Brain-Training Treatment for Long COVID in Older Adults

NCT05705193 | Recruiting

• 3 other identifiers: 23-089-2Departmental FundsP30AG067988
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Acute COVID-19 Syndrome

Keywords

Post-Acute COVID-19 Syndrome; Computerized Cognitive Remediation; Older Adults

Outcome Measures

Primary Outcomes (4)

• 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)

• 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

Secondary Outcomes (9)

• Trail Making Test Part B

  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)

  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)

  The investigators will evaluate change in Total WHODAS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)

• Everyday Cognition (ECog)

  The investigators will evaluate change in Total ECog Score at post-treatment (6 weeks) relative to pre-treatment (baseline)

• Verbal Fluency

  The investigators will evaluate change in total number of words produced at post-treatment (6 weeks) relative to pre-treatment (baseline)

Study Arms (1)

Computerized Cognitive Remediation

EXPERIMENTAL

Other: NeuroFlex (computerized gamified tasks)

Interventions

NeuroFlex (computerized gamified tasks) OTHER

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.

Computerized Cognitive Remediation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥ 60 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 and/or endorsing any item on the FACT-Cog PCI Subscale as occurring nearly every day or several times a day
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cutter Lindbergh, Ph.D.

  UConn Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly Eddy, Ph.D., LMFT-S

CONTACT

860-679-3751; eddy@uchc.edu

Jennifer Brindisi, M.A.

CONTACT

860-679-7581; brindisi@uchc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: January 30, 2023
• Study Start: April 7, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)