NCT07148609

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

August 23, 2025

Last Update Submit

August 23, 2025

Conditions

Keywords

Video gameSchizophreniaSocial functionQuality of life

Outcome Measures

Primary Outcomes (2)

  • The changes of quality of life

    The changes of quality of life will be assessed by the World Health Organization Quality of Life-BREF (WHOQOL-BREF).

    The outcome will be assessed at baseline, week 12, and week 24.

  • The changes of social function.

    The changes of social function will be evaluated by the Personal and Social Performance Scale (PSP).

    The outcome will be assessed at baseline, week 12, and week 24

Secondary Outcomes (4)

  • 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.

Other Outcomes (2)

  • Demographic data

    Demographic data will be assessed at baseline.

  • The change of daily antipsychotic dose equivalences.

    This outcome will be assessed at the baseline, Week 12, and Week 24.

Study Arms (2)

Interventional arm

ACTIVE COMPARATOR
Behavioral: Video game-facilitated group activity

Controlled arm

NO INTERVENTION

Interventions

The intervention is a 12-week group activity program for each participant in the intervention group, and the program consists of three 50-minute video game facilitated group activity sessions per week. Participants in the intervention group will engage in those group activity session which will be mediated by the game of Super Mario Party on Nintendo Switch.

Interventional arm

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tsao-Tun Psychiatric Center, Ministry of Health and Welfare

Nantou City, Taiwan, 54249, Taiwan

Location

MeSH Terms

Conditions

SchizophreniaSocial Adjustment

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Yung-Jen Yang

    Tsao-Tun Psychiatric Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident psychiatrist

Study Record Dates

First Submitted

August 23, 2025

First Posted

August 29, 2025

Study Start

May 3, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations