Long Covid19
Conditions
Keywords
cognitive rehabilitation, brain fog, Covid19
Brief summary
Cognitive impairment is increasingly recognised as a major component of long Covid, and is estimated to be present in 25-75% of affected individuals. This impairment impacts quality of life and the loss of functional ability has major consequences for affected people, their families and the wider economy given people's difficulty in returning to work. This study will focus on helping people recover from cognitive Covid. This will involve use of rehabilitation strategies aimed at improving function in those cognitive functions identified in Stage 1 as being most affected, and assessing the benefit of rehabilitation on quality of life and people's ability to return to everyday function. These strategies will be co-produced in collaboration with a group of people living with cognitive Covid. At the end of Stage 2 we will produce a freely available Covid-19 Cognitive Recovery Guide for affected people, their close contacts and clinicians. In conclusion, cognitive impairment is frequently observed in long Covid but at present little is understood about its nature, or how it can be treated. The sheer scale of the CV19 pandemic makes this a top priority unmet need for healthcare worldwide. The aim of this study is to meet this need and to deliver a treatment plan for affected people which will help them return to normal life and working ability.
Interventions
BEHAVIORALCognitive rehabilitation
Set of restorative and compensatory strategies to rehabilitate cognitive function combined with emotional regulation techniques.
Sponsors
Bangor University
St George's University Hospitals NHS Foundation Trust
University of Brighton
University Hospital Southampton NHS Foundation Trust
Greater Manchester Mental Health NHS Foundation Trust
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 30 and 60 years 2. Evidence of prior CV19 infection: * either positive CV19 PCR * or positive CV19 antibody test * or acute symptoms consistent with the recognised core features of acute CV19 infection and post-acute symptoms consistent with the recognised core features of long Covid 3. Cognitive impairment persisting more than three months after the acute CV19 infection, defined in terms of subjective reports of cognitive decline post-infection
Exclusion criteria
1. Cognitive impairment prior to CV19 infection 2. Occurrence of acute neurological disorder, such as stroke or encephalitis, that could give rise to cognitive sequelae 3. People who are on any medications that are considered by the study investigators to have significant adverse effects on cognition 4. A pre-existing major psychiatric or medical disorder that is considered by the study investigators to have potential to affect cognition 5. High alcohol intake 6. Recreational drug use 7. Loss of mental capacity such that the affected individual is unable to give informed consent 8. Participants will not be eligible for Workstream 2 if they do not exhibit significant impairment on baseline cognitive assessments, as they will not gain from cognitive rehabilitation. 9. Participants with pacemakers or other implanted devices, those with metal foreign bodies (e.g. shrapnel from war injuries) and those who have had certain types of surgery will be excluded from the MRI substudy. Although MRI is not known to affect the unborn child, we will also exclude subjects who may be pregnant just to be on the safe side.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Goal-attainment | measured at baseline, 3 and 6 months post-randomisation | performance on goals selected by participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life (EQ-5D-5L) | measured at baseline, 3 and 6 months post-randomisation | Measure of quality of life |
| Change in Life Space Questionnaire | measured at baseline, 3 and 6 months post-randomisation | Measures the extent of mobility |
| Social Functioning (SF-DEM) | measured at baseline, 3 and 6 months post-randomisation | patient reported outcome measure to assess social functioning |
| Change in Instrumental Activities of Daily Living (IADL) Scale | measured at baseline, 3 and 6 months post-randomisation | assessment of independent living skills |
| Generalised Anxiety Disorder Assessment (GAD-7) | measured at baseline, 3 and 6 months post-randomisation | measures levels of anxiety |
| Change in cognitive function | measured at baseline, 3 and 6 months post-randomisation | set of tests to measure objective improvements in cognitive function |
| Change in Chalder Fatigue Scale | measured at baseline, 3 and 6 months post-randomisation | measures the severity of tiredness in fatiguing illnesses |
| Change in Pittsburgh Sleep Quality (PSQI) | measured at baseline, 3 and 6 months post-randomisation | slef reported questionnaire that assesses sleep quality |
| Change in DePaul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM). | measured at baseline, 3 and 6 months post-randomisation | measures presence and severity of post-exertional malaise |
| Change in Client Service Receipt Inventory (CSRI) | measured at baseline, 3 and 6 months post-randomisation | tool used to collect information on the whole range of services and supports study participants may use |
| Change in Patient Health Questionnaire (PHQ-8) | measured at baseline, 3 and 6 months post-randomisation | measures depressive disorders |
Countries
United Kingdom
Outcome results
None listed