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临床试验/NCT06543732
NCT06543732招募中不适用

Vital@Work: a Personalized Reintegration Program for Employees with Stress-related Complaints

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)4 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2025年1月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
208
试验地点
4
主要终点
Lasting return to work

研究概览

简要总结

The objective of this study, Vital@Work reintegration program, is to support sick-listed workers with stress-related complaints in their return to work based on a personalized program. Therefore, the aim of this study is test whether participants supported by a tailored eHealth program, and if needed, additionally supported by a structured and stepwise Participatory Approach (PA) involving the sick-listed worker, their direct supervisor and a neutral party, show a faster and sustainable return to work as compared to participants in the control condition. This program 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.

详细描述

This study evaluates the effectiveness of a program, incorporating diverse components, to improve sustainable return to work, stress-related outcomes and cost effectiveness among sick-listed workers with stress-related complaints compared to usual care. The study design is a randomized controlled trial, including an intervention and control group. Sick-listed workers between 2 - 12 weeks sick, in the intervention group receive a tailored eHealth program based on their questions on a distress screener, if needed followed by the Participatory Approach (PA). Sick-listed workers in the control group receive standard practice and general information about return to work. If sick-listed workers did not return to work after 6 weeks in the eHealth program, the PA starts. The PA is a structured and stepwise procedure that involves the sick-listed worker, their direct supervisor, and a neutral party (either physically present or working in the background) to guide the conversation. This collaborative process aims to identify workplace-related bottlenecks, and subsequently develop a consensus-based return to work plan based on a strong commitment of both the sick listed worker and employer. This study offers two different forms of PA: individual work modifications (guided by a neutral process facilitator) and job coaching (guided by the employer, with the process facilitator providing support in the background). If sick-listed workers are experiencing stress-related complaints originating from work, they will be offered individual work modifications. Conversely, if the issues are unrelated to work, the worker will receive job coaching. As information on this tailored PA approach is lacking, the effectiveness of this approach is investigated. By combining these different intervention components, the investigators strive to fill the research gap concerning the identification of an effective re-integration program for sick-listed workers suffering from stress-related complaints. Participants will be followed for 1 year.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Due to the PA intervention, it is not possible to blind the researchers and process facilitators. However, workers randomized to the intervention or control group are not aware of the research design. Process facilitators providing the PA are informed about the research design and the outcome of randomization, and they are asked not to communicate the research design to the employees.

入排标准

年龄范围
18 Years 至 68 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Sick-listed employees from participating organisations (Amsterdam UMC, GGZ inGeest, Rijksschoonmaakorganisatie [RSO], and Transavia)
  • •Aged 18-68
  • •Between 2 and 12 weeks on sick leave
  • •Suffering from stress-related complaints

排除标准

  • •Non-sick-listed employees
  • •Suffering from severe psychiatric disorders (e.g., suicidality, mania, psychosis, schizophrenia) or other chronic conditions (e.g., terminal illness) that could significantly affect the employee's mental health and, hence, prevent the return-to work process
  • •Being pregnant or less than three months after delivery
  • •Sick-listed for more than 12 weeks
  • •Inability to complete either the eHealth modules or questionnaires
  • •Presence of a legal conflict with the employer
  • •Not signing informed consent

研究组 & 干预措施

eHealth with Participatory Approach if needed

Experimental

Participants receive a personalized eHealth program and if needed, after 6 weeks the Participatory Approach (intervention) next to care as usual from occupational health care.

干预措施: Return to work program (Other)

Control condition

No Intervention

Participants receive links to existing websites on return to work next to care as usual from occupational health care.

结局指标

主要结局

Lasting return to work

时间窗: Baseline - 3 months - 6 months -12 months

Lasting return to work of at least 28 consecutive days without (partial or full) relapse

次要结局

  • Stress-related complaints(Baseline - 3 months - 6 months -12 months)
  • Psychosocial job characteristics(Baseline - 3 months - 6 months - 12 months)
  • Behaviour change(Baseline - 3 months - 6 months - 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Trees Juurlink

Senior researcher

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (4)

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