Schizophrenia PatientsNCT07148609
Video Game-facilitated Group Activity for Quality of Life and Social Function in Chronic Schizophrenia Inpatients.
A study testing Video game-facilitated group activity in people with Schizophrenia Patients, run by TsaoTun Psychiatric Center, Department of Health, Taiwan at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to learn if video game-facilitated group activity helps to improve the quality of life and social function in inpatients with chronic schizophrenia. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia Patients
- What is being tested?
- Video game-facilitated group activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 May 2025to 31 Mar 2026
- 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
- Individuals aged between >18 and <65 years with a principal diagnosis of schizophrenia, as defined by the International Classification of Diseases (ICD-10) codes F20.0-F20.9 which was diagnosed according to DSM-5-TR criteria.
- Possessing a valid Catastrophic Illness Certificate for schizophrenia and being continuously hospitalized for more than six months.
- Being able to read Chinese and communicate effectively in either Mandarin or Taiwanese.
- Being able to comprehend the purpose of the study and to provide written informed consent after the study has been explained by the researchers.
Who cannot join
- Individuals exhibiting unstable psychiatric or consciousness conditions, or those unable to comply with video game-based instruction and operation.
- Individuals with a history of ocular diseases, severe cardiovascular disorders, epilepsy, or brain injuries; or those who have experienced acute cardiovascular or cerebrovascular events, bone fractures, undergone hip or knee joint replacement, or present with lower limb balance impairments or structural injuries-such as amputations, post-lumbar surgery status, or acute ankle sprains-rendering participation unsuitable within the past six months.
- Concurrent participation in other research studies during the study period, where the intervention may potentially influence the primary or secondary outcomes of this study.
- Individuals who are legally declared under guardianship.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Tsao-Tun Psychiatric Center, Ministry of Health and Welfare
Nantou City, Taiwan, 54249
About this study
Official title: Video Game-facilitated Group Activity for Quality of Life and Social Function in Chronic Schizophrenia Inpatients: A Randomized Controlled Parallel-group Pilot Trial.
The goal of this clinical trial is to learn if video game-facilitated group activity helps to improve the quality of life and social function in inpatients with chronic schizophrenia.
The main questions it aims to answer are:
Read more
- Does video game-facilitated group activity enhance the quality of life as measured by a standardized scale (WHOQOL) in patients with schizophrenia hospitalized in a psychiatric hospital?
- Can video game-facilitated group activity promote social function as measured by a specific scale (PSP) in patients with schizophrenia hospitalized in a psychiatric hospital?
Researchers will compare video game-facilitated group activity to regular occupational therapy to see if the intervention is beneficial to patients with chronic schizophrenia.
Participants will:
- Attend to video game-facilitated group activity or regular occupational therapy three times a week for 12 weeks.
- Receive assessments upon and after the 12-week intervention, and another 12 weeks after the intervention ends.
- Conditions
- Schizophrenia Patients
- Being tested
- Video game-facilitated group activity
- Keywords
- Video game, Schizophrenia, Social function, Quality of life
- Medical subject headings
- Schizophrenia, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video game-facilitated group activityBehavioural
The intervention is a 12-week group activity program for each participant in the intervention group, and the program consists of three 50-minute video game facilitated group activity sessions per week. Participants in the intervention group will engage in those group activity session which will be mediated by the game of Super Mario Party on Nintendo Switch.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Active comparator | Not described Receives: Behavioral: Video game-facilitated group activity |
| Controlled arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of quality of life
The changes of quality of life will be assessed by the World Health Organization Quality of Life-BREF (WHOQOL-BREF).
Measured: The outcome will be assessed at baseline, week 12, and week 24.
The changes of social function.
The changes of social function will be evaluated by the Personal and Social Performance Scale (PSP).
Measured: The outcome will be assessed at baseline, week 12, and week 24
Secondary outcomes (4)
The changes of cerebral blood flow.
The changes in cerebral blood be measured by Near-Infrared Spectroscopy (NIRS).
Measured: The outcome will be assessed at baseline and week 12.
The change of cognitive function.
The Montreal Cognitive Assessment (MoCA) will be used to evaluate changes in cognitive function.
Measured: The outcome will be assessed at baseline and week 12.
The change of psychiatric symptoms.
The Brief Psychiatric Rating Scale (BPRS) will be used to assess changes in positive and negative psychiatric symptoms.
Measured: The outcome will be assessed at baseline and week 12.
The change of physical fitness
Physical fitness assessments will be conducted to measure changes in participants' physical fitness levels, including cardiopulmonary endurance, the strength and flexibility of upper and lower limbs, as well as dynamic and static balance.
- The cardiopulmonary endurance would be measured by 6-minute walk test and march-in-place test.
- The upper limbs strength will be measured by arm curl test and hand grip strength test.
- The lower limbs strength will be measured by 30-second chair stand test.
- The upper limbs flexibility will be measured by back scratch test.
