NCT06964477

A Trial of Extended Reality Activities to Enhance Leisure Participation Among Inpatients With Persistent Mental Health Conditions

A Randomized Controlled Trial of an Extended Reality-Based Occupational Therapy Intervention to Improve Leisure Participation in Inpatients With Persistent Mental Health Conditions

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Chia-Hui Hung · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the effects of an extended reality (XR)-enhanced occupational therapy leisure intervention on motivation, emotional engagement, and therapeutic participation among inpatients with chronic psychiatric conditions. The main questions it aims to answer are: Can the XR intervention improve leisure motivation, leisure-related attitudes, and emotional coping strategies in long-term hospitalized individuals with mental illness? Does the XR intervention promote improvements in psychological health, volition, and occupational performance? Researchers will compare an XR-based leisure therapy group to a usual care group engaged in standard hospital leisure activities such as art, music, or reading. Participants will take part in weekly 40-minute sessions for 6 weeks. The XR group will use a custom-designed mobile VR program featuring immersive 360° leisure scenarios aligned with participants' interests and functional goals. Data collection includes standardized assessments (e.g., Interest Checklist, Volitional Questionnaire, COPM, PANSS) and semi-structured interviews to explore changes in motivation, coping, and perceived benefits.

Detailed description

This randomized controlled trial investigates the effectiveness of an extended reality (XR)-based occupational therapy leisure intervention for inpatients with persistent mental health conditions. The study aims to improve patients' leisure motivation, leisure-related attitudes (including cognitive and behavioral engagement), emotional responses, and coping strategies through immersive therapeutic activities. It also examines the intervention's potential benefits for psychological well-being, volition, and occupational performance. Participants are randomly assigned to either the experimental group or the control group. The experimental group receives an XR-enhanced leisure therapy program designed around three immersive features of extended reality: imagination, interaction, and immersion. The goal is to enhance the subjective quality of leisure experience and support the development of self-regulated leisure participation. Over a six-week period, participants in the intervention group will attend one 40-minute session per week, consisting of a 10-minute preparatory warm-up, a 20-minute immersive leisure experience utilizing virtual and augmented reality technologies, and a 10-minute structured feedback discussion. The XR content is developed using the AR2VR application platform, integrating real-world 360-degree panoramic video footage of leisure environments. These environments are tailored to participants' interests, as identified using the Occupational Therapy Interest Checklist, and categorized according to eight types of leisure (e.g., physical activity, social interaction, hobbies, games, creative expression). The VR content includes embedded tasks, guided questions, audio-visual prompts, and simulated activities to stimulate engagement, cognition, and emotional regulation. To ensure safety and accessibility for individuals with chronic psychiatric conditions, a lightweight cardboard VR viewer is used instead of commercial electronic headsets. This approach minimizes the risk of sensory overstimulation, dizziness, or adverse events, which are more common in this population. The control group participates in standard hospital leisure activities, such as newspaper reading, drawing, rhythmic movement, and basic group interactions. Both groups receive the intervention once weekly over six consecutive weeks. Outcome evaluation includes both quantitative and qualitative data. Quantitative outcomes are assessed using validated tools: The Occupational Therapy Interest Checklist measures leisure preferences and motivation. The Volitional Questionnaire captures therapist-rated changes in volition during activity. The Canadian Occupational Performance Measure (COPM) assesses participants' self-perceived competence and satisfaction in self-care, productivity, and leisure. The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptom severity. The Wellness Toolbox, a semi-structured interview tool, explores participants' emotional coping strategies before and after the intervention. Qualitative data are collected through participant interviews and therapist observations and analyzed using grounded theory (open coding, axial coding, and selective coding). Quantitative data are analyzed using descriptive statistics and inferential statistics, including independent samples t-tests and repeated measures t-tests, to assess within- and between-group differences in outcome scores. This study is expected to contribute new evidence regarding the therapeutic application of XR technologies in psychiatric settings and inform future models for integrating immersive digital tools into occupational therapy practice, particularly for enhancing engagement in meaningful leisure among individuals with long-term mental illness.

Conditions

• Schizophrenia and Related Disorders
• Mental Disorders
• Inpatients

Interventions

Type	Name	Description
BEHAVIORAL	XR-Based Leisure Intervention	The XR-based leisure intervention was developed based on occupational therapy principles and the therapeutic use of leisure to support engagement, volition, and emotional regulation in individuals with chronic mental illness. The intervention content was designed using the AR2VR platform and the MAKAR marker-based AR development system. Leisure scenarios were created by capturing real-world environments using 360-degree panoramic video and embedding interactive elements, such as contextual prompts, virtual objects, and multimedia cues, to enhance immersion and engagement. Sessions are guided by trained occupational therapists and follow a standardized protocol to ensure consistency. A simple cardboard VR viewer is used to reduce sensory overload and avoid adverse effects common with electronic head-mounted displays, such as dizziness or nausea. Activities target various leisure domains, including physical movement, creative expression, social activities, and cognitive play. Weekly con

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-09-15
• Completion: 2025-10-31
• First posted: 2025-05-09
• Last updated: 2025-05-09

Locations

1 site across 1 country: Taiwan