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Cognitive Rehabilitation in Post-COVID-19 Condition

Study acronym: TRAINCOVID
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment increased: 120 → 135 participants
    • Study completion moved earlier from Jan 2029 to Dec 2028
    • Secondary endpoints: 11 to 12
    v7
  2. Enrollment target: 240 to 120
    • Primary completion date changed from estimate of Feb 2025 to Feb 1, 2025
    • Secondary endpoints: 12 to 11
    • Eligibility criteria shortened, about 5 words
    v6
  3. Primary completion date: Jul 2024 to Feb 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2023 to Sep 8, 2023
    • Study sites: 0 to 1
    • Secondary endpoints revised (12)
    v4
  5. Secondary endpoints: 9 to 12
    • Eligibility criteria expanded, about 1 word
    v3
  6. Secondary endpoints revised (9)v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 was designed 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 originally aimed to recruit 240 participants (120 per group). A total of 135 participants were enrolled, of whom 129 participants completed baseline assessments and were randomized to either group-based GMT (GMT; n = 64) or wait-list control (WL; n = 65), all 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. GMT was internet-delivered to groups of 4-7 participants in six weekly two-hour sessions. The primary outcome was 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 included 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 long-term effects of GMT at 2- and 4-year follow-up.
Trial Details
NCT Number NCT05494424
Lead Sponsor Lovisenberg Diakonale Hospital
Collaborators: University of Oslo, Icahn School of Medicine at Mount Sinai, University of Toronto, UiT The Arctic University of Norway, Oslo University Hospital
Conditions
(from sponsor)		 COVID-19
Related terms COVID-19
Enrollment 135 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov