Clinical trial NCT06440200: Exploring the Health Effects of Group Game-based Activities on Individuals With Chronic Mental Illness
Official title: Applying Group Game-based Activities to Improve the Health of Patients With Chronic Mental Illness
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Mental Illness
Schizophrenia
Psychiatry
Keywords: group game-based activities
physiological values
depression rating scales
quality of life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Height
timeFrame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
measure: Ｗeight
timeFrame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
measure: BMI
timeFrame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
measure: Ｗaist circumference
timeFrame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
measure: Buttocks circumference
timeFrame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
measure: 10-meter walking time at comfortable
timeFrame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
measure: 10-meter walking time at maximum
timeFrame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
measure: Get up and Go test
timeFrame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
measure: 5 times sit-to-stand-test
timeFrame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
measure: Body fat percentage
timeFrame: T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
Secondary outcomes:
measure: Patient health questionnaire-9
timeFrame: 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).
measure: World Health Organization Quality-of-Life Scale
timeFrame: 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).
measure: Chinese version of interactive video games questionnaire on satisfaction and feasibility
timeFrame: Motivation of group game-based activities will be done at T2=first post-test(Week 12) and T3=second post-test(Week 16).
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: