NCT07557368 Effects of Gamified Rehabilitation on Cognitive and Psychosocial Outcomes in Inpatients With Schizophrenia
| NCT ID | NCT07557368 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Mental Health Center |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2026-04-19 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2026-04-19 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Schizophrenia is a severe and chronic mental disorder that profoundly impacts patients' psychological, social, and occupational functions. Cognitive impairment is a core symptom that severely limits daily living abilities. Systematic rehabilitation is crucial for delaying disease progression and improving social functions. Traditional rehabilitation typically relies on pharmacological treatments and conventional cognitive remediation therapies. However, cognitive training alone rarely translates spontaneously into real-world functional improvement; integration with functional skills training is generally required before meaningful gains in daily living are achieved. Furthermore, traditional interventions are typically delivered in contexts detached from patients' everyday lives and are often perceived as monotonous, resulting in poor treatment adherence and compromised long-term rehabilitation outcomes. With the development of digital health technologies, gamified interventions offer new opportunities for psychiatric rehabilitation. Among these innovative approaches, integrating psychoeducation with interactive storytelling has shown unique advantages. Such immersive narrative contexts can effectively enhance patients' illness awareness, treatment motivation, and medication adherence. Nevertheless, existing digital tools still have room for improvement. On one hand, many applications are confined to static screen-based interactions, overlooking the elevated somatic disease burden and sedentary risks prevalent in this population. On the other hand, existing applications rarely successfully integrate cognitive interventions with coherent psychosocial interventions, making it difficult for cognitive improvements to genuinely translate into real-life skills. To this end, the present study developed an interactive digital rehabilitation application specifically designed for individuals with schizophrenia. This intervention innovatively combines cognitive remediation with psychosocial rehabilitation through two distinct yet highly complementary modules: a sensory-motion cognitive module, which leverages the built-in motion-sensing capabilities of mobile devices to engage patients in moderate physical activity while performing cognitive tasks; and an interactive narrative module, encompassing medication management, symptom management, psychological recovery, and social rehabilitation. Through a randomized controlled trial, this study evaluates the practical effectiveness of this multimodal approach in improving patients' overall rehabilitation outcomes, ultimately seeking to provide a highly engaging rehabilitation pathway that facilitates the transfer of skills to daily life.
Eligibility 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.
Contact & Investigator
Jun Cai
PRINCIPAL INVESTIGATOR
Shanghai Mental Health Center
Frequently Asked Questions
Who can join the NCT07557368 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07557368 currently recruiting?
Yes, NCT07557368 is actively recruiting participants. Contact the research team at zhangweibo600@163.com for enrollment information.
Where is the NCT07557368 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07557368 clinical trial?
NCT07557368 is sponsored by Shanghai Mental Health Center. The principal investigator is Jun Cai at Shanghai Mental Health Center. The trial plans to enroll 84 participants.
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