Condition category
Mental and Behavioural Disorders
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
27/10/2010
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 C.M. Feltz-Cornelis, van der

ORCID ID

Contact details

Trimbos-instituut
Department of Diagnosis and Treatment
P.O. Box 725
Utrecht
3500 AS
Netherlands
cfeltz@trimbos.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

BACO Trial

Study hypothesis

In a randomized controlled study comparing psychiatric consultation with care as usual by the company physician, patients will improve in the intervention group in terms of duration of sick leave, general functioning and quality of life.

Ethics approval

Approval received from local ethics committee (METiGG [Kamer Zuid]), date of approval: November 16, 2005 (ref: 5127).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Psychiatric, mental disorders/illness, depressive disorders, anxiety disorders

Intervention

Company physicians are randomised over 2 conditions:
1. The intervention group
2. Care-as-usual group
All company physicians in both conditions receive continuing education and follow a training programme targeted at diagnosis and treatment of depressive disorder and anxiety disorder.
In the intervention group patients of company physicians receive psychiatric consultation as well, resulting in an individually tailored diagnosis and treatment advice.
These psychiatric consultations are embedded in the continuing education to company physicians.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Reduction of symptoms as measured with the PHQ and quality of life as measured with the SF-20.

Secondary outcome measures

Number of complaints, general functioning, fatigue, duration of sick leave.

Overall trial start date

03/10/2005

Overall trial end date

01/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Employees with absence from work for a period of at least 6 weeks and no plan for resumption of work within 12 weeks, and a positive screen on either the PHQ or the Whiteley Index.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

400

Participant exclusion criteria

Insufficient command of Dutch language, negative outcome of PHQ screen, dementia, psychotic symptoms or suicide risk, or the expectation of the company physician of a work related conflict.

Recruitment start date

03/10/2005

Recruitment end date

01/05/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Trimbos-instituut
Utrecht
3500 AS
Netherlands

Sponsor information

Organisation

Trimbos-instituut Netherlands Institute of Mental Health and Addiction

Sponsor details

Da Costakade 45 Postbus 725
Utrecht
3500 AS
Netherlands
+31 (0)30 2971100
info@trimbos.nl

Sponsor type

Not defined

Website

http://www.trimbos.nl

Funders

Funder type

Charity

Funder name

ArboUnie, ArboNed, STECR Alladin Program

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. 2007 protocol on http://www.ncbi.nlm.nih.gov/pubmed/17326830
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20856601

Publication citations

  1. Protocol

    van der Feltz-Cornelis CM, Meeuwissen JA, de Jong FJ, Hoedeman R, Elfeddali I, Randomised controlled trial of a psychiatric consultation model for treatment of common mental disorder in the occupational health setting., BMC Health Serv Res, 2007, 7, 29, doi: 10.1186/1472-6963-7-29.

  2. Results

    van der Feltz-Cornelis CM, Hoedeman R, de Jong FJ, Meeuwissen JA, Drewes HW, van der Laan NC, Adèr HJ, Faster return to work after psychiatric consultation for sicklisted employees with common mental disorders compared to care as usual. A randomized clinical trial., Neuropsychiatr Dis Treat, 2010, 6, 375-385.

Additional files

Editorial Notes