Psychological risk factors for Long COVID and their modification: study protocol of a three-arm, randomised controlled trial (SOMA.COV)
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Psychological risk factors for Long COVID and their modification: study protocol of a three-arm, randomised controlled trial (SOMA.COV). / Engelmann, Petra; Büchel, Christian; Frommhold, Jördis; Klose, Hans; Lohse, Ansgar Wilhelm; Maehder, Kerstin; Nestoriuc, Yvonne; Scherer, Martin; Suling, Anna ; Toussaint, Anne-Kristin; Weigel, Angelika; Zapf, Antonia; Löwe, Bernd.
In: BJPSYCH OPEN, Vol. 9, No. 6, 03.11.2023, p. e207.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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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 -