AnxietyNCT06351436
Virtual Reality Cave Experience With Mindfulness for Mental Wellbeing
A study testing Mindfulness in people with Anxiety, run by The Hong Kong Polytechnic University.
Trial summary
The aim of this study is to investigate the effectiveness of a mindfulness-based intervention using a virtual reality cave system for promoting mental wellbeing in youths. The mindfulness-based intervention will last for three months, with 6-8 weekly sessions lasting 1.5 hours each. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Aug 2025
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Hong Kong Chinese youths;
- aged between 11 and 18;
- screened positive for mild to moderate anxiety symptoms (a summed score of ≥ 10 as measured by the Generalized Anxiety Disorder-7).
Who cannot join
- screened positive for clinical depression (a summed score of ≥ 9 as measured by the Patient Health Questionnaire-9).
Trial locations and contacts
No sites are listed yet.
Yim Kwan Tsang contact
About this study
Official title: Using Mindfulness With Immersive Virtual Reality Cave Experience in Promoting Mental Well-Being: A Feasibility Study
The aim of this study is to investigate the effectiveness of a mindfulness-based intervention using a virtual reality cave system for promoting mental wellbeing in youths. The mindfulness-based intervention will last for three months, with 6-8 weekly sessions lasting 1.5 hours each. Participants will attend the sessions in a group format, and the sessions will be administered by registered social worker who are specialized in counselling. The intervention content is designed by a registered clinical psychologist accredited for delivering mindfulness-based intervention and nurses who are experienced in mindfulness training.
A single-group pre-post uncontrolled design will be employed. Evaluations will be conducted at baseline (0 weeks) and post-intervention (3 months).
Read the detailed description
Anxiety disorders in youths are associated with poorer social relationships and academic achievements. If left unaddressed, youth anxiety disorders can progress into adult anxiety disorders, depression, substance abuse, suicide attempts, and hospitalization. Mindfulness-based interventions show promise as an intervention for targeting anxiety symptoms in youths. Recently, virtual reality has emerged as an appealing modality for delivering mindfulness-based interventions. Compared to traditional delivery methods, virtual reality offers a highly engaging and interactive environment for mindfulness practice, allowing users to fully immerse themselves in the virtual setting and minimizing distractions from the physical world. As an innovative pedagogical tool, virtual reality provides an experiential learning environment for mindfulness training, facilitating the cultivation of mindfulness skills through immersive experiences. Preliminary evidence suggests that virtual reality-based mindfulness-based interventions can effectively reduce anxiety symptoms in clinical populations. However, it remains unclear whether these findings can be generalized to a younger population. This pilot feasibility study aims to investigate the effectiveness of a virtual reality-based mindfulness-based intervention in reducing anxiety symptoms among this specific population.
A single-group pre-post uncontrolled design will be employed. The target population for this study will be Hong Kong Chinese youths with mild to moderate anxiety symptoms. Convenience sampling will be used to recruit participants. Interested participants will be assessed for eligibility. After interested and eligible participants provide their consent, they will receive the mindfulness-based intervention using a virtual reality cave system.
The mindfulness-based intervention will last for three months, with 6-8 weekly sessions lasting 1.5 hours each. Participants will attend the sessions in a group format, and the sessions will be administered by registered social worker who are specialized in counselling. The intervention is delivered using an immersive virtual reality cave system. The intervention content is designed by a registered clinical psychologist accredited for delivering mindfulness-based intervention and nurses who are experienced in mindfulness training. To ensure protocol adherence, the social workers administering the intervention will receive close supervision from the clinical psychologist. Weekly meetings will be held to discuss and resolve any difficulties or challenges encountered by the social workers.
The outcome measures assessed included mental wellbeing (primary) and heart rate variability (secondary). Feasibility measures include eligibility and enrollment, attendance rate, and retention rate. Evaluations will be conducted at baseline (0 weeks) and post-intervention (3 months).
- Conditions
- Anxiety
- Being tested
- Mindfulness
- Keywords
- Anxiety, Mental Well-Being, Mindfulness-Based Intervention, Virtual Reality, Youths
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
The mindfulness-based intervention will last for three months, with 6-8 weekly sessions lasting 1.5 hours each. Participants will attend the sessions in a group format, and the sessions will be administered by registered social worker who are specialized in counseling. The intervention is delivered using an immersive virtual reality cave system. The intervention content is designed by a registered clinical psychologist accredited for delivering mindfulness-based intervention and nurses who are experienced in mindfulness training. To ensure protocol adherence, the social workers administering the intervention will receive close supervision from the clinical psychologist. Weekly meetings will be held to discuss and resolve any difficulties or challenges encountered by the social workers.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Not described Receives: Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Well-Being in Youths
The Depression Anxiety Stress Scale-21 (DASS) consists of 21 items that assess three domains: anxiety, depression, and stress. Each item is rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me much or most of the time). The total score for each subscale ranges from 0 to 21, with higher scores indicating greater severity in the respective domain.
Measured: 3 months
Secondary outcomes (4)
Stress Level in Youths
Heart rate variability is a measure of the variation in the time intervals between consecutive heartbeats and is commonly used as an indicator of stress levels. To assess heart rate variability, we utilized Upmood®, a wearable device equipped with a photoplethysmogram (PPG) sensor. This device enables non-invasive measurement of HRV by analyzing pulse signal power and calculating various indices such as HF (high frequency), LF (low frequency), LF/HF ratio, and VLF (very low frequency), with a lower level of heart rate variability indicating a higher level of stress.
