Non-suicidal Self-injuryVRNCT05734872
Research on the Intervention of VR-based Emotion Regulation Technology on Adolescent Non-suicide Self-injury Behavior
A study testing Virtual Reality Technology and Routine mental health course training in people with Non-suicidal Self-injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Non-suicidal Self-injury
- What is being tested?
- Virtual Reality Technology and Routine mental health course training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2022to 26 Oct 2024
- 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 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Those who have serious physical diseases
- Those who cannot cooperate with the completion of virtual reality technology finally complete the intervention content<50%.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
About this study
Official title: Psychiatry Department of The Second Affiliated Hospital of Zhejiang University School of Medicine
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.
- Conditions
- Non-suicidal Self-injury
- Being tested
- Virtual Reality Technology, Routine mental health course training
- Keywords
- Non-suicidal Self-injury, Virtual Reality Technology, Adolescent
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality TechnologyDevice
Make a pair of glasses through virtual reality technology, through which participants can observe and participate in the treatment process.
Routine mental health course trainingOther
Conduct mental health education for patients by making a speech.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Device: Virtual Reality Technology |
| Control group | Other | Not described Receives: Other: Routine mental health course training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ottawa Self-injury Inventory Chinese Revision
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.
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start26 Oct 2022
- Primary completion26 Dec 2023 (estimated)
- Study completion26 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-suicidal Self-injuryStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fang Chen, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734872
- Sponsor's protocol ID
- 2022-0754
- Acronym
- VR
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatry Department of The Second Affiliated Hospital of Zhejiang University School of Medicine
- ClinicalTrials.gov ID
- NCT05734872
- Acronym / sponsor ID
- VR / 2022-0754
- Conditions
- Non-suicidal Self-injury
- Keywords
- Non-suicidal Self-injury, Virtual Reality Technology, Adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 26 Dec 2023 (estimated)
- Study completion
- 26 Oct 2024 (estimated)
- First posted
- 21 Feb 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Virtual Reality Technology |
| Control group | Other | Other: Routine mental health course training |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Those who have serious physical diseases
- Those who cannot cooperate with the completion of virtual reality technology finally complete the intervention content<50%.
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 |
|---|---|---|
| Virtual Reality TechnologyMake a pair of glasses through virtual reality technology, through which participants can observe and participate in the treatment process. | Device | Experimental group |
| Routine mental health course trainingConduct mental health education for patients by making a speech. | Other | Control group |
Primary outcome
Ottawa Self-injury Inventory Chinese Revision
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents
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Neurobiological Markers of Non-suicidal Self-injury and Treatment Mechanisms of Adolescent Self-injury Intervention Skills Training
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Efficacy of Triple-daily 15mA tACS on Adolescent NSSI
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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.
Fang Chen study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Technology and Routine mental health course training in people with Non-suicidal Self-injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 21 Feb 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang Chen, bachelor (+86 15867161868, 2201066@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ottawa Self-injury Inventory Chinese Revision (time frame: up to one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2023.