A Trial of Extended Reality Activities to Enhance Leisure Participation Among Inpatients With Persistent Mental Health Conditions (XR-MHLP)

Chia-Hui Hung

Status: Not yet enrolling

Conditions: Inpatients; Mental Disorders; Schizophrenia and Related Disorders

Treatments: Behavioral: XR-Based Leisure Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06964477

NSTC 113-2410-H-040 -003 -MY3

CS1-24114 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 20 to 65 years
• Diagnosed with chronic schizophrenia or schizoaffective disorder (ICD-10 F20.x or F25.x)
• Hospitalized continuously for at least 6 months
• Clinically stable with no acute psychiatric symptoms
• Able to walk independently and communicate verbally
• Mini-Mental State Examination (MMSE) score ≥ 24

Exclusion criteria

• History of epilepsy, severe motion sickness, or other seizure-related conditions
• Significant visual or auditory impairments that may interfere with XR experience
• Physical conditions that limit participation in leisure activities
• Current diagnosis of substance abuse or major organic brain disorder
• Inability to distinguish between reality and virtual environments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

XR-Based Leisure Intervention

Experimental group

Description:

Participants assigned to this arm will receive an extended reality (XR)-based leisure intervention that integrates both virtual reality (VR) and augmented reality (AR) technologies. The intervention is delivered once per week for six weeks. Each 40-minute session includes a 10-minute preparatory warm-up, a 20-minute immersive leisure experience using XR content, and a 10-minute structured feedback discussion. The XR experience is developed using the AR2VR platform and incorporates 360-degree panoramic video footage combined with interactive AR elements. The AR content is created using the MAKAR platform, a marker-based augmented reality development tool, enabling participants to interact with digital content through visual markers embedded in the physical or virtual environment. These AR features include interactive prompts, layered visuals, and context-based tasks designed to enhance engagement and therapeutic value.

Treatment:

Behavioral: XR-Based Leisure Intervention

Standard Leisure Activities

Active Comparator group

Description:

Participants assigned to this arm will engage in standard hospital-based leisure activities once per week for six weeks. Each session lasts approximately 40 minutes and includes a 10-minute warm-up, a 20-minute activity segment, and a 10-minute group discussion. Activities include therapeutic recreation commonly offered in psychiatric inpatient settings, such as drawing, music appreciation, newspaper reading, or light group exercises. The timing and structure of these sessions are designed to match those of the XR-based intervention group to ensure consistency in session duration and therapist involvement.

Treatment:

Behavioral: XR-Based Leisure Intervention