Chronic Mental IllnessNCT06440200
Exploring the Health Effects of Group Game-based Activities on Individuals With Chronic Mental Illness
A study testing group gamed-based activity in people with Chronic Mental Illness and Schizophrenia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to explore the health effects of group games for patients with chronic mental illness. The goal of this clinical intervention study is to compare the efficacy of group games in two ways (experimental group/ group game-based or control group) to improve the health of patients with chronic mental… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Mental Illness, Schizophrenia, Psychiatry
- What is being tested?
- group gamed-based activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Mar 2024to 19 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults whose age is above 18
- Patients who diagnosed with schizophrenia spectrum disorders or bipolar disorders
- At present, you can go out, make friends, take care of your daily life, fully exercise your rights, and have full capacity as an adult, and have not been restricted by any legal declaration, so you do not need to obtain the consent of your legal representative to sign to participate in this study.
Who cannot join
- Those who have obvious limb movement disorders, such as congenital disability or hemiplegia after stroke, etc., which make them unable to participate in the group's game activities
- Those who are unwilling or unable to complete the signing of the written consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Applying Group Game-based Activities to Improve the Health of Patients With Chronic Mental Illness
This study aims to explore the health effects of group games for patients with chronic mental illness. The goal of this clinical intervention study is to compare the efficacy of group games in two ways (experimental group/ group game-based or control group) to improve the health of patients with chronic mental illness. The main questions it aims to answer are:
The efficacy of applying group game-based activities to increase interest and improve the physical fitness of patients with chronic mental illness. Also, the goal of this clinical interventional study is to clarify the positive benefits of psychological and social aspects.
Read more
Subjects will be asked to complete the questionnaire and physical ability examination after filling out the consent of this study. Participants will be randomly divided into two groups. Participants in the experimental group will accept the group game-based activities for 12 weeks (twice per week, 22 times). In contrast, Participants in the control group will accept the activities the psychiatric day wards and halfway house offer as usual. After 12 weeks of intervention, The Participants in both groups will be asked to fill out the questionnaire and physical ability examination. One month later, Participants in both groups will be asked to fill out the questionnaire and physical ability examination again. The study will last for 4 months. The time points for completing the questionnaire are listed following:
Baseline/ pre-intervention test(T1), First post-intervention test (T2, 12 weeks later) and Second post-intervention test (T3, 4 weeks later). The researchers will compare the difference in effectiveness between the two groups.
Read the detailed description
This study is a randomized controlled study. Researchers use a random assignment. One is an experimental group (group game-based), and the other is a control group(activities as usual). This Parallel two-group pre-test, first post-test and second post-test are designed to conduct a 12-week interventional study regarding group game-based activities for patients with chronic mental illness. A total of 3 questionnaires will be collected to compare the differences between the two groups to clarify the efficacy of group game-based activities. The investigators will discuss the outcome and the change in physiological values, physical ability, depression rating scale, quality of life and the motivation of group game-based activities.
Once the participants fill out the consent form, they will be asked to conduct the pre-test questionnaire including physiological values, physical ability, depression rating scale and quality of life. Then, the random numbers table will be used to divide subjects into the experimental group or the control group. The experimental group will accept group game-based activity twice a week lasting 12 weeks. There will be many motion-sensing games in the group game-based activities. The games designed for activities can provide somatosensory control including tactual, visual and auditory feedback. On the contrary, Participants in the control group will accept the activities the psychiatric day wards and halfway house offer as usual.
After 12 weeks, subjects in two groups will be asked to complete the first post-test questionnaire and physical examination(T2) which physiological values, physical ability, depression rating scale quality of life and motivation of group game-based activities will be included. Then, they will be asked to do the second post-test after 4 weeks without any intervention to investigate the long-term effect of the group game-based activities. The content of the questionnaire and physical examination will be the same as T2.
- Conditions
- Chronic Mental Illness, Schizophrenia, Psychiatry
- Being tested
- group gamed-based activity
- Keywords
- group game-based activities, physiological values, depression rating scales, quality of life
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group gamed-based activityBehavioural
Participants in interventional group will play the active-type software with Switch game console which develops by Nintendo company. Team building, cooperation, cohesion, sense of belonging and sense of achieving will be emphasized.
| Study group | Role | What they receive |
|---|---|---|
| group gamed-based activites | Experimental | The group game-based activity will be twice a week lasting 12 weeks. There will be many motion sensing games in the group game-based activities. The games designed for activities can provide somatosensory control and visual and auditory feedback. Receives: Behavioral: group gamed-based activity |
| control group | No intervention | The activities will be the psychiatric day wards and half-way house offered as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
Height in meters.
Measured: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
Ｗeight
Weight in kilograms. Weighing machine will be used.
Measured: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
BMI
Body Mass Index(BMI), Weight and height will be combined to report BMI in kg/m^2.
Measured: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
Ｗaist circumference
The measuring tape will pass through the middle point between the upper edge of the left and right intestinal bones and the lower edge of the ribs. The Length of the measuring tape will be the results of Ｗaist circumference.
Measured: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
Buttocks circumference
The measuring tape will pass through the high point of buttocks. The Length of the measuring tape will be the results of Ｗaist circumference.
Measured: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
10-meter walking time at comfortable
Time in second. To measuring time of walking at comfortable for 10 meters.
Measured: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
10-meter walking time at maximum
Time in second. Investigators will measure the time of walking at maximum for 10 meters.
Measured: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
Get up and Go test
Time in second. First, The patient will sit on a chair. Second, he/she will stand up and go for 3 meters. At last, he/she will turn around and go back to have a sit. Investigators will measure time of the process.
Measured: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
5 times sit-to-stand-test
Time in second. First, The patient will sit on a chair. Second, he/she will stand up and sit down immediately. The patients will be asked to do this process for 5 times.
Measured: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
Body fat percentage
Investigators will measure patients' body fat percentage by the body fat machine produced by Inbody company.
Measured: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
Secondary outcomes (3)
Patient health questionnaire-9
The abbreviation of patient health questionnaire-9 is PHQ-9. The total number of questions is 9. The minimum and maximum values are 0 and 27 respectively. Then, the higher scores mean a worse outcome.
Measured: Depression rating scale will be done at T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16). motivation of group game-based activities will be at T2=first post-test(Week 12) and T3=second post-test(Week 16).
World Health Organization Quality-of-Life Scale
The abbreviation of World Health Organization Quality-of-Life Scale is WHOQOL-BREF. The total number of questions is 28. The minimum and maximum values are 28 and 140 respectively. Then, the higher scores mean a better outcome.
Measured: The questionnaire of quality of life will be done at T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16). motivation of group game-based activities will be at T2=first post-test(Week 12) and T3=second post-test(Week 16).
Chinese version of interactive video games questionnaire on satisfaction and feasibility
The total number of questions is 13. The content of the questionnaire includes whether the games is easy, the games can bring happiness and deserve to play, etc.
Measured: Motivation of group game-based activities will be done at T2=first post-test(Week 12) and T3=second post-test(Week 16).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start18 Mar 2024
- Primary completion19 Aug 2024
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Mental IllnessStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440200
- Sponsor's protocol ID
- 202401209RINE
- Status last verified
- Jul 2025
- First submitted
- 28 Mar 2024
- Last updated
- 23 Jul 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 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Group Game-based Activities to Improve the Health of Patients With Chronic Mental Illness
- ClinicalTrials.gov ID
- NCT06440200
- Acronym / sponsor ID
- 202401209RINE
- Conditions
- Chronic Mental Illness, Schizophrenia, Psychiatry
- Keywords
- group game-based activities, physiological values, depression rating scales, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 3 Jun 2024 (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.
This study aims to explore the health effects of group games for patients with chronic mental illness. The goal of this clinical intervention study is to compare the efficacy of group games in two ways (experimental group/ group game-based or control group) to improve the health of patients with chronic mental illness. The main questions it aims to answer are:
The efficacy of applying group game-based activities to increase interest and improve the physical fitness of patients with chronic mental illness. Also, the goal of this clinical interventional study is to clarify the positive benefits of psychological and social aspects.
Subjects will be asked to complete the questionnaire and physical ability examination after filling out the consent of this study. Participants will be randomly divided into two groups. Participants in the experimental group will accept the group game-based activities for 12 weeks (twice per week, 22 times). In contrast, Participants in the control group will accept the activities the psychiatric day wards and halfway house offer as usual. After 12 weeks of intervention, The Participants in both groups will be asked to fill out the questionnaire and physical ability examination. One month later, Participants in both groups will be asked to fill out the questionnaire and physical ability examination again. The study will last for 4 months. The time points for completing the questionnaire are listed following:
Baseline/ pre-intervention test(T1), First post-intervention test (T2, 12 weeks later) and Second post-intervention test (T3, 4 weeks later). The researchers will compare the difference in effectiveness between the two groups.
Detailed description
This study is a randomized controlled study. Researchers use a random assignment. One is an experimental group (group game-based), and the other is a control group(activities as usual). This Parallel two-group pre-test, first post-test and second post-test are designed to conduct a 12-week interventional study regarding group game-based activities for patients with chronic mental illness. A total of 3 questionnaires will be collected to compare the differences between the two groups to clarify the efficacy of group game-based activities. The investigators will discuss the outcome and the change in physiological values, physical ability, depression rating scale, quality of life and the motivation of group game-based activities.
Once the participants fill out the consent form, they will be asked to conduct the pre-test questionnaire including physiological values, physical ability, depression rating scale and quality of life. Then, the random numbers table will be used to divide subjects into the experimental group or the control group. The experimental group will accept group game-based activity twice a week lasting 12 weeks. There will be many motion-sensing games in the group game-based activities. The games designed for activities can provide somatosensory control including tactual, visual and auditory feedback. On the contrary, Participants in the control group will accept the activities the psychiatric day wards and halfway house offer as usual.
After 12 weeks, subjects in two groups will be asked to complete the first post-test questionnaire and physical examination(T2) which physiological values, physical ability, depression rating scale quality of life and motivation of group game-based activities will be included. Then, they will be asked to do the second post-test after 4 weeks without any intervention to investigate the long-term effect of the group game-based activities. The content of the questionnaire and physical examination will be the same as T2.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group gamed-based activites | Experimental | Behavioral: group gamed-based activityThe group game-based activity will be twice a week lasting 12 weeks. There will be many motion sensing games in the group game-based activities. The games designed for activities can provide somatosensory control and visual and auditory feedback. |
| control group | No intervention | –The activities will be the psychiatric day wards and half-way house offered as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults whose age is above 18
- Patients who diagnosed with schizophrenia spectrum disorders or bipolar disorders
- At present, you can go out, make friends, take care of your daily life, fully exercise your rights, and have full capacity as an adult, and have not been restricted by any legal declaration, so you do not need to obtain the consent of your legal representative to sign to participate in this study.
Key exclusion criteria (2 listed)
- Those who have obvious limb movement disorders, such as congenital disability or hemiplegia after stroke, etc., which make them unable to participate in the group's game activities
- Those who are unwilling or unable to complete the signing of the written consent form.
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 |
|---|---|---|
| group gamed-based activityParticipants in interventional group will play the active-type software with Switch game console which develops by Nintendo company. Team building, cooperation, cohesion, sense of belonging and sense of achieving will be emphasized. | Behavioural | group gamed-based activites |
Primary outcome
Height
Time frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
Height in meters.
Ｗeight
Time frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
Weight in kilograms. Weighing machine will be used.
BMI
Time frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
Body Mass Index(BMI), Weight and height will be combined to report BMI in kg/m^2.
Ｗaist circumference
Time frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
The measuring tape will pass through the middle point between the upper edge of the left and right intestinal bones and the lower edge of the ribs. The Length of the measuring tape will be the results of Ｗaist circumference.
Buttocks circumference
Time frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
The measuring tape will pass through the high point of buttocks. The Length of the measuring tape will be the results of Ｗaist circumference.
10-meter walking time at comfortable
Time frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
Time in second. To measuring time of walking at comfortable for 10 meters.
10-meter walking time at maximum
Time frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
Time in second. Investigators will measure the time of walking at maximum for 10 meters.
Get up and Go test
Time frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
Time in second. First, The patient will sit on a chair. Second, he/she will stand up and go for 3 meters. At last, he/she will turn around and go back to have a sit. Investigators will measure time of the process.
5 times sit-to-stand-test
Time frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
Time in second. First, The patient will sit on a chair. Second, he/she will stand up and sit down immediately. The patients will be asked to do this process for 5 times.
Body fat percentage
Time frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
Investigators will measure patients' body fat percentage by the body fat machine produced by Inbody company.
3 secondary outcomes
Patient health questionnaire-9
Time frame: Depression rating scale will be done at T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16). motivation of group game-based activities will be at T2=first post-test(Week 12) and T3=second post-test(Week 16).
World Health Organization Quality-of-Life Scale
Time frame: The questionnaire of quality of life will be done at T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16). motivation of group game-based activities will be at T2=first post-test(Week 12) and T3=second post-test(Week 16).
Chinese version of interactive video games questionnaire on satisfaction and feasibility
Time frame: Motivation of group game-based activities will be done at T2=first post-test(Week 12) and T3=second post-test(Week 16).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group gamed-based activity in people with Chronic Mental Illness and Schizophrenia, run by National Taiwan University Hospital 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 23 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Height (time frame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)). The study lists 10 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 23 Jul 2025.