Cognitive Dysfunction, COVID-19
Conditions
Brief summary
The purpose of the study is to explore the potential effectiveness of two common low-dose interventions, one targeting cognitive difficulties and the other targeting affective difficulties on quality of life and cognition in people suffering from long-COVID with cognitive complaints.
Interventions
BEHAVIORALPsychoeducation
Psychoeducation refers to the process of providing education and information to those seeking or receiving mental health services.
Sponsors
University Hospital, Antwerp
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subjects able to understand the information and consent forms; * Medically stable and at least 3 months after positive PCR for Covid-19; * Self-reported sufficiently good physical condition to attend the appointment; * No major hearing or vision disorders; * Cognitive complaints that place the person in the top 20% of dissatisfied functioning on the BRIEF or MMQ questionnaires; * Poor objective performance supported by a score below the 20th percentile on one task of the cognitive battery.
Exclusion criteria
* Any chronic or remote neurological disorder (i.e. stroke, head trauma, epilepsy, tumor); * Cognitive impairment (minor or major neurocognitive disorder; intellectual disability) preexisting to the Covid-19 episode; * Acute brain injury or acute encephalopathy from another aetiology than covid (e.g., sepsis, liver or renal failure, alcohol or drug withdrawal, drug toxicity); * Documented preexisting history of psychiatric illness, including substance abuse; Open-heart cardiac surgery or cardiac arrest during the last 6 months; * Current hospitalization; * Current revalidation care with cognitive treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of change in subjective cognitive difficulties between the two intervention arms | Two months post-intervention | Subjective report of difficulties experienced by patients in daily life: BRIEF (Behavioral Rating Inventory of Executive Function) and MMQ (Multifactorial Memory Questionnaire) questionnaires. The BRIEF summary index scales (Behavioral Regulation Index and Metacognition Index) and the scale reflecting overall functioning (Global Executive Composite) are expressed at t-scores (M=50, SD=10) ranging from 30 to 100. Higher scores indicates better outcome. There are three scales in the MMQ : Satisfaction Scale, Ability Scale and Strategy Scale. The individual score will range from 0 to 72, from 0 to 80 and from 0 to 76 respectively for each scale. Higher scores indicate better ratings. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of change in subjective cognitive difficulties between the two intervention arms | Eight months post-intervention | Subjective report of difficulties experienced by patients in daily life: scores from BRIEF and MMQ questionnaires The BRIEF summary index scales (Behavioral Regulation Index and Metacognition Index) and the scale reflecting overall functioning (Global Executive Composite) are expressed at t-scores (M=50, SD=10) ranging from 30 to 100. Higher scores indicates better outcome. There are three scales in the MMQ : Satisfaction Scale, Ability Scale and Strategy Scale. The individual score will range from 0 to 72, from 0 to 80 and from 0 to 76 respectively for each scale. Higher scores indicate better ratings. |
| Comparison of change in quality of life assessment between the two intervention arms | 2 and 8 months post-intervention | Subjective report of quality of life experienced by patients in daily life: scores from ISQV (Inventaire Systématique de Qualité de Vie) and EQ-5D (from the EuroQol Group). Scores at ISQV range from 1 (smallest possible gap between 'desired situation' and 'current situation' ) to 100 (largest possible gap). Scores at the EQ-5D range from 5 (full health) to 25 (worst health). |
| Comparison of changes in cognitive performance between the two intervention arms | 2 and 8 months post-intervention | Cognitive scores in the domains of attention, working memory, long term memory and executive functions, as well as global cognitive efficiency. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Work productivity and activity impairment between the two intervention arms | 2 and 8 months post-intervention | Scores at the WPAI (Work Productivity and Activity Impairment) scale. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity. |
| Comparison of fatigue level between the two intervention arms | 2 and 8 months post-intervention | Score at the M-FIS scale (Modified Fatigue Impact Scale). The individual score will range from 0 \[no fatigue\] to 84 \[extreme fatigue\] |
| Comparison of sleep quality between the two intervention arms | 2 and 8 months post-intervention | Score at the PSQI (Pittsburgh Sleep Quality Inventory) scale. The individual score will range from 0 to 21. Higher score indicates lower sleep quality |
| Comparison of psychological distress between the two intervention arms | 2 and 8 months post-intervention | Score at the OQ-45 (Outcome Questionnaire 45) scale. Scores range from 0 to 180, Higher scores indicate more severe psychological distress and functional impairment. |
Countries
Belgium
Outcome results
None listed