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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorChia-Hui Hung

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • XR-Based Leisure Intervention

    Behavioral

    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

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: XR-Based Leisure InterventionExperimental treatment 1 intervention
Group B: Standard Leisure ActivitiesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Leisure Motivation Measured by the Occupational Therapy Interest Checklist

The Occupational Therapy Interest Checklist will be used to assess changes in leisure motivation, preferred activity domains, and engagement levels. Participants rate their interest in different activities before and after the 6-week intervention period.

Time frame
Baseline and after 6 weeks of intervention
2

Change in Occupational Performance and Satisfaction Measured by the Canadian Occupational Performance Measure

The Chinese version of the Canadian Occupational Performance Measure (COPM-C), originally developed by Law et al. and translated by Pan (2002), will be used to evaluate changes in self-perceived occupational performance and satisfaction. Participants identify up to five personally important occupational problems across three domains (self-care, productivity, and leisure) using a semi-structured interview. For each selected problem, participants rate their performance and satisfaction using a 10-point Likert scale. Higher scores indicate better performance or satisfaction. Final scores are calculated by averaging the performance and satisfaction ratings across the selected problems.

Time frame
Baseline and after 6 weeks of intervention
3

Change in Volition Observed Using the Volitional Questionnaire (VQ)

The Volitional Questionnaire (VQ), developed by de las Heras et al. based on the Model of Human Occupation, will be used to observe changes in participants' volition during occupational activity. The VQ includes 14 items categorized into three levels of volitional development: exploration, competence, and achievement. Trained occupational therapists observe participants during activity sessions and rate behaviors on a 4-point scale: passive, hesitant, involved, and spontaneous. Ratings reflect the degree of autonomy and internal motivation demonstrated during activity. Higher levels represent increased volitional expression and reduced therapist assistance.

Time frame
Weekly throughout the 6-week intervention period

Secondary outcomes

1

Change in Psychiatric Symptoms Measured by the Positive and Negative Syndrome Scale (PANSS)

The Positive and Negative Syndrome Scale (PANSS), developed by Kay, Opler, and Fiszbein (1987), will be used to evaluate changes in symptom severity among participants. The PANSS includes 30 items grouped into positive symptoms (7 items), negative symptoms (7 items), and general psychopathology (16 items), plus 3 additional items. Each item is scored from 1 (absent) to 7 (extreme), with total scores ranging from 30 to 231. Higher scores indicate more severe psychiatric symptoms. Severity categories are defined as mild (≤58), moderate (59-75), severe (76-95), and very severe (≥96).

Time frame
Baseline and after 6 weeks of intervention
2

Change in Emotional Coping Strategies Assessed Using the Wellness Toolbox Interview

The Wellness Toolbox is a semi-structured interview designed to explore participants' coping strategies for managing emotional distress and stress. It will be used to compare the number and types of self-reported strategies before and after the intervention. Participants will be asked to describe the strategies they typically use to regulate mood and handle stressful situations. Thematic and content analysis will be used to categorize qualitative changes, and the intervention's impact on emotional regulation and psychological well-being will be examined.

Time frame
Baseline and after 6 weeks of intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chia-Hui Hung

Lead sponsor

Chung Shan Medical University

Sponsor institution

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