PACS-Cog: Computer Cognitive Training for Post-acute COVID-19 Syndrome

Sponsor
Nova Southeastern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05338749
Collaborator
(none)
10
1
1
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Training
Early Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open labelOpen label
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label Trial of Computer-delivered Cognitive Training in Persons With Post-acute COVID-19 Syndrome
Actual Study Start Date :
Apr 26, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cognitive Training

Participants in this condition will received game-based cognitive training.

Behavioral: Cognitive Training
Gamified cognitive training intervention to improve mental speed and attention.

Outcome Measures

Primary Outcome Measures

  1. Technology Acceptance Model Questionnaire, Usefulness subscale [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 Outcome Measures

  1. Cognitive Failures Questionnaire [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Collaborative Research, Nova Southeastern University Fort Lauderdale Florida United States 33314

Sponsors and Collaborators

  • Nova Southeastern University

Investigators

  • Principal Investigator: Raymond L Ownby, MD, PhD, Nova Southeastern University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT05338749
Other Study ID Numbers:
  • 20211020
First Posted:
Apr 21, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022