Measured: 3 months
Feasibility of Eligibility and Enrollment
Number of eligible participants, and the proportion of those eligible that enrolled will be assessed.
Measured: 3 months
Feasibility of Attendance Rate
Number and proportion of attended participants.
Measured: 3 months
Feasibility of Retention Rate
Number and proportion of participants completing all assessments.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study startAug 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group non-randomized uncontrolled trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick KOR Pui Kin, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351436
- Sponsor's protocol ID
- TBC20240402
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Mindfulness With Immersive Virtual Reality Cave Experience in Promoting Mental Well-Being: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06351436
- Acronym / sponsor ID
- TBC20240402
- Conditions
- Anxiety
- Keywords
- Anxiety, Mental Well-Being, Mindfulness-Based Intervention, Virtual Reality, Youths
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 8 Apr 2024 (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.
The aim of this study is to investigate the effectiveness of a mindfulness-based intervention using a virtual reality cave system for promoting mental wellbeing in youths. The mindfulness-based intervention will last for three months, with 6-8 weekly sessions lasting 1.5 hours each. Participants will attend the sessions in a group format, and the sessions will be administered by registered social worker who are specialized in counselling. The intervention content is designed by a registered clinical psychologist accredited for delivering mindfulness-based intervention and nurses who are experienced in mindfulness training.
A single-group pre-post uncontrolled design will be employed. Evaluations will be conducted at baseline (0 weeks) and post-intervention (3 months).
Detailed description
Anxiety disorders in youths are associated with poorer social relationships and academic achievements. If left unaddressed, youth anxiety disorders can progress into adult anxiety disorders, depression, substance abuse, suicide attempts, and hospitalization. Mindfulness-based interventions show promise as an intervention for targeting anxiety symptoms in youths. Recently, virtual reality has emerged as an appealing modality for delivering mindfulness-based interventions. Compared to traditional delivery methods, virtual reality offers a highly engaging and interactive environment for mindfulness practice, allowing users to fully immerse themselves in the virtual setting and minimizing distractions from the physical world. As an innovative pedagogical tool, virtual reality provides an experiential learning environment for mindfulness training, facilitating the cultivation of mindfulness skills through immersive experiences. Preliminary evidence suggests that virtual reality-based mindfulness-based interventions can effectively reduce anxiety symptoms in clinical populations. However, it remains unclear whether these findings can be generalized to a younger population. This pilot feasibility study aims to investigate the effectiveness of a virtual reality-based mindfulness-based intervention in reducing anxiety symptoms among this specific population.
A single-group pre-post uncontrolled design will be employed. The target population for this study will be Hong Kong Chinese youths with mild to moderate anxiety symptoms. Convenience sampling will be used to recruit participants. Interested participants will be assessed for eligibility. After interested and eligible participants provide their consent, they will receive the mindfulness-based intervention using a virtual reality cave system.
The mindfulness-based intervention will last for three months, with 6-8 weekly sessions lasting 1.5 hours each. Participants will attend the sessions in a group format, and the sessions will be administered by registered social worker who are specialized in counselling. The intervention is delivered using an immersive virtual reality cave system. The intervention content is designed by a registered clinical psychologist accredited for delivering mindfulness-based intervention and nurses who are experienced in mindfulness training. To ensure protocol adherence, the social workers administering the intervention will receive close supervision from the clinical psychologist. Weekly meetings will be held to discuss and resolve any difficulties or challenges encountered by the social workers.
The outcome measures assessed included mental wellbeing (primary) and heart rate variability (secondary). Feasibility measures include eligibility and enrollment, attendance rate, and retention rate. Evaluations will be conducted at baseline (0 weeks) and post-intervention (3 months).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group non-randomized uncontrolled trial
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Hong Kong Chinese youths;
- aged between 11 and 18;
- screened positive for mild to moderate anxiety symptoms (a summed score of ≥ 10 as measured by the Generalized Anxiety Disorder-7).
Key exclusion criteria (1 listed)
- screened positive for clinical depression (a summed score of ≥ 9 as measured by the Patient Health Questionnaire-9).
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 |
|---|---|---|
| MindfulnessThe mindfulness-based intervention will last for three months, with 6-8 weekly sessions lasting 1.5 hours each. Participants will attend the sessions in a group format, and the sessions will be administered by registered social worker who are specialized in counseling. The intervention is delivered using an immersive virtual reality cave system. The intervention content is designed by a registered clinical psychologist accredited for delivering mindfulness-based intervention and nurses who are experienced in mindfulness training. To ensure protocol adherence, the social workers administering the intervention will receive close supervision from the clinical psychologist. Weekly meetings will be held to discuss and resolve any difficulties or challenges encountered by the social workers. | Behavioural | Mindfulness |
Primary outcome
Mental Well-Being in Youths
Time frame: 3 months
The Depression Anxiety Stress Scale-21 (DASS) consists of 21 items that assess three domains: anxiety, depression, and stress. Each item is rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me much or most of the time). The total score for each subscale ranges from 0 to 21, with higher scores indicating greater severity in the respective domain.
4 secondary outcomes
Stress Level in Youths
Time frame: 3 months
Feasibility of Eligibility and Enrollment
Time frame: 3 months
Feasibility of Attendance Rate
Time frame: 3 months
Feasibility of Retention Rate
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Yim Kwan Tsang contact
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Anxiety, run by The Hong Kong Polytechnic University.
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 3 inclusion and 1 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 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Alex Pak Lik Tsang, PhD (85295516940, paklik.tsang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Well-Being in Youths (time frame: 3 months). 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 8 Apr 2024.