Randomized controlled trial of psychiatric consultation embedded in continuing education to company physicians for employees with sick leave absence through psychiatric disorders

ISRCTN	ISRCTN86722376
DOI	https://doi.org/10.1186/ISRCTN86722376
Secondary identifying numbers	N/A

Submission date: 19/12/2005
Registration date: 19/12/2005
Last edited: 27/10/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr C.M. Feltz-Cornelis, van der
Scientific

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

Email	cfeltz@trimbos.nl

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	BACO Trial
Study objectives	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(s)	Approval received from local ethics committee (METiGG [Kamer Zuid]), date of approval: November 16, 2005 (ref: 5127).
Health condition(s) or problem(s) studied	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
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 study start date	03/10/2005
Completion date	01/05/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	400
Key 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.
Key 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.
Date of first enrolment	03/10/2005
Date of final enrolment	01/05/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Trimbos-instituut

Utrecht
3500 AS
Netherlands

Sponsor information

Trimbos-instituut Netherlands Institute of Mental Health and Addiction
Not defined

Da Costakade 45 Postbus 725
Utrecht
3500 AS
Netherlands

Phone	+31 (0)30 2971100
Email	info@trimbos.nl
Website	http://www.trimbos.nl
"ROR"	https://ror.org/02amggm23

Funders

Funder type

Charity

ArboUnie, ArboNed, STECR Alladin Program

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	27/02/2007		Yes	No
Results article	results	07/09/2010		Yes	No