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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
135
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.
Lovisenberg Diaconal Hospital
Oslo, Norway
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.
Time frame: Change from baseline up to 6 months
The Behaviour regulation Index from Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Self-report measure of daily life executive function (behaviour regulation). Range: 70-210. Higher score indicate greater executive dysfunction.
Time frame: Change from baseline to 6 months, 2 years, and 4 years
Cambridge Neuropsychological Test Automated Battery (CANTAB), subtests: Spatial Working Memory, Rapid Visual Information Processing, One Touch Stockings of Cambridge
Performance-based neurocognitive test battery
Time frame: Change from baseline to 6 months, 2 years, and 4 years
The Hospital Anxiety and Depression Scale
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.
Time frame: Change from baseline to 6 months, 2 years, and 4 years
The Generalized Self-Efficacy Scale
Self-report measure of self-efficacy. Range:10-40. Higher score indicate higher self-efficacy.
Time frame: Change from baseline to 6 months, 2 years, and 4 years
Fatigue Severity Scale
Self-report measure of fatigue. 7 items. Range 7-49. Higher score indicate more fatigue.
Time frame: Change from baseline to 6 months, 2 years, and 4 years
The Perceived Deficits Questionnaire
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.
Time frame: Change from baseline to 6 months, 2 years, and 4 years
Everyday Memory Questionnaire
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.
Time frame: Change from baseline to 6 months, 2 years, and 4 years
RAND 12-Item Health Survey (RAND-12)
Self-report measure of quality of life. Range 0-10; a high score defines a more favorable health state.
Time frame: Change from baseline to 6 months, 2 years, and 4 years
EuroQol five-dimension scale questionnaire (EQ-5D)
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.
Time frame: Change from baseline to 6 months, 2 years, and 4 years
DePaul Symptom Questionnaire short version
Self-report measure of fatigue symptoms. 14 items. The total score range from 0 to 56 for both frequency and severity for each item.
Time frame: Change from baseline up to 6 months
Insomnia Severity Index
Self-report measure of insomnia. Range: 0-28. Higher score indicate more acute symptoms of insomnia
Time frame: Change from baseline up to 6 months
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.
Time frame: Change from baseline to 2 years and 4 years
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