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Completed

NCT Number: NCT05167266

Long-Covid: Treatment of Cognitive Difficulties

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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Key information

Conditions

COVID-19 Cognition Disorders Cognitive Dysfunction Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Neurocognitive Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ULB - CHU Erasme, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducation

Behavioral

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

Primary outcomes

  1. Comparison of change in subjective cognitive difficulties between the two intervention arms

    Time frame: Two months post-intervention

    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 outcomes

  1. Comparison of change in subjective cognitive difficulties between the two intervention arms

    Time frame: Eight months post-intervention

    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.

  2. Comparison of change in quality of life assessment between the two intervention arms

    Time frame: 2 and 8 months post-intervention

    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).

  3. Comparison of changes in cognitive performance between the two intervention arms

    Time frame: 2 and 8 months post-intervention

    Cognitive scores in the domains of attention, working memory, long term memory and executive functions, as well as global cognitive efficiency.

Other outcomes

  1. Comparison of Work productivity and activity impairment between the two intervention arms

    Time frame: 2 and 8 months post-intervention

    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. Comparison of fatigue level between the two intervention arms

    Time frame: 2 and 8 months post-intervention

    Score at the M-FIS scale (Modified Fatigue Impact Scale). The individual score will range from 0 [no fatigue] to 84 [extreme fatigue]

  3. Comparison of sleep quality between the two intervention arms

    Time frame: 2 and 8 months post-intervention

    Score at the PSQI (Pittsburgh Sleep Quality Inventory) scale. The individual score will range from 0 to 21. Higher score indicates lower sleep quality

  4. Comparison of psychological distress between the two intervention arms

    Time frame: 2 and 8 months post-intervention

    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.

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Collaborators

  • University Hospital, Antwerp

Registry information

Official study title

Immediate and Long Term Cognitive Improvement After Cognitive Versus Emotion Management Psychoeducation Programs: a Randomised Trial in Covid Patients With Neuropsychological Difficulties

Acronym: COV-COG

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 22, 2021
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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