Clinical trial NCT06964477: A Trial of Extended Reality Activities to Enhance Leisure Participation Among Inpatients With Persistent Mental Health Conditions
Official title: A Randomized Controlled Trial of an Extended Reality-Based Occupational Therapy Intervention to Improve Leisure Participation in Inpatients With Persistent Mental Health Conditions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Leisure Motivation Measured by the Occupational Therapy Interest Checklist
timeFrame: Baseline and after 6 weeks of intervention
measure: Change in Occupational Performance and Satisfaction Measured by the Canadian Occupational Performance Measure
timeFrame: Baseline and after 6 weeks of intervention
measure: Change in Volition Observed Using the Volitional Questionnaire (VQ)
timeFrame: Weekly throughout the 6-week intervention period
Secondary outcomes:
measure: Change in Psychiatric Symptoms Measured by the Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline and after 6 weeks of intervention
measure: Change in Emotional Coping Strategies Assessed Using the Wellness Toolbox Interview
timeFrame: Baseline and after 6 weeks of intervention
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Jing-Ho Hospital
Study officials:
References: