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

University of Liege

Status: Completed

Conditions: COVID-19; Cognitive Dysfunction

Treatments: Behavioral: Psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT05167266

LCOV21-1303

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

Cognitive psychoeducation

Experimental group

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.

Treatment:

Behavioral: Psychoeducation

Affective psychoeducation

Active Comparator group

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.

Treatment:

Behavioral: Psychoeducation