Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445101
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-27
First Post:
2024-05-31
Brief Title:
VitalWork an Intervention for Prevention of Mental Health Complaints at Work
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
VitalWork an Evidence-based Intervention Program for Prevention of Mental Health Complaints at Work Tailored to Specific Organisational Needs and Contextual Factors
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the current study VitalWork is to keep employees in the Netherlands vital on the long term by preventing work-related mental health problems Therefore we test an evidence based Participatory Approach PA to compose a mental health program tailored to behavioral organizational contextual BOC determinants of individuals and populations at risk The PA is investigated in four different organizations which differ in sector size small and large organizations type of organization private or public and type of work The varied organizations each characterized by unique BOC-determinants provide an opportunity for researching tailored intervention activities that aim to effectively prevent work-related mental health problems By identifying common factors across these diverse organizations we aim to grasp patterns of mechanisms for interventions to mental health at work By doing this we come closer to opening black box of how and why interventions work and thus closer to tailoring interventions to needs of both individuals and organizations
Detailed Description:
This study evaluates the PA as a strategy to implement measures to prevent or reduce work-related mental health problems by a cluster randomized controlled trial including an intervention and control group Employees in departments allocated to the intervention group receive the PA intervention in addition to the existing range of preventive mental health measures within the organization Departments assigned to the control group receive standard practice and therefore only the existing range of preventive interventions will be highlighted and further drawn to the attention of employees without the PA intervention Due to the PA intervention and associated activities it is not possible to blind the researchers and department managers However employees in the departments randomized to the intervention or control group are not aware of the research design Only department managers are informed about the research design and the outcome of randomization and they are asked not to communicate the research design to the employees
The PA consists of six steps 1 preparation create prerequisites and initiate the PA 2 risk assessment analysis of bottlenecks and risks 3 solutions Analysis of potential solutions 4 action planning jointly formulating a plan of action to realize solutions 5 implementation implementing measures by means of the action plan and 6 evaluation evaluation of the approach
For each intervention group a participatory working group will be established comprising 5-7 employees a department managersupervisor a health and safety coordinator an HR representative and a communication specialist Each intervention group is coordinated by a process facilitator who is responsible for preparing the meetings with the working group and leading the discussions during these sessions To prepare individuals for this role the process facilitator receives training provided by researchers experienced in the PA
The participative working group will go through steps 2 to 4 of the PA during a day session resulting in an action plan for the intervention activities to be implemented Subsequently this action plan will be implemented throughout the entire team comprising the intervention group This implementation process will be led by the process facilitator supported by change agents Ideally some of the working group members will act as change agents Change agents have the task of implementing interventions as widely as possible within the department and ensuring a smooth implementation process so that employees actually make use of the innovations In order to act as catalysts for the implementation process within the department the change agents and the process facilitator are trained by researchers experienced in the PA The duration of the entire implementation period is approximately 12 months but depends on the selected intervention activities with short-term implementations lasting 3 months and long-term implementations lasting 3 months
The PA consists of six steps 1 preparation create prerequisites and initiate the PA 2 risk assessment analysis of bottlenecks and risks 3 solutions Analysis of potential solutions 4 action planning jointly formulating a plan of action to realize solutions 5 implementation implementing measures by means of the action plan and 6 evaluation evaluation of the approach
For each intervention group a participatory working group will be established comprising 5-7 employees a department managersupervisor a health and safety coordinator an HR representative and a communication specialist Each intervention group is coordinated by a process facilitator who is responsible for preparing the meetings with the working group and leading the discussions during these sessions To prepare individuals for this role the process facilitator receives training provided by researchers experienced in the PA
The participative working group will go through steps 2 to 4 of the PA during a day session resulting in an action plan for the intervention activities to be implemented Subsequently this action plan will be implemented throughout the entire team comprising the intervention group This implementation process will be led by the process facilitator supported by change agents Ideally some of the working group members will act as change agents Change agents have the task of implementing interventions as widely as possible within the department and ensuring a smooth implementation process so that employees actually make use of the innovations In order to act as catalysts for the implementation process within the department the change agents and the process facilitator are trained by researchers experienced in the PA The duration of the entire implementation period is approximately 12 months but depends on the selected intervention activities with short-term implementations lasting 3 months and long-term implementations lasting 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None