Towards a shortened sick leave duration of employees sick-listed due to common mental disorders
| ISRCTN | ISRCTN86605310 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86605310 |
| Secondary identifying numbers | 208030001 |
- Submission date
- 30/06/2010
- Registration date
- 11/08/2010
- Last edited
- 05/12/2016
- 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 Evelien Brouwers
Scientific
Scientific
Tilburg University
Department Tranzo
Warandelaan 2
Tilburg
5000 LE
Netherlands
| Phone | +31 (0)13 466 2962 |
|---|---|
| e.p.m.brouwers@uvt.nl |
Study information
| Study design | Multicentre randomised controlled trial longitudinal design with follow up |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | Effectiveness of the guideline management of workers with common mental health problems by occupational physicians: a randomised controlled trial |
| Study objectives | Sick listed employees treated by occupational physicians (OPs) who are trained in and closely follow the guideline will have a shorter sick leave duration than those in the control group. |
| Ethics approval(s) | Medical Research Ethics Committee of St. Elisabeth Hospital in Tilburg, MREC number 1162 |
| Health condition(s) or problem(s) studied | Sick leave due to common mental disorders |
| Intervention | OPs in the experimental condition are trained in the Dutch guideline 'management of workers with common mental health problems by occupational physicians'. OPs will be divided into groups of 6 - 10 OPs, and will gather for monthly meetings of approximately 1 hour, over 1 year. Using action research and focus group discussions it will be investigated which barriers OPs encounter in using the guideline. Subsequently, barriers will be explored and possible solutions will be discussed by means of a 'plan, do, check, act' cycle. OPs from the control group provide care as usual. The total duration of follow up will be 12 months. |
| Intervention type | Other |
| Primary outcome measure | Time to full return to work, defined as the number of days between the first day of sickness absence and the first day of full return to work |
| Secondary outcome measures | 1. Partial return to work 2. Total days of sick leave at 12 months 3. Patient satisfaction, assessed by a short questionnaire developed for this study 4. Symptoms, measured using the 4DSQ (Terluin 2002) Outcomes will be assessed at baseline, 3, 6 and 12 months. |
| Overall study start date | 15/10/2010 |
| Completion date | 15/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 232 |
| Key inclusion criteria | 1. A common mental disorder, i.e. anxiety, depression, burnout or emotional distress, is the primary reason for sick leave at the time of inclusion. Physical problems may be present, but should not cause absenteeism 2. Dutch speaking 3. Counseled by an OP that takes part in the study |
| Key exclusion criteria | 1. Acute crisis or suicidality 2. Sick leave duration of less than 4 weeks, as a quick recovery of part of this group may dilute the statistical power of the study 3. Sick leave duration of more than 8 weeks, as the study aims to prevent long term sick leave |
| Date of first enrolment | 15/10/2010 |
| Date of final enrolment | 15/10/2014 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Tilburg University
Tilburg
5000 LE
Netherlands
5000 LE
Netherlands
Sponsor information
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Government
Government
Laan van Nieuw Oost Indië 334
The Hague
2593 CE
Netherlands
| Phone | +31 (0)70 3495111 |
|---|---|
| info@zonmw.nl | |
| Website | http://www.zonmw.nl/nl/ |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Government
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) - (ref: 208030001)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 06/03/2013 | Yes | No | |
| Results article | results | 19/08/2015 | Yes | No | |
| Results article | results | 01/12/2017 | Yes | No |
Editorial Notes
05/12/2016: Publication reference added.
15/03/2016: Publication reference added.
