Brain-Training Treatment for Long COVID in Older Adults
Computerized Cognitive Remediation of Long COVID Symptoms in Older Adults
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Holly Eddy, Ph.D., LMFT-S
- Phone Number: 860-679-3751
- Email: eddy@uchc.edu
Study Contact Backup
- Name: Jennifer Brindisi, M.A.
- Phone Number: 860-679-7581
- Email: brindisi@uchc.edu
Study Locations
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Connecticut
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Farmington, Connecticut, United States, 06030
- UConn Health
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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 ≥ 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.
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Computerized Cognitive Remediation
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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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feasibility (proportion of subjects who agree to participate in the offered treatment, complete assigned exercises, and complete the entire treatment regimen)
Time Frame: Our feasibility criteria will be assessed by calculating percentages at the conclusion of the study
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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.
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Our feasibility criteria will be assessed by calculating percentages at the conclusion of the study
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Treatment Acceptability/Adherence Scale (TAAS)
Time Frame: The investigators will evaluate TAAS Total Score at the outset of treatment (expected/anticipated acceptability and adherence) and at post-treatment (6 weeks)
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Treatment acceptability and adherence as measured by the TAAS Total Score; higher scores on this self-report measure indicate greater treatment acceptability and adherence
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The investigators will evaluate TAAS Total Score at the outset of treatment (expected/anticipated acceptability and adherence) and at post-treatment (6 weeks)
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Credibility/Expectancy Questionnaire (CEQ)
Time Frame: 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)
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Treatment credibility and expectancy as measured by the CEQ Total Score; higher scores on this self-report measure indicate greater treatment credibility and expectancy
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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)
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System Usability Scale (SUS)
Time Frame: 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)
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Usability of the intervention as measured by the SUS Total Score; higher scores on this self-report measure indicate greater perceived usability
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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)
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Trail Making Test Part B
Time Frame: 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)
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Set-shifting abilities as measured by time to complete the Trail Making Test Part B in seconds; lower scores indicate better set-shifting performance
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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)
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Montgomery-Asberg Depression Scale (MADRS)
Time Frame: The investigators will evaluate change in Total MADRS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
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Depressive symptoms as measured by the Total MADRS Score; lower scores indicate less depressive symptoms
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The investigators will evaluate change in Total MADRS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
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World Health Organization Disability Assessment Schedule (WHODAS)
Time Frame: The investigators will evaluate change in Total WHODAS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
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Functional disability as measured by the Total WHODAS Score; lower scores indicate less functional disability
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The investigators will evaluate change in Total WHODAS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
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Everyday Cognition (ECog)
Time Frame: The investigators will evaluate change in Total ECog Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
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Subjective cognitive concerns as measured by the Total ECog Score; lower scores indicate less subjective cognitive concern
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The investigators will evaluate change in Total ECog Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
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Verbal Fluency
Time Frame: The investigators will evaluate change in total number of words produced at post-treatment (6 weeks) relative to pre-treatment (baseline)
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Verbal generativity as measured by the total number of words produced according to pre-specified rules; higher scores indicate better verbal generativity performance
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The investigators will evaluate change in total number of words produced at post-treatment (6 weeks) relative to pre-treatment (baseline)
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Stroop Color and Word Test
Time Frame: The investigators will evaluate change in total correct responses at post-treatment (6 weeks) relative to pre-treatment (baseline)
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Inhibitory control as measured by total correct responses on the inhibition condition of the Stroop Test; higher scores indicate better inhibitory control performance
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The investigators will evaluate change in total correct responses at post-treatment (6 weeks) relative to pre-treatment (baseline)
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Fatigue Assessment Scale (FAS)
Time Frame: The investigators will evaluate change in total FAS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
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Fatigue as measured by the Total FAS Score; lower scores indicate less fatigue
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The investigators will evaluate change in total FAS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
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California Verbal Learning Test (CVLT)
Time Frame: The investigators will evaluate change in long delayed free recall at post-treatment (6 weeks) relative to pre-treatment (baseline)
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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
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The investigators will evaluate change in long delayed free recall at post-treatment (6 weeks) relative to pre-treatment (baseline)
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Short Physical Performance Battery (SPPB)
Time Frame: The investigators will evaluate change in physical performance at post-treatment (6 weeks) relative to pre-treatment (baseline)
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Physical performance as measured by the Total SPPB Score; higher scores indicate better physical performance.
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The investigators will evaluate change in physical performance at post-treatment (6 weeks) relative to pre-treatment (baseline)
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Cutter Lindbergh, Ph.D., UConn Health
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- COVID-19
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Pathological Conditions, Signs and Symptoms
- Post-Acute COVID-19 Syndrome
Other Study ID Numbers
Other Study ID Numbers
- 23-089-2
- Departmental Funds (Other Identifier: UConn Health)
- P30AG067988 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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