Mental DisordersPKRWNCT01989767
Application of Psychiatric Knowledge in the Rehabilitation Process in Return to Work.
A study testing education in people with Mental Disorders, run by Hans Joergen Soegaard at 1 site in Denmark.
Trial summary
The hypothesis was that education of rehabilitation officers who were responsible for rehabilitation back to work for sick-listed individuals in screening for mental disorders and psychiatric topics would increase the rate of return to work and reduce the number of sicklisted days Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mental Disorders
- What is being tested?
- education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Oct 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- sick-listed and belonging to the case-load of rehabilitation officers who participated in the intervention
Who cannot join
- no
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 education of rehabilitation officers who were responsible for rehabilitation back to work for sick-listed individuals in screening for mental disorders and psychiatric topics would increase the rate of return to work and reduce the number of sicklisted days
- Conditions
- Mental Disorders
- Being tested
- control Rehabilitation as usual, education
- Keywords
- sickness absence, rehabilitation, mental disorders, screening
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control Rehabilitation as usualBehavioural
Rehabilitation as usual
educationBehavioural
Education as add on to to rehabilitation as usual
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | Rehabilitation as usual Receives: Behavioral: control Rehabilitation as usual |
| education | Experimental | education of rehabilitation officers in psychiatric topics plus rehabilitation as usual Receives: Behavioral: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of return to work
The rate of return to work was estimated by Poisson regression and Cox regression based on the duration from the date being sicklisted until the date of return to normal work.
Measured: 1 year
Secondary outcomes (1)
number of sickness absence days
After eight weeks of continuous sickness absence the number of sickness absence days within ½ year was counted
Measured: ½ 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 2011
- Primary completionOct 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hans Joergen Soegaard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hans Joergen Soegaard, Region MidtJylland Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989767
- Sponsor's protocol ID
- sickness absence 2
- Acronym
- PKRW
- Status last verified
- Nov 2013
- First submitted
- 10 Nov 2013
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
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
- Application of Psychiatric Knowledge in the Rehabilitation Process in Return to Work.
- ClinicalTrials.gov ID
- NCT01989767
- Acronym / sponsor ID
- PKRW / sickness absence 2
- Conditions
- Mental Disorders
- Keywords
- sickness absence, rehabilitation, mental disorders, screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Hans Joergen SoegaardUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2013 (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 education of rehabilitation officers who were responsible for rehabilitation back to work for sick-listed individuals in screening for mental disorders and psychiatric topics would increase the rate of return to work and reduce the number of sicklisted days
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Behavioral: control Rehabilitation as usualRehabilitation as usual |
| education | Experimental | Behavioral: educationeducation of rehabilitation officers in psychiatric topics plus rehabilitation as usual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- sick-listed and belonging to the case-load of rehabilitation officers who participated in the intervention
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| control Rehabilitation as usualRehabilitation as usual | Behavioural | control |
| educationEducation as add on to to rehabilitation as usual | Behavioural | education |
Primary outcome
rate of return to work
Time frame: 1 year
The rate of return to work was estimated by Poisson regression and Cox regression based on the duration from the date being sicklisted until the date of return to normal work.
1 secondary outcome
number of sickness absence days
Time frame: ½ 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.
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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 education in people with Mental Disorders, run by Hans Joergen Soegaard 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?
rate of return to work (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.