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XR2ESILIENCE - XR-Based Resilience Training for Stress and Mental Health in Healthcare Workers

A Pragmatic Randomized Controlled Trial Study Protocol: XR2ESILIENCE - Pioneering XR Technology for the Promotion of Resilience and Mental Health of the Healthcare Workforce

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07544498
Acronym
XR2ESILIENCE
Enrollment
232
Registered
2026-04-22
Start date
2026-09-01
Completion date
2028-03-01
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burnout, Mental Health, Occupational Stress, Resilience, Work-Related Stress

Keywords

Extended Reality, Virtual Reality, XR-based Intervention, Resilience Training, Stress Reduction, Nurses, Healthcare Workers, Occupational Health, Mental Well-Being, Digital Mental Health, Preventive Intervention, Randomized Controlled Trial

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.

Detailed description

This study is part of the XR2ESILIENCE project, a European multicenter research initiative aimed at promoting resilience and mental health among healthcare professionals through innovative extended reality (XR) technologies. The present randomized controlled trial evaluates the effectiveness of a newly developed XR-based resilience training program for nurses working in hospital settings. Nurses are frequently exposed to high workload, emotional labor, time pressure, and organizational stressors, which are associated with increased stress levels, burnout symptoms, and mental health impairments. Despite the high relevance of resilience promotion in this occupational group, accessible and scalable preventive interventions remain limited. XR technology offers the opportunity to deliver immersive, engaging, and standardized resilience training that can be flexibly integrated into clinical and non-clinical settings. The study uses a pragmatic, parallel-group, waitlist-controlled randomized design. A total of approximately 232 nurses aged 18 to 65 years will be recruited across multiple hospital sites in Europe. After completion of baseline assessments and provision of informed consent, participants are randomly allocated in a 1:1 ratio either to the XR-based intervention group or to a waitlist control group. The control group continues with care as usual and receives access to the intervention after the waiting period. The XR-based resilience training consists of eight sessions delivered over approximately ten weeks using a standalone head-mounted display. Each session lasts around 20 to 30 minutes. The training is structured into modules addressing behavioral coping (e.g., problem-solving and proactive coping), cognitive coping (e.g., appraisal and reappraisal of stressors), and emotional coping (e.g., emotion regulation, acceptance, and fostering positive emotions). The intervention is theoretically grounded in contemporary resilience frameworks and the concept of regulatory flexibility. Participants complete the sessions individually, with technical support available if needed. The primary outcome is perceived stress measured by the 10-item Perceived Stress Scale at post-intervention. Secondary outcomes include resilience, occupational self-efficacy, psychological distress, burnout symptoms, coping strategies, work-related rumination, quality of life, and career-related variables such as turnover intentions. Data are collected at baseline, immediately after the intervention period, and at a 20-week follow-up. In addition to questionnaire-based outcomes, optional digital biomarker data are collected during selected XR sessions to explore physiological indicators of stress and recovery, such as heart rate variability and other sensor-based measures, depending on study site capabilities. User experience, technology acceptance, satisfaction, and potential side effects of XR use are assessed descriptively after completion of the intervention. The study follows an intention-to-treat approach for primary analyses. Results are expected to provide robust evidence on whether XR-based resilience training can reduce perceived stress and improve mental health outcomes among nurses. The findings will also inform the feasibility, acceptability, and potential health-economic value of implementing XR-supported resilience interventions in hospital workplaces.

Interventions

BEHAVIORALXR-based Resilience Training

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.

OTHERWaitlist Control

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.

Sponsors

Medical University of Graz
Lead SponsorOTHER
MINDCONSOLE GMBH
CollaboratorUNKNOWN
Medizinische Privatuniversität Burgenland
CollaboratorUNKNOWN
Central Institute of Mental Health, Mannheim
CollaboratorOTHER
St. Pölten University of Applied Sciences
CollaboratorOTHER
University of Évora
CollaboratorOTHER
Leibniz Institute for Resilience Research (LIR), Mainz, Germany
CollaboratorUNKNOWN
Leuphana Universität Lünenberg
CollaboratorUNKNOWN
University of Lisbon
CollaboratorOTHER
Sveti Ivan Psychiatric Hospital
CollaboratorOTHER
mindconsole
CollaboratorUNKNOWN
PredictBy Research and Consulting, S.L
CollaboratorINDUSTRY
Servicio Madrileño de Salud (SERMAS)
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Masking description

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.

Intervention model description

waitlist-controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

1. working as a nurse in direct patient care within a clinical setting; 2. working at least 10h/week in their profession; 3. speaking the language in which the RCT is conducted sufficiently well; 4. able and willing to participate in all aspects of the study; 5. understanding and signing the appropriate informed consent form.

Exclusion criteria

1. 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); 2. a current major depressive episode or a current post-traumatic stress disorder (PTSD); 3. 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; 4. an acute eye infection (e.g., conjunctivitis); 5. unstable medication related to a mental health condition, defined as recent changes in dosage or class of psychotropic medication; 6. initiation of psychotherapy or any structured stress-management training within the past three months.

