Идёт набор NCT07557368

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

Без фазы С лечением Schizophrenia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Gamified Digital Rehabilitation.
Кому может быть актуально: Состояния в реестре: Schizophrenia. Базовые параметры: 18 лет — 45 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effects of Gamified Rehabilitation on Cognitive and Psychosocial Outcomes in Inpatients With Schizophrenia: A Randomized Controlled Trial[

Обзор

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.

Подробное описание

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 .

Вмешательства

Другое Gamified Digital Rehabilitation
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

Первичные конечные точки

MCCB [Срок оценки: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).]
GAD-7 [Срок оценки: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).]
PHQ-9 [Срок оценки: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).]
MMAS-8 [Срок оценки: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).]
SDSS [Срок оценки: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).]

Вторичные конечные точки (3)

BPRS [Срок оценки: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).]
WHOQOL-BREF [Срок оценки: Baseline (T0), 8 weeks (immediately post-intervention, T1), and at 1, 3, 6, 12, and 24 months post-intervention (T2-T6).]
uMARS [Срок оценки: 8 weeks (immediately post-intervention, T1)]

Критерии участия

Критерии включения

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.