Cognitive Rehabilitation for Post-COVID-19 Cognitive Impairment
- Conditions
- Cognitive Impairment
- Interventions
- Behavioral: Cognitive RehabilitationBehavioral: Brain Health Education Program
- Registration Number
- NCT05498493
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief Summary
This pilot randomized controlled trial is to investigate the feasibility and efficacy of cognitive rehabilitation for patients with post-COVID-19 cognitive impairment. Additionally, the study will obtain preliminary data, using rsfMRI, regarding the potential underlying connectivity networks, mediating the effect of CR on cognitive improvements.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 67
- Adults ≥18 years of age
- Have a confirmed SARS-CoV-2 infection (positive PCR or are serum antibody positive [against spike protein if unvaccinated or N-capsid peptide if vaccinated])
- Speak English
- Have objective mild to moderate cognitive impairment, which will be defined as impairment in executive function (a z-score >1.5 standard deviations below the normative mean) and in at least one other cognitive domain
- Endorse comfort and familiarity with technology.
- No method of contact
- Major neurocognitive disorder, as defined by a score <17 on the Montreal Cognitive Assessment (MoCA)
- History of pre-COVID-19 neurologic disease (e.g., stroke)
- History of severe head injury (as defined by loss of consciousness >30 minutes)
- Ongoing substance use disorder (Mini International Neuropsychiatric Interview Version 7.0.2 [MINI] or Alcohol Use Disorders Test-Consumption [AUDIT-C] >8)
- Unstable medical, neurologic, or psychiatric conditions precluding participation in research activities, and
- Contraindication for MRI (e.g., metallic/electronic implants).
- Not involved in cognitive rehabilitation/training or daily meditative practices during study enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Rehabilitation Cognitive Rehabilitation Active Group participants will receive nine 1.5-h sessions of virtual (via Zoom platform) group-based training, three individual virtual 1-h training sessions, and approximately 20 h of home practice and CCT over 12 weeks. Brain Health Education Program Brain Health Education Program The control group format will be twelve 1.5 or 1 h virtual sessions over 12 weeks, in addition to 20 h of home practice of a computerized control program (e.g., consisting of publicly available computer games such as sudoku and crossword puzzles).
- Primary Outcome Measures
Name Time Method Enrollment yield end of study, at 12 months Practicality measured by enrollment yield which is #enrolled/approached.
Acceptability Scale end of study, at 12 months Acceptability: using 7 Likert-rated items (scores will be coded as: Low: ≤3; Moderate: 3-3.9; Good: ≥4).
Full range from 1-7, with higher score indicating higher acceptability.Treatment Credibility and Expectancy Questionnaire. end of study, at 12 months Participants' beliefs about how likely they are to benefit from the intervention using the Treatment Credibility and Expectancy Questionnaire. Full scale from 0-10, with higher score indicating higher treatment expectancy.
Resting state functional connectivity (rsFC) end of study, at 12 months Neuroimaging Outcomes: Resting state functional connectivity (rsFC) within the central executive network (CEN).
Trail Making Test - Part B end of study, at 12 months Trail Making Test - Part B: a measure of aspects of executive functioning (e.g., set- shifting and cognitive flexibility), where participants connect the dots on a page scattered with numbers and letters in alternating sequence. Scored by time in seconds. Higher number of seconds implies deficiencies in cognitive functioning.
Wisconsin Card Sorting Task (WCST)-64 end of study, at 12 months Wisconsin Card Sorting Task (WCST)-64: Computer Version 2. The WCST-64 is a measure of executive functioning assessing novel problem solving and abstract thinking. The software scores the test and generates percentile scores (0-100). Scored by percentile. Higher percentile implies scoring better than others who have completed the task.
Dropout number end of study, at 12 months Practicality measured by number of dropout
Staff Practicality end of study, at 12 months Open-ended questions to staff regarding challenges conducting intervention (e.g., difficulty enrolling, reaching, engaging participants; scores will be coded as: Low: \<50%; Moderate: 50-70%; Good: \>70%).
- Secondary Outcome Measures
Name Time Method The Hopkins Verbal Learning Test-Revised (HVLT-R) end of study, at 12 months A list learning task that assesses learning (immediate recall) and memory (delayed recall) and recognition discrimination. The total score (higher score means a better outcome) is converted to a standardized "T" score using normative data. The possible "T" score for each participant ranges from 20 to 80, with higher scores indicative of better performance.
Wide Range Achievement Test, reading subtest, 4th edition (WRAT-4) end of study, at 12 months A measure of premorbid intellectual estimate. Scores range from 0-70, where a higher score indicates greater premorbid intellectual ability.
Trail Making Test, Part A end of study, at 12 months Requires participants to connect numbered dots in order as quickly as possible. A higher number of seconds implies worse performance.
The Symbol Digit Modalities Text (SDMT) end of study, at 12 months Requires an individual to substitute digits for abstract symbols using a reference key as quickly as possible. Reaction times in seconds for the performance of the symbol-digit modalities test. A higher number of seconds implies worse performance.
NACC battery's verbal phonemic and category fluency tests end of study, at 12 months Requires participants to name as many words as they can beginning with a particular letter in 60 seconds, and then as many animals as they can, respectively. A higher number of words or animals named is indicative of better performance.
NACC battery's abbreviated Multilingual Naming Test (MINT) end of study, at 12 months The MINT is a research measure intended to assess word retrieval deficits. It requires participants to name a series of individually presented line drawings that range from highly common (e.g. butterfly) to more obscure (e.g., axle) objects. The total scores range from 0 to 32, with higher scores indicating better performance.
National Alzheimer's Coordinating Center (NACC) battery's Number Span end of study, at 12 months Participants hear digit sequences of increasing lengths and have to recall them forward and in reversed order. Each level contains two equal number series with different numbers. Max score is 14 points for forward span and 14 points for backwards span. Higher score indicates better performance.
Paced Auditory Serial Addition Task (PASAT) end of study, at 12 months Single digits are presented every 3 seconds and the participant must add each new digit to the one immediately prior to it. The score is the total number correct out of 60 possible answers. Full scale range from 0-60. Higher scores represent better performance.
Trial Locations
- Locations (1)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States