About this trial
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
This trial does not accept healthy volunteersQualifiers
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);
18 - 45 years old;
Good self-care ability;
Disqualifiers
not reside in Shanghai after discharge;
suffering from serious physical or brain organic diseases;
comorbid with other psychotic disorders.
Trial design
Parallel
Treatments tested in this trial
Gamified Digital Rehabilitation
Other interventionA digital application consisting of two complementary modules: 1. Somatosensory cognitive games utilizing the device's gyroscope to engage patients in moderate physical activity while completing cognitive tasks, consisting of 10 games set in a community background; 2. Interactive narrative games divided into four modules: medication management, symptom management, psychological rehabilitation, and social rehabilitation, comprising a total of 24 stories. Patients complete one cognitive game and two narrative games per session.
Treatment groups
Trial outcomes
Primary outcomes
MCCB
Cognitive function is assessed using the MATRICS Consensus Cognitive Battery (MCCB) . 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 (mean = 50, standard deviation = 10) based on normative data. Higher T-scores indicate better cognitive performance.
GAD-7
The Generalized Anxiety Disorder Screener (GAD-7) is a brief, 7-item self-report measure for anxiety symptoms in adolescents and adults. Although developed primarily as a screening tool for GAD, it can also be used as a diagnostic tool to monitor changes in symptoms over time, and as a screener for social anxiety, panic disorder, and post-traumatic stress disorder. Each item is rated on a likert-type scale from zero ('not at all') to three ('nearly every day'), with total scores ranging from 0 to 21.
PHQ-9
The Patient Health Questionnaire-9 (PHQ-9) is a multipurpose instrument for screening , diagnosing, monitoring and measuring the severity of depression. The tool rates the frequency of the symptoms which factors into the scoring severity index. The PHQ -9 is brief and useful in clinical practice. The PHQ -9 can be administered repeatedly , which can reflect improvement or worsening of depression in response to treatment .Each item is rated on a likert-type scale from zero ('not at all') to three ('nearly every day').
MMAS-8
Medication adherence is assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8) . 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.
Secondary outcomes
BPRS
Psychiatric symptoms are assessed using the Brief Psychiatric Rating Scale (BPRS) . The BPRS consists of 18 items covering five factors: anxiety-depression, anergia, thought disturbance, activation, and hostile-suspiciousness. 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.
WHOQOL-BREF
Quality of life is assessed using the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) . This 26-item instrument measures physical health, psychological health, social relationships, and environment domains. Higher scores indicate a better overall quality of life.
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).
Sponsors and contacts
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