Long-Covid: Treatment of Cognitive Difficulties

Not Applicable

Completed

• Conditions: Cognitive Dysfunction; COVID-19

• Registration Number: NCT05167266
• Lead Sponsor: University of Liege

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2021-12-21
• Study First Posted: 2021-12-22
• Study Start: 2022-03-15
• Primary Completion: 2024-01-26
• Status Verified: 2024-07
• Study Completion: 2024-07-02
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of change in subjective cognitive difficulties between the two intervention arms	Two months post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of change in quality of life assessment between the two intervention arms	2 and 8 months post-intervention	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).
Comparison of changes in cognitive performance between the two intervention arms	2 and 8 months post-intervention	Cognitive scores in the domains of attention, working memory, long term memory and executive functions, as well as global cognitive efficiency.
Comparison of change in subjective cognitive difficulties between the two intervention arms	Eight months post-intervention	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.

Trial Locations

Locations (5)

ULB - CHU Erasme; 🇧🇪 Bruxelles, Belgium

CHC Mont Légia; 🇧🇪 Liège, Belgium

CHR Citadelle; 🇧🇪 Liège, Belgium

ULiège - CHU; 🇧🇪 Liège, Belgium

ULiège - CPLU; 🇧🇪 Liège, Belgium