视频游戏对精神分裂症患者认知功能的影响（GAME-S）：一项随机对照试验的研究方案。

The impact of video gaming on cognitive functioning of people with schizophrenia (GAME-S): study protocol of a randomised controlled trial.

机构信息

Xiangya Nursing School, Central South University, 172 Tongzipo Road, Changsha, 410013, Hunan, China.

School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong, Hong Kong SAR.

出版信息

BMC Psychiatry. 2021 Jan 18;21(1):46. doi: 10.1186/s12888-020-03031-y.

DOI:10.1186/s12888-020-03031-y

PMID:33461506

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7814579/

Abstract

BACKGROUND

Video gaming is a promising intervention for cognitive and social impairment in patients with schizophrenia. A number of gaming interventions have been evaluated in small-scale studies with various patient groups, but studies on patients with schizophrenia remain scarce and rarely include the evaluation of both clinical and neurocognitive outcomes. In this study, we will test the effectiveness of two interventions with gaming elements to improve cognitive and clinical outcomes among persons with schizophrenia.

METHODS

The participants will be recruited from different outpatient units (e.g., outpatient psychiatric units, day hospitals, residential care homes). The controlled clinical trial will follow a three-arm parallel-group design: 1) cognitive training (experimental group, CogniFit), 2) entertainment gaming (active control group, SIMS 4), and 3) treatment as usual. The primary outcomes are working memory function at 3-month and 6-month follow-ups. The secondary outcomes are patients' other cognitive and social functioning, the ability to experience pleasure, self-efficacy, and negative symptoms at 3-month and 6-month follow-ups. We will also test the effectiveness of gaming interventions on neurocognitive outcomes (EEG and 3 T MRI plus rs-fMRI) at a 3-month follow-up as an additional secondary outcome. Data will be collected in outpatient psychiatric services in Hong Kong. Participants will have a formal diagnosis of schizophrenia and be between 18 and 60 years old. We aim to have a total of 234 participants, randomly allocated to the three arms. A sub-sample of patients (N = 150) will be recruited to undergo an EEG. For neuroimaging assessment, patients will be randomly allocated to a subset of patients (N=126). We will estimate the efficacy of the interventions on the primary and secondary outcomes based on the intention-to-treat principle. Behavioural and EEG data will be analysed separately.

DISCUSSION

The study will characterise benefits of gaming on patients' health and well-being, and contribute towards the development of new treatment approaches for patients with schizophrenia.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03133143 . Registered on April 28, 2017.

摘要

背景

视频游戏是一种有前途的干预措施，可以改善精神分裂症患者的认知和社交障碍。许多游戏干预措施已经在各种患者群体的小规模研究中进行了评估，但针对精神分裂症患者的研究仍然很少，并且很少包括对临床和神经认知结果的评估。在这项研究中，我们将测试两种具有游戏元素的干预措施的有效性，以改善精神分裂症患者的认知和临床结果。

方法

参与者将从不同的门诊单位（如门诊精神科单位、日间医院、住宿护理院）招募。这项对照临床试验将采用三臂平行组设计：1）认知训练（实验组，CogniFit），2）娱乐游戏（主动对照组，SIMS 4）和 3）常规治疗。主要结局是 3 个月和 6 个月随访时的工作记忆功能。次要结局是患者的其他认知和社会功能、体验愉悦的能力、自我效能感和 3 个月和 6 个月随访时的阴性症状。我们还将测试游戏干预措施对神经认知结果（EEG 和 3T MRI 加 rs-fMRI）的有效性，作为额外的次要结果，在 3 个月随访时进行。数据将在香港的门诊精神科服务中收集。参与者将有精神分裂症的正式诊断，年龄在 18 至 60 岁之间。我们的目标是总共招募 234 名参与者，随机分配到三个组。一个亚组患者（N=150）将被招募进行 EEG。对于神经影像学评估，患者将随机分配到患者的一个亚组（N=126）。我们将根据意向治疗原则估计干预措施对主要和次要结局的疗效。行为和脑电图数据将分别进行分析。