NCT07544498

Brief Summary

This study investigates the effectiveness of an extended reality (XR) based resilience training program designed to support the mental health and well-being of nurses working in hospital settings. Nurses are exposed to high emotional, cognitive, and organizational demands and show elevated levels of work-related stress and stress-associated mental health problems. Strengthening resilience and coping capacities is therefore an important preventive approach to support nurses' well-being and sustain quality of care. The study is conducted as a pragmatic randomized controlled trial with a waitlist control group and includes approximately 232 nurses from hospitals in several European countries. Participants are randomly assigned either to an XR-based resilience training group or to a waitlist control group that continues with care as usual during the waiting period. The XR-based intervention consists of eight immersive training sessions delivered over approximately ten weeks using a head-mounted display. The training focuses on behavioral, cognitive, and emotional coping strategies and aims to enhance key resilience factors such as problem-solving, cognitive reappraisal, emotion regulation, and positive self-care. The primary outcome is perceived stress, assessed using the Perceived Stress Scale. Secondary outcomes include resilience, occupational self-efficacy, quality of life, psychological distress, burnout symptoms, coping strategies, work-related rumination, and turnover intentions. Assessments are conducted at baseline, post-intervention, and at a 20-week follow-up. In addition, a subgroup of participants will optionally provide physiological data during selected XR sessions to explore digital biomarkers related to stress and recovery. The findings of this study will provide evidence on the effectiveness, feasibility, and acceptance of XR-based resilience training for nurses and inform future implementation of digital mental health interventions in healthcare workplaces.

Trial Health

70
Monitor

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Sep 2026

Geographic Reach
5 countries

8 active sites

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 22, 2026

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

April 15, 2026

Last Update Submit

April 15, 2026

Conditions

Keywords

Extended RealityVirtual RealityXR-based InterventionResilience TrainingStress ReductionNursesHealthcare WorkersOccupational HealthMental Well-BeingDigital Mental HealthPreventive InterventionRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress

    Perceived stress measured using the 10-item Perceived Stress Scale (PSS-10). The PSS-10 assesses the degree to which situations in one's life are appraised as stressful during the past month. Scores range from 0 to 40, with higher scores indicating higher perceived stress.

    Baseline and 10 weeks post-randomization

Secondary Outcomes (8)

  • Resilience

    Baseline, 10 weeks post-randomization and 20 weeks post-randomization

  • Occupational self-efficacy

    Baseline and 10 weeks post-randomization

  • Psychological distress

    Baseline and 10 weeks post-randomization

  • Burnout symptoms

    Baseline 10 weeks post-randomization and 20 weeks post-randomization

  • Coping strategies

    Baseline 10 weeks post-randomization and 20 weeks post-randomization

  • +3 more secondary outcomes

Study Arms (2)

XR-based Resilience Training

EXPERIMENTAL

Participants in this arm receive an XR-based resilience training consisting of eight immersive sessions delivered over approximately ten weeks using a head-mounted display. The training focuses on behavioral, cognitive, and emotional coping strategies and aims to strengthen resilience and stress management skills. Each session lasts approximately 20 to 30 minutes and is completed individually.

Behavioral: XR-based Resilience TrainingOther: Waitlist Control

Waitlist Control

NO INTERVENTION

Participants in this arm are assigned to a waitlist control condition and continue with care as usual during the waiting period. They do not receive the XR-based resilience training during the first ten weeks of the study but are offered access to the intervention after completion of the post-intervention assessment.

Interventions

The XR-based resilience training is delivered via a standalone extended reality head-mounted display and consists of eight immersive sessions over approximately ten weeks. The training addresses behavioral coping strategies such as problem solving, cognitive coping strategies such as appraisal and reappraisal of stressors, and emotional coping strategies including emotion regulation and positive self-care. Sessions last approximately 20 to 30 minutes and are completed individually with technical support available if needed.

XR-based Resilience Training

Participants assigned to the waitlist control condition receive no active intervention during the initial study period and continue with care as usual. After completion of the post-intervention assessment, participants are offered access to the XR-based resilience training.

XR-based Resilience Training

Eligibility Criteria

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

You may qualify if:

  • working as a nurse in direct patient care within a clinical setting;
  • working at least 10h/week in their profession;
  • speaking the language in which the RCT is conducted sufficiently well;
  • able and willing to participate in all aspects of the study;
  • understanding and signing the appropriate informed consent form.

You may not qualify if:

  • a diagnosed severe mental disorder associated with alterations in reality perception (e.g., delusions, hallucinations, derealization, depersonalization, or dementia), including in particular schizophrenia, bipolar disorder, severe major depressive disorder, or other psychotic disorders (lifetime);
  • a current major depressive episode or a current post-traumatic stress disorder (PTSD);
  • an acute or clinically significant medical condition that may interfere with the safe use of an XR headset or study participation, including but not limited to epilepsy, pronounced dizziness, balance disorders, or acute cardiovascular conditions;
  • an acute eye infection (e.g., conjunctivitis);
  • unstable medication related to a mental health condition, defined as recent changes in dosage or class of psychotropic medication;
  • initiation of psychotherapy or any structured stress-management training within the past three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Medical University of Graz, Clinical Division of Psychiatry and Psychotherapeutic Medicine

Graz, Styria, 8036, Austria

Location

Klinika za psihijatriju Sveti Ivan

Zagreb, 10000, Croatia

Location

University Medical Center of Johannes Gutenberg University Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Hospital José Joaquim Fernandes

Beja, Beja District, 7801-849, Portugal

Location

Del Henares University Hospital

Coslada, Madrid, 28822, Spain

Location

Summa 112

Madrid, Madrid, 28005, Spain

Location

Infanta Leonor University Hospital

Madrid, Madrid, 28031, Spain

Location

Infanta Sofía University Hospital

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Related Links

MeSH Terms

Conditions

Occupational StressPsychological Well-BeingBurnout, Psychological

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorPersonal Satisfaction

Central Study Contacts

Nina Dalkner Research Prof. Priv.-Doz. Mag. rer.nat. Dr. rer.nat.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label trial. Due to the nature of the XR-based intervention and the waitlist control design, blinding of participants and study personnel is not feasible.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: waitlist-controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 22, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

April 22, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

De-identified individual participant data that underlie the results reported in publications will be made available upon reasonable request. Data will be shared in a pseudonymized form to qualified researchers for purposes of academic research and secondary analyses that are consistent with the original study objectives. Requests will be reviewed by the study steering committee and require a methodologically sound proposal and a data use agreement. Data sharing will be subject to applicable data protection regulations and ethical approvals.

Time Frame
Beginning 6 months after publication of the primary results and ending 5 years thereafter
Access Criteria
Researchers must submit a written request including a study proposal statistical analysis plan and intended use of the data. Approval by the study steering committee and a signed data use agreement are required prior to data access.

Locations