Stress Related DisorderNCT04611399
MIND-VR: Virtual Reality for COVID-19 Operators' Psychological Support
A study testing VR for psychoeducation and relaxation in people with Stress Related Disorder, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Related Disorder
- What is being tested?
- VR for psychoeducation and relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 5 Mar 2021to 5 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Physical illness: cardiovascular issues, neurological illness, epilepsy;
- Pharmacotherapy with: psychotropic drugs, anti-hypertensive drugs, anti-epileptics;
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stress Related Disorder
- Being tested
- VR for psychoeducation and relaxation, Control (CR)
- Keywords
- virtual reality, stress, anxiety, prevention, treatment, relaxation techniques, psychoeducation, COVID-19, healthcare workers
- Medical subject headings
- Anxiety Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR for psychoeducation and relaxationBehavioural
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)Other
The CR Group will undergo pre- and post-protocol tests without undergoing any treatment.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) Group | Experimental | 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". Receives: Behavioral: VR for psychoeducation and relaxation |
| Control (CR) Group | Active comparator | The CR Group will undergo pre- and post-protocol tests without undergoing any treatment. Receives: Other: Control (CR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score at the State-Trait Anxiety Inventory -Y2
A 20 item measure of the level of the state anxiety
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
Secondary outcomes (1)
Change in score at the EQ-5D-5L
A measure which defines the state of health and the perceived quality of life
Measured: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start5 Mar 2021
- Primary completion1 Dec 2022
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (64)Papers the sponsor has linked to this study.
- Other trials for Stress Related DisorderStudies of the same condition, open and under way.
- More trials run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca
- Responsible party
- Sponsor
- Investigators
- Federica Pallavicini, PhD, Study director, University of Milano BicoccaEleonora F Orena, PhD, Principal investigator, Foundation IRCCS Neurological Institute Carlo Besta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611399
- Sponsor's protocol ID
- MIND-VR/Besta
- Status last verified
- Jan 2023
- First submitted
- 8 Oct 2020
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anderson AP, Mayer MD, Fellows AM, Cowan DR, Hegel MT, Buckey JC. Relaxation with Immersive Natural Scenes Presented Using Virtual Reality. Aerosp Med Hum Perform. 2017 Jun 1;88(6):520-526. doi: 10.3357/AMHP.4747.2017.
PubMed 28539139Anderson E, Shivakumar G. Effects of exercise and physical activity on anxiety. Front Psychiatry. 2013 Apr 23;4:27. doi: 10.3389/fpsyt.2013.00027. eCollection 2013. No abstract available.
PubMed 23630504Bailenson, J. N., Yee, N., Blascovich, J., Beall, A. C., Lundblad, N., & Jin, M. (2008). The Use of Immersive Virtual Reality in the Learning Sciences: Digital Transformations of Teachers, Students, and Social Context. Journal of the Learning Sciences, 17(1), 102-141.
Bakker M, Wicherts JM. The (mis)reporting of statistical results in psychology journals. Behav Res Methods. 2011 Sep;43(3):666-78. doi: 10.3758/s13428-011-0089-5.
PubMed 21494917Bangor, A., Kortum, P. T., & Miller, J. T. (2008). An Empirical Evaluation of the System Usability Scale. International Journal of Human-Computer Interaction, 24(6), 574-594.
Basso JC, Suzuki WA. The Effects of Acute Exercise on Mood, Cognition, Neurophysiology, and Neurochemical Pathways: A Review. Brain Plast. 2017 Mar 28;2(2):127-152. doi: 10.3233/BPL-160040.
PubMed 29765853Beck JG, Palyo SA, Winer EH, Schwagler BE, Ang EJ. Virtual Reality Exposure Therapy for PTSD symptoms after a road accident: an uncontrolled case series. Behav Ther. 2007 Mar;38(1):39-48. doi: 10.1016/j.beth.2006.04.001. Epub 2006 Sep 22.
PubMed 17292693Botella C, Serrano B, Banos RM, Garcia-Palacios A. Virtual reality exposure-based therapy for the treatment of post-traumatic stress disorder: a review of its efficacy, the adequacy of the treatment protocol, and its acceptability. Neuropsychiatr Dis Treat. 2015 Oct 3;11:2533-45. doi: 10.2147/NDT.S89542. eCollection 2015.
PubMed 26491332Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.
PubMed 32112714Chen Q, Liang M, Li Y, Guo J, Fei D, Wang L, He L, Sheng C, Cai Y, Li X, Wang J, Zhang Z. Mental health care for medical staff in China during the COVID-19 outbreak. Lancet Psychiatry. 2020 Apr;7(4):e15-e16. doi: 10.1016/S2215-0366(20)30078-X. Epub 2020 Feb 19. No abstract available.
PubMed 32085839Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417De Freitas, S., Rebolledo-Mendez, G., Liarokapis, F., Magoulas, G., & Poulovassilis, A. (2010). Learning as immersive experiences: Using the four-dimensional framework for designing and evaluating immersive learning experiences in a virtual world. British Journal of Educational Technology, 41(1),69-85.
Difede J, Cukor J, Jayasinghe N, Patt I, Jedel S, Spielman L, Giosan C, Hoffman HG. Virtual reality exposure therapy for the treatment of posttraumatic stress disorder following September 11, 2001. J Clin Psychiatry. 2007 Nov;68(11):1639-47.
PubMed 18052556Difede J, Cukor J, Wyka K, Olden M, Hoffman H, Lee FS, Altemus M. D-cycloserine augmentation of exposure therapy for post-traumatic stress disorder: a pilot randomized clinical trial. Neuropsychopharmacology. 2014 Apr;39(5):1052-8. doi: 10.1038/npp.2013.317. Epub 2013 Nov 12.
