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| Name | Class |
|---|---|
| University Hospital, Antwerp | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive psychoeducation | Experimental | 1) The cognitive intervention is a 4-session, 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:
The structure of the sessions will be similar: (1) explanation about (dys)functioning of processes associated to the domain of interest: (2) identification of problems in daily life translated into functional objectives (e.g. keeping papers organized; scheduling activities to avoid fatigue); (3) discovery and application of (meta)cognitive strategies. Material (videos, tips,…) will be provided that the patients can consult when needed. The patients will have a diary to complete to explain when they applied the content of the intervention in daily life, and how successful it was. |
|
| Affective psychoeducation | Active Comparator | 2) The affective intervention is also a psychoeducation program based on four sessions, in which different strategies and resources will be proposed to increase self-efficacy for emotion management:
Material (videos, tips,…) will be provided that the patients can consult when needed. The patients will have a diary to complete to explain when they applied the content of the intervention in daily life, and how successful it was. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychoeducation | Behavioral | Psychoeducation refers to the process of providing education and information to those seeking or receiving mental health services. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of change in subjective cognitive difficulties between the two intervention arms | 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. | Two months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of change in subjective cognitive difficulties between the two intervention arms | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Work productivity and activity impairment between the two intervention arms | 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. | 2 and 8 months post-intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie Willems, PhD | ULiège | Study Director |
| Fabienne Collette, PhD | ULiège | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ULB - CHU Erasme | Brussels | Belgium | ||||
| CHC Mont Légia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41277895 | Derived | Cabello Fernandez C, Didone V, Lesoinne A, Slama H, Fery P, Rousseau AF, Moutschen M; COVCOG group; Collette F, Willems S. Cognitive and affective psychoeducation for Long COVID: a randomized controlled trial. Brain Commun. 2025 Nov 11;7(6):fcaf447. doi: 10.1093/braincomms/fcaf447. eCollection 2025. | |
| 40645608 | Derived |
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Research data upon request after publication of the main results
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Eight months post-intervention |
| Comparison of change in quality of life assessment between the two intervention arms | 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). | 2 and 8 months post-intervention |
| Comparison of changes in cognitive performance between the two intervention arms | Cognitive scores in the domains of attention, working memory, long term memory and executive functions, as well as global cognitive efficiency. | 2 and 8 months post-intervention |
| Comparison of fatigue level between the two intervention arms |
Score at the M-FIS scale (Modified Fatigue Impact Scale). The individual score will range from 0 [no fatigue] to 84 [extreme fatigue] |
| 2 and 8 months post-intervention |
| Comparison of sleep quality between the two intervention arms | Score at the PSQI (Pittsburgh Sleep Quality Inventory) scale. The individual score will range from 0 to 21. Higher score indicates lower sleep quality | 2 and 8 months post-intervention |
| Comparison of psychological distress between the two intervention arms | 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. | 2 and 8 months post-intervention |
| Liège |
| 4000 |
| Belgium |
| CHR Citadelle | Liège | 4000 | Belgium |
| ULiège - CHU | Liège | 4000 | Belgium |
| ULiège - CPLU | Liège | 4000 | Belgium |
| Cabello Fernandez C, Didone V, Slama H, Dupuis G, Fery P, Delrue G, Lesoinne A, Collette F, Willems S. Profiles of Individuals With Long COVID Reporting Persistent Cognitive Complaints. Arch Clin Neuropsychol. 2025 Nov 24;40(8):1455-1472. doi: 10.1093/arclin/acaf064. |
| 37596541 | Derived | Willems S, Didone V, Cabello Fernandez C, Delrue G, Slama H, Fery P, Goin J, Della Libera C; COVCOG Group; Collette F. COVCOG: Immediate and long-term cognitive improvement after cognitive versus emotion management psychoeducation programs - a randomized trial in covid patients with neuropsychological difficulties. BMC Neurol. 2023 Aug 18;23(1):307. doi: 10.1186/s12883-023-03346-9. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |