| - candidate number | 2332 |
| - NTR Number | NTR819 |
| - ISRCTN | ISRCTN78462860 |
| - Date ISRCTN created | 1-dec-2006 |
| - date ISRCTN requested | 1-dec-2006 |
| - Date Registered NTR | 21-nov-2006 |
| - Secondary IDs | 2006/246 |
| - Public Title | Collaborative Care: Depression in Occupational Care. |
| - Scientific Title | The cost effectiveness of collaborative care for depressive disorder in the occupational health setting. |
| - ACRONYM | CC:DOC |
| - 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. |
| - Healt Condition(s) or Problem(s) studied | Depressive disorders |
| - Inclusion criteria | Employees on sick leave lasting between 6 and 52 weeks with major depressive disorder and who do not have the prospect of full return to work yet. |
| - Exclusion criteria | Patients who are suicidal, psychotic or have dementia, as noticed by the company doctor, are excluded from this study. Also patients who are addicted to drugs or alcohol, as assessed by the MINI-interview, and patients who do not speak Dutch sufficiently to fill in the questionnaires, are excluded. Patients who are already receiving psychiatric treatment can be included in the study, in case of mutual agreement with the current care giver. |
| - mec approval received | no |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Active |
| - group | Parallel |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 1-mrt-2007 |
| - planned closingdate | 1-jun-2010 |
| - Target number of participants | 126 |
| - Interventions | The intervention follows a collaborative care model with adherence and compliance enhancing techniques, contracting, Problem Solving Treatment (PST), antidepressant medication prescribed by the consultant psychiatrist, and manual guided self help aimed at return to work and healthy lifestyle. |
| - Primary outcome | The primary outcome measure is the extent of reduction in depressive symptoms, as measured by the PHQ-9. |
| - Secondary outcome | 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. |
| - Timepoints | |
| - Trial web site | N/A |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | Drs. M.C. Vlasveld |
| - CONTACT for SCIENTIFIC QUERIES | Prof. Dr. C.M. Feltz-Cornelis, van der |
| - Sponsor/Initiator | Trimbos-institute - Netherlands Institute of Mental Health and Addiction |
| - Funding (Source(s) of Monetary or Material Support) | Foundation Reserves Voormalige Vrijwillige Ziekenfondsverzekering (RVVZ) |
| - Publications | N/A |
| - Brief summary | Background: Depressive disorder is a common mental health problem, which burdens individual patients as well as society. Not only is major depressive disorder associated with absenteeism from work, absence caused by mental disorders is of longer duration on average than absence caused by physical illness. Although evidence-based treatments for major depressive disorder are available, these are applied insufficiently and with less result than possible. Also, in most treatments occupational functioning is not a focus. In the occupational health setting, there is a need for more efficient screening and treatment of major depressive disorder. The collaborative care approach has proven to be an effective model in the treatment in primary care in the USA. Methods / design: CC: DOC (Collaborative Care: Depression initiative in Occupational Care) is a randomized controlled trial in which the treatment of major depressive disorder in the occupational health setting will be evaluated in the Netherlands. The cost-effectiveness of a collaborative care model, containing adherence enhancing techniques, contracting, Problem Solving Treatment, antidepressants, and manual guided self-help aimed at return to work, will be compared with care as usual. Patients on sick leave between 6 and 52 weeks who are diagnosed with major depressive disorder are included. Data will be collected at baseline and 3, 6, 9 and 12 months after baseline. Outcome measures are reduction of symptoms, return to work and cost-effectiveness of the intervention. Discussion: A collaborative care intervention in the treatment of major depressive disorder is evaluated for its cost-effectiveness in the occupational health setting in the Netherlands. Collaborative care has been studied for its effectiveness in the primary care setting in the US, but to our knowledge, it has not been studied in the occupational health setting yet. The occupational health setting appears to be an appropriate setting to incorporate work-related functioning into the treatment of patients with major depressive disorder on sick leave. Hallmark of collaborative care are activated patients who take responsibility for their treatment, which could make collaborative care an effective way to deal with major depressive disorder in the occupational health setting. |
| - Main changes (audit trail) | |
| - RECORD | 21-nov-2006 - 8-feb-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl