Plain English Summary

Not provided at time of registration

Trial website

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

http://www.zonmw.nl/nl/

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

  1. 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.

Editorial Notes