Long-Covid: Treatment of Cognitive Difficulties

COVID-19 Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05167266
• Other study ID #: LCOV21-1303
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: June 21, 2024

Study information

• Verified date: May 2024
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: June 21, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• COVID-19

Intervention

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

Locations

Country	Name	City	State
Belgium	ULB - CHU Erasme	Bruxelles
Belgium	CHC Mont Légia	Liège
Belgium	CHR Citadelle	Liège
Belgium	ULiège - CHU	Liège
Belgium	ULiège - CPLU	Liège

Sponsors (2)

Lead Sponsor	Collaborator
University of Liege	University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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