- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07544498
XR2ESILIENCE - XR-Based Resilience Training for Stress and Mental Health in Healthcare Workers (XR2ESILIENCE)
A Pragmatic Randomized Controlled Trial Study Protocol: XR2ESILIENCE - Pioneering XR Technology for the Promotion of Resilience and Mental Health of the Healthcare Workforce
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nina Dalkner Research Prof. Priv.-Doz. Mag. rer.nat. Dr. rer.nat.
- Phone Number: +43 316 385 30081
- Email: nina.dalkner@medunigraz.at
Study Locations
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-
Styria
-
Graz, Styria, Austria, 8036
- Medical University of Graz, Clinical Division of Psychiatry and Psychotherapeutic Medicine
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Contact:
- Melissa L Behrend, MSc
- Phone Number: +43 316 385 30081
- Email: melissa.behrend@medunigraz.at
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Principal Investigator:
- Nina Dalkner, Res.-Prof. Priv.-Doz. Mag. Dr.
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Zagreb, Croatia, 10000
- Klinika za psihijatriju Sveti Ivan
-
Contact:
- Ena Ivezic, mag. psih.
- Phone Number: +385 1 3430 171
- Email: ena.ivezic@pbsvi.hr
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Principal Investigator:
- Igor Filipcic, Prof. prim. dr. sc.
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-
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Rhineland-Palatinate
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Mainz, Rhineland-Palatinate, Germany, 55131
- University Medical Center of Johannes Gutenberg University Mainz
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Contact:
- Annika Hasch, MSc
- Phone Number: +49 6131 89448 00
- Email: Annika.Hasch@lir-mainz.de
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Principal Investigator:
- Klaus Lieb, Prof. Dr.
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Beja District
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Beja, Beja District, Portugal, 7801-849
- Hospital José Joaquim Fernandes
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Contact:
- Fátima Cano
- Email: fatima.cano@uevora.pt
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Sub-Investigator:
- Elisabete Alves
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Principal Investigator:
- Lara Guedes de Pinho, Prof. PhD Dr.
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Madrid
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Coslada, Madrid, Spain, 28822
- Del Henares University Hospital
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Contact:
- Javier C Fernández
- Phone Number: +34 606896258
- Email: drocio.diaz@salud.madrid.org
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Principal Investigator:
- Dania R D Rodríguez, Dr.
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Madrid, Madrid, Spain, 28005
- Summa 112
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Contact:
- Cristina V Lorenzo
- Phone Number: +34 638210690
- Email: cristina.veiras@salud.madrid.org
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Principal Investigator:
- María J A Carretón, Dr.
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Madrid, Madrid, Spain, 28031
- Infanta Leonor University Hospital
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Contact:
- María F González
- Phone Number: +34 608732331
- Email: maria.fgonzalez@salud.madrid.org
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Principal Investigator:
- Carmen B León, Dr.
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San Sebastián de los Reyes, Madrid, Spain, 28702
- Infanta Sofía University Hospital
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Contact:
- Marta G Granado
- Phone Number: +34 638210687
- Email: marta.gonzalez.granado@salud.madrid.org
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Principal Investigator:
- Inés C Hammel, Dr.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: XR-based Resilience Training
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.
|
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.
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.
|
|
No Intervention: Waitlist Control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Assessed by PSS-10
Time Frame: Baseline, 10 weeks post-randomization & 20 weeks post-randomization
|
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, 10 weeks post-randomization & 20 weeks post-randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resilience Assessed by BRS
Time Frame: Baseline, 10 weeks post-randomization & 20 weeks post-randomization
|
Self-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.
|
Baseline, 10 weeks post-randomization & 20 weeks post-randomization
|
|
Occupational Self-Efficacy Assessed by OSE-SF
Time Frame: Baseline and 10 weeks post-randomization
|
Occupational 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.
|
Baseline and 10 weeks post-randomization
|
|
Psychological Distress Assessed by GHQ-12
Time Frame: Baseline and 10 weeks post-randomization
|
Psychological 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.
|
Baseline and 10 weeks post-randomization
|
|
Burnout symptoms Assessed by BAT-12
Time Frame: Baseline and 10 weeks post-randomization
|
Burnout 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.
|
Baseline and 10 weeks post-randomization
|
|
Coping Strategies Assessed by CSI-SF
Time Frame: Baseline, 10 weeks post-randomization & 20 weeks post-randomization
|
Coping 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.
|
Baseline, 10 weeks post-randomization & 20 weeks post-randomization
|
|
Coping Flexibility Assessed by CFS-R
Time Frame: Baseline, 10 weeks post-randomization & 20 weeks post-randomization
|
Coping 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.
|
Baseline, 10 weeks post-randomization & 20 weeks post-randomization
|
|
Health-Related Quality of Life Assessed by EQ-5D-5L
Time Frame: Baseline and 10 weeks post-randomization
|
Health-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.
|
Baseline and 10 weeks post-randomization
|
|
Turnover intentions
Time Frame: Baseline and 10 weeks post-randomization
|
Turnover intentions assessed using self-developed items measuring intention to leave the profession or current workplace.
|
Baseline and 10 weeks post-randomization
|
|
User Experience Assessed With the AttrakDiff Mini
Time Frame: 10 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.
|
10 weeks post-randomization (Training Group) or 20 weeks post-randomization (Control Group)
|
|
User Satisfaction Assessed With the Client Satisfaction Questionnaire for Internet-Based Interventions
Time Frame: 10 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.
|
10 weeks post-randomization (Training Group) or 20 weeks post-randomization (Control Group)
|
|
VR-Related Side Effects Assessed With the Virtual Reality Neuroscience Questionnaire
Time Frame: 10 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.
|
10 weeks post-randomization (Training Group) or 20 weeks post-randomization (Control Group)
|
|
Positive Effects Assessed With Adapted Items From the Oxford VR Side Effects Checklist
Time Frame: 10 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.
|
10 weeks post-randomization (Training Group) or 20 weeks post-randomization (Control Group)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101137237 (Other Grant/Funding Number: EU Horizon 2030 grant)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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