PubMed 24217129Duan YY, Zhang JY, Xie M, Feng XB, Xu S, Ye ZW. Application of Virtual Reality Technology in Disaster Medicine. Curr Med Sci. 2019 Oct;39(5):690-694. doi: 10.1007/s11596-019-2093-4. Epub 2019 Oct 14.
PubMed 31612384
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIND-VR: Virtual Reality for COVID-19 Operators' Psychological Support
- ClinicalTrials.gov ID
- NCT04611399
- Acronym / sponsor ID
- MIND-VR/Besta
- Conditions
- Stress Related Disorder
- Keywords
- virtual reality, stress, anxiety, prevention, treatment, relaxation techniques, psychoeducation, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Collaborators
- University of Milano Bicocca
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) Group | Experimental | Behavioral: VR for psychoeducation and relaxationThe 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". |
| Control (CR) Group | Active comparator | Other: Control (CR)The CR Group will undergo pre- and post-protocol tests without undergoing any treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Physical illness: cardiovascular issues, neurological illness, epilepsy;
- Pharmacotherapy with: psychotropic drugs, anti-hypertensive drugs, anti-epileptics;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR for psychoeducation and relaxationUse 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"). | Behavioural | Virtual Reality (VR) Group |
| Control (CR)The CR Group will undergo pre- and post-protocol tests without undergoing any treatment. | Other | Control (CR) Group |
Primary outcome
Change in score at the State-Trait Anxiety Inventory -Y2
Time frame: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
A 20 item measure of the level of the state anxiety
Change in score at the Perceived Stress Scale
Time frame: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
A 10 item measure of the level of stress perceived in the last month
Change in score at the Depression, Anxiety ans Stress Scale-21 items
Time frame: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
A 21 item in 3 self-report scales which measures depression, anxiety and stress
Change in score of knowledge on stress and anxiety
Time frame: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
A 7 item measure at the ad hoc questionnaire to assess the knowledge of stress and anxiety
1 secondary outcome
Change in score at the EQ-5D-5L
Time frame: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Background: PubMed 28539139Anderson AP, Mayer MD, Fellows AM, Cowan DR, Hegel MT, Buckey JC. Relaxation with Immersive Natural Scenes Presented Using Virtual Reality. Aerosp Med Hum Perform. 2017 Jun 1;88(6):520-526. doi: 10.3357/AMHP.4747.2017.
- Background: PubMed 23630504Anderson E, Shivakumar G. Effects of exercise and physical activity on anxiety. Front Psychiatry. 2013 Apr 23;4:27. doi: 10.3389/fpsyt.2013.00027. eCollection 2013. No abstract available.
- BackgroundBailenson, J. N., Yee, N., Blascovich, J., Beall, A. C., Lundblad, N., & Jin, M. (2008). The Use of Immersive Virtual Reality in the Learning Sciences: Digital Transformations of Teachers, Students, and Social Context. Journal of the Learning Sciences, 17(1), 102-141.
- Background: PubMed 21494917Bakker M, Wicherts JM. The (mis)reporting of statistical results in psychology journals. Behav Res Methods. 2011 Sep;43(3):666-78. doi: 10.3758/s13428-011-0089-5.
- BackgroundBangor, A., Kortum, P. T., & Miller, J. T. (2008). An Empirical Evaluation of the System Usability Scale. International Journal of Human-Computer Interaction, 24(6), 574-594.
- Background: PubMed 29765853Basso JC, Suzuki WA. The Effects of Acute Exercise on Mood, Cognition, Neurophysiology, and Neurochemical Pathways: A Review. Brain Plast. 2017 Mar 28;2(2):127-152. doi: 10.3233/BPL-160040.
- Background: PubMed 17292693Beck JG, Palyo SA, Winer EH, Schwagler BE, Ang EJ. Virtual Reality Exposure Therapy for PTSD symptoms after a road accident: an uncontrolled case series. Behav Ther. 2007 Mar;38(1):39-48. doi: 10.1016/j.beth.2006.04.001. Epub 2006 Sep 22.
- Background: PubMed 26491332Botella C, Serrano B, Banos RM, Garcia-Palacios A. Virtual reality exposure-based therapy for the treatment of post-traumatic stress disorder: a review of its efficacy, the adequacy of the treatment protocol, and its acceptability. Neuropsychiatr Dis Treat. 2015 Oct 3;11:2533-45. doi: 10.2147/NDT.S89542. eCollection 2015.
- Background: PubMed 32112714Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.
- Background: PubMed 32085839Chen Q, Liang M, Li Y, Guo J, Fei D, Wang L, He L, Sheng C, Cai Y, Li X, Wang J, Zhang Z. Mental health care for medical staff in China during the COVID-19 outbreak. Lancet Psychiatry. 2020 Apr;7(4):e15-e16. doi: 10.1016/S2215-0366(20)30078-X. Epub 2020 Feb 19. No abstract available.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- BackgroundDe Freitas, S., Rebolledo-Mendez, G., Liarokapis, F., Magoulas, G., & Poulovassilis, A. (2010). Learning as immersive experiences: Using the four-dimensional framework for designing and evaluating immersive learning experiences in a virtual world. British Journal of Educational Technology, 41(1),69-85.
- World Health Organization. (2019). Occupational safety and health in public health emergencies: a manual for protecting health workers and responders.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federica Pallavicini, PhD study director
University of Milano Bicocca
Eleonora F Orena, PhD principal investigator
Foundation IRCCS Neurological Institute Carlo Besta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR for psychoeducation and relaxation in people with Stress Related Disorder, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in score at the State-Trait Anxiety Inventory -Y2 (time frame: Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04611399, which also lists 64 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.