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

Official title

The Effect of a 2-month Somatic Serious Games on the Cognition of Schizophrenia Patients

Overview

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.

Detailed description

Traditional cognitive rehabilitation methods, such as computerized cognitive remediation therapy (CCRT), require a significant amount of time and manpower, and are costly. Patients cannot achieve the best improvement within a short period of time; moreover, they cannot replicate real-life scenarios, and lack real interaction and immersion, which limits the application of training results in daily life. Patients with schizophrenia may have difficulty adhering to treatment due to their sense of stigma and the time and energy costs required for treatment, resulting in poor treatment compliance and significant impact on treatment outcomes. Sensory interactive games are based on multitasking and require the brain to simultaneously integrate low-level and high-level cognitive resources, which have a very good effect on overall cognitive function. This study first determined the cognitive dimensions that needed intervention by reviewing literature, collecting data, and discussing with experts in related fields. The game content was designed referring to relevant cognitive psychology paradigms, existing research foundations, and actual community scenarios. The game was developed using the gyroscope of mobile devices for sensory interactive serious games. Through the design of a randomized controlled trial and the use of standardized measurement tools, the changes in patients' cognitive functions before and after the intervention were quantitatively evaluated from a scientific perspective, providing a scientific basis for the implementation of such intervention measures; at the same time, the quality of life, social function, and motor ability, which are more relevant to actual rehabilitation performance, were evaluated to assess their significance in the entire rehabilitation process.

Interventions

• Other Somatic Serious Games
  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.

Primary outcome measures

• MCCB [Time frame: 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 outcome measures (5)

• BPRS [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: immediately post-intervention]

Eligibility criteria

Inclusion criteria

• 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;
• 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

China · 1 center

• Shanghai Mental Health Center — Shanghai

Identifiers

NCT: NCT07557381 · JCai1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