Back to resultsBrain-Training Treatment for Long COVID in Older Adults
Primary Purpose
Post-Acute COVID-19 Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeuroFlex (computerized gamified tasks)
Sponsored by
About this trial
This is an interventional treatment trial for Post-Acute COVID-19 Syndrome focused on measuring Post-Acute COVID-19 Syndrome, Computerized Cognitive Remediation, Older Adults
Eligibility Criteria
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
Sites / Locations
- UConn HealthRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Computerized Cognitive Remediation
Arm Description
Outcomes
Primary Outcome Measures
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
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
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
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.
Secondary Outcome Measures
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
Montgomery-Asberg Depression Scale (MADRS)
Depressive symptoms as measured by the Total MADRS Score; lower scores indicate less depressive symptoms
World Health Organization Disability Assessment Schedule (WHODAS)
Functional disability as measured by the Total WHODAS Score; lower scores indicate less functional disability
Everyday Cognition (ECog)
Subjective cognitive concerns as measured by the Total ECog Score; lower scores indicate less subjective cognitive concern
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
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
Fatigue Assessment Scale (FAS)
Fatigue as measured by the Total FAS Score; lower scores indicate less fatigue
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05705193
Brief Title
Brain-Training Treatment for Long COVID in Older Adults
Official Title
Computerized Cognitive Remediation of Long COVID Symptoms in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Acute COVID-19 Syndrome
Keywords
Post-Acute COVID-19 Syndrome, Computerized Cognitive Remediation, Older Adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Computerized Cognitive Remediation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
NeuroFlex (computerized gamified tasks)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Acceptability/Adherence Scale (TAAS)
Description
Treatment acceptability and adherence as measured by the TAAS Total Score; higher scores on this self-report measure indicate greater treatment acceptability and adherence
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)
Title
Credibility/Expectancy Questionnaire (CEQ)
Description
Treatment credibility and expectancy as measured by the CEQ Total Score; higher scores on this self-report measure indicate greater treatment credibility and expectancy
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)
Title
System Usability Scale (SUS)
Description
Usability of the intervention as measured by the SUS Total Score; higher scores on this self-report measure indicate greater perceived usability
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)
Title
Feasibility (proportion of subjects who agree to participate in the offered treatment, complete assigned exercises, and complete the entire treatment regimen)
Description
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.
Time Frame
Our feasibility criteria will be assessed by calculating percentages at the conclusion of the study
Secondary Outcome Measure Information:
Title
Trail Making Test Part B
Description
Set-shifting abilities as measured by time to complete the Trail Making Test Part B in seconds; lower scores indicate better set-shifting performance
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)
Title
Montgomery-Asberg Depression Scale (MADRS)
Description
Depressive symptoms as measured by the Total MADRS Score; lower scores indicate less depressive symptoms
Time Frame
The investigators will evaluate change in Total MADRS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
Title
World Health Organization Disability Assessment Schedule (WHODAS)
Description
Functional disability as measured by the Total WHODAS Score; lower scores indicate less functional disability
Time Frame
The investigators will evaluate change in Total WHODAS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
Title
Everyday Cognition (ECog)
Description
Subjective cognitive concerns as measured by the Total ECog Score; lower scores indicate less subjective cognitive concern
Time Frame
The investigators will evaluate change in Total ECog Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
Title
Verbal Fluency
Description
Verbal generativity as measured by the total number of words produced according to pre-specified rules; higher scores indicate better verbal generativity performance
Time Frame
The investigators will evaluate change in total number of words produced at post-treatment (6 weeks) relative to pre-treatment (baseline)
Title
Stroop Color and Word Test
Description
Inhibitory control as measured by total correct responses on the inhibition condition of the Stroop Test; higher scores indicate better inhibitory control performance
Time Frame
The investigators will evaluate change in total correct responses at post-treatment (6 weeks) relative to pre-treatment (baseline)
Title
Fatigue Assessment Scale (FAS)
Description
Fatigue as measured by the Total FAS Score; lower scores indicate less fatigue
Time Frame
The investigators will evaluate change in total FAS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
Title
California Verbal Learning Test (CVLT)
Description
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
Time Frame
The investigators will evaluate change in long delayed free recall at post-treatment (6 weeks) relative to pre-treatment (baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Brindisi
Phone
(860) 679-7581
Email
brindisi@uchc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cutter Lindbergh, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Brindisi
Phone
860-679-7581
Email
brindisi@uchc.edu
First Name & Middle Initial & Last Name & Degree
Cutter Lindbergh, Ph.D.
First Name & Middle Initial & Last Name & Degree
David Steffens, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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Brain-Training Treatment for Long COVID in Older Adults
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