Zusammenfassung (Niederländisch oder Französisch oder Englisch)
TRIAL DESCRIPTION
| Title | Immediate and long term cognitive and quality of life improvement after cognitive versus emotion management psychoeducation programs: a randomised trial in covid patients with neuropsychological difficulties - CovCOG |
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Participants (P) |
Patients with confirmed diagnosis of covid19 (PCR) that express cognitive complaints after 2 months. Inclusion criteria: 18-65 years; in a sufficient physical and mental health to take part in study; no major hearing or vision disorders; objective cognitive deficit at cognitive assessment. Exclusion Criteria: Any chronic neurological disorder or preexisting cognitive impairment; history of psychiatric illness. |
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Intervention (I) |
Short psycho-educational cognitive intervention: a 4-sessions (1x/week), psycho-educative, integrative and multidimensional intervention designed to prevent post-acute cognitive symptoms. Each individual session will last 90’ and will concern a specific cognitive domain (Attention, executive function, memory, mental fatigue). |
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Control (C) |
Short psycho-educational affective intervention: a 4-sessions (1x/week), psycho-educative, intervention designed to prevent post-acute affective symptoms that could increase the cognitive complaints. Each individual session will last 90’. During four individual sessions, different strategies and resources will be proposed to increase self-efficacy for emotions management. |
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Outcome (O) |
Improved quality of life (estimated with ISQV and EQ-5ED scales) and cognitive complaints (estimated with BRIEF and CDS questionnaires) 3 months after the inclusion in one of the arms. |
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Trial Design |
A multicentre two arms, 1:1, comparative trial comparing psychoeducation interventions that focuses on cognitive versus affective difficulties |
|
Sample Size |
128 patients |
|
Trial duration |
20 Months |
|
Budget |
€ 850 000 (incl. VAT) |
TRIAL TEAM
|
Sponsor |
University of Liège |
|
Chief Investigator |
Sylvie Willems (contact: covcog@uliege.be) |
| Ethics Committee | CHU Liège |
| External Partners | UZA CTC |
| Number of participating sites | 5 |
DOKUMENTE
| Protocol | View protocol BMC Neurology |
| Results | Download report |
For timelines and recruitment, see dashboard
REFERENZEN
ClinicalTrials.gov: NCT05167266
Webpage:
