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Completed

NCT Number: NCT05338749

Computer Cognitive Training for Post-acute COVID-19 Syndrome

This study will assess the acceptability, feasibility, and impact of game-based computer-delivered cognitive training on cognitive function in persons with cognitive symptoms that persist after recovery from acute coronavirus-19 (COVID) infection.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Collaborative Research, Nova Southeastern University

Fort Lauderdale, Florida, 33314, United States

About this study

Over the course of the past several years, it has become apparent that a number of individuals have residual symptoms after COVID-19 infection after they have recovered from the acute phase of the illness (Al-Aly, Xie, & Bowe, 2021; Davis et al., 2021; Greenhalgh, Knight, A'Court, Buxton, & Husain, 2020; Hewitt et al., 2021). The constellation of symptoms experienced by these individuals has been termed "post-acute COVID syndrome" or PACS (Nalbandian et al., 2021). A key part of helping affected individuals is supporting their efforts at self-management of these symptoms (National Institute for Health and Care Excellence, 2020; Wade, 2020). Although a diverse number of physical and psychological symptoms have been seen as sequelae of COVID (Davis et al., 2021), among the most troubling for patients have been difficulties in attention, concentration, working memory, and long-term memory, commonly referred to as "brain fog" (Graham et al., 2021; Hampshire et al., 2021; Hewitt et al., 2021). In the proposed study, we will complete a pilot study of game-based cognitive training in persons with symptoms of long COVID using a protocol that was useful and acceptable to participants in a previous study (Ownby & Kim, 2021). We will explore participants' views on the cognitive training intervention, its effects on their perceived cognitive functioning, and assess the intervention's impact on participants' processing speed. We will also explore their preferences for type of cognitive training activity and the impact of information about memory functioning.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Persons with a history of COVID-19 infection confirmed through screening of symptom pattern or testing and report of mental symptoms (difficulties in attention, memory, or executive functions such as coordinating two activities at once) more than 30 days after resolution of the initial acute infection.

Exclusion criteria

  • Cognitive or psychiatric conditions of a severity that precludes the person's ability to give informed consent for their participation or to attend and cooperate with assessment and training, as judged by the investigators.

Treatment and study plan

Cognitive training

Behavioral

Gamified cognitive training intervention to improve mental speed and attention.

Primary outcomes

  1. Technology Acceptance Model Questionnaire, Usefulness subscale

    Time frame: Three weeks

    User self-report of their perception that an application serves a function that may be helpful The score is the average of several items rated by the user from 0 to 6, so that the final score itself can range from 0 to 6. Higher scores indicate that the user found the intervention more useful. Higher scores are better.

Secondary outcomes

  1. Cognitive Failures Questionnaire

    Time frame: Three weeks

    A standard self-report measure of problems in memory, attention, and self-regulated behavior. This measures includes self-report ratings on 25 items, with ratings ranging from 0 to 4. The total score can thus range from 0 to 100, with higher scores indicating that the person experiences more problems with thinking and remembering.

  2. Trail Making Test, Part B

    Time frame: Three weeks

    This is a measure of how rapidly a person can remember alternating sequences of numbers and letters while connecting them on a paper with a pencil. The score is time in seconds to complete the task, with the provision that if a person cannot finish the task within three minutes, the task is discontinued and the person is assigned a score of 180 (for 3 minutes times 60 seconds). Lower scores indicate better performance.

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Registry information

Official study title

An Open-label Trial of Computer-delivered Cognitive Training in Persons With Post-acute COVID-19 Syndrome

Acronym: PACS-Cog

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2022
Registry last updated
Mar 29, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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