Exploring the Health Effects of Group Game-based Activities on Individuals With Chronic Mental Illness

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.

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Chronic Mental Illness; Psychiatry
• Intervention / Treatment: Behavioral: group gamed-based activity

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 Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100225
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group gamed-based activites; 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.	Behavioral: group gamed-based activity; 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.
No Intervention: control group; The activities will be the psychiatric day wards and half-way house offered as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Height in meters.	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.	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.	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.	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.	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.	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.	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.	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.	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.	T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Motivation of group game-based activities will be done at T2=first post-test(Week 12) and T3=second post-test(Week 16).

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Actual): August 19, 2024
• Study Completion (Actual): August 19, 2024

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; group game-based activities; physiological values; depression rating scales
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Mental Disorders
• Other Study ID Numbers: 202401209RINE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No