Design outcomes

Primary

MeasureTime frameDescription
Perceived Stress Assessed by PSS-10Baseline, 10 weeks post-randomization & 20 weeks post-randomizationPerceived 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.

Secondary

MeasureTime frameDescription
Resilience Assessed by BRSBaseline, 10 weeks post-randomization & 20 weeks post-randomizationSelf-perceived resilience will be assessed using the Brief Resilience Scale (BRS), a self-report measure consisting of six items rated on a 5-point Likert scale. Total scores are calculated by summing item responses (range: 6 to 30) and dividing by the number of items answered, resulting in a mean score ranging from 1 to 5. Higher scores indicate greater resilience.
Occupational Self-Efficacy Assessed by OSE-SFBaseline and 10 weeks post-randomizationOccupational self-efficacy will be assessed using the Occupational Self-Efficacy Scale - Short Form (OSE-SF), a self-report measure consisting of items rated on a 6-point Likert scale ranging from 1 (not at all true) to 6 (completely true). Total scores are calculated by summing item responses, with higher scores indicating greater occupational self-efficacy.
Psychological Distress Assessed by GHQ-12Baseline and 10 weeks post-randomizationPsychological distress will be assessed using the General Health Questionnaire-12 (GHQ-12), a 12-item self-report measure with items rated on a 4-point Likert scale (0 to 3). Total scores range from 0 to 36, with higher scores indicating greater psychological distress.
Burnout symptoms Assessed by BAT-12Baseline and 10 weeks post-randomizationBurnout symptoms will be assessed using the Burnout Assessment Tool - Short Version (BAT-12), a 12-item self-report measure with items rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). Total scores range from 12 to 60, with higher scores indicating higher levels of burnout-related symptoms.
Coping Strategies Assessed by CSI-SFBaseline, 10 weeks post-randomization & 20 weeks post-randomizationCoping strategies will be assessed using the Coping Strategies Inventory - Short Form (CSI-SF). The CSI-SF is a 16-item measure rated on a 5-point Likert scale ranging from 1 to 5. Subscale scores range from 4 to 20, with higher scores indicating greater use of coping strategies.
Coping Flexibility Assessed by CFS-RBaseline, 10 weeks post-randomization & 20 weeks post-randomizationCoping flexibility will be assessed using the Coping Flexibility Scale - Revised (CFS-R). The CFS-R is a 10-item measure rated on a 4-point Likert scale ranging from 0 to 3. Total scores range from 0 to 30, with higher scores indicating greater coping flexibility.
Health-Related Quality of Life Assessed by EQ-5D-5LBaseline and 10 weeks post-randomizationHealth-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), a standardized instrument comprising five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on a 5-level scale (1 to 5). Health states are converted into a single index value using a country-specific value set, typically ranging from less than 0 (worse than death) to 1 (full health), with higher values indicating better perceived health status.
Turnover intentionsBaseline and 10 weeks post-randomizationTurnover intentions assessed using self-developed items measuring intention to leave the profession or current workplace.
User Experience Assessed With the AttrakDiff Mini10 weeks post-randomization (Training Group) or 20 weeks post-randomization (Control Group)User experience will be assessed using the AttrakDiff Mini. The AttrakDiff Mini is a 10-item measure rated on a 7-point bipolar scale ranging from -3 to +3. Higher scores indicate a more positive user experience.
User Satisfaction Assessed With the Client Satisfaction Questionnaire for Internet-Based Interventions10 weeks post-randomization (Training Group) or 20 weeks post-randomization (Control Group)User satisfaction will be assessed using the Client Satisfaction Questionnaire adapted for Internet-based interventions (CSQ-I). The CSQ-I is an 8-item measure rated on a 4-point Likert scale. Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
VR-Related Side Effects Assessed With the Virtual Reality Neuroscience Questionnaire10 weeks post-randomization (Training Group) or 20 weeks post-randomization (Control Group)VR-related side effects will be assessed using the Virtual Reality Neuroscience Questionnaire (VRNQ), specifically the Virtual Reality-Induced Symptoms and Effects (VRISE) subscale. Items are rated on a 7-point Likert scale, with higher scores indicating lower intensity of side effects.
Positive Effects Assessed With Adapted Items From the Oxford VR Side Effects Checklist10 weeks post-randomization (Training Group) or 20 weeks post-randomization (Control Group)Positive effects will be assessed using three adapted items from the Oxford VR Side Effects Checklist (O-VRES). Items are rated on a 5-point Likert scale. Total scores range from 3 to 15, with higher scores indicating greater endorsement of positive effects.

Countries

Austria, Croatia, Germany, Portugal, Spain

Contacts

CONTACTNina Dalkner Research Prof. Priv.-Doz. Mag. rer.nat. Dr. rer.nat.
nina.dalkner@medunigraz.at+43 316 385 30081

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026