Collaborative Care: Depression in Occupational Care

ISRCTN	ISRCTN78462860
DOI	https://doi.org/10.1186/ISRCTN78462860
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms M C Vlasveld
Scientific

Trimbos-instituut/Netherlands institute of Mental Health and Addiction
Da Costakade 45
P.O. Box 725
Utrecht
3500 AS
Netherlands

Phone	+31 (0)30 2959303
Email	mvlasveld@trimbos.nl

Study design	Randomised controlled parallel armed trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	CC:DOC
Study objectives	A collaborative care intervention for patients with major depressive disorder who are on sick leave will result in more reduction in depressive symptoms and a faster return to work than usual care.
Ethics approval(s)	Ethics approval received from the Ethics Committee of the VUmc (METc, VUmc, Amsterdam) on the 3rd August 2007 (ref: 2006/246).
Health condition(s) or problem(s) studied	Depressive disorders
Intervention	The intervention follows a collaborative care model with adherence and compliance enhancing techniques, contracting, Problem Solving Treatment (PST), antidepressant medication, a workplace intervention, and manual guided self help aimed at return to work and healthy lifestyle.
Intervention type	Other
Primary outcome measure	The primary outcome measure is the extent of reduction in depressive symptoms, as measured by the PHQ-9.
Secondary outcome measures	The secondary outcome measure is time to return to work, which will be acquired upon inquiry with company doctor and patient and which refers to the duration of absence through illness until work is resumed.
Overall study start date	01/03/2007
Completion date	01/06/2010

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	126
Key inclusion criteria	Employees on sick leave lasting between 4 to 12 weeks with major depressive disorder and who do not have the prospect of full return to work yet.
Key exclusion criteria	1. Patients who are suicidal, psychotic or have dementia, as noticed by the company doctor 2. Addicted to drugs or alcohol, as assessed by the Mini International Neuropsychiatric Interview (MINI) 3. Patients who do not speak Dutch sufficiently to fill in the questionnaires Patients who are already receiving psychiatric treatment can be included in the study, in case of mutual agreement with the current care giver.
Date of first enrolment	01/03/2007
Date of final enrolment	01/06/2010

Trimbos-instituut/Netherlands institute of Mental Health and Addiction

Utrecht
3500 AS
Netherlands

Trimbos-institute/Netherlands Institute of Mental Health and Addiction (The Netherlands)
Hospital/treatment centre

P.O. Box 725
Utrecht
3500 AS
Netherlands

Phone	+31 (0)30 2971100
Email	info@trimbos.nl
Website	http://www.trimbos.nl/default37.html
"ROR"	https://ror.org/02amggm23

Research organisation

Foundation Reserves Voormalige Vrijwillige Ziekenfondsverzekering (RVVZ) (The Netherlands)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2012		Yes	No