Welcome
Support Centre
19 September 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Towards a shortened sick leave duration of employees sick-listed due to common mental disorders
ISRCTN ISRCTN86605310
DOI 10.1186/ISRCTN86605310
ClinicalTrials.gov identifier
EudraCT number
Public title Towards a shortened sick leave duration of employees sick-listed due to common mental disorders
Scientific title Effectiveness of the guideline ‘management of workers with common mental health problems by occupational physicians’: A randomised controlled trial
Acronym N/A
Serial number at source 208030001
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.
Lay summary Not provided at time of registration
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
Countries of recruitment Netherlands
Disease/condition/study domain Sick leave due to common mental disorders
Participants - 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
Participants - 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
Anticipated start date 15/10/2010
Anticipated end date 15/10/2014
Status of trial Ongoing
Patient information material Not available in web format, please use contact details below to request a patient information sheet
Target number of participants 232
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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.
Sources of funding Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) - (ref: 208030001)
Trial website
Publications 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23496948
Contact name Dr  Evelien  Brouwers
  Address Tilburg University
Department Tranzo
Warandelaan 2
  City/town Tilburg
  Zip/Postcode 5000 LE
  Country Netherlands
  Tel +31 (0)13 466 2962
  Fax +31 (0)13 466 3637
  Email e.p.m.brouwers@uvt.nl
Sponsor Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
  Address Laan van Nieuw Oost Indië 334
  City/town The Hague
  Zip/Postcode 2593 CE
  Country Netherlands
  Tel +31 (0)70 3495111
  Fax +31 (0)70 3495100
  Email info@zonmw.nl
  Sponsor website: http://www.zonmw.nl/nl/
Date applied 30/06/2010
Last edited 26/07/2013
Date ISRCTN assigned 11/08/2010
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.