Effectiveness evaluation of the complex medical and psychological method of treating patients with insomnia

A. V. Vasil'eva, T. A. Karavaeva, Yu. P. Kolesova, D. S. Radionov, D. A. Starunskaya, M. V. Fomicheva, S. M. Abdullaeva
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Abstract

This article presents an assessment of the effectiveness of the program for providing medical and psychological care to patients with insomnia, based on psychotherapeutic and psychophysiological approaches, including using a light lamp, biofeedback devices, taking into account clinical and psychological and socio-psychological characteristics, and also evaluates the effectiveness this program. The scientific literature does not describe analogues of the totality of the use of these methods for the contingent of patients with outpatient insomnia. The uniqueness of the developed program lies in its clear algorithmization, the absence of complex techniques of psychological (psychotherapeutic) intervention, which ensures the reproducibility of the program in practical health care institutions if there is a psychotherapist or clinical psychologist on staff who knows the skills of cognitive behavioral therapy and diaphragmatic breathing. The technique has passed clinical testing approved by the Ministry of Health of the Russian Federation (protocol 2020-37-3). The quantitative evaluation of the effectiveness of the method was carried out on seven indicators: (1) Improvement in the subjective characteristics of sleep, (2) Improvement in the quality of sleep, (3) Reduction of the insomnia severity index, (4) Reduction of daytime sleepiness, (5) Reduction of the consequences of sleep disorders, (6) Decreased anxiety, (7) Improved overall clinical impression. As part of the assessment of the achievement of the target result, in accordance with Order 46n of the Ministry of Health of the Russian Federation dated February 2, 2022 (Regulations on Clinical Approbation), a threshold of 85% was set. In terms of (1) Improvement in the subjective characteristics of sleep, (2) Improvement in the quality of sleep, (3) Decrease in the severity index of insomnia, (4) Decrease in daytime sleepiness, the target result was more than 85%, which is significantly higher compared to the control group. An assessment was made of the correspondence of the distribution of indicators to the normal law using the Kholmogorov-Smirnov criterion. Comparison of groups using methods of analytical statistics was carried out using Student's t-test for dependent samples and Mann Whitney's U-test for independent samples. The assessment of the correlation of quantitative results was carried out using the Pearson coefficient (r) for interval variables with a normal distribution. The results are considered to be significant at p<0.01. All obtained empirical values were in the zone of statistical significance. Evaluation of the data obtained in the course of clinical testing shows the effectiveness of the proposed clinical and psychological method for the treatment of insomnia.
综合医学与心理学方法治疗失眠症的疗效评价
本文基于心理治疗和心理生理学方法,包括使用灯光、生物反馈装置,考虑到临床、心理和社会心理特征,对该方案为失眠患者提供医疗和心理护理的有效性进行了评估,并对该方案的有效性进行了评估。科学文献没有描述这些方法对门诊失眠症患者的总体使用的类似物。开发项目的独特之处在于其明确的算法,没有复杂的心理(心理治疗)干预技术,这确保了项目在实际卫生保健机构的可重复性,如果工作人员中有心理治疗师或临床心理学家,他们知道认知行为治疗和膈肌呼吸的技能。该技术已通过俄罗斯联邦卫生部批准的临床试验(议定书2020-37-3)。对该方法的有效性进行了七个指标的定量评价:(1)睡眠主观特征的改善,(2)睡眠质量的改善,(3)失眠严重程度指数的降低,(4)白天嗜睡的减少,(5)睡眠障碍后果的减少,(6)焦虑的减少,(7)整体临床印象的改善。作为目标结果实现评估的一部分,根据俄罗斯联邦卫生部2022年2月2日第46n号命令(临床批准条例),设定了85%的门槛。在(1)睡眠主观特征改善、(2)睡眠质量改善、(3)失眠严重程度指数降低、(4)白天嗜睡减少等方面,目标结果均在85%以上,明显高于对照组。利用Kholmogorov-Smirnov准则评估了指标分布与正态律的对应关系。使用分析统计方法进行组间比较,对相关样本使用Student's t检验,对独立样本使用Mann Whitney's u检验。定量结果的相关性评估采用正态分布区间变量的Pearson系数(r)进行。在p<0.01时,结果被认为是显著的。所得经验值均在统计学显著区。对临床试验过程中获得的数据的评估表明,所提出的临床和心理治疗失眠的方法是有效的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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