Effects of Gamified Rehabilitation on Cognitive and Psychosocial Outcomes in Inpatients With Schizophrenia: A Randomized Controlled Trial[
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- MCCB
研究概览
简要总结
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.
详细描述
In this study, the investigators aimed to investigate the effectiveness of a multimodal digital intervention on the rehabilitation outcomes of inpatients with schizophrenia, with an 8-week intervention and a 24-month duration of follow up. The investigators hypothesized that patients assigned into the digital intervention group would show better improvement in cognitive functions, social function, and overall rehabilitation outcomes. The study protocol was approved by the Institutional Review Board in Shanghai Mental Health Center. Aim of the study: 1.1 To explore the effectiveness of the gamified somatosensory and narrative intervention in patients with schizophrenia. 1.2 The patients were followed up for 24 months to explore the long-term effects of the digital intervention . Introduction of the study: Patients aged 18 to 45 years who previously diagnosed as schizophrenia according to International Classification of Diseases 10th Revision (ICD-10) would receive routine psychiatric care in the hospital. The selected schizophrenic patients were randomly assigned into intervention group and control group . During the 8-week intervention period, the control group received routine inpatient psychiatric rehabilitation while the intervention group received additional gamified rehabilitation (including somatosensory cognitive games and interactive narrative games) three times a week, 30 minutes per session . Clinical assessments were conducted at baseline, 8 weeks (immediately post-intervention), and 1, 3, 6, 12, and 24 months post-intervention . A single-blind method was used, in which all the assessments were independently completed by trained investigators who didn't know the grouping . The MATRICS Consensus Cognitive Battery (MCCB), Social Disability Screening Schedule (SDSS), Brief Psychiatric Rating Scale (BPRS), Morisky Medication Adherence Scale (MMAS-8), Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), and World Health Organization Quality of Life Brief Version (WHOQOL-BREF) were measured at the designated time points during the study .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •not reside in Shanghai after discharge;
- •suffering from serious physical or brain organic diseases;
- •comorbid with other psychotic disorders.
研究组 & 干预措施
Controlled group
Participants in this group will receive only routine inpatient psychiatric rehabilitation and care[8.1]. No additional digital game intervention will be provided.
Intervention Group (Gamified Digital Rehabilitation)
Participants in this group will receive an 8-week gamified digital rehabilitation intervention in addition to routine inpatient psychiatric care. The digital intervention comprises somatosensory cognitive games and interactive narrative games, administered for 30 minutes per session, three times a week .
干预措施: Gamified Digital Rehabilitation (Other)
结局指标
主要结局
MCCB
时间窗: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).
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
时间窗: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).
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
时间窗: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).
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
时间窗: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).
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.
SDSS
时间窗: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).
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.
次要结局
- 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))