The Effect of Game-Based Intervention on the Cognition of Schizophrenia Patients
ConditionSchizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorShanghai Mental Health Center
About this trial
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.
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
Design model
Parallel
Treatments tested in this trial
Somatic Serious Games
Other interventionA 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Intervention group (Gamified Digital Rehabilitation)Experimental treatment 1 intervention
Group B: Controlled group (Routine Rehabilitation Group)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
MCCB
Using MATRIC Consensus Cognitive Battery (MCCB) to measure the cognition. 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 based on normative data. Higher T-scores indicate better cognitive performance.
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-upSecondary outcomes
1
BPRS
Using the Brief Psychiatric Rating Scale (BPRS) to measure the presence and severity of psychiatric symptoms entailing positive symptoms, general psychopathology, and affective symptoms. 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.
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-up2
WHOQOL-BREF
Using WHO Quality of Life - BREF (WHOQOL-BREF) to measure four domains: physical health, mental health, social relationship and environmental health. Higher scores indicate a better overall quality of life.
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-up3
MMAS-8
Using the 8-item Morisky medication adherence scale (MMAS-8) to measure the medication adherence. 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.
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-up4
SDSS
Using the 10-item social disability screening schedule (SDSS) to measure social function. 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.
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-upSponsors and contacts
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Source ClinicalTrials.gov