Long-Covid: Treatment of Cognitive Difficulties (COV-COG)

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Cognitive Dysfunction
• Intervention / Treatment: Behavioral: Psychoeducation

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium
    • ULB - CHU Erasme
  • Liège, Belgium, 4000
    • CHR Citadelle
  • Liège, Belgium, 4000
    • CHC Mont Légia
  • Liège, Belgium, 4000
    • ULiège - CHU
  • Liège, Belgium, 4000
    • ULiège - CPLU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive psychoeducation; 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; Psychoeducation refers to the process of providing education and information to those seeking or receiving mental health services.
Active Comparator: Affective psychoeducation; 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; Psychoeducation refers to the process of providing education and information to those seeking or receiving mental health services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Liege
• Collaborators: University Hospital, Antwerp
• Investigators: Study Director: Sylvie Willems, PhD, ULiège; Principal Investigator: Fabienne Collette, PhD, ULiège

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): January 26, 2024
• Study Completion (Actual): July 2, 2024

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: LCOV21-1303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Research data upon request after publication of the main results
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No