Contact information
Type
Scientific
Primary contact
Ms M C Vlasveld
ORCID ID
Contact details
Trimbos-instituut/Netherlands institute of Mental Health and Addiction
Da Costakade 45
P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 2959303
mvlasveld@trimbos.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
CC:DOC
Study hypothesis
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
Ethics approval received from the Ethics Committee of the VUmc (METc, VUmc, Amsterdam) on the 3rd August 2007 (ref: 2006/246).
Study design
Randomised controlled parallel armed trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/03/2007
Overall trial end date
01/06/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
126
Participant 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.
Recruitment start date
01/03/2007
Recruitment end date
01/06/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Trimbos-instituut/Netherlands institute of Mental Health and Addiction
Utrecht
3500 AS
Netherlands
Sponsor information
Organisation
Trimbos-institute/Netherlands Institute of Mental Health and Addiction (The Netherlands)
Sponsor details
P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 2971100
info@trimbos.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Foundation Reserves Voormalige Vrijwillige Ziekenfondsverzekering (RVVZ) (The Netherlands)
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. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22116977
Publication citations
-
Results
Vlasveld MC, van der Feltz-Cornelis CM, Adèr HJ, Anema JR, Hoedeman R, van Mechelen W, Beekman AT, Collaborative care for major depressive disorder in an occupational healthcare setting., Br J Psychiatry, 2012, 200, 6, 510-511, doi: 10.1192/bjp.bp.111.095687.