Collaborative Care: Depression in Occupational Care
| ISRCTN | ISRCTN78462860 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78462860 |
| Protocol serial number | N/A |
| Sponsor | Trimbos-institute/Netherlands Institute of Mental Health and Addiction (The Netherlands) |
| Funder | Foundation Reserves Voormalige Vrijwillige Ziekenfondsverzekering (RVVZ) (The Netherlands) |
- Submission date
- 01/12/2006
- Registration date
- 01/12/2006
- Last edited
- 23/08/2012
- 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
Ms M C Vlasveld
Scientific
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 |
|---|---|
| mvlasveld@trimbos.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled parallel armed trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
The primary outcome measure is the extent of reduction in depressive symptoms, as measured by the PHQ-9. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Trimbos-instituut/Netherlands institute of Mental Health and Addiction
Utrecht
3500 AS
Netherlands
3500 AS
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2012 | Yes | No |
