Gamified somatosensory and narrative rehabilitation to improve thinking and social skills in hospitalized adults with schizophrenia
Effects of Gamified Rehabilitation on Cognitive and Psychosocial Outcomes in Inpatients With Schizophrenia: A Randomized Controlled Trial[
This trial will test whether an 8-week gamified digital rehabilitation program can improve cognitive and social functioning for hospitalized adults with schizophrenia and whether benefits last over 24 months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Shanghai Mental Health Center Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07557368 on ClinicalTrials.gov |
What this trial studies
Hospitalized patients with ICD-10 schizophrenia aged 18–45 who are clinically stable are randomly assigned to receive routine inpatient psychiatric rehabilitation with or without additional gamified digital interventions. The intervention group receives somatosensory cognitive games and interactive narrative games three times per week for 30 minutes over 8 weeks, while the control group receives standard care alone. Clinical assessments are performed at baseline, immediately after 8 weeks, and periodically during a 24-month follow-up to track cognitive, psychosocial, and functional outcomes. The protocol was approved by the Institutional Review Board at Shanghai Mental Health Center and participants must be able to use a smartphone or tablet independently.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults aged 18–45 with ICD-10 schizophrenia who are clinically stable, have basic education and self-care ability, and can independently use a smartphone or tablet.
Not a fit: Patients with acute psychotic exacerbation, significant motor or sensory impairments that prevent device use, lack of device access, or outside the 18–45 age range are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could boost cognitive skills, social functioning, and engagement during inpatient rehabilitation and support longer-term everyday functioning.
How similar studies have performed: Previous digital and gamified cognitive remediation studies in schizophrenia have shown mixed but promising improvements in cognition and engagement, though consistent long-term real-world functional gains remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai
- Shanghai Mental Health Center — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jun Cai — Shanghai Mental Health Center
- Study coordinator: Weibo Zhang
- Email: zhangweibo600@163.com
- Phone: 86-13764694223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.