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

NCT06964477 | Not Yet Recruiting

• 2 other identifiers: NSTC 113-2410-H-040 -003 -MY3CS1-24114
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia and Related Disorders; Mental Disorders; Inpatients

Keywords

Leisure Activities; Virtual Reality Exposure Therapy; Augmented reality; Extend reality; Schizoaffective Disorder; Volition; Motivation; Emotional Regulation

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and after 6 weeks of intervention

• 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.

  Baseline and after 6 weeks of intervention

• 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.

  Weekly throughout the 6-week intervention period

Secondary Outcomes (2)

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

  Baseline and after 6 weeks of intervention

• Change in Emotional Coping Strategies Assessed Using the Wellness Toolbox Interview

  Baseline and after 6 weeks of intervention

Study Arms (2)

XR-Based Leisure Intervention

EXPERIMENTAL

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.

Behavioral: XR-Based Leisure Intervention

Standard Leisure Activities

ACTIVE COMPARATOR

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.

Behavioral: XR-Based Leisure Intervention

Interventions

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

Standard Leisure Activities; XR-Based Leisure Intervention

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chia-Hui Hung: lead

Study Sites (1)

Jing-Ho Hospital

Taichung, Taichung, 40246, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia; Mental Disorders; Psychotic Disorders; Self-Control; Emotional Regulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Social Behavior; Behavior

Central Study Contacts

Chia-Hui Hung, Ph.D

CONTACT

+886424730022; chhung@csmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No blinding was implemented because the intervention involved observable differences between study groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 9, 2025
• Study Start: July 1, 2025
• Primary Completion: September 15, 2025
• Study Completion: October 31, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)