Brain-Training Treatment for Long COVID in Older Adults

Computerized Cognitive Remediation of Long COVID Symptoms in Older Adults

This research is being done to collect preliminary data on the potential of computerized "brain-training" exercises for treating Long COVID symptoms in older adults. The investigators hypothesize that computerized brain-training will be an acceptable and feasible intervention for treating Long COVID symptoms in older adults. The investigators also expect to provide initial evidence that computerized brain-training has potential for improving thinking, mood, and other aspects of everyday functioning in older adults with Long COVID.

Study Overview

• Status: Recruiting
• Conditions: Post-Acute COVID-19 Syndrome
• Intervention / Treatment: Other: NeuroFlex (computerized gamified tasks)

Detailed Description

Some patients who contract coronavirus disease 2019 (COVID-19), especially older adults, show lingering neuropsychiatric symptoms such as cognitive impairment, brain fog, and depression. These neuropsychiatric symptoms-commonly referred to under the umbrella term "Long COVID"-are debilitating and may last for months or even years after viral infection. The purpose of the present study is to help address this public health crisis by determining whether computerized "brain-training" treatment has potential for improving thinking, mood, and other aspects of functioning in older adults with Long COVID. More specifically, the first aim is to determine the acceptability and feasibility of using brain-training treatment in individuals with Long COVID. The second aim is to evaluate for potential efficacy by determining whether brain-training treatment appears to improve cognitive function, mood, and other aspects of daily functioning in Long COVID.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Brindisi; Phone Number: (860) 679-7581; Email: brindisi@uchc.edu

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Recruiting
      • UConn Health
      • Principal Investigator: Cutter Lindbergh, Ph.D.
      • Sub-Investigator: David Steffens, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• prior history of COVID-19 based on Centers for Disease Control and Prevention (CDC) guidelines including a positive laboratory test (e.g., nucleic acid amplification test) or a positive rapid test
• age ≥ 55 years old
• current self-reported cognitive symptoms persisting after the acute phase of the illness (i.e., >4 weeks after COVID-19 symptom onset) that cannot be explained by alternative diagnoses
• evidence of subjective cognitive impairment with a Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Perceived Cognitive Impairment (PCI) Subscale Score of ≤ 40
• Telephone Interview for Cognitive Status (TICS) ≥ 27
• fluent in English
• off psychiatric medications or on a stable dose for at least 1 month prior to commencing the study with no intention to change dose prior to completion of the study.

Exclusion Criteria:

• history of neurological disorder or other medical condition with potential to impair cognitive functioning or interfere with study participation (e.g., epilepsy, stroke, dementia, head trauma followed by persistent neurological deficits or known structural brain abnormalities)
• prior diagnosis of Mild Cognitive Impairment (MCI) or Mild Neurocognitive Disorder unrelated to the participant's history of COVID-19
• history of significant psychiatric illness per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), criteria that may interfere with study participation or confound results (e.g., schizophrenia or other psychotic disorder, bipolar and related disorders, major depressive disorder with psychotic features, personality disorder)
• history of significant neurodevelopmental condition that may interfere with study participation or confound results (e.g., intellectual disability, autism spectrum disorder)
• alcohol or other substance use disorder within the past 2 years
• significant sensory or motor impairments (e.g., blindness) that may interfere with the ability to complete neuropsychological measures or engage in the intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Computerized Cognitive Remediation

Other: NeuroFlex (computerized gamified tasks); The computerized cognitive remediation intervention ("NeuroFlex") consists of a series of gamified tasks (e.g., BrainHQ, Neurogrow, Ultimate Word Master) administered via computer tablet. The intervention provides both "bottom up" training to improve basic processing of sensory stimuli and "top down" training to improve executive functions. Participants will be asked to complete approximately 7.5 hours a week of computer treatment over an approximately 6-week period, for a total of approximately 45 hours of treatment. The treatment will be completed remotely by the participant within their own home or other private location that is most convenient for the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility (proportion of subjects who agree to participate in the offered treatment, complete assigned exercises, and complete the entire treatment regimen)	Feasibility will be assessed according to the following criteria: 1) at least 80% of eligible subjects offered the treatment agree to participate; 2) subjects will complete at least 80% of assigned treatment exercises; 3) at least 80% of participants who start the treatment will finish it.	Our feasibility criteria will be assessed by calculating percentages at the conclusion of the study
Treatment Acceptability/Adherence Scale (TAAS)	Treatment acceptability and adherence as measured by the TAAS Total Score; higher scores on this self-report measure indicate greater treatment acceptability and adherence	The investigators will evaluate TAAS Total Score at the outset of treatment (expected/anticipated acceptability and adherence) and at post-treatment (6 weeks)
Credibility/Expectancy Questionnaire (CEQ)	Treatment credibility and expectancy as measured by the CEQ Total Score; higher scores on this self-report measure indicate greater treatment credibility and expectancy	The investigators will evaluate CEQ Total Score at the outset of treatment (to assess initial perceptions of treatment credibility) and at post-treatment (6 weeks)
System Usability Scale (SUS)	Usability of the intervention as measured by the SUS Total Score; higher scores on this self-report measure indicate greater perceived usability	The investigators will evaluate SUS Total Score at the outset of treatment (to assess initial perceptions of treatment usability) and at post-treatment (6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trail Making Test Part B	Set-shifting abilities as measured by time to complete the Trail Making Test Part B in seconds; lower scores indicate better set-shifting performance	The investigators will evaluate change in time (seconds) to complete the Trail Making Test Part B at post-treatment (6 weeks) relative to pre-treatment (baseline)
Montgomery-Asberg Depression Scale (MADRS)	Depressive symptoms as measured by the Total MADRS Score; lower scores indicate less depressive symptoms	The investigators will evaluate change in Total MADRS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
World Health Organization Disability Assessment Schedule (WHODAS)	Functional disability as measured by the Total WHODAS Score; lower scores indicate less functional disability	The investigators will evaluate change in Total WHODAS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
Everyday Cognition (ECog)	Subjective cognitive concerns as measured by the Total ECog Score; lower scores indicate less subjective cognitive concern	The investigators will evaluate change in Total ECog Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
Verbal Fluency	Verbal generativity as measured by the total number of words produced according to pre-specified rules; higher scores indicate better verbal generativity performance	The investigators will evaluate change in total number of words produced at post-treatment (6 weeks) relative to pre-treatment (baseline)
Stroop Color and Word Test	Inhibitory control as measured by total correct responses on the inhibition condition of the Stroop Test; higher scores indicate better inhibitory control performance	The investigators will evaluate change in total correct responses at post-treatment (6 weeks) relative to pre-treatment (baseline)
Fatigue Assessment Scale (FAS)	Fatigue as measured by the Total FAS Score; lower scores indicate less fatigue	The investigators will evaluate change in total FAS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
California Verbal Learning Test (CVLT)	Verbal memory as measured by the total number of words correctly recalled on the long delayed free recall trial; higher scores indicate better episodic memory performance	The investigators will evaluate change in long delayed free recall at post-treatment (6 weeks) relative to pre-treatment (baseline)

Collaborators and Investigators

• Sponsor: UConn Health
• Investigators: Principal Investigator: Cutter Lindbergh, Ph.D., UConn Health

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Older Adults; Post-Acute COVID-19 Syndrome; Computerized Cognitive Remediation
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 23-089-2; Departmental Funds (Other Identifier: UConn Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No