Cognitive Rehabilitation in Post-COVID-19 Condition

Study Overview
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Brief Summary
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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 240 participants aged 18 to 65 years with a history of laboratory- or home-test confirmed, SARS-CoV-2 infection (> 3 months since 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 = 120) or WL (n = 120). 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.

Official Title
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Cognitive Rehabilitation in Post-COVID-19 Condition: A Study Protocol for a Randomized Controlled Trial

Conditions
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COVID-19

Intervention / Treatment
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* Behavioral: Goal Management Training (GMT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: history of laboratory- or home-test confirmed, SARS-CoV-2 infection (> 3 months since 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal Management Training (GMT)<br>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)<br>* 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.<br>* Other names: GMT;|
| No Intervention: Wait list<br>Wait list control condition | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline up to 6 months | 
| Cambridge Neuropsychological Test Automated Battery (CANTAB), subtests: the Stop Signal Task, Spatial Working Memory, Intra-Extra Dimensional Set Shift and Rapid Visual Information Processing | Performance-based neurocognitive test battery | Change from baseline up to 6 months | 
| 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. | Change from baseline up to 6 months | 
| The Generalized Self-Efficacy Scale | Self-report measure of self-efficacy. Range:10-40. Higher score indicate higher self-efficacy. | Change from baseline up to 6 months | 
| Fatigue Severity Scale | Self-report measure of fatigue. 7 items. Range 7-49. Higher score indicate more fatigue. | Change from baseline up to 6 months | 
| 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. | Change from baseline up to 6 months | 
| 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. | Change from baseline up to 6 months | 
| 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. | Change from baseline up to 6 months | 
| 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. | Change from baseline up to 6 months | 
| DUKE-UNC Functional Social Support Questionnaire (FSSQ) | Self-report measure of social support. 8 items. The total score range from 8 to 40. Higher score indicates more social support. | Change from baseline up to 6 months | 
| 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. | Change from baseline up to 6 months | 
| The Resilience Scale for Adults | Self-report measure of resilience. 33 items. The total score range from 33 to 165 | Change from baseline up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation