COVID-19
Conditions
Keywords
Rehabilitation
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 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.
Interventions
BEHAVIORALGoal Management Training (GMT)
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.
Sponsors
Lovisenberg Diakonale Hospital
University of Oslo
Icahn School of Medicine at Mount Sinai
University of Toronto
UiT The Arctic University of Norway
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Metacognition Index from the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) | Change from baseline up to 6 months | Self-report measure of daily life executive function (metacognition). Range:70-210. Higher score indicate greater executive dysfunction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Behaviour regulation Index from Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) | Change from baseline to 6 months, 2 years, and 4 years | Self-report measure of daily life executive function (behaviour regulation). Range: 70-210. Higher score indicate greater executive dysfunction. |
| Cambridge Neuropsychological Test Automated Battery (CANTAB), subtests: Spatial Working Memory, Rapid Visual Information Processing, One Touch Stockings of Cambridge | Change from baseline to 6 months, 2 years, and 4 years | Performance-based neurocognitive test battery |
| The Hospital Anxiety and Depression Scale | Change from baseline to 6 months, 2 years, and 4 years | Self-report measure of symptoms of anxiety and depression. The maximum score is 21 for depression and 21 for anxiety, range 0-21 on each scale. A higher score = more symptoms. |
| The Generalized Self-Efficacy Scale | Change from baseline to 6 months, 2 years, and 4 years | Self-report measure of self-efficacy. Range:10-40. Higher score indicate higher self-efficacy. |
| Fatigue Severity Scale | Change from baseline to 6 months, 2 years, and 4 years | Self-report measure of fatigue. 7 items. Range 7-49. Higher score indicate more fatigue. |
| The Perceived Deficits Questionnaire | Change from baseline to 6 months, 2 years, and 4 years | Self-report measure of daily-life cognitive difficulties. The total score range from 0 to 80, with a higher score indicating greater perceived cognitive impairment. |
| Everyday Memory Questionnaire | Change from baseline to 6 months, 2 years, and 4 years | Self-report measure of daily-life cognitive difficulties. The total score range from 0 to 52, with a higher score indicating greater perceived cognitive impairment. |
| RAND 12-Item Health Survey (RAND-12) | Change from baseline to 6 months, 2 years, and 4 years | Self-report measure of quality of life. Range 0-10; a high score defines a more favorable health state. |
| EuroQol five-dimension scale questionnaire (EQ-5D) | Change from baseline to 6 months, 2 years, and 4 years | Self-report measure of quality of life. The range of the EQ-5D index scores is 0 to 1 (1 indicates the best health state), but negative scores as low as-0.59 are possible for health states deemed to be worse than death. |
| DePaul Symptom Questionnaire short version | Change from baseline up to 6 months | Self-report measure of fatigue symptoms. 14 items. The total score range from 0 to 56 for both frequency and severity for each item. |
| Insomnia Severity Index | Change from baseline up to 6 months | Self-report measure of insomnia. Range: 0-28. Higher score indicate more acute symptoms of insomnia |
| The Metacognition Index from the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) | Change from baseline to 2 years and 4 years | Self-report measure of daily life executive function (metacognition). Range: 70-210. Higher score indicate greater executive dysfunction. |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORJan Stubberud, PhD
University of Oslo and Lovisenberg Hospital
Outcome results
None listed