UMIN-CTR Clinical Trial

Public title

An exploratory study of specific biomarkers of social anxiety patients using the metaverse

Acronym

Exploratory study of social anxiety disorder using metaverse

Scientific Title

An exploratory study of specific biomarkers of social anxiety patients using the metaverse

Scientific Title:Acronym

Exploratory study of social anxiety disorder using metaverse

Region

Japan

Condition

general anxiety disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In the medical industry, along with the spread of the new coronavirus infection, the use of online medical consultations in clinical settings is expanding. The technological evolution of virtual reality (VR) and augmented reality (AR) is attracting attention, and research is progressing toward the use of VR and AR in clinical settings. Also, the concept called "metaverse", which is active through avatars in a three-dimensional virtual space, is attracting attention.
Social anxiety disorder (SAD) is an anxiety disorder that causes fear and anxiety related to exposure to certain social situations. According to the results of the 2015 World Mental Health Japan Survey 2nd, the 12-month prevalence of SAD in Japan is 1.0%, which is the third highest among mental disorders after depression (2.7%) and specific phobias (1.1%). Although SAD occurs most frequently in the teens and twenties, it often goes untreated and leads to other psychiatric disorders such as depression and alcoholism. While SAD is diagnosed according to the DSM-5 diagnostic criteria announced by the American Psychiatric Association (APA), the number of potential SAD patients in Japan is said to be 3 million.
Therefore, in this study, by reproducing the Trier Social Stress Test (TSST) in VR, we compared the behavior and biological information in the virtual space between SAD patients and healthy subjects, and conducted exploratory research on SAD diagnostic items. If the obtained data show a significant difference between SAD patients and healthy subjects, it can be an effective diagnostic method for discovering potential SAD patients.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Subject's LSAS score (severity score)
Subject's TSAS score (severity score)
Subject's TSAI score
Subject's FNE (fear scale of negative evaluation from others)
Subject's VAS (Stress Scale)
SPS for VR-TSST
Subject's DSM-5 diagnosis result
Speech characteristics of the subject
Subject's eye movement data: number of blinks, pupil meridian, distance traveled by line of sight
Heart rate, heart rate variability
Blood oxygen saturation
saliva

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

59

years-old

>=

Gender

Male and Female

Key inclusion criteria

Social anxiety disorder
1 Age between 18 and 59 years old at the time of obtaining consent
2 Those who have communication skills in Japanese
3 Patients who have been diagnosed with SAD according to the DSM-5 diagnostic criteria and are currently undergoing treatment or planning to start treatment
4 Those who have given written consent of the research subject's own free will after receiving a sufficient explanation regarding participation in this research.

Health control
Those that satisfy 1, 2, and 4 above

Key exclusion criteria

Social anxiety disorder
1 When other mental illnesses (depression, etc.) are observed
2 When the patient's life is in dangerous situation due to severe mental states and we judge it difficult to continue the test
3 Those from who we cannot obtain voice data
4 Head Mount Display- Virtual Reality: Those who cannot use HMD-VR
5 In addition, those who the research director judges to be inappropriate as research subjects

Health control
1 When other mental illnesses (depression, etc.) are observed
2 When the patient's life is in dangerous situation due to severe mental states and we judge it difficult to continue the test
3 Those from who we cannot obtain voice data
4 Head Mount Display- Virtual Reality: Those who cannot use HMD-VR
5 In addition, those who the research director judges to be inappropriate as research subjects

Target sample size

80

Name of lead principal investigator

1st name	Masanobu
Middle name
Last name	Ito

Organization

Juntendo University Faculty of medicine

Division name

Department of medical metaverse

Zip code

1138421

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3813-3111

Email

masa110@juntendo.ac.jp

Name of contact person

1st name	Masanobu
Middle name
Last name	Ito

Organization

Juntendo University Faculty of Medicine

Division name

Department of medhical metaverse

Zip code

1138421

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3813-3111

Homepage URL

Email

masa110@juntendo.ac.jp

Institute

Juntendo University Faculty of medicine Department of medical metaverse

Institute

Department

Personal name

Organization

Juntendo University Faculty of medicine Department of medical metaverse

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Juntendo University Faculty of Medicine

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan

Tel

03-3813-3111

Email

hongo-rinri@juntendo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

12

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2022

Year

07

Month

15

Day

Date of IRB

2022

Year

07

Month

22

Day

Anticipated trial start date

2022

Year

12

Month

20

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

We compared the behavior and biological information in the virtual space between SAD patients and healthy subjects by reproducing the Trier Social Stress Test (TSST) in VR, and conducted exploratory research on SAD diagnostic items.

Registered date

2022

Year

12

Month

13

Day

Last modified on

2023

Year

06

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056216