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ISRCTN
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ISRCTN86605310
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ClinicalTrials.gov identifier
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Public title
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Towards a shortened sick leave duration of employees sick-listed due to common mental disorders
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Scientific title
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Effectiveness of the guideline ‘management of workers with common mental health problems by occupational physicians’: A randomised controlled trial
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Acronym
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N/A
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Serial number at source
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208030001
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Study hypothesis
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Sick listed employees treated by occupational physicians (OPs) who are trained in and closely follow the guideline will have a shorter sick leave duration than those in the control group.
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Lay summary
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Ethics approval
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The study protocol will be submitted to the Medical Ethics Board of the St. Elisabeth Hospital in Tilburg around November 2010
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Study design
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Multicentre randomised controlled trial longitudinal design with follow up
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Sick leave due to common mental disorders
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Participants - inclusion criteria
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1. A common mental disorder, i.e. anxiety, depression, burnout or emotional distress, is the primary reason for sick leave at the time of inclusion. Physical problems may be present, but should not cause absenteeism.
2. Dutch speaking
3. Counseled by an OP that takes part in the study
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Participants - exclusion criteria
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1. Acute crisis or suicidality
2. Sick leave duration of less than 4 weeks, as a quick recovery of part of this group may dilute the statistical power of the study
3. Sick leave duration of more than 8 weeks, as the study aims to prevent long term sick leave
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Anticipated start date
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15/10/2010
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Anticipated end date
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15/10/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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232
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Interventions
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OPs in the experimental condition are trained in the Dutch guideline 'management of workers with common mental health problems by occupational physicians'. OPs will be divided into groups of 6 - 10 OPs, and will gather for monthly meetings of approximately 1 hour, over 1 year. Using action research and focus group discussions it will be investigated which barriers OPs encounter in using the guideline. Subsequently, barriers will be explored and possible solutions will be discussed by means of a 'plan, do, check, act' cycle.
OPs from the control group provide care as usual.
The total duration of follow up will be 12 months.
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Primary outcome measure(s)
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Time to full return to work, defined as the number of days between the first day of sickness absence and the first day of full return to work
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Secondary outcome measure(s)
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1. Partial return to work
2. Total days of sick leave at 12 months
3. Patient satisfaction, assessed by a short questionnaire developed for this study
4. Symptoms, measured using the 4DSQ (Terluin 2002)
Outcomes will be assessed at baseline, 3, 6 and 12 months.
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Sources of funding
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Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) - (ref: 208030001)
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Trial website
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Publications
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Contact name
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Dr
Evelien
Brouwers
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Address
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Tilburg University
Department Tranzo
Warandelaan 2
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City/town
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Tilburg
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Zip/Postcode
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5000 LE
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Country
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Netherlands
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Tel
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+31 (0)13 466 2962
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Fax
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+31 (0)13 466 3637
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Email
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e.p.m.brouwers@uvt.nl
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Sponsor
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Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
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Address
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Laan van Nieuw Oost Indië 334
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City/town
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The Hague
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Zip/Postcode
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2593 CE
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Country
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Netherlands
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Tel
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+31 (0)70 3495111
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Fax
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+31 (0)70 3495100
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Email
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info@zonmw.nl
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Sponsor website:
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http://www.zonmw.nl/nl/
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Date applied
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30/06/2010
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Last edited
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11/08/2010
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Date ISRCTN assigned
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11/08/2010
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