Research on the Intervention of VR-based Emotion Regulation Technology on Adolescent Non-suicide Self-injury Behavior

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05734872
Collaborator
(none)
60
1
2
24
2.5

Study Details

Study Description

Brief Summary

Non suicidal self injury (NSSI) has become a serious social and public health problem allover the world, and the incidence rate is increasing year by year. Although the aim of NSSI is not to suicide, but its negative impact is extremely serious, which will seriously threaten the physical and mental health of adolescents. Virtual Reality (VR), a computer simulation technology, can enable people to enter and experience the artificial virtual world in an immersive way, has been used for the auxiliary treatment of anxiety disorder, post-traumatic stress disorder and other diseases. This study explored the impact of VR on the depression and mental health of NSSI adolescents, so as to reduce the incidence of non-suicide self-injury behavior in NSSI adolescent patients and improve the quality of life of such patients.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality Technology
  • Other: Routine mental health course training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Psychiatry Department of The Second Affiliated Hospital of Zhejiang University School of Medicine
Actual Study Start Date :
Oct 26, 2022
Anticipated Primary Completion Date :
Dec 26, 2023
Anticipated Study Completion Date :
Oct 26, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

Device: Virtual Reality Technology
Make a pair of glasses through virtual reality technology, through which participants can observe and participate in the treatment process.

Other: Control group

Other: Routine mental health course training
Conduct mental health education for patients by making a speech.

Outcome Measures

Primary Outcome Measures

  1. Ottawa Self-injury Inventory Chinese Revision [up to one month]

    This item describes the addictive characteristics of non-suicidal self-injury behavior. There are seven items in total. Add the seven items to get the original total score. The higher the original total score, the more addictive the non-suicidal self-injury behavior of the individual. The minimum value is 0 and maximum value is 28.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 24 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • According to the diagnostic criteria of NSSI in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders.

  • Have a past history of non-suicidal self-injury behavior.

  • No virtual reality technology intervention before enrollment.

  • age: ≥ 18 to<24.

Exclusion Criteria:
  • Those who have serious physical diseases

  • Those who cannot cooperate with the completion of virtual reality technology finally complete the intervention content<50%.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Second Affiliated Hospital of Zhejiang University Hangzhou Zhejiang China

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Chair: Fang Chen, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05734872
Other Study ID Numbers:
  • 2022-0754
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2023