|- candidate number||1574|
|- NTR Number||NTR363|
|- Date ISRCTN created||19-dec-2005|
|- date ISRCTN requested||28-okt-2005|
|- Date Registered NTR||12-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Randomized controlled trial of psychiatric consultation embedded in continuing education to company physicians for employees with sick leave absence through psychiatric disorders.|
|- Scientific Title||Psychiatric consultation embedded in continuing education to company physicians for employees with sick leave absence through psychiatric disorders. A randomised trial. |
|- ACRONYM||BACO Trial|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Mental illness, Depressive disorders, Anxiety disorders|
|- 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.|
|- 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.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||3-okt-2005|
|- planned closingdate||1-mei-2008|
|- Target number of participants||400|
|- Interventions||Company physicians are randomised over 2 conditions: |
1. the intervention group and
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 consultation are enbedded in the continuing education to company physicians.
|- Primary outcome||Reduction of symptoms as measured with the PHQ and quality of life as measured with the SF-20.|
|- Secondary outcome||Number of complaints, general functioning, fatigue, duration of sick leave.|
|- Trial web site||http://www.trimbos.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. C.M. Feltz-Cornelis, van der|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. C.M. Feltz-Cornelis, van der|
|- Sponsor/Initiator ||Trimbos-institute - Netherlands Institute of Mental Health and Addiction|
(Source(s) of Monetary or Material Support)
|STECR Alladin Program, ArboNed, ArboUnie|
|- Publications||Hoedeman R, Van de Beek EJ, Te Koppele A, Wijers JHL. STECR |
werkwijzer ‘Somatisatie”. Tijdschrift voor Bedrijfs- en Verzekeringsgeneeskunde 2005; 13:4:113-115.
Van der Feltz-Cornelis, C.M., Wijkel, D., Verhaak, P.F.M., Collijn, D.H., Huyse, F.J., Dyck van, R. 'Psychiatric consultation for somatizing patients in the family practice setting: a feasibility study'. International Journal of Psychiatry in Medicine 1996; 26:2¬: 223-239.
Van der Feltz-Cornelis, C.M. Transmurale psychiatrische consultatie. In: F.J. Huyse, A.F.G. Leentjens, M. Bannink, & A.D. Boenink (Red): Consultatieve Psychiatrie. Van Gorcum, 2004.
|- Brief summary||This study is a randomised trial on the effect of combined psychiatric consultations and continuing education to company doctors for patients with sick leave absence through mental illness. |
The study population consists of employees who after the usual care during 6 weeks of sick leave absence did not resume work, and have no plan for complete resumption of work within the next 6 weeks; that are PHQ screen positive on depression or anxiety or on the WI somatoform disorder.
The training of company physicians is developed in congruence with NVAB and STECR guidelines and will be presented as such for further elaboration of these guidelines.
Company physicians will be cluster randomised between an intervention group that receives consultation, and a CAU group. 2 x 200 employees will be included. 276 completers will be aimed at.
Assessment: PHQ-9, SCL-90, MOS SF-20, EQ-5D, MVI-20, TIC-P, satisfaction of employees on a VAS-scale. Follow up will be after 3 and 6 months.
|- Main changes (audit trail)|
|- RECORD||12-sep-2005 - 26-nov-2006|