|- candidate number||6705|
|- NTR Number||NTR2108|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-nov-2009|
|- Secondary IDs||80-82310-97-10094 Zon-Mw Doelmatigheid|
|- Public Title||Doelmatigheid van digitale werkhervattingsmodule bij depressieve werknemers.|
|- Scientific Title||Cost effectiveness of an E-health module on Return to Work embedded in collaborative occupational
health care for depressive disorders.|
|- hypothesis||We expect that the mean health care costs per depressed worker won sick leave will be lower in the intervention group, which will be treated by an E-health module on return to work embedded in collaborative occupationalhealth care, as it
implies a transition of care from expensive mental health to the less costly OH setting, and as many contacts will be facilitated by the E health module and webbased tracking system, which will be much cheaper. We expect the number of days absent from work to be lower in the intervention group as well as the costs due to reduced efficiency due to better effectiveness. Hence, the productivity costs will on average be lower for patients in the intervention group. Thus, we expect the ECO-intervention to be cost-effective.|
|- Healt Condition(s) or Problem(s) studied||Depressive Disorder , Return to work|
|- Inclusion criteria||This study will focus on workers with MDD who have been on sick leave for between 4 and 12 weeks. By choosing this duration of sick leave, we try to facilitate inclusion and prevent a transition to long-term absenteeism. Workers who give informed consent and have a score of 10 or more for moderate to severe MDD on the PHQ-9 will undergo a Mini-International Neuropsychiatric Interview (MINI). If they classify for DSM-IV MDD, they will be included. The PHQ-9 is a brief, reliable instrument that can be used as a screener to detect depressive disorders and also to monitor treatment response in primary care. PHQ-9 scores of 5, 10, 15 and 20 represent cut points for, respectively, mild, moderate, moderately severe, and severe MDD. |
|- Exclusion criteria||Patients who are suicidal, psychotic or with a primary
diagnosis of substance abuse or dependence, as assessed by the MINI interview, will be excluded from
the study. Also, patients who do not have sufficient command of the Dutch language to fill in the
questionnair-es and patients who are pregnant will be excluded, as well as patients with a legal
involvement against their employer, e.g. due to a conflict at work. |
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2010|
|- planned closingdate||1-okt-2014|
|- Target number of participants||200|
|- Interventions||The ECO-intervention comprises:|
1. Detection of Major Depressive Disorder (MDD) amongst workers on sick leave by screening;
2. Supporting diagnosis and treatment by occupational physicians (OPs), both by a webbased tracking system;
3. Empowerment of the worker by an E-health return to work (RTW) module;
4. Facilitating collaborative and stepped care of MDD by evidence-based treatment recommendations given by training and supervision of OPs and supported by a tracking system and consultant psychiatrist;
5. Relapse prevention;
6. Work interventions, including consultation with employer and eventual work-accomodations.
These elements of the intervention run parallel to each other. ECO follows the process steps of the guideline and facilitates evidence-based treatment facilitating RTW by means of minor inter-ventions that precede more invasive treatments.
Controls will receive care as usual.
|- Primary outcome||Primary outcome measure is time to fulltime return to work (RTW).|
|- Secondary outcome||Secondary outcome measures are severity of depressive symptoms, as measured with the Patient Health Questionnaire (PHQ9), and Costs: Direct health care and indirect productivity loss (average daily wage multiplied by number of sick leave days) costs will be collected. A cost-minimalisation analysis will be performed.|
|- Timepoints||Follow up at 3, 6, 9 and 12 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. D. Volker|
|- 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)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Background |
The burden of CMD on the level of sickness
absence is huge, for society as well as for individual workers.
Given the implications for the workers quality of life and
the huge costs incurred by sickness absence, return to
work (RTW) is an important issue. In the Netherlands,
the occupational physician (OP) plays a central role in the
guidance of sick listed workers in RTW. Evidence based
guidelines for OPs are available, but the availability of
guidelines alone is not sufficient. An intervention is needed
which supports the OP in the guidance of sick listed workers
with CMD. The ECO-intervention comprises a decision aid
supporting the OP and an E-health module for the depressed,
sick listed worker.
ECO is a two-armed cluster-randomized
trial in which the ECO-intervention for CMD will be compared
to usual care (CAU). Randomization will occur at the level
of OPs. Workers on sickness absence between 4 and 26
weeks will be included in the study. OPs allocated to the
intervention group will receive training in following up on the
recommendations derived from the decision aid. Workers
whose OP is allocated to the intervention group will receive
the ECO-intervention: they will receive guidance from their
OP following the decision aid system, and they will work
through the E-health module. OPs allocated to CAU will give
sickness guidance as usual. Follow-up measurements will
take place at 3, 6, 9 and 12 months after baseline. Primary
outcome measure is the duration until first RTW. Secondary
outcome measure is the severity of depressive, anxiety and
somatisation symptoms in terms of respons and remission.
An economic evaluation will also be performed from a
In the present study, the ECO-intervention
to improve sickness guidance for sick listed, workers with
CMD will be evaluated for its cost-effectiveness. The ECO-
intervention is aimed at supporting the OP in the sickness
guidance of workers with CMD. Existing guidelines and laws
on the privacy of workers and the exchange of information
will be followed.
|- Main changes (audit trail)||29-apr-2014: Due to an additional sponsor (Achmea SZ), which interests are mostly fear and somatisation, the study protocol changed. See below and brief summary. - AB |
- New title: Cost effectiveness of an E-health module on Return to Work embedded in collaborative occupational health care for common mental disorders.
- New hypothesis: It is expected that workers in the intervention group (ECO) return to work faster than workers in the usual care group (CAU). Furthermore, it is expected that workers in the intervention group have a larger reduction in depressive, anxiety or somatisation symptoms than workers in the CAU group. ECO is expected to be cost-effective through lower health care costs and lower productivity losses.
- Inclusion criteria: Workers on sickness absence between 4 and 26 weeks with common mental disorder (CMD).
- Exclusion criteria: Workers who do not have sufficient command of the Dutch language to fill in the questionnaires and workers who are pregnant will be excluded, as well as workers with a legal involvement against their employer, e.g. due to a conflict at work.
- Primary outcome: Time to first return to work (RTW)
- Secondary outcome: Secondary outcome measures are severity of depressive, anxiety and somatization symptoms in terms of respons and remission, as measured with the Patient Health Questionnaire subscale for depression (PHQ9) and somatization (PHQ15) and the Generalized Anxiety Disorder Questionnaire (GAD7). Tertiary outcome is the cost-effectiveness.
- End date changed (was 1-nov-2013)
- Interventions: The ECO-intervention comprises a decision aid for the occupational physician (OP) and an E-health module for the depressed worker. The decision aid will support OPs in the guidance of sick-listed workers with CMD and comprises elements based on Collaborative Care, such as continuously monitoring of progress and access to psychiatric consultation. The effectiveness of ECO will be compared with that of usual care (CAU)
|- RECORD||10-nov-2009 - 8-mei-2014|