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

NCT07557381 | Recruiting

• 1 other identifier: JCai1
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Keywords

Cognition; Schizophrenia; Game-Based Intervention

Outcome Measures

Primary Outcomes (1)

• MCCB

  Using MATRIC Consensus Cognitive Battery (MCCB) to measure the cognition.

  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 Outcomes (5)

• BPRS

  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

  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

  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

  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

• uMARS

  immediately post-intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Controlled group

NO INTERVENTION

Participants in this arm (n = 42) will receive routine inpatient psychiatric rehabilitation and care during the same period.

Interventions

Somatic Serious Games OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Registered in the Shanghai Mental Health Information Management System and hospitalized in the designated district-level mental health center wards;
• Schizophrenia patients meeting the diagnostic criteria of schizophrenia in the International Classification of Diseases (ICD-10);
• years old;
• Good self-care ability;
• 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;
• No hand disabilities, and can use mobile phones or tablets normally;
• Have a primary school education or above;
• Normal vision and hearing, or within the normal range after correction;
• Own and be able to independently use a smart phone or other electronic devices;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Jun Cai

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weibo Zhang

CONTACT

86-13764694223; zhangweibo600@163.com

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: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: April 19, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)