Cognitive rehabilitation in post-COVID-19 condition: A study protocol for a randomized controlled trial

Bjørn Ingulfsvann Hagen, Anners Lerdal, Arne Søraas, Nils Inge Landrø, Ragnhild Bø, Milada Cvancarova Småstuen, Jacqueline Becker, Jan Stubberud, Bjørn Ingulfsvann Hagen, Anners Lerdal, Arne Søraas, Nils Inge Landrø, Ragnhild Bø, Milada Cvancarova Småstuen, Jacqueline Becker, Jan Stubberud

Abstract

Background: Post-COVID-19 condition is frequently comprised of persistent cognitive sequela, including deficits in attention and executive functions (EFs), which can act as a barrier for regaining pre-illness functional levels. Goal Management Training (GMT) is a cognitive rehabilitation (CR) intervention for improving attention and EFs that has received empirical support in studies of other patient groups. The present study aims to determine the efficacy of GMT for improving everyday attention and EFs in adults who experience persistent cognitive deficits after COVID-19.

Methods: This study protocol describes an open-label randomized controlled trial comparing the efficacy of GMT to a wait list control condition (WL), for improving persistent (> 2 months) cognitive sequela in post-COVID-19 condition. The study aims to recruit 240 participants aged 18 to 65 years with a history of SARS-CoV-2 infection and perceived attentional and EF difficulties in daily life. Participants will be block randomized (computer-algorithm) to either group-based GMT (n = 120) or WL (n = 120). GMT will be internet-delivered to groups of six participants in six two-hour sessions delivered once a week. The primary outcome will be the Metacognition Index of the Behavior Rating Inventory of Executive Function - Adult Version, a self-report measure assessing everyday EF difficulties, specifically metacognition, at six months post-treatment. Secondary outcomes include performance-based neurocognitive measures, and tertiary outcomes include rating scales of cognition, emotional health, quality of life, and fatigue.

Conclusion: Study findings could contribute to providing an evidence-based treatment option for symptoms that are frequent and debilitating following a prevalent condition.

Trial registration number: NCT05494424.

Keywords: COVID-19; Cognition; Cognitive rehabilitation; Executive functions; Randomized controlled trial.

Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.

Figures

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Fig. 1
Study flowchart.

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