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长新冠的心理风险因素及其调整:一项三臂随机对照试验(SOMA.COV)的研究方案

Psychological risk factors for Long COVID and their modification: study protocol of a three-arm, randomised controlled trial (SOMA.COV).

作者信息

Engelmann Petra, Büchel Christian, Frommhold Jördis, Klose Hans F E, Lohse Ansgar W, Maehder Kerstin, Nestoriuc Yvonne, Scherer Martin, Suling Anna, Toussaint Anne, Weigel Angelika, Zapf Antonia, Löwe Bernd

机构信息

Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Germany.

Institute of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Germany.

出版信息

BJPsych Open. 2023 Nov 3;9(6):e207. doi: 10.1192/bjo.2023.591.

DOI:10.1192/bjo.2023.591
PMID:37920139
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10753953/
Abstract

BACKGROUND

Growing evidence suggests that in addition to pathophysiological, there are psychological risk factors involved in the development of Long COVID. Illness-related anxiety and dysfunctional symptom expectations seem to contribute to symptom persistence.

AIMS

With regard to the development of effective therapies, our primary aim is to investigate whether symptoms of Long COVID can be improved by a targeted modification of illness-related anxiety and dysfunctional symptom expectations. Second, we aim to identify additional psychosocial risk factors that contribute to the persistence of Long COVID, and compare them with risk factors for symptom persistence in other clinical conditions.

METHOD

We will conduct an observer-blinded, three-arm, randomised controlled trial. A total of 258 patients with Long COVID will be randomised into three groups of equal size: targeted expectation management in addition to treatment as usual (TAU), non-specific supportive treatment plus TAU, or TAU only. Both active intervention groups will comprise three individual online video consultation sessions and a booster session after 3 months. The primary outcome is baseline to post-interventional change in overall somatic symptom severity.

CONCLUSIONS

The study will shed light onto the action mechanisms of a targeted expectation management intervention for Long COVID, which, if proven effective, can be used stand-alone or in the context of broader therapeutic approaches. Further, the study will enable a better understanding of symptom persistence in Long COVID by identifying additional psychological risk factors.

摘要

背景

越来越多的证据表明,除了病理生理因素外,长新冠的发展还涉及心理风险因素。与疾病相关的焦虑和功能失调的症状预期似乎会导致症状持续存在。

目的

为了开发有效的治疗方法,我们的主要目的是研究通过有针对性地改变与疾病相关的焦虑和功能失调的症状预期,长新冠的症状是否可以得到改善。其次,我们旨在确定导致长新冠持续存在的其他社会心理风险因素,并将它们与其他临床疾病中症状持续存在的风险因素进行比较。

方法

我们将进行一项观察者盲法、三臂随机对照试验。总共258名长新冠患者将被随机分为三组,每组人数相等:在常规治疗(TAU)基础上进行有针对性的预期管理、非特异性支持治疗加TAU或仅接受TAU。两个积极干预组都将包括三次个人在线视频咨询会议和3个月后的一次强化会议。主要结局是从基线到干预后总体躯体症状严重程度的变化。

结论

该研究将阐明针对长新冠的有针对性的预期管理干预的作用机制,如果被证明有效,该干预可以单独使用或在更广泛的治疗方法中使用。此外,该研究将通过识别其他心理风险因素,更好地理解长新冠中的症状持续存在问题。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0719/10753953/72c585e2cafb/S2056472423005914_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0719/10753953/e75cca518151/S2056472423005914_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0719/10753953/72c585e2cafb/S2056472423005914_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0719/10753953/e75cca518151/S2056472423005914_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0719/10753953/72c585e2cafb/S2056472423005914_fig2.jpg

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