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

NCT06440200 | Completed

• 1 other identifier: 202401209RINE
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Mental Illness; Schizophrenia; Psychiatry

Keywords

group game-based activities; physiological values; depression rating scales; quality of life

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (3)

• Patient health questionnaire-9

  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 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

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

Study Arms (2)

group gamed-based activites

EXPERIMENTAL

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

control group

NO INTERVENTION

The activities will be the psychiatric day wards and half-way house offered as usual.

Interventions

group gamed-based activity BEHAVIORAL

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.

group gamed-based activites

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100225, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: June 3, 2024
• Study Start: March 18, 2024
• Primary Completion: August 19, 2024
• Study Completion: August 19, 2024
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)