The Effect of Game-Based Intervention on the Cognition of Schizophrenia Patients

The Effect of a 2-month Somatic Serious Games on the Cognition of Schizophrenia Patients

Schizophrenia is a common and severe mental disorder that imposes a significant burden on patients. Cognitive impairment can be regarded as one of the core symptoms of schizophrenia, which is prevalent among patients with schizophrenia. In recent years, digital rehabilitation therapy based on games has shown a remarkable development trend among schizophrenia patients. Serious games, or application games, refer to those games aimed not only for entertainment. They can educate, train, or change the behavior of players through interesting intervention forms and have been applied in many healthcare fields. This study aims to develop a somatosensory interactive game for patients with cognitive impairment of schizophrenia to improve their cognitive functions and verify its effectiveness and feasibility through a randomized controlled trial.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Other: Somatic Serious Games

Detailed Description

Traditional cognitive rehabilitation methods, such as computerized cognitive remediation therapy (CCRT), require a significant amount of time and manpower, and are costly. Patients cannot achieve the best improvement within a short period of time; moreover, they cannot replicate real-life scenarios, and lack real interaction and immersion, which limits the application of training results in daily life. Patients with schizophrenia may have difficulty adhering to treatment due to their sense of stigma and the time and energy costs required for treatment, resulting in poor treatment compliance and significant impact on treatment outcomes. Sensory interactive games are based on multitasking and require the brain to simultaneously integrate low-level and high-level cognitive resources, which have a very good effect on overall cognitive function. This study first determined the cognitive dimensions that needed intervention by reviewing literature, collecting data, and discussing with experts in related fields. The game content was designed referring to relevant cognitive psychology paradigms, existing research foundations, and actual community scenarios. The game was developed using the gyroscope of mobile devices for sensory interactive serious games. Through the design of a randomized controlled trial and the use of standardized measurement tools, the changes in patients' cognitive functions before and after the intervention were quantitatively evaluated from a scientific perspective, providing a scientific basis for the implementation of such intervention measures; at the same time, the quality of life, social function, and motor ability, which are more relevant to actual rehabilitation performance, were evaluated to assess their significance in the entire rehabilitation process.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weibo Zhang; Phone Number: 86-13764694223; Email: zhangweibo600@163.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Mental Health Center
    • Contact: Jun Cai

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Registered in the Shanghai Mental Health Information Management System and hospitalized in the designated district-level mental health center wards;
2. Schizophrenia patients meeting the diagnostic criteria of schizophrenia in the International Classification of Diseases (ICD-10);
3. 18 - 45 years old;
4. Good self-care ability;
5. Clinically stable (without acute exacerbation) for at least 1 week before enrollment, with a stable dose of antipsychotic drugs or other concomitant psychotropic drugs for at least 1 week;
6. No hand disabilities, and can use mobile phones or tablets normally;
7. Have a primary school education or above;
8. Normal vision and hearing, or within the normal range after correction;
9. Own and be able to independently use a smart phone or other electronic devices;
10. Patients and their families have given informed consent to this study, and voluntarily cooperate to participate in the intervention and sign the informed consent form.

Exclusion Criteria:

1. not reside in Shanghai after discharge;
2. suffering from serious physical or brain organic diseases;
3. comorbid with other psychotic disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group (Gamified Digital Rehabilitation); The group member (n = 42) will receive approximately 30 minutes of digital rehabilitation training at least three times a week for 8 weeks, with professional supervision and guidance as they use the games. Cognitive function and quality of life were assessed at baseline and follow-up.	Other: Somatic Serious Games; A serious game for 5 cognitive functions, including 10 games, uses somatosensory technology to achieve interaction, and provides cognitive training close to life scenes for patients with schizophrenia.
No Intervention: Controlled group (Routine Rehabilitation Group); Participants in this arm (n = 42) will receive routine inpatient psychiatric rehabilitation and care during the same period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MCCB	Using MATRIC Consensus Cognitive Battery (MCCB) to measure the cognition. The MCCB includes 9 standardized tests covering domains such as processing speed, attention, and working memory. The raw scores are converted into standardized T-scores based on normative data. Higher T-scores indicate better cognitive performance.	Baseline, immediately post-intervention , 1-month follow-up, 3-month follow-up, 6-month follow-up, 12-month follow-up, and 24-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
uMARS	Satisfaction and engagement with the digital intervention are assessed using the User Version of Mobile Application Rating Scale (uMARS) . The uMARS includes 14 items across 3 dimensions (information, functionality, user engagement) rated on a 5-point scale. Higher scores indicate better app quality and higher user satisfaction. (Note: This measure is only evaluated for participants in the intervention group).	immediately post-intervention
BPRS	Using the Brief Psychiatric Rating Scale (BPRS) to measure the presence and severity of psychiatric symptoms entailing positive symptoms, general psychopathology, and affective symptoms. Each item is rated on a 7-point scale (1 = not present, 7 = extremely severe). The total score ranges from 18 to 126, with higher scores indicating more severe psychiatric symptoms.	Baseline, immediately post-intervention , 1-month follow-up, 3-month follow-up, 6-month follow-up, 12-month follow-up, and 24-month follow-up
WHOQOL-BREF	Using WHO Quality of Life - BREF (WHOQOL-BREF) to measure four domains: physical health, mental health, social relationship and environmental health. Higher scores indicate a better overall quality of life.	Baseline, immediately post-intervention , 1-month follow-up, 3-month follow-up, 6-month follow-up, 12-month follow-up, and 24-month follow-up
MMAS-8	Using the 8-item Morisky medication adherence scale (MMAS-8) to measure the medication adherence. The total score ranges from 0 to 8. A score of 8 indicates high adherence, 6 to less than 8 indicates medium adherence, and less than 6 indicates low adherence. Higher scores indicate better adherence to the prescribed medication regimen.	Baseline, immediately post-intervention , 1-month follow-up, 3-month follow-up, 6-month follow-up, 12-month follow-up, and 24-month follow-up
SDSS	Using the 10-item social disability screening schedule (SDSS) to measure social function. Each item is scored from 0 to 2. The total score ranges from 0 to 20, with lower scores indicating better social functioning and less social disability.	Baseline, immediately post-intervention , 1-month follow-up, 3-month follow-up, 6-month follow-up, 12-month follow-up, and 24-month follow-up

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Principal Investigator: Jun Cai, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Schizophrenia; Cognition; Game-Based Intervention
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: JCai1

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