MIND-VR: Virtual Reality for COVID-19 Operators' Psychological Support

Study Overview
=================
Brief Summary
-----------------
Since the COVID-19 pandemic began, several psychological support programs for health care workers have been implemented, especially group or individual counseling sessions delivered face-to-face or using phones and video conferencing platforms. However, there are significant barriers to the delivery of such psychological initiatives. In this context, digital interventions to improve health services and care outcomes are recommended for implementing and providing remote psychological support. Virtual reality can play a relevant role in providing psychological care to healthcare workers facing COVID-19. New commercial head-mounted display have made virtual reality accessible even to the mass audience, breaking down the barriers in the diffusion and use of this technology. Thanks to this fact, virtual reality can now be autonomously used by people and offered to provide psychological assistance remotely. Within this context, this randomized controlled study aims to investigate the efficacy of a virtual reality home-based program for diminishing stress and anxiety in a sample of Italian healthcare workers involved in the COVID-19 pandemic.

Detailed Description
-----------------
Since the COVID-19 pandemic began, several psychological support programs for health care workers have been implemented, especially group or individual counseling sessions delivered face-to-face or using phones and video conferencing platforms. However, there are significant barriers to the delivery of such psychological initiatives. In this context, digital interventions to improve health services and care outcomes are recommended for implementing and providing remote psychological support. Virtual reality can play a relevant role in providing psychological care to healthcare workers facing COVID-19. New commercial head-mounted display have made virtual reality accessible even to the mass audience, breaking down the barriers in the diffusion and use of this technology. Thanks to this fact, virtual reality can now be autonomously used by people and offered to provide psychological assistance remotely. Within this context, this randomized controlled trial (RCT) aims to investigate the efficacy of a virtual reality home-based program for diminishing stress and anxiety in a sample of Italian healthcare workers involved in the COVID-19 pandemic. In particular, the objective is to compare the efficacy of this type of training with respect to the same program without virtual reality and a waiting list.

Official Title
-----------------
MIND-VR: Virtual Reality for COVID-19 Operators' Psychological Support

Conditions
-----------------
Stress Related Disorder

Intervention / Treatment
-----------------
* Behavioral: VR for psychoeducation and relaxation
* Other: Control (CR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18, < 65; Having worked on the front line as a doctor or nurse during the COVID-19 emergency (i.e., having assisted COVID-19 patients or having worked in departments dedicated to COVID-19 patients); Normal or corrected to normal visual acuity; Normal or corrected to normal hearing ability. Exclusion Criteria: Physical illness: cardiovascular issues, neurological illness, epilepsy; Pharmacotherapy with: psychotropic drugs, anti-hypertensive drugs, anti-epileptics;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study can be defined as a controlled and randomized clinical trial, single-blind and monocentric, aimed at studying the efficacy of the intervention with virtual reality contents in reducing stress and anxiety in healthcare personnel involved in the care of COVID-19 patients. The study will be conducted according to the indications of Good Clinical Practices. The clinical efficacy of the intervention will be assessed at two different time distances (T0, T1).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality (VR) Group<br>The treatment for the participants allocated to the VR Group consists of three home-sessions of approximately 30 minutes each, conducted over one week. In each session, participants will be asked to try for about 15 minutes MIND-VR. Subsequently, they will try the virtual relaxation content The Secret Garden. | Behavioral: VR for psychoeducation and relaxation<br>* Use of specifically developed VR contents to deliver psychoeducational content on stress and anxiety (i.e., MIND-VR) and to train on relaxation techniques (i.e., The Secret Garden).<br>|
| Active Comparator: Control (CR) Group<br>The CR Group will undergo pre- and post-protocol tests without undergoing any treatment. | Other: Control (CR)<br>* The CR Group will undergo pre- and post-protocol tests without undergoing any treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score at the State-Trait Anxiety Inventory -Y2 | A 20 item measure of the level of the state anxiety | Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up | 
| Change in score at the Perceived Stress Scale | A 10 item measure of the level of stress perceived in the last month | Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up | 
| Change in score at the Depression, Anxiety ans Stress Scale-21 items | A 21 item in 3 self-report scales which measures depression, anxiety and stress | Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up | 
| Change in score of knowledge on stress and anxiety | A 7 item measure at the ad hoc questionnaire to assess the knowledge of stress and anxiety | Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score at the EQ-5D-5L | A measure which defines the state of health and the perceived quality of life | Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
virtual reality, stress, anxiety, prevention, treatment, relaxation techniques, psychoeducation, COVID-19, healthcare workers