Clinical trial NCT06351436: Virtual Reality Cave Experience With Mindfulness for Mental Wellbeing
Official title: Using Mindfulness With Immersive Virtual Reality Cave Experience in Promoting Mental Well-Being: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Mental Well-Being
Mindfulness-Based Intervention
Virtual Reality
Youths
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-group non-randomized uncontrolled trial
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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).

Eligibility criteria: 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).

Primary outcomes:
measure: Mental Well-Being in Youths
timeFrame: 3 months
Secondary outcomes:
measure: Stress Level in Youths
timeFrame: 3 months
measure: Feasibility of Eligibility and Enrollment
timeFrame: 3 months
measure: Feasibility of Attendance Rate
timeFrame: 3 months
measure: Feasibility of Retention Rate
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
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