MIND-VR: Virtual Reality for COVID-19 Operators' Psychological Support
NCT ID: NCT04611399
Last Updated: 2023-06-05
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-03-05
Study Completion Date
2023-02-05
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Stress Related Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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).
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Virtual Reality (VR) Group
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".
Group Type
EXPERIMENTAL
VR for psychoeducation and relaxation
Intervention Type
BEHAVIORAL
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").
Control (CR) Group
The CR Group will undergo pre- and post-protocol tests without undergoing any treatment.
Group Type
ACTIVE_COMPARATOR
Control (CR)
Intervention Type
OTHER
The CR Group will undergo pre- and post-protocol tests without undergoing any treatment.
Interventions
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VR for psychoeducation and relaxation
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").
Intervention Type
BEHAVIORAL
Control (CR)
The CR Group will undergo pre- and post-protocol tests without undergoing any treatment.
Intervention Type
OTHER
Eligibility Criteria
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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.
* 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;
* Pharmacotherapy with: psychotropic drugs, anti-hypertensive drugs, anti-epileptics;
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Milano Bicocca
OTHER
Sponsor Role
collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Federica Pallavicini, PhD
Role: STUDY_DIRECTOR
University of Milano Bicocca
Eleonora F Orena, PhD
Role: PRINCIPAL_INVESTIGATOR
Foundation IRCCS Neurological Institute Carlo Besta
Locations
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Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, , Italy
Site Status
Countries
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Italy
References
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Reference Type
DERIVED
Pallavicini F, Orena E, di Santo S, Greci L, Caragnano C, Ranieri P, Vuolato C, Pepe A, Veronese G, Stefanini S, Achille F, Dakanalis A, Bernardelli L, Sforza F, Rossini A, Caltagirone C, Fascendini S, Clerici M, Riva G, Mantovani F. A virtual reality home-based training for the management of stress and anxiety among healthcare workers during the COVID-19 pandemic: study protocol for a randomized controlled trial. Trials. 2022 Jun 2;23(1):451. doi: 10.1186/s13063-022-06337-2.
Reference Type
DERIVED
Related Links
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https://coronavirus.jhu.edu/map.html
Johns Hopkins Coronavirus Resource Center. (2020). COVID-19 Map.
https://www.who.int/publications/i/item/9789241514347
World Health Organization. (2019). Occupational safety and health in public health emergencies: a manual for protecting health workers and responders.
Other Identifiers
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MIND-VR/Besta
Identifier Type: -
Identifier Source: org_study_id
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NA
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NCT01683617
COMPLETED
NA
Online and Mobile Mindfulness Intervention to Reduce Distress
NCT04035304
UNKNOWN
NA
Big Mind for Veterans With PTSD
NCT02541630
WITHDRAWN
NA
Neurofeedback and Well-Being Among People With Co-Occurring Obsessive Compulsive Disorder and Post-traumatic Stress Symptoms
NCT07217925
NOT_YET_RECRUITING
NA
Virtual Reality Treatment for Trauma Related to COVID-19 Infection
NCT07213596
NOT_YET_RECRUITING
NA
Pilot Internet-based Self-Help Program for Managing Corona (COVID-19) Stress
NCT04394403
UNKNOWN
NA
3MDR to Treat PTSD With mTBI (3MDR)
NCT03796936
COMPLETED
PHASE2
Virtual Reality (VR) Therapy for Post-Traumatic Stress Disorder (PTSD)
NCT00992953
COMPLETED
PHASE1/PHASE2
Train Your Brain: Neurofeedback Intervention for PTSD
NCT03858933
TERMINATED
NA
Primary Care-Based Mindfulness Intervention for Veterans With PTSD
NCT02399696
COMPLETED
NA
Addressing COVID-19 Mental Health Problems Among US Veterans
NCT04484207
COMPLETED
NA
Video-based Psychotherapy for COVID-19 Patients in Isolation Ward in Jakarta
NCT04841681
COMPLETED
NA
Developing an Integrative, Recovery-Based, Post-Acute COVID-19 Syndrome (PACS) Psychotherapeutic Intervention
NCT05453201
COMPLETED
NA
EEG Biofeedback in the Treatment of Chronic Treatment-Resistant PTSD
NCT01259921
COMPLETED
NA
Neurofeedback Prevention For Early Stress Related Adversity
NCT02477722
UNKNOWN
NA
Cognitive Behavioral Treatment of Posttraumatic Stress Disorder Enhanced by Virtual Reality for Individuals With PTSD and Substance Abuse
NCT00656344
COMPLETED
NA
Real-time fMRI and Neurofeedback of Brain Networks Mediating Trauma Memory Recall in PTSD
NCT02500719
COMPLETED
NA
Mindfulness Training in U.S. Army Cohorts
NCT03310112
COMPLETED
NA
Interpretation Training to Reduce Anxiety: Evaluating Technology-based Delivery Models and Methods to Reduce Attrition
NCT03498651
COMPLETED
PHASE2
Reality-monitoring & Stress
NCT05595434
RECRUITING
NA