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COVID-19COV-COGNCT05167266

Long-Covid: Treatment of Cognitive Difficulties

A study testing Psychoeducation in people with COVID-19 and Cognitive Dysfunction, run by University of Liege at 5 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
COVID-19, Cognitive Dysfunction
What is being tested?
Psychoeducation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
5 sitesBelgium
Study dates
15 Mar 2022to 2 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Belgium5 sites

  • ULB - CHU Erasme

    Brussels

  • CHC Mont Légia

    Liège, 4000

  • CHR Citadelle

    Liège, 4000

  • ULiège - CHU

    Liège, 4000

  • ULiège - CPLU

    Liège, 4000

Other trials in Belgium

About this study

Official title: Immediate and Long Term Cognitive Improvement After Cognitive Versus Emotion Management Psychoeducation Programs: a Randomised Trial in Covid Patients With Neuropsychological Difficulties

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.

Being tested
Psychoeducation
Medical subject headings
COVID-19, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PsychoeducationBehavioural

    Psychoeducation refers to the process of providing education and information to those seeking or receiving mental health services.

Study groups in NCT05167266
Study groupRoleWhat they receive
Cognitive psychoeducationExperimental1) 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: * Cognition in covid, fatigue and sleep * Working memory and attentional functioning * Executive functioning * Memory functioning 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.
Receives: Behavioral: Psychoeducation
Affective psychoeducationActive comparator2) 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: * Recognizing emotions and affective states * Accepting and communicating emotions and difficulties * Accepting the uncertainty associated with difficulties * Behavioural activation 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.
Receives: Behavioral: Psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Two months post-intervention

Secondary outcomes (3)

  1. 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.

    Measured: Eight months post-intervention

  2. 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).

    Measured: 2 and 8 months post-intervention

  3. 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.

    Measured: 2 and 8 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2021
  2. Study start15 Mar 2022
  3. Primary completion26 Jan 2024
  4. Study completion2 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05167266
Sponsor's protocol ID
LCOV21-1303
Acronym
COV-COG
Status last verified
Jul 2024
First submitted
21 Dec 2021
Last updated
9 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Research data upon request after publication of the main results

Publications

  • 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.

    PubMed 41277895

  • 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.

    PubMed 40645608

  • 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.

    PubMed 37596541

Questions about this trial

What is this clinical trial studying?

A study testing Psychoeducation in people with COVID-19 and Cognitive Dysfunction, run by University of Liege at 5 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of change in subjective cognitive difficulties between the two intervention arms (time frame: Two months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05167266, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.

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