- The lower limbs flexibility will be measured by chair sit-and-reach test.
- The dynamic balance test will be measured by chair stand and obstacle walk test.
- The static balance test will be measured by one-leg stand test with eyes open.
Measured: The outcome will be assessed at baseline and week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start3 May 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia PatientsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TsaoTun Psychiatric Center, Department of Health, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Yu Chiang, TsaoTun Psychiatric Center, Department of Health, Taiwan
- Investigators
- Yung-Jen Yang, Study chair, Tsao-Tun Psychiatric Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148609
- Sponsor's protocol ID
- TTPC-114015
- Status last verified
- Aug 2025
- First submitted
- 23 Aug 2025
- Last updated
- 29 Aug 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 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Game-facilitated Group Activity for Quality of Life and Social Function in Chronic Schizophrenia Inpatients: A Randomized Controlled Parallel-group Pilot Trial.
- ClinicalTrials.gov ID
- NCT07148609
- Acronym / sponsor ID
- TTPC-114015
- Conditions
- Schizophrenia Patients
- Keywords
- Video game, Schizophrenia, Social function, Quality of life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- TsaoTun Psychiatric Center, Department of Health, TaiwanUniversity, hospital or other
- Study start
- 3 May 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 29 Aug 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 learn if video game-facilitated group activity helps to improve the quality of life and social function in inpatients with chronic schizophrenia.
The main questions it aims to answer are:
- Does video game-facilitated group activity enhance the quality of life as measured by a standardized scale (WHOQOL) in patients with schizophrenia hospitalized in a psychiatric hospital?
- Can video game-facilitated group activity promote social function as measured by a specific scale (PSP) in patients with schizophrenia hospitalized in a psychiatric hospital?
Researchers will compare video game-facilitated group activity to regular occupational therapy to see if the intervention is beneficial to patients with chronic schizophrenia.
Participants will:
- Attend to video game-facilitated group activity or regular occupational therapy three times a week for 12 weeks.
- Receive assessments upon and after the 12-week intervention, and another 12 weeks after the intervention ends.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Active comparator | Behavioral: Video game-facilitated group activity |
| Controlled arm | No intervention | – |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals aged between >18 and <65 years with a principal diagnosis of schizophrenia, as defined by the International Classification of Diseases (ICD-10) codes F20.0-F20.9 which was diagnosed according to DSM-5-TR criteria.
- Possessing a valid Catastrophic Illness Certificate for schizophrenia and being continuously hospitalized for more than six months.
- Being able to read Chinese and communicate effectively in either Mandarin or Taiwanese.
- Being able to comprehend the purpose of the study and to provide written informed consent after the study has been explained by the researchers.
Key exclusion criteria (4 listed)
- Individuals exhibiting unstable psychiatric or consciousness conditions, or those unable to comply with video game-based instruction and operation.
- Individuals with a history of ocular diseases, severe cardiovascular disorders, epilepsy, or brain injuries; or those who have experienced acute cardiovascular or cerebrovascular events, bone fractures, undergone hip or knee joint replacement, or present with lower limb balance impairments or structural injuries-such as amputations, post-lumbar surgery status, or acute ankle sprains-rendering participation unsuitable within the past six months.
- Concurrent participation in other research studies during the study period, where the intervention may potentially influence the primary or secondary outcomes of this study.
- Individuals who are legally declared under guardianship.
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 |
|---|---|---|
| Video game-facilitated group activityThe intervention is a 12-week group activity program for each participant in the intervention group, and the program consists of three 50-minute video game facilitated group activity sessions per week. Participants in the intervention group will engage in those group activity session which will be mediated by the game of Super Mario Party on Nintendo Switch. | Behavioural | Interventional arm |
Primary outcome
The changes of quality of life
Time frame: The outcome will be assessed at baseline, week 12, and week 24.
The changes of quality of life will be assessed by the World Health Organization Quality of Life-BREF (WHOQOL-BREF).
The changes of social function.
Time frame: The outcome will be assessed at baseline, week 12, and week 24
The changes of social function will be evaluated by the Personal and Social Performance Scale (PSP).
4 secondary outcomes
The changes of cerebral blood flow.
Time frame: The outcome will be assessed at baseline and week 12.
The change of cognitive function.
Time frame: The outcome will be assessed at baseline and week 12.
The change of psychiatric symptoms.
Time frame: The outcome will be assessed at baseline and week 12.
The change of physical fitness
Time frame: The outcome will be assessed at baseline and week 12.
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 29 Aug 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. This study is not recruiting at the moment.
Yung-Jen Yang study chair
Tsao-Tun Psychiatric Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video game-facilitated group activity in people with Schizophrenia Patients, run by TsaoTun Psychiatric Center, Department of Health, Taiwan 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 29 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of quality of life (time frame: The outcome will be assessed at baseline, week 12, and week 24.). The study lists 2 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 29 Aug 2025.