Virtual Reality Cave Experience With Mindfulness for Mental Wellbeing

NCT06351436 | Not Yet Recruiting

• 1 other identifier: TBC20240402
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Anxiety

Keywords

Anxiety; Mental Well-Being; Mindfulness-Based Intervention; Virtual Reality; Youths

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Stress Level in Youths

  3 months

• Feasibility of Eligibility and Enrollment

  3 months

• Feasibility of Attendance Rate

  3 months

• Feasibility of Retention Rate

  3 months

Study Arms (1)

Mindfulness

EXPERIMENTAL

Behavioral: Mindfulness

Interventions

Mindfulness BEHAVIORAL

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.

Mindfulness

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Anxiety Disorders; Psychological Well-Being

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Alex Pak Lik Tsang, PhD

CONTACT

85295516940; paklik.tsang@polyu.edu.hk

Yim Kwan Tsang

CONTACT

yimkwan1.tsang@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single-group non-randomized uncontrolled trial

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share