Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
17/10/2007
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 David S. Rebergen

ORCID ID

Contact details

Institute for Research in Extramural Medicine
Department of Public and Occupational Health
VU University Medical Centre
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 4449680
d.rebergen@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

n/a

Study information

Scientific title

Acronym

Study hypothesis

Treatment according to the Dutch National Guideline on the Management of Employees with Mental Health Problems by Occupational Physicians will cause less work disability than treatment according to usual care, with minimal involvement of the occupational physician and frequent referral to a psychologist.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, single blinded, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Mental health problems

Intervention

Treatment according to the Dutch national guideline on the management of employees with mental health problems by occupational physicians. This guideline focuses on four aspects of the management of mental health problems:
1. The occupational physician acknowledges the interaction between the disabled employee and his surroundings (work, personal and care)
2. A simplified classification of mental health problems is introduced, with only four categories
3. The occupational physician acts as case manager, who intervenes when recovery stagnates
4. Finally, the occupational physician may also act as care manager by counseling employees with work related problems

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Return to work.

Secondary outcome measures

1. Patient satisfaction
2. Satisfaction of the employer
3. Evaluation of the occupational physician
4. Cost benefits

Overall trial start date

01/01/2002

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Physical or mental health symptoms which cause suffering or malfunctioning for the patient
2. Disability to work on the moment of inclusion by the occupational physician

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

200

Participant exclusion criteria

1. Symptoms are caused by a physical disorder
2. Disagreement about the diagnosis by the occupational physician and the patient
3. Mistrust between occupational physician and patient
4. Earlier inclusion in the study

Recruitment start date

01/01/2002

Recruitment end date

01/01/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Institute for Research in Extramural Medicine
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

VU University Medical Center (The Netherlands)

Sponsor details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor type

University/education

Website

http://www.vumc.nl/zorg/

Funders

Funder type

Government

Funder name

Dutch Ministry of Internal Affairs (The Netherlands) - Occupational Health and Safety Service (OHSS) committee

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

Study protocol: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17655758

Publication citations

  1. Study protocol

    Rebergen DS, Bruinvels DJ, van der Beek AJ, van Mechelen W, Design of a randomized controlled trial on the effects of counseling of mental health problems by occupational physicians on return to work: the CO-OP-study., BMC Public Health, 2007, 7, 183, doi: 10.1186/1471-2458-7-183.

Additional files

Editorial Notes