Virtual Reality Cave Experience With Mindfulness for Mental Wellbeing

Anxiety Clinical Trial

Official title:

Using Mindfulness With Immersive Virtual Reality Cave Experience in Promoting Mental Well-Being: A Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06351436
• Other study ID #: TBC20240402
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: The Hong Kong Polytechnic University
• Contact: Alex Pak Lik Tsang, PhD
• Phone: 85295516940
• Email: paklik.tsang[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• screened positive for clinical depression (a summed score of = 9 as measured by the Patient Health Questionnaire-9).

Related Conditions & MeSH terms

• Anxiety

Intervention

Behavioral:
• Mindfulness
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	3 months
Secondary	Feasibility of Eligibility and Enrollment	Number of eligible participants, and the proportion of those eligible that enrolled will be assessed.	3 months
Secondary	Feasibility of Attendance Rate	Number and proportion of attended participants.	3 months
Secondary	Feasibility of Retention Rate	Number and proportion of participants completing all assessments.	3 months