|- candidate number||23460|
|- NTR Number||NTR5527|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-dec-2015|
|- Secondary IDs||200210025 ZonMw|
|- Public Title||Stress Prevention at Work: Evaluating the effectiveness of an implementation strategy for interventions that aim to reduce work-related stress|
|- Scientific Title||Stress Prevention at Work: Collaborative learning and information technology as the key to an integral stress prevention strategy for sectors, organisations and employees.|
|- hypothesis||It is hypothesised that a multifaceted, integral stress prevention strategy will reduce work-related stress and its related outcomes.|
|- Healt Condition(s) or Problem(s) studied||Work-related disease, Stress, Implementation|
|- Inclusion criteria||- Minimum age of 18 years. |
- Participating departments should have at least 15 participating employees.
|- Exclusion criteria||- Sick leave longer than one month |
- Planned retirement within one year
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jan-2016|
|- planned closingdate||31-dec-2017|
|- Target number of participants||278|
|- Interventions||The intervention group will receive; 1. a stepwise protocol to implement preventive stress measures. The different steps involve: 1. awareness, 2. assessment, 3. planning, 4. implementation, 5. evaluation. A digital platform is available to guide organisations through the stepwise protocol. 2 Participation in a collaborative learning network of different organisations to discuss progress and problems encountered during the implementation of the preventive stress measures.
The control group will be on a waiting list for 12 month. They will receive the baseline measurements at the same time as the implementation group. After the 12-month follow up measurement, this group will also receive the integral stress prevention strategy.
|- Primary outcome||The stress subscale of the Depression, Anxiety and Stress Scale (DASS-21)|
|- Secondary outcome||Work stress determinants |
- Physical characteristics of an imbalance between job demands and resources.
- Psychological characteristics of an imbalance between job demands and resources.
- work performance
- job satisfaction
- presenteism and productivity
- Sick leave
- cost utilities
- engagement of the employer and supervisors with the stepwise work-related stress prevention approach
- intermediate measures such as motivation, readiness to engage in stress prevention.
- reach, dose delivered, dose received, fidelity, barriers and facilitators
|- Timepoints||Baseline assessment of the work stress determinants and work outcomes
Follow-up measurements after 6 and 12 months
of the workstress determinants, work outcomes and proces variables.|
|- Trial web site||https://www.stresspreventieportaal.nl/portal/page/portal/TNO/WERKSTRESS/PUBLIEK/HOME|
|- CONTACT FOR PUBLIC QUERIES||Ms. PhD. Cecile R.L. Boot|
|- CONTACT for SCIENTIFIC QUERIES||Ms. PhD. Cecile R.L. Boot|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale: Although several measures directed at the prevention and management of work-related stress are effective, these interventions are hardly used by organisations. The most important barrier for use of evidence based stress prevention measures is that organisations gather their information from their own networks and peers rather than from searching in databases. Employers indicate that risk management will be much facilitated when organisations are working together, can learn from one another and have easier access to knowledge and professional expertise. An innovative collaborative learning network with involvement of different organisations and an information technology platform enabling access to effective instruments and measures can facilitate and stimulate the prevention of work-related stress.
Objective: The two main objectives are: 1. To evaluate the effectiveness of the integral stress prevention strategy on stress and work-related outcomes and to calculate a business case. 2. To investigate barriers and facilitators associated with the implementation of the integral stress prevention strategy at the level of the sector, organisation and employees.
Study design: In a randomised controlled trial, the effectiveness of the implementation strategy on stress and work-related outcome measures will be evaluated. Six months and 12 months after the baseline measure, a follow-up measurement will be conducted. A business case will be calculated for one organisation within the health care sector and one organisation within the education sector.
Study population: Dutch Organisations in health care and education. Intervention: The intervention under study is an implementation strategy, with the aim to implement existing measures to prevent stress in organizations. The organisations in the control group will not receive the implementation strategy immediately, but will be offered the implementation strategy after 12 months (waiting list design).
Main study parameters/endpoints: The main study parameter is stress, measured by the 7-item stress subscale of the Depression, Anxiety and Stress scale (DASS-21). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The intervention group will receive the implementation strategy. This implementation strategy consist of a digital platform (to be completed by HR professionals), a stepwise protocol (to be followed by the HR professional) and a collaborative learning network in which the HR professional participates. Rather than dictating the use of any particular intervention, the manipulation in this study consists of having access to the implementation strategy intervention group), or not (control group). On the level of the individual worker, participation exists of completion of questionnaires and (voluntary) participation in the stress prevention measures chosen by the organisation. These stress measures are all available for every organisation, so they are not experimental.
|- Main changes (audit trail)||16-sept-2016:
Change studytype: from a randomized controlled trial to a cluster controlled trial|
|- RECORD||7-dec-2015 - 29-sep-2016|