NCT06035666

Brief Summary

Introduction Up to half of hospital employees worldwide are experiencing symptoms of burnout. Therefore, interventions to improve mental health among hospital workers are urgently needed. Your World is an inexpensive and easy-to-use intervention that aims to reduce stress and increase resilience among hospital employees. Your world uses a blended approach, which includes a real-life personal session and challenges in the Your World app (for smartphone). Hypothesis The investigators hypothesize that Your World will improve resilience and well-being and reduce stress among hospital employees. Research objectives Main objective \- Does Your World reduce stress among hospital employees as measured by the PSS-10? Design Randomised controlled trial Population Employees of the Erasmus University Medical Center including students and volunteers Methods and study procedures Five hundred participants will be randomized 1:1 to receive either Your World (intervention) or the control app (control). In the intervention group, subjects will participate in one 'vitality session' before installing the app. At baseline and after 3 months hair samples questionnaires will be collected among the participants of both groups. At 6 months, same questionnaires will be collected. Burden and risks There are no risks associated with participation in this study. The questionnaires can be filled out online in 15 minutes, hair collection takes 5 minutes. The vitality sessions take 1 hour and the use of the app takes 5 minutes a day.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 4, 2023

Last Update Submit

September 11, 2023

Conditions

Keywords

eHealthVitalityStressHeath care workersAppYour World

Outcome Measures

Primary Outcomes (1)

  • PSS-10

    Perceived stress scale 10

    T=0 months, T=3 months, T=6 months

Secondary Outcomes (2)

  • Vita-16

    T=0 months, T=3 months, T=6 months

  • Hair cortisol

    T=0 months, T=3 months

Other Outcomes (1)

  • Other study parameters

    T=0 months, T=3 months, T=6 months

Study Arms (2)

Control

SHAM COMPARATOR

Control app

Other: Control app

Intervention

EXPERIMENTAL

Your World (vitality session + app)

Other: Your World

Interventions

Your World consists of a vitality session and use of the Your World app

Intervention

Control app, no effect on stress/vitality

Control

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Employee, student, trainee or volunteer at the Erasmus University Medical Center
  • years old

You may not qualify if:

  • Inadequate comprehension of the Dutch language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC, University Medical Center Rotterdam

Rotterdam, South Holland, 3015GD, Netherlands

Location

MeSH Terms

Conditions

Stress, PsychologicalAlzheimer Disease

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Not possible
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2023

First Posted

September 13, 2023

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Data available upon reasonable request.

Locations