Contact information
Type
Scientific
Primary contact
Dr Evelien Brouwers
ORCID ID
Contact details
Tilburg University
Department Tranzo
Warandelaan 2
Tilburg
5000 LE
Netherlands
+31 (0)13 466 2962
e.p.m.brouwers@uvt.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
208030001
Study information
Scientific title
Effectiveness of the guideline management of workers with common mental health problems by occupational physicians: A randomised controlled trial
Acronym
Study hypothesis
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.
Ethics approval
The study protocol will be submitted to the Medical Ethics Board of the St. Elisabeth Hospital in Tilburg around November 2010
Study design
Multicentre randomised controlled trial longitudinal design with follow up
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Sick leave due to common mental disorders
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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
Secondary outcome measures
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.
Overall trial start date
15/10/2010
Overall trial end date
15/10/2014
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
232
Participant exclusion criteria
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
Recruitment start date
15/10/2010
Recruitment end date
15/10/2014
Locations
Countries of recruitment
Netherlands
Trial participating centre
Tilburg University
Tilburg
5000 LE
Netherlands
Sponsor information
Organisation
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Sponsor details
Laan van Nieuw Oost Indië 334
The Hague
2593 CE
Netherlands
+31 (0)70 3495111
info@zonmw.nl
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) - (ref: 208030001)
Alternative name(s)
ZonMw
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23496948
Publication citations
-
Protocol
van Beurden KM, Brouwers EP, Joosen MC, Terluin B, van der Klink JJ, van Weeghel J, Effectiveness of guideline-based care by occupational physicians on the return-to-work of workers with common mental disorders: design of a cluster-randomised controlled trial., BMC Public Health, 2013, 13, 193, doi: 10.1186/1471-2458-13-193.