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

Standard

Harvard

APA

Vancouver

Bibtex

@article{4707b8ebcd84495eb8873b82178bd32f,
title = "Psychological risk factors for Long COVID and their modification: study protocol of a three-arm, randomised controlled trial (SOMA.COV)",
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.",
author = "Petra Engelmann and Christian B{\"u}chel and J{\"o}rdis Frommhold and Hans Klose and Lohse, {Ansgar Wilhelm} and Kerstin Maehder and Yvonne Nestoriuc and Martin Scherer and Anna Suling and Anne-Kristin Toussaint and Angelika Weigel and Antonia Zapf and Bernd L{\"o}we",
year = "2023",
month = nov,
day = "3",
doi = "10.1192/bjo.2023.591",
language = "English",
volume = "9",
pages = "e207",
journal = "BJPSYCH OPEN",
issn = "2056-4724",
publisher = "Cambridge University Press",
number = "6",

}

RIS

TY - JOUR

T1 - Psychological risk factors for Long COVID and their modification: study protocol of a three-arm, randomised controlled trial (SOMA.COV)

AU - Engelmann, Petra

AU - Büchel, Christian

AU - Frommhold, Jördis

AU - Klose, Hans

AU - Lohse, Ansgar Wilhelm

AU - Maehder, Kerstin

AU - Nestoriuc, Yvonne

AU - Scherer, Martin

AU - Suling, Anna

AU - Toussaint, Anne-Kristin

AU - Weigel, Angelika

AU - Zapf, Antonia

AU - Löwe, Bernd

PY - 2023/11/3

Y1 - 2023/11/3

N2 - 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.

AB - 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.

U2 - 10.1192/bjo.2023.591

DO - 10.1192/bjo.2023.591

M3 - SCORING: Journal article

C2 - 37920139

VL - 9

SP - e207

JO - BJPSYCH OPEN

JF - BJPSYCH OPEN

SN - 2056-4724

IS - 6

ER -