Lian Anbei, Fan Qing, Wang Wenzheng, Liu Qinxin, Shi Jiacheng, Zhuang Min, Li Yujie, Liu Xiaodan
Department of Occupational Therapy, Shanghai YangZhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center), Shanghai, China.
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Contemp Clin Trials Commun. 2023 Oct 3;36:101214. doi: 10.1016/j.conctc.2023.101214. eCollection 2023 Dec.
Negative symptoms and cognitive impairment are common residual symptoms of schizophrenia that seriously affect the quality of life and social function of patients. The intervention of residual symptoms is an important part of schizophrenia rehabilitation. Traditional Chinese exercise has been applied as a supplementary rehabilitation method for schizophrenia. However, research on its use and pertinence in the rehabilitation of residual symptoms remains lacking. In this study, we will verify the intervention effect of a new method, namely, shen-based qigong exercise, on the residual symptoms of schizophrenia, in the hopes of finding a safe and effective rehabilitation method for the residual symptoms of schizophrenia.
This is a single-centre randomised controlled trial. A total of 60 schizophrenics who meet the criteria will be randomly divided into the control and intervention groups in accordance with the ratio of 1:1. Conventional drug treatment will remain unchanged in both groups. In this case, the control group will be given daily rehabilitation, whereas the intervention group will be given daily rehabilitation and shen-based qigong exercise intervention. The intervention period will be 12 weeks. The primary outcome will be negative symptoms assessed by the Scale for the Assessment of Negative Symptoms. The secondary outcome will be the global cognitive function assessed by the Repeatable Battery for the Assessment of Neuropsychological Status and event-related potential P300. Other outcomes will include specific cognitive domain (i.e. working memory), quality of life and social function. The results will be measured within 1 week before and after the intervention.
The results of this study will likely help find an economical and convenient rehabilitation method for the residual symptoms of schizophrenia and, at the same time, may promote the popularisation and application of traditional Chinese exercises and traditional Chinese medicine theories in the treatment of mental diseases.
ClinicalTrials.gov registry number: NCT05310955.
阴性症状和认知障碍是精神分裂症常见的残留症状,严重影响患者的生活质量和社会功能。残留症状的干预是精神分裂症康复的重要组成部分。传统中医运动已被用作精神分裂症的辅助康复方法。然而,关于其在残留症状康复中的应用及针对性的研究仍很缺乏。在本研究中,我们将验证一种新方法,即基于神的气功练习,对精神分裂症残留症状的干预效果,以期找到一种安全有效的精神分裂症残留症状康复方法。
这是一项单中心随机对照试验。共有60名符合标准的精神分裂症患者将按照1:1的比例随机分为对照组和干预组。两组的常规药物治疗保持不变。在此情况下,对照组将接受每日康复治疗,而干预组将接受每日康复治疗和基于神的气功练习干预。干预期为12周。主要结局将是通过阴性症状评定量表评估的阴性症状。次要结局将是通过可重复性神经心理状态评估量表和事件相关电位P300评估的整体认知功能。其他结局将包括特定认知领域(即工作记忆)、生活质量和社会功能。结果将在干预前后1周内进行测量。
本研究结果可能有助于找到一种经济便捷的精神分裂症残留症状康复方法,同时可能促进传统中医运动和中医理论在精神疾病治疗中的推广和应用。
ClinicalTrials.gov注册号:NCT05310955。