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 |
| Protocol serial number | N/A |
| Sponsor | Trimbos-instituut Netherlands Institute of Mental Health and Addiction |
| Funder | ArboUnie, ArboNed, STECR Alladin Program |
- 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
Scientific
Trimbos-instituut
Department of Diagnosis and Treatment
P.O. Box 725
Utrecht
3500 AS
Netherlands
| cfeltz@trimbos.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Reduction of symptoms as measured with the PHQ and quality of life as measured with the SF-20. |
| Key secondary outcome measure(s) |
Number of complaints, general functioning, fatigue, duration of sick leave. |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
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 | 07/09/2010 | Yes | No | |
| Protocol article | protocol | 27/02/2007 | Yes | No |
