Clinical trial NCT05167266: Long-Covid: Treatment of Cognitive Difficulties
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
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Cognitive Dysfunction
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
First posted: 2021-12-22
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Comparison of change in subjective cognitive difficulties between the two intervention arms
timeFrame: Two months post-intervention
Secondary outcomes:
measure: Comparison of change in subjective cognitive difficulties between the two intervention arms
timeFrame: Eight months post-intervention
measure: Comparison of change in quality of life assessment between the two intervention arms
timeFrame: 2 and 8 months post-intervention
measure: Comparison of changes in cognitive performance between the two intervention arms
timeFrame: 2 and 8 months post-intervention
Other outcomes:
measure: Comparison of Work productivity and activity impairment between the two intervention arms
timeFrame: 2 and 8 months post-intervention
measure: Comparison of fatigue level between the two intervention arms
timeFrame: 2 and 8 months post-intervention
measure: Comparison of sleep quality between the two intervention arms
timeFrame: 2 and 8 months post-intervention
measure: Comparison of psychological distress between the two intervention arms
timeFrame: 2 and 8 months post-intervention
Locations:
city: Bruxelles
country: Belgium
facility: ULB - CHU Erasme
city: Liège
country: Belgium
facility: CHC Mont Légia
city: Liège
country: Belgium
facility: CHR Citadelle
city: Liège
country: Belgium
facility: ULiège - CHU
city: Liège
country: Belgium
facility: ULiège - CPLU
Study officials:
affiliation: ULiège
name: Sylvie Willems, PhD
role: STUDY_DIRECTOR
affiliation: ULiège
name: Fabienne Collette, PhD
role: PRINCIPAL_INVESTIGATOR
References: