Schizophrenia and Related DisordersXR-MHLPNCT06964477
A Trial of Extended Reality Activities to Enhance Leisure Participation Among Inpatients With Persistent Mental Health Conditions
A study testing XR-Based Leisure Intervention in people with Schizophrenia and Related Disorders and Mental Disorders, run by Chia-Hui Hung at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia and Related Disorders, Mental Disorders, Inpatients
- What is being tested?
- XR-Based Leisure Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Jing-Ho Hospital
Taichung, Taichung, 40246
Jian-Cheng Duan, +886 04 2371 1129, chenliyu0983505705@gmail.com
Chia-Hui Hung
About this study
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
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?
Read more
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.
Read the 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.
- Being tested
- XR-Based Leisure Intervention
- Keywords
- Leisure Activities, Virtual Reality Exposure Therapy, Augmented reality, Extend reality, Schizoaffective Disorder, Volition, Motivation, Emotional Regulation
- Medical subject headings
- Schizophrenia, Mental Disorders, Psychotic Disorders, Self-Control, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XR-Based Leisure InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: XR-Based Leisure Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Weekly throughout the 6-week intervention period
Secondary outcomes (2)
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).
Measured: Baseline and after 6 weeks of intervention
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.
Measured: Baseline and after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia-Hui Hung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chia-Hui Hung, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964477
- Sponsor's protocol ID
- NSTC 113-2410-H-040 -003 -MY3
- Other IDs
- CS1-24114
- Acronym
- XR-MHLP
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06964477
- Acronym / sponsor ID
- XR-MHLP / NSTC 113-2410-H-040 -003 -MY3
- Keywords
- Leisure Activities, Virtual Reality Exposure Therapy, Augmented reality, Extend reality, Schizoaffective Disorder, Volition, Motivation, Emotional Regulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Chia-Hui HungUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XR-Based Leisure Intervention | Experimental | Behavioral: XR-Based Leisure InterventionParticipants 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. |
| Standard Leisure Activities | Active comparator | Behavioral: XR-Based Leisure InterventionParticipants 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XR-Based Leisure InterventionThe 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 | Behavioural | Standard Leisure Activities, XR-Based Leisure Intervention |
Primary outcome
Change in Leisure Motivation Measured by the Occupational Therapy Interest Checklist
Time frame: Baseline and after 6 weeks of intervention
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.
Change in Occupational Performance and Satisfaction Measured by the Canadian Occupational Performance Measure
Time frame: Baseline and after 6 weeks of intervention
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.
Change in Volition Observed Using the Volitional Questionnaire (VQ)
Time frame: Weekly throughout the 6-week intervention period
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.
2 secondary outcomes
Change in Psychiatric Symptoms Measured by the Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline and after 6 weeks of intervention
Change in Emotional Coping Strategies Assessed Using the Wellness Toolbox Interview
Time frame: Baseline and after 6 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XR-Based Leisure Intervention in people with Schizophrenia and Related Disorders and Mental Disorders, run by Chia-Hui Hung at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chia-Hui Hung, Ph.D (+886424730022 ext. +886 095340598, chhung@csmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Leisure Motivation Measured by the Occupational Therapy Interest Checklist (time frame: Baseline and after 6 weeks of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.