NCT07148609
Active, not recruiting
Not Applicable
Video Game-facilitated Group Activity for Quality of Life and Social Function in Chronic Schizophrenia Inpatients: A Randomized Controlled Parallel-group Pilot Trial.
TsaoTun Psychiatric Center, Department of Health, Taiwan1 site in 1 country64 target enrollmentStarted: May 3, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- TsaoTun Psychiatric Center, Department of Health, Taiwan
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- The changes of quality of life
Overview
Brief Summary
The goal of this clinical trial is to learn if video game-facilitated group activity helps to improve the quality of life and social function in inpatients with chronic schizophrenia.
The main questions it aims to answer are:
- Does video game-facilitated group activity enhance the quality of life as measured by a standardized scale (WHOQOL) in patients with schizophrenia hospitalized in a psychiatric hospital?
- Can video game-facilitated group activity promote social function as measured by a specific scale (PSP) in patients with schizophrenia hospitalized in a psychiatric hospital?
Researchers will compare video game-facilitated group activity to regular occupational therapy to see if the intervention is beneficial to patients with chronic schizophrenia.
Participants will:
- Attend to video game-facilitated group activity or regular occupational therapy three times a week for 12 weeks.
- Receive assessments upon and after the 12-week intervention, and another 12 weeks after the intervention ends.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals aged between \>18 and \<65 years with a principal diagnosis of schizophrenia, as defined by the International Classification of Diseases (ICD-10) codes F20.0-F20.9 which was diagnosed according to DSM-5-TR criteria.
- •Possessing a valid Catastrophic Illness Certificate for schizophrenia and being continuously hospitalized for more than six months.
- •Being able to read Chinese and communicate effectively in either Mandarin or Taiwanese.
- •Being able to comprehend the purpose of the study and to provide written informed consent after the study has been explained by the researchers.
Exclusion Criteria
- •Individuals exhibiting unstable psychiatric or consciousness conditions, or those unable to comply with video game-based instruction and operation.
- •Individuals with a history of ocular diseases, severe cardiovascular disorders, epilepsy, or brain injuries; or those who have experienced acute cardiovascular or cerebrovascular events, bone fractures, undergone hip or knee joint replacement, or present with lower limb balance impairments or structural injuries-such as amputations, post-lumbar surgery status, or acute ankle sprains-rendering participation unsuitable within the past six months.
- •Concurrent participation in other research studies during the study period, where the intervention may potentially influence the primary or secondary outcomes of this study.
- •Individuals who are legally declared under guardianship.
Outcomes
Primary Outcomes
The changes of quality of life
Time Frame: The outcome will be assessed at baseline, week 12, and week 24.
The changes of quality of life will be assessed by the World Health Organization Quality of Life-BREF (WHOQOL-BREF).
The changes of social function.
Time Frame: The outcome will be assessed at baseline, week 12, and week 24
The changes of social function will be evaluated by the Personal and Social Performance Scale (PSP).
Secondary Outcomes
- The changes of cerebral blood flow.(The outcome will be assessed at baseline and week 12.)
- The change of cognitive function.(The outcome will be assessed at baseline and week 12.)
- The change of psychiatric symptoms.(The outcome will be assessed at baseline and week 12.)
- The change of physical fitness(The outcome will be assessed at baseline and week 12.)
Investigators
Wei-Yu Chiang
Resident psychiatrist
TsaoTun Psychiatric Center, Department of Health, Taiwan
Study Sites (1)
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