Clinical trial NCT06543732: Vital@Work: Reintegration Program for Employees with Stress-related Complaints
Official title: Vital@Work: a Personalized Reintegration Program for Employees with Stress-related Complaints
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Return to Work
Mental Health
Keywords: Return to work
Stress
Absenteeism
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Health Holland
name: Trimbos
First posted: 2024-08-09
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial comparing intervention group with care as usual group. Randomization is carried out at the individual level stratified by organisation type and whether problems are perceived as work-related or not.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Lasting return to work
timeFrame: Baseline - 3 months - 6 months -12 months
Secondary outcomes:
measure: Stress-related complaints
timeFrame: Baseline - 3 months - 6 months -12 months
measure: Psychosocial job characteristics
timeFrame: Baseline - 3 months - 6 months - 12 months
measure: Behaviour change
timeFrame: Baseline - 3 months - 6 months - 12 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Amsterdam
country: Netherlands
facility: GGZ inGeest
city: Amsterdam
country: Netherlands
facility: Transavia
city: Den Haag
country: Netherlands
facility: RSO
Study officials:
References: