The presence of residual cognitive difficulties in patients with severe to moderate COVID-19 has been demonstrated, and such difficulties also exist in milder forms. The prevalence of difficulties remains significant after several months. Such cognitive difficulties have repercussions on quality of life and return to work.
There is still no data to guide the clinician in the choice of the most helpful cognitive intervention. We therefore propose to implement an intervention based on current practice in a population, patients with mild traumatic brain injury, that report cognitive symptoms similar to the ones observed in long-COVID. In these patients, persistent cognitive difficulties can best be treated by psychoeducation, an approach that aims to inform about the different factors involved in the symptoms and to empower patients to better manage their recovery. Psychoeducation allows patients to regain control of their symptoms by focusing on the controllable parameters related to their complaints. These psychoeducation programs can be offered in 4-5 sessions. Some programs will focus on cognitive disorders, others on the management of emotions associated with the disorders.
In this trial, we will compare the effect of cognitive and affective psycho-education interventions on the reduction of the perception of symptoms and on the quality of life of the patients. The two intervention programs will aim to teach adequate behaviours and strategies to limit the impact of cognitive and affective difficulties on activities of daily living (with face-to-face session and bibliotherapy).
Psycho-intervention is a first-line and low-cost intervention associated with real benefit on family, social and work-related aspects of daily life. We consider it will be particularly relevant for long-covid patients that are confronted with cognitive difficulties when they return to work at full-time by managing in parallel family and social duties.
| Summary of results |
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| The COV-COG study assessed the effectiveness of two interventions designed to alleviate the cognitive difficulties experienced on a daily basis by people with Long COVID. It compared two psychoeducation programs, one focused on cognitive aspects, the other on emotional aspects. One hundred and thirty patients with Long COVID were included and randomly assigned to one of the two programs, consisting of four 90-minute sessions spread over a month (one per week). The effectiveness of the interventions was assessed primarily by comparing self-reported attention and memory difficulties before and after the intervention, as well as 8 months later to evaluate long-term effectiveness. Following the two interventions, we observed a slight decrease in cognitive complaints and an improvement in cognitive performance, quality of life, fatigue, and sleep. The results did not show that one program was superior to the other, though each had specific benefits. The study highlights the feasibility and relevance of this type of approach, while suggesting that a longer intervention could reinforce the observed effects. |
| 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 |
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Sample Size |
128 patients |
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Trial duration |
20 Months |
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Budget |
€ 850 000 (incl. VAT) |
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Sponsor |
University of Liège |
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Chief Investigator |
Sylvie Willems (contact: covcog@uliege.be) |
| Ethics Committee | CHU Liège |
| External Partners | UZA CTC |
| Number of participating sites | 5 |
| Protocol | View protocol BMC Neurology |
| Results | Download report |
For timelines and recruitment, see dashboard
Clinicaltrials.gov: NCT05167266
Webpage:
