Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440200
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-03
First Post:
2024-03-28
Brief Title:
Exploring the Health Effects of Group Game-based Activities on Individuals With Chronic Mental Illness
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Applying Group Game-based Activities to Improve the Health of Patients With Chronic Mental Illness
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 testT1 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
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 testT1 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 groupactivities 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 examinationT2 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
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 examinationT2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None