Cognitive Rehabilitation in Post-COVID-19 Condition

NCT05494424 | Active Not Recruiting

• 1 other identifier: Traincovid
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (1)

• The Metacognition Index from the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)

  Self-report measure of daily life executive function (metacognition). Range:70-210. Higher score indicate greater executive dysfunction.

  Change from baseline up to 6 months

Secondary Outcomes (11)

• The Behaviour regulation Index from Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)

  Change from baseline up to 6 months

• Cambridge Neuropsychological Test Automated Battery (CANTAB), subtests: Spatial Working Memory, Rapid Visual Information Processing, One Touch Stockings of Cambridge

  Change from baseline up to 6 months

• The Hospital Anxiety and Depression Scale

  Change from baseline up to 6 months

• The Generalized Self-Efficacy Scale

  Change from baseline up to 6 months

• Fatigue Severity Scale

  Change from baseline up to 6 months

Study Arms (2)

Goal Management Training (GMT)

EXPERIMENTAL

Internet-delivered group-based GMT to groups of six participants in six two-hour sessions delivered weekly (five weeks). Manualized intervention.

Behavioral: Goal Management Training (GMT)

Wait list

NO INTERVENTION

Wait list control condition

Interventions

Goal Management Training (GMT) BEHAVIORAL

Goal Management Training is a cognitive rehabilitation intervention that relies on metacognitive strategies to reengage top-down attention processes, in addition to teaching problem-solving techniques, attempting to address executive dysfunctions.

Also known as: GMT

Goal Management Training (GMT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lovisenberg Diakonale Hospital: lead
• University of Oslo: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• University of Toronto: collaborator
• UiT The Arctic University of Norway: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Lovisenberg Diaconal Hospital

Oslo, Norway

Location

Related Publications (1)

• 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.

  PMID: 36208718 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jan Stubberud, PhD

  University of Oslo and Lovisenberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 10, 2022
• Study Start: September 8, 2023
• Primary Completion: February 1, 2025
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)