Cognitive Rehabilitation for Post-COVID-19 Cognitive Impairment

July 27, 2023 updated by: Juan P Wisnivesky, Icahn School of Medicine at Mount Sinai

Assessing the Effectiveness of Cognitive Rehabilitation for Post-COVID-19 Cognitive Impairment: A Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 rehabiliation/training or daily meditative practices during study enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Cognitive Rehabilitation
The virtual small group format will include two to five participants and one facilitator per group. The three individual sessions are distributed at the beginning, middle, and towards the end of the training program. Individual Session 1 occurs after Group Session 1. It covers orientation to the training program, including orientation to and clarification of the Participant Handbook. Individual Session 2 occurs after Group Session 5 and involves review and implementation of training strategies. Individual Session 3 occurs after Group Session 9 and covers review of learned strategies, implementation of training strategies in daily life, and review of execution, obstacles, and adjustments required for individual projects.
Active Comparator: 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).
Behavioral: Brain Health Education Program
The active control group will control for non-specific effects inherent to supervised CR. Participants will receive a manualized brain health education (BHE) training program, matched with the adapted CR intervention for therapist time and homework. Once these participants complete the 12 weeks of the control intervention and undergo the post-intervention assessments, participants will be offered the 12 weeks active intervention to ensure that all study participants have the potential of benefitting from CR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trail Making Test - Part B
Time Frame: 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.
end of study, at 12 months
Wisconsin Card Sorting Task (WCST)-64
Time Frame: 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.
end of study, at 12 months
Acceptability Scale
Time Frame: 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.
end of study, at 12 months
Enrollment yield
Time Frame: end of study, at 12 months
Practicality measured by enrollment yield which is #enrolled/approached.
end of study, at 12 months
Dropout number
Time Frame: end of study, at 12 months
Practicality measured by number of dropout
end of study, at 12 months
Staff Practicality
Time Frame: 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%).
end of study, at 12 months
Treatment Credibility and Expectancy Questionnaire.
Time Frame: 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.
end of study, at 12 months
Resting state functional connectivity (rsFC)
Time Frame: end of study, at 12 months
Neuroimaging Outcomes: Resting state functional connectivity (rsFC) within the central executive network (CEN).
end of study, at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Alzheimer's Coordinating Center (NACC) battery's Number Span
Time Frame: 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.
end of study, at 12 months
Paced Auditory Serial Addition Task (PASAT)
Time Frame: 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.
end of study, at 12 months
Trail Making Test, Part A
Time Frame: 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.
end of study, at 12 months
The Symbol Digit Modalities