Effects of Gamified Rehabilitation on Cognitive and Psychosocial Outcomes in Inpatients With Schizophrenia

NCT07557368 | Recruiting

• 1 other identifier: JCai2
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Gamified Rehabilitation; Schizophrenia; Cognitive; Psychosocial

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).

• 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.

  Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).

• 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').

  Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).

• 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.

  Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).

• SDSS

  Social functioning is assessed using the Social Disability Screening Schedule (SDSS) . The SDSS is a 10-item scale evaluating various aspects of social and occupational impairment in psychiatric patients. 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 (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).

Secondary Outcomes (3)

• BPRS

  Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).

• WHOQOL-BREF

  Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).

• uMARS

  8 weeks (immediately post-intervention, T1)

Study Arms (2)

Intervention Group (Gamified Digital Rehabilitation)

EXPERIMENTAL

Participants in this group will receive an 8-week gamified digital rehabilitation intervention in addition to routine inpatient psychiatric care\[6.1\]. The digital intervention comprises somatosensory cognitive games and interactive narrative games, administered for 30 minutes per session, three times a week .

Other: Gamified Digital Rehabilitation

Controlled group

NO INTERVENTION

Participants in this group will receive only routine inpatient psychiatric rehabilitation and care\[8.1\]. No additional digital game intervention will be provided.

Interventions

Gamified Digital Rehabilitation OTHER

A 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.

Intervention Group (Gamified Digital Rehabilitation)

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)