Clinical trial NCT05705193: Brain-Training Treatment for Long COVID in Older Adults
Official title: Computerized Cognitive Remediation of Long COVID Symptoms in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Acute COVID-19 Syndrome
Keywords: Post-Acute COVID-19 Syndrome
Computerized Cognitive Remediation
Older Adults
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 ≥ 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

Primary outcomes:
measure: Treatment Acceptability/Adherence Scale (TAAS)
timeFrame: The investigators will evaluate TAAS Total Score at the outset of treatment (expected/anticipated acceptability and adherence) and at post-treatment (6 weeks)
measure: Credibility/Expectancy Questionnaire (CEQ)
timeFrame: 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)
measure: System Usability Scale (SUS)
timeFrame: 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)
measure: Feasibility (proportion of subjects who agree to participate in the offered treatment, complete assigned exercises, and complete the entire treatment regimen)
timeFrame: Our feasibility criteria will be assessed by calculating percentages at the conclusion of the study
Secondary outcomes:
measure: Trail Making Test Part B
timeFrame: 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)
measure: Montgomery-Asberg Depression Scale (MADRS)
timeFrame: The investigators will evaluate change in Total MADRS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
measure: World Health Organization Disability Assessment Schedule (WHODAS)
timeFrame: The investigators will evaluate change in Total WHODAS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
measure: Everyday Cognition (ECog)
timeFrame: The investigators will evaluate change in Total ECog Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
measure: Verbal Fluency
timeFrame: The investigators will evaluate change in total number of words produced at post-treatment (6 weeks) relative to pre-treatment (baseline)
measure: Stroop Color and Word Test
timeFrame: The investigators will evaluate change in total correct responses at post-treatment (6 weeks) relative to pre-treatment (baseline)
measure: Fatigue Assessment Scale (FAS)
timeFrame: The investigators will evaluate change in total FAS Score at post-treatment (6 weeks) relative to pre-treatment (baseline)
measure: California Verbal Learning Test (CVLT)
timeFrame: The investigators will evaluate change in long delayed free recall at post-treatment (6 weeks) relative to pre-treatment (baseline)
measure: Short Physical Performance Battery (SPPB)
timeFrame: The investigators will evaluate change in physical performance at post-treatment (6 weeks) relative to pre-treatment (baseline)
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
Study officials:
affiliation: UConn Health
name: Cutter Lindbergh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: