Computerized Cognitive Remediation of Long COVID Symptoms in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Treatment Acceptability/Adherence Scale (TAAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Computerized Cognitive Remediation
干预措施: NeuroFlex (computerized gamified tasks) (Other)
结局指标
主要结局
Treatment Acceptability/Adherence Scale (TAAS)
时间窗: The investigators will evaluate TAAS Total Score at the outset of treatment (expected/anticipated acceptability and adherence) and at post-treatment (6 weeks)
Treatment acceptability and adherence as measured by the TAAS Total Score; higher scores on this self-report measure indicate greater treatment acceptability and adherence
System Usability Scale (SUS)
时间窗: 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)
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)
时间窗: Our feasibility criteria will be assessed by calculating percentages at the conclusion of the study
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.
Credibility/Expectancy Questionnaire (CEQ)
时间窗: 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)
Treatment credibility and expectancy as measured by the CEQ Total Score; higher scores on this self-report measure indicate greater treatment credibility and expectancy
次要结局
- Stroop Color and Word Test(The investigators will evaluate change in total correct responses 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))
- 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))
- 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))
- Short Physical Performance Battery (SPPB)(The investigators will evaluate change in physical performance 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))
- Everyday Cognition (ECog)(The investigators will evaluate change in Total ECog Score at post-treatment (6 weeks) relative to pre-treatment (baseline))
- California Verbal Learning Test (CVLT)(The investigators will evaluate change in long delayed free recall at post-treatment (6 weeks) relative to pre-treatment (baseline))
- Fatigue Assessment Scale (FAS)(The investigators will evaluate change in total FAS Score at post-treatment (6 weeks) relative to pre-treatment (baseline))
研究者
Cutter Lindbergh
Assistant Professor
UConn Health