PsychiatryNCT04346303
Applying Short-term Interactive Video Games on Community Patients With Mental Disorders
A study testing Short-term Interactive Video Games in people with Psychiatry and Nursing, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to design prospective experiments before and after the test. The purpose is to explore whether short-term interactive video games can improve the motivation, interpersonal interaction, and physical and mental health of patients with mental illness in community rehabilitation homes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Psychiatry, Nursing
- What is being tested?
- Short-term Interactive Video Games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Mar 2020to 31 Dec 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis conforms to the international classification standards for the diagnosis of dysphoria or bipolar disorder.
- Be older than 20 years old.
- those who have a clear sense and can communicate.
- You can read the instructions carefully, and after you explain, you are willing to participate in the research plan and fill out the consent form.
- The judges of the researchers can independently answer the interview questionnaires of this research and perform short-term interactive video game players.
- At present, you can go out, make friends, take care of yourself, and fully exercise your rights. You have the full capacity of an adult and have not been restricted by any laws. Therefore, you do not need to obtain an additional legal agent to participate in this study Sign the consent form.
Who cannot join
- People with difficulties in cognitive understanding, such as those who cannot communicate or suffer from cognitive impairments, such as Alzheimer's disease.
- Those who have obvious obstacles to the physical function of their limbs, who are unable to participate in sports video games.
- Slow development or lack of moderate intelligence may affect the understanding of interviews or participation in activities.
- The physical and mental condition has been unstable in the past two weeks, such as instability of vital signs or obvious impaired sense of reality, obvious symptoms of delusions or hallucinations, etc., cannot be interviewed or coordinated with activities.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chang Jung-Chen, PhD, (02) 223123456 ext. 88905, jungchenchang@ntu.edu.tw
About this study
Official title: Intervention Feasibility and Outcomes Evaluation of Applying Short-term Interactive Video Games on Community Patients With Mental Disorders
The purpose of this study is to design prospective experiments before and after the test. The purpose is to explore whether short-term interactive video games can improve the motivation, interpersonal interaction, and physical and mental health of patients with mental illness in community rehabilitation homes. Samples of mentally ill patients from community rehabilitation homes (full-day rehabilitation institutions) in the northern region were collected using a structured questionnaire for the recipients, as follows:
- Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information.
- Three data collections were performed, namely the baseline period (T0) and the pre-program (T1) two weeks later. Three weeks of intervention activities were provided twice a week, followed by a post-test ( post-program, T2).
- After a total of six times mentioned above, each 60 minutes of interactive video game intervention, the patient completed the activity feedback form, reflecting the feelings and feedback of participating in the activity.
Read the detailed description
The purpose of this study is to design prospective experiments before and after the test. The purpose is to explore whether short-term interactive video games can improve the motivation, interpersonal interaction, and physical and mental health of patients with mental illness in community rehabilitation homes. Samples of mentally ill patients from community rehabilitation homes (full-day rehabilitation institutions) in the northern region were collected using a structured questionnaire for the recipients, as follows:
- Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information.
- Three data collections were performed, namely the baseline period (T0) and the pre-program (T1) two weeks later. Three weeks of intervention activities were provided twice a week, followed by a post-test ( post-program, T2).
- After a total of six times mentioned above, each 60 minutes of interactive video game intervention, the patient completed the activity feedback form, reflecting the feelings and feedback of participating in the activity.
Primary Outcome Measure:
The changes of quality of life (WHOQOL-BREF: WHO Quality of Life: Brief form) After Short-term Interactive Video Games the changes of quality of life. This is a 28-items quality of life measurement to assess patient's quality of life.
[Time Frame: 5 Weeks]
Secondary Outcome Measures:
Body Mass Index Measuring height and weight [Time Frame: 5 Weeks]
Waist-hip ratio Measuring the ratio of waist to hip [Time Frame: 5 Weeks]
10-m walking time at comfortable Measuring the 10-m walking time at comfortable [Time Frame: 5 Weeks]
10-m walking time at maximum Measuring the 10-m walking time at maximum [Time Frame: 5 Weeks]
Get Up and Go test Measuring the Get Up and Go test [Time Frame: 5 Weeks]
5 times sit-to-stand test Measuring the 5 times sit-to-stand test [Time Frame: 5 Weeks]
Hierarchy of the Care Required This is a 18-item questionnaire to assess the patient's ADL and IADL as well as daily function.
[Time Frame: 5 Weeks]
CHQ-12 (Chinese Health Questionnaire) This is a 12-item scale to assess the patient's life stress indicating anxiety and depression symptoms.
[Time Frame: 5 Weeks]
Short FES-I (Chinese version of the Falls Efficacy Scale ) This is a 7-item scale to assess patient's vulnerability to fall. [Time Frame: 5 Weeks]
- Conditions
- Psychiatry, Nursing
- Being tested
- Short-term Interactive Video Games
- Keywords
- Short-term Interactive Video Games, Community Patients with Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-term Interactive Video GamesOther
- Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information.
- Three data collections were performed, namely the baseline period (T0) and the pre-program (T1) two weeks later. Three weeks of intervention activities were provided twice a week, followed by a post-test ( post-program, T2).
- After a total of six times mentioned above, each 60 minutes of interactive video game intervention, the patient completed the activity feedback form, reflecting the feelings and feedback of participating in the activity.
| Study group | Role | What they receive |
|---|---|---|
| Short-term Interactive Video Games | Other | Short-term video games will be applied to patients with mental illness who are staying in communities. Games will be applied in a group-activity format with 8 to 12 patients in each session. The interventions will be conducted at a two sessions per week for a 3-week long period. There are 3 time points for data collection, including 2-weeks before the intervention, the week before the intervention, and the week after the intervention. Each patient will be his/her own controlled comparison. Receives: Other: Short-term Interactive Video Games |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of quality of life (WHOQOL-BREF: WHO Quality of Life: Brief form)
After Short-term Interactive Video Games the changes of quality of life. This is a 28-items quality of life measurement to assess patient's quality of life.
Measured: 5 Weeks
Secondary outcomes (9)
Body Mass Index
Measuring height and weight
Measured: 5 Weeks
Waist-hip ratio
Measuring the ratio of waist to hip
Measured: 5 Weeks
10-m walking time at comfortable
Measuring the 10-m walking time at comfortable
Measured: 5 Weeks
10-m walking time at maximum
Measuring the 10-m walking time at maximum
Measured: 5 Weeks
Get Up and Go test
Measuring the Get Up and Go test
Measured: 5 Weeks
5 times sit-to-stand test
Measuring the 5 times sit-to-stand test
Measured: 5 Weeks
Hierarchy of the Care Required
This is a 18-item questionnaire to assess the patient's ADL and IADL as well as daily function.
Measured: 5 Weeks
CHQ-12 (Chinese Health Questionnaire)
This is a 12-item scale to assess the patient's life stress indicating anxiety and depression symptoms.
Measured: 5 Weeks
Short FES-I (Chinese version of the Falls Efficacy Scale )
This is a 7-item scale to assess patient's vulnerability to fall.
Measured: 5 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start16 Mar 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychiatryStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chang Jung-Chen, PhD, Principal investigator, National Taiwan University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346303
- Sponsor's protocol ID
- 202001106RIND
- Status last verified
- Mar 2020
- First submitted
- 31 Mar 2020
- Last updated
- 15 Apr 2020
- Results posted
- 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 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Feasibility and Outcomes Evaluation of Applying Short-term Interactive Video Games on Community Patients With Mental Disorders
- ClinicalTrials.gov ID
- NCT04346303
- Acronym / sponsor ID
- 202001106RIND
- Conditions
- Psychiatry, Nursing
- Keywords
- Short-term Interactive Video Games, Community Patients with Mental Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 15 Apr 2020 (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 purpose of this study is to design prospective experiments before and after the test. The purpose is to explore whether short-term interactive video games can improve the motivation, interpersonal interaction, and physical and mental health of patients with mental illness in community rehabilitation homes. Samples of mentally ill patients from community rehabilitation homes (full-day rehabilitation institutions) in the northern region were collected using a structured questionnaire for the recipients, as follows:
- Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information.
- Three data collections were performed, namely the baseline period (T0) and the pre-program (T1) two weeks later. Three weeks of intervention activities were provided twice a week, followed by a post-test ( post-program, T2).
- After a total of six times mentioned above, each 60 minutes of interactive video game intervention, the patient completed the activity feedback form, reflecting the feelings and feedback of participating in the activity.
Detailed description
The purpose of this study is to design prospective experiments before and after the test. The purpose is to explore whether short-term interactive video games can improve the motivation, interpersonal interaction, and physical and mental health of patients with mental illness in community rehabilitation homes. Samples of mentally ill patients from community rehabilitation homes (full-day rehabilitation institutions) in the northern region were collected using a structured questionnaire for the recipients, as follows:
- Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information.
- Three data collections were performed, namely the baseline period (T0) and the pre-program (T1) two weeks later. Three weeks of intervention activities were provided twice a week, followed by a post-test ( post-program, T2).
- After a total of six times mentioned above, each 60 minutes of interactive video game intervention, the patient completed the activity feedback form, reflecting the feelings and feedback of participating in the activity.
Primary Outcome Measure:
The changes of quality of life (WHOQOL-BREF: WHO Quality of Life: Brief form) After Short-term Interactive Video Games the changes of quality of life. This is a 28-items quality of life measurement to assess patient's quality of life.
[Time Frame: 5 Weeks]
Secondary Outcome Measures:
Body Mass Index Measuring height and weight [Time Frame: 5 Weeks]
Waist-hip ratio Measuring the ratio of waist to hip [Time Frame: 5 Weeks]
10-m walking time at comfortable Measuring the 10-m walking time at comfortable [Time Frame: 5 Weeks]
10-m walking time at maximum Measuring the 10-m walking time at maximum [Time Frame: 5 Weeks]
Get Up and Go test Measuring the Get Up and Go test [Time Frame: 5 Weeks]
5 times sit-to-stand test Measuring the 5 times sit-to-stand test [Time Frame: 5 Weeks]
Hierarchy of the Care Required This is a 18-item questionnaire to assess the patient's ADL and IADL as well as daily function.
[Time Frame: 5 Weeks]
CHQ-12 (Chinese Health Questionnaire) This is a 12-item scale to assess the patient's life stress indicating anxiety and depression symptoms.
[Time Frame: 5 Weeks]
Short FES-I (Chinese version of the Falls Efficacy Scale ) This is a 7-item scale to assess patient's vulnerability to fall. [Time Frame: 5 Weeks]
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Short-term Interactive Video Games | Other | Other: Short-term Interactive Video GamesShort-term video games will be applied to patients with mental illness who are staying in communities. Games will be applied in a group-activity format with 8 to 12 patients in each session. The interventions will be conducted at a two sessions per week for a 3-week long period. There are 3 time points for data collection, including 2-weeks before the intervention, the week before the intervention, and the week after the intervention. Each patient will be his/her own controlled comparison. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The diagnosis conforms to the international classification standards for the diagnosis of dysphoria or bipolar disorder.
- Be older than 20 years old.
- those who have a clear sense and can communicate.
- You can read the instructions carefully, and after you explain, you are willing to participate in the research plan and fill out the consent form.
- The judges of the researchers can independently answer the interview questionnaires of this research and perform short-term interactive video game players.
Key exclusion criteria (4 listed)
- People with difficulties in cognitive understanding, such as those who cannot communicate or suffer from cognitive impairments, such as Alzheimer's disease.
- Those who have obvious obstacles to the physical function of their limbs, who are unable to participate in sports video games.
- Slow development or lack of moderate intelligence may affect the understanding of interviews or participation in activities.
- The physical and mental condition has been unstable in the past two weeks, such as instability of vital signs or obvious impaired sense of reality, obvious symptoms of delusions or hallucinations, etc., cannot be interviewed or coordinated with activities.
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 |
|---|---|---|
| Short-term Interactive Video Games1. Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information. 2. Three data collections were performed, namely the baseline period (T0) and the pre-program (T1) two weeks later. Three weeks of intervention activities were provided twice a week, followed by a post-test ( post-program, T2). 3. After a total of six times mentioned above, each 60 minutes of interactive video game intervention, the patient completed the activity feedback form, reflecting the feelings and feedback of participating in the activity. | Other | Short-term Interactive Video Games |
Primary outcome
The changes of quality of life (WHOQOL-BREF: WHO Quality of Life: Brief form)
Time frame: 5 Weeks
After Short-term Interactive Video Games the changes of quality of life. This is a 28-items quality of life measurement to assess patient's quality of life.
9 secondary outcomes
Body Mass Index
Time frame: 5 Weeks
Waist-hip ratio
Time frame: 5 Weeks
10-m walking time at comfortable
Time frame: 5 Weeks
10-m walking time at maximum
Time frame: 5 Weeks
Get Up and Go test
Time frame: 5 Weeks
5 times sit-to-stand test
Time frame: 5 Weeks
Hierarchy of the Care Required
Time frame: 5 Weeks
CHQ-12 (Chinese Health Questionnaire)
Time frame: 5 Weeks
Short FES-I (Chinese version of the Falls Efficacy Scale )
Time frame: 5 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- 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.
Chang Jung-Chen, PhD principal investigator
National Taiwan University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short-term Interactive Video Games in people with Psychiatry and Nursing, 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 6 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: status not confirmed, as of the sponsor's last update on 15 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang Jung-Chen, PhD ((02)223123456 ext. 88905, jungchenchang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of quality of life (WHOQOL-BREF: WHO Quality of Life: Brief form) (time frame: 5 Weeks). 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 15 Apr 2020.