Clinical trial NCT05494424: Cognitive Rehabilitation in Post-COVID-19 Condition
Official title: Cognitive Rehabilitation in Post-COVID-19 Condition: A Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COVID-19
Keywords: Rehabilitation
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Icahn School of Medicine at Mount Sinai
name: University of Toronto
name: UiT The Arctic University of Norway
name: Oslo University Hospital
First posted: 2022-08-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post-COVID-19 condition is frequently comprised of persistent cognitive sequela, including deficits in attention and executive functions (EFs). 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. The study is a randomized controlled trial (RCT), comparing the efficacy of GMT to a wait list control condition (WL), for improving persistent cognitive sequela in post-COVID-19 condition. The study aims to recruit 120 participants aged 18 to 65 years with a history of laboratory- or home-test confirmed, SARS-CoV-2 infection and perceived attentional and EF difficulties in daily life that have lasted for at least two months and that cannot be explained by an alternative diagnosis. Participants will be randomized to either group-based GMT (n = 60) or WL (n = 60). GMT will be internet-delivered to groups of six participants in six two-hour sessions delivered weekly (five weeks). 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, at six months post-treatment. Secondary outcomes include performance-based neurocognitive measures and rating scales of cognition, emotional health, quality of life, and fatigue.

Secondary aims include to explore to what extent potential early change predicts outcome, and to examine what characterize those who profit from GMT, in addition to describe the neurocognitive and emotional health in a Covid-19 sample. The investigators will also examine potential effects of GMT at 2- and 5-year follow-up.


Eligibility criteria: Inclusion Criteria:

* history of laboratory- or home-test confirmed, SARS-CoV-2 infection
* perceived cognitive difficulties (attention, memory, EF) affecting everyday functioning that have lasted for at least two months and that cannot be explained by an alternative diagnosis
* age between 18-65 years

Exclusion Criteria:

* ongoing alcohol- or substance abuse, premorbid insult and/or comorbid neurological disease, severe neurocognitive problems interfering with the capacity to participate, sensory disorders biasing cognitive assessment, psychotic disorders, lack of proficiency in Norwegian, and being previously enrolled in a GMT trial.

Primary outcomes:
measure: The Metacognition Index from the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
timeFrame: Change from baseline up to 6 months
Secondary outcomes:
measure: The Behaviour regulation Index from Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
timeFrame: Change from baseline up to 6 months
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB), subtests: Spatial Working Memory, Rapid Visual Information Processing, One Touch Stockings of Cambridge
timeFrame: Change from baseline up to 6 months
measure: The Hospital Anxiety and Depression Scale
timeFrame: Change from baseline up to 6 months
measure: The Generalized Self-Efficacy Scale
timeFrame: Change from baseline up to 6 months
measure: Fatigue Severity Scale
timeFrame: Change from baseline up to 6 months
measure: The Perceived Deficits Questionnaire
timeFrame: Change from baseline up to 6 months
measure: Everyday Memory Questionnaire
timeFrame: Change from baseline up to 6 months
measure: RAND 12-Item Health Survey (RAND-12)
timeFrame: Change from baseline up to 6 months
measure: EuroQol five-dimension scale questionnaire (EQ-5D)
timeFrame: Change from baseline up to 6 months
measure: DePaul Symptom Questionnaire short version
timeFrame: Change from baseline up to 6 months
measure: Insomnia Severity Index
timeFrame: Change from baseline up to 6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lovisenberg Diaconal Hospital
Study officials:
affiliation: University of Oslo and Lovisenberg Hospital
name: Jan Stubberud, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hagen BI, Lerdal A, Soraas A, Landro NI, Bo R, Smastuen MC, Becker J, Stubberud J. Cognitive rehabilitation in post-COVID-19 condition: A study protocol for a randomized controlled trial. Contemp Clin Trials. 2022 Nov;122:106955. doi: 10.1016/j.cct.2022.106955. Epub 2022 Oct 5.