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

Schizophrenia Clinical Trial

Official title:

Applying Group Game-based Activities to Improve the Health of Patients With Chronic Mental Illness

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06440200
• Other study ID #: 202401209RINE
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 18, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: March 2024
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: August 30, 2024
• Est. primary completion date: July 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Mental Illness
• Mental Disorders
• Psychiatry
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height	Height in meters.	T1=pre test, T2=first post-test(Week 12) and T3=second post-test(Week 16)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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).
Secondary	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).
Secondary	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).