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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
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
-
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.
-
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.