Applying Short-term Interactive Video Games on Community Patients With Mental Disorders
Primary Purpose
Psychiatry, Nursing
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Short-term Interactive Video Games
Sponsored by
About this trial
This is an interventional supportive care trial for Psychiatry focused on measuring Short-term Interactive Video Games, Community Patients with Mental Disorders
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Short-term Interactive Video Games
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Body Mass Index
Measuring height and weight
Waist-hip ratio
Measuring the ratio of waist to hip
10-m walking time at comfortable
Measuring the 10-m walking time at comfortable
10-m walking time at maximum
Measuring the 10-m walking time at maximum
Get Up and Go test
Measuring the Get Up and Go test
5 times sit-to-stand test
Measuring the 5 times sit-to-stand test
Hierarchy of the Care Required
This is a 18-item questionnaire to assess the patient's ADL and IADL as well as daily function.
CHQ-12 (Chinese Health Questionnaire)
This is a 12-item scale to assess the patient's life stress indicating anxiety and depression symptoms.
Short FES-I (Chinese version of the Falls Efficacy Scale )
This is a 7-item scale to assess patient's vulnerability to fall.
Full Information
NCT ID
NCT04346303
First Posted
March 31, 2020
Last Updated
April 14, 2020
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04346303
Brief Title
Applying Short-term Interactive Video Games on Community Patients With Mental Disorders
Official Title
Intervention Feasibility and Outcomes Evaluation of Applying Short-term Interactive Video Games on Community Patients With Mental Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 16, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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]
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatry, Nursing
Keywords
Short-term Interactive Video Games, Community Patients with Mental Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Short-term Interactive Video Games
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Short-term Interactive Video Games
Intervention Description
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 Information:
Title
The changes of quality of life (WHOQOL-BREF: WHO Quality of Life: Brief form)
Description
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 Measure Information:
Title
Body Mass Index
Description
Measuring height and weight
Time Frame
5 Weeks
Title
Waist-hip ratio
Description
Measuring the ratio of waist to hip
Time Frame
5 Weeks
Title
10-m walking time at comfortable
Description
Measuring the 10-m walking time at comfortable
Time Frame
5 Weeks
Title
10-m walking time at maximum
Description
Measuring the 10-m walking time at maximum
Time Frame
5 Weeks
Title
Get Up and Go test
Description
Measuring the Get Up and Go test
Time Frame
5 Weeks
Title
5 times sit-to-stand test
Description
Measuring the 5 times sit-to-stand test
Time Frame
5 Weeks
Title
Hierarchy of the Care Required
Description
This is a 18-item questionnaire to assess the patient's ADL and IADL as well as daily function.
Time Frame
5 Weeks
Title
CHQ-12 (Chinese Health Questionnaire)
Description
This is a 12-item scale to assess the patient's life stress indicating anxiety and depression symptoms.
Time Frame
5 Weeks
Title
Short FES-I (Chinese version of the Falls Efficacy Scale )
Description
This is a 7-item scale to assess patient's vulnerability to fall.
Time Frame
5 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang Jung-Chen, PhD
Phone
(02)223123456
Ext
88905
Email
jungchenchang@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Hsu Fang-Chi, University
Phone
(02)223123456
Ext
88905
Email
r06426011@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Jung-Chen, PhD
Organizational Affiliation
National Taiwan University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Jung-Chen, PhD
Phone
(02) 223123456
Ext
88905
Email
jungchenchang@ntu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
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Applying Short-term Interactive Video Games on Community Patients With Mental Disorders
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