Psychiatric DisordersPRWNCT01989728
Prevalence and Effect of Detecting Common Mental Disorders in Long-term Sickness Absence
A study testing psychiatric examination and feedback in people with Psychiatric Disorders and Common Mental Disorders, run by Region MidtJylland Denmark at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Psychiatric Disorders, Common Mental Disorders, Depression
- What is being tested?
- psychiatric examination and feedback
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,121 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2004to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First sick-listing between August 30, 2004 and August 29, 2005 in six municipalities (118,000 inhabitants)
Who cannot join
- Unable to understand Danish and absence due to pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Psychiatric Research Unit west, regional Psychiatric Services West
Herning, 7400
About this study
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.
- Being tested
- psychiatric examination and feedback
- Keywords
- sickness absence, return to work, psychiatric examination, feedback, psychological distress, quality of life, attrition analysis, multiple imputation
- Medical subject headings
- Mental Disorders, Depression, Anxiety Disorders, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychiatric examination and feedbackProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| care as usual | Active comparator | Not described Receives: Procedure: psychiatric examination and feedback |
| psychiatric examination and feedback | Experimental | Not described Receives: Procedure: psychiatric examination and feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration until return to work
Included individuals were followed until payment of sickness absence compensation was ended
Measured: 1-2 years
Secondary outcomes (1)
Psychological distress by subscales of Hopkins Symptom Checklist Revised (SCL-90-R)
At baseline when entering long-term sickness absence (eight weeks of continuous sickness absence) the psychological distress was measured
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startNov 2004
- Primary completionOct 2005
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region MidtJylland Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans Joergen Soegaard, Region MidtJylland Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989728
- Sponsor's protocol ID
- sickness absence 1
- Other IDs
- RA
- Acronym
- PRW
- Status last verified
- Nov 2013
- First submitted
- 8 Nov 2013
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19700479Sogaard 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.
PubMed 19717571Sogaard 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.
PubMed 19717573Sogaard 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.
PubMed 19736249Sogaard 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.
PubMed 19850649Sogaard 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.
PubMed 20529969Sogaard 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.
PubMed 20651000
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Effect of Detecting Common Mental Disorders in Long-term Sickness Absence
- ClinicalTrials.gov ID
- NCT01989728
- Acronym / sponsor ID
- PRW / sickness absence 1
- Keywords
- sickness absence, return to work, psychiatric examination, feedback, psychological distress, quality of life, attrition analysis, multiple imputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,121 participants (actual)
- Lead sponsor
- Region MidtJylland DenmarkUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| care as usual | Active comparator | Procedure: psychiatric examination and feedback |
| psychiatric examination and feedback | Experimental | Procedure: psychiatric examination and feedback |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First sick-listing between August 30, 2004 and August 29, 2005 in six municipalities (118,000 inhabitants)
Key exclusion criteria (1 listed)
- Unable to understand Danish and absence due to pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychiatric examination and feedback | Procedure or surgery | care as usual, psychiatric examination and feedback |
Primary outcome
duration until return to work
Time frame: 1-2 years
Included individuals were followed until payment of sickness absence compensation was ended
1 secondary outcome
Psychological distress by subscales of Hopkins Symptom Checklist Revised (SCL-90-R)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
- Results publication: PubMed 19700479Sogaard 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.
- Results publication: PubMed 19717571Sogaard 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.
- Results publication: PubMed 19717573Sogaard 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.
- Results publication: PubMed 19736249Sogaard 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.
- Results publication: PubMed 19850649Sogaard 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.
- Results publication: PubMed 20529969Sogaard 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.
- Results publication: PubMed 20651000Sogaard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychiatric examination and feedback in people with Psychiatric Disorders and Common Mental Disorders, run by Region MidtJylland Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration until return to work (time frame: 1-2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01989728, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.