Long-Covid: Treatment of Cognitive Difficulties

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2024-07-02

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19 Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Psychoeducation

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

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

Interventions

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Psychoeducation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No