Back to resultsLong-Covid: Treatment of Cognitive Difficulties (COV-COG)
Primary Purpose
COVID-19, Cognitive Dysfunction
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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
Sites / Locations
- ULB - CHU ErasmeRecruiting
- CHC Mont LégiaRecruiting
- CHR CitadelleRecruiting
- ULiège - CHURecruiting
- ULiège - CPLURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive psychoeducation
Affective psychoeducation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
Full Information
NCT ID
NCT05167266
First Posted
December 21, 2021
Last Updated
June 1, 2023
Sponsor
University of Liege
Collaborators
University Hospital, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT05167266
Brief Title
Long-Covid: Treatment of Cognitive Difficulties
Acronym
COV-COG
Official Title
Immediate and Long Term Cognitive Improvement After Cognitive Versus Emotion Management Psychoeducation Programs: a Randomised Trial in Covid Patients With Neuropsychological Difficulties
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
Collaborators
University Hospital, Antwerp
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Cognitive Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive psychoeducation
Arm Type
Experimental
Arm Description
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.
Arm Title
Affective psychoeducation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
Psychoeducation refers to the process of providing education and information to those seeking or receiving mental health services.
Primary Outcome Measure Information:
Title
Comparison of change in subjective cognitive difficulties between the two intervention arms
Description
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.
Time Frame
Two months post-intervention
Secondary Outcome Measure Information:
Title
Comparison of change in subjective cognitive difficulties between the two intervention arms
Description
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.
Time Frame
Eight months post-intervention
Title
Comparison of change in quality of life assessment between the two intervention arms
Description
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).
Time Frame
2 and 8 months post-intervention
Title
Comparison of changes in cognitive performance between the two intervention arms
Description
Cognitive scores in the domains of attention, working memory, long term memory and executive functions, as well as global cognitive efficiency.
Time Frame
2 and 8 months post-intervention
Other Pre-specified Outcome Measures:
Title
Comparison of Work productivity and activity impairment between the two intervention arms
Description
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.
Time Frame
2 and 8 months post-intervention
Title
Comparison of fatigue level between the two intervention arms
Description
Score at the M-FIS scale (Modified Fatigue Impact Scale). The individual score will range from 0 [no fatigue] to 84 [extreme fatigue]
Time Frame
2 and 8 months post-intervention
Title
Comparison of sleep quality between the two intervention arms
Description
Score at the PSQI (Pittsburgh Sleep Quality Inventory) scale. The individual score will range from 0 to 21. Higher score indicates lower sleep quality
Time Frame
2 and 8 months post-intervention
Title
Comparison of psychological distress between the two intervention arms
Description
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.
Time Frame
2 and 8 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carmen Cabello, MD
Phone
+32 4 3663359
Email
C.Cabello@uliege.be
First Name & Middle Initial & Last Name or Official Title & Degree
Alexia Lesoinne, MD
Phone
+32 4 3662989
Email
Alexia.Lesoinne@uliege.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie Willems, PhD
Organizational Affiliation
ULiège
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fabienne Collette, PhD
Organizational Affiliation
ULiège
Official's Role
Principal Investigator
Facility Information:
Facility Name
ULB - CHU Erasme
City
Bruxelles
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hichem Slama, Phd
Email
Hichem.Slama@erasme.ulb.ac.be
Facility Name
CHC Mont Légia
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Quitte
Email
AnANNE.QUITTRE@CHC.BE
Facility Name
CHR Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leens Frédérique
Email
Frederique.Leens@citadelle.be
Facility Name
ULiège - CHU
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gael Delrue, MD
Email
gael.delrue@chuliege.be
First Name & Middle Initial & Last Name & Degree
Md
Facility Name
ULiège - CPLU
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Cabello, MD
First Name & Middle Initial & Last Name & Degree
Alexia Lesoinne, MD
Email
Alexia.Lesoinne@uliege.be
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Research data upon request after publication of the main results
Learn more about this trial
Long-Covid: Treatment of Cognitive Difficulties
We'll reach out to this number within 24 hrs