Long-Covid: Treatment of Cognitive Difficulties

NCT05167266 | Completed DMC

• 1 other identifier: LCOV21-1303
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 5

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.

Conditions

COVID-19; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (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.

  Two months post-intervention

Secondary Outcomes (3)

• Comparison of change in subjective cognitive difficulties between the two intervention arms

  Eight months post-intervention

• Comparison of change in quality of life assessment between the two intervention arms

  2 and 8 months post-intervention

• Comparison of changes in cognitive performance between the two intervention arms

  2 and 8 months post-intervention

Other Outcomes (4)

• Comparison of Work productivity and activity impairment between the two intervention arms

  2 and 8 months post-intervention

• Comparison of fatigue level between the two intervention arms

  2 and 8 months post-intervention

• Comparison of sleep quality between the two intervention arms

  2 and 8 months post-intervention

Study Arms (2)

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: * 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.

Behavioral: Psychoeducation

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: * 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.

Behavioral: Psychoeducation

Interventions

Psychoeducation BEHAVIORAL

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

Affective psychoeducation; Cognitive psychoeducation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liege: lead
• University Hospital, Antwerp: collaborator

Study Sites (5)

ULB - CHU Erasme

Brussels, Belgium

Location

CHC Mont Légia

Liège, 4000, Belgium

Location

CHR Citadelle

Liège, 4000, Belgium

Location

ULiège - CHU

Liège, 4000, Belgium

Location

ULiège - CPLU

Liège, 4000, Belgium

Location

Related Publications (3)

• 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.

  PMID: 41277895 DERIVED

• 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.

  PMID: 40645608 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.

  PMID: 37596541 DERIVED

MeSH Terms

Conditions

COVID-19; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sylvie Willems, PhD

  ULiège

  STUDY DIRECTOR

• Fabienne Collette, PhD

  ULiège

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: December 22, 2021
• Study Start: March 15, 2022
• Primary Completion: January 26, 2024
• Study Completion: July 2, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

BE (5)