders -- Screening Questionnaire (CMD-SQ) in long-term sickness absence. Scand J Public Health. 2009 Nov;37(8):855-63. doi: 10.1177/1403494809344653. Epub 2009 Aug 28.
- Sogaard HJ. Choosing screening instrument and cut-point on screening instruments. A comparison of methods. Scand J Public Health. 2009 Nov;37(8):872-80. doi: 10.1177/1403494809344442. Epub 2009 Aug 28.
- Sogaard HJ, Bech P. The effect on length of sickness absence by recognition of undetected psychiatric disorder in long-term sickness absence. A randomized controlled trial. Scand J Public Health. 2009 Nov;37(8):864-71. doi: 10.1177/1403494809347551. Epub 2009 Sep 7.
- Sogaard HJ, Bech P. Predictive validity of common mental disorders screening questionnaire as a screening instrument in long term sickness absence. Scand J Public Health. 2010 Jun;38(4):375-85. doi: 10.1177/1403494809350520. Epub 2009 Oct 22.
- Sogaard HJ, Bech P. Compensating for non-response in a study estimating the incidence of mental disorders in long-term sickness absence by a two-phased design. Scand J Public Health. 2010 Aug;38(6):625-32. doi: 10.1177/1403494810373673. Epub 2010 Jun 7.
- Sogaard HJ, Bech P. The effect of detecting undetected common mental disorders on psychological distress and quality of life in long-term sickness absence: a randomised controlled trial. Scand J Public Health. 2010 Dec;38(8):845-56. doi: 10.1177/1403494810379292. Epub 2010 Jul 22.
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
November 1, 2004
Primary Completion (Actual)
October 1, 2005
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
November 8, 2013
First Submitted That Met QC Criteria
November 14, 2013
First Posted (Estimate)
November 21, 2013
Study Record Updates
Last Update Posted (Estimate)
November 21, 2013
Last Update Submitted That Met QC Criteria
November 14, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sickness absence 1
- RA (Other Identifier: Ringkøbing Amt)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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