Condition category
Mental and Behavioural Disorders
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
23/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Han J.R. Anema

ORCID ID

Contact details

VU University Medical Center
Department of Public and Occupational Health and EMGO-Institute
Body@Work TNO
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 4446495/(0)6 13186986
h.anema@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR473

Study information

Scientific title

Acronym

Study hypothesis

Is participatory ergonomics for workers with common mental disorders more (cost-)effective on return-to-work than usual clinical medical care?

Ethics approval

Added as of 23/08/2007: The Medical Ethics Committee of the VU University Medical Center (Amsterdam, The Netherlands) has approved the study protocol.

Study design

Randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Mental disorders

Intervention

A project group consisting of experts in the field of mental disorders will develop a protocol for workplace adaptations based on methods used in participatory ergonomics (PE).
Work(place) adaptations, will be applied by a trained occupational nurse. A group of stakeholders (sick listed worker, the worker's supervisor, and potential other stakeholders) in the return-to-work (RTW) process will be formed and guided by the occupational nurse. The protocol is directed to achieve consensus among stakeholders regarding feasible work(place) adaptations to facilitate RTW.
Patients will be randomised to PE or usual clinical care (n = 2 x 72). A process analysis will be included.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Sickleave duration until full return-to-work

Secondary outcome measures

1. Psychological complaints
2. Functional status
3. Coping
4. Direct and indirect costs

Overall trial start date

15/09/2005

Overall trial end date

15/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Sicklisted due to distress problems due to overwork (completely or partially)
2. Between 18 and 65 years of age

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. Duration of sick leave longer than 3 months
2. Juridical conflict at work
3. No ability to complete questionnaires written in the Dutch language

Recruitment start date

15/09/2005

Recruitment end date

15/09/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Center
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

TNO Quality of Life (Work & Employment) (Netherlands)

Sponsor details

P.O. Box 718
Hoofddorp
2130 AS
Netherlands

Sponsor type

Research organisation

Website

Funders

Funder type

Other

Funder name

Expert Reintegration Studies Centre (STECR) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18194525
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20363809
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20798027

Publication citations

  1. Protocol

    van Oostrom SH, Anema JR, Terluin B, de Vet HC, Knol DL, van Mechelen W, Cost-effectiveness of a workplace intervention for sick-listed employees with common mental disorders: design of a randomized controlled trial., BMC Public Health, 2008, 8, 12, doi: 10.1186/1471-2458-8-12.

  2. Results

    van Oostrom SH, Heymans MW, de Vet HC, van Tulder MW, van Mechelen W, Anema JR, Economic evaluation of a workplace intervention for sick-listed employees with distress., Occup Environ Med, 2010, 67, 9, 603-610, doi: 10.1136/oem.2009.051979.

  3. van Oostrom SH, van Mechelen W, Terluin B, de Vet HC, Knol DL, Anema JR, A workplace intervention for sick-listed employees with distress: results of a randomised controlled trial., Occup Environ Med, 2010, 67, 9, 596-602, doi: 10.1136/oem.2009.050849.

Additional files

Editorial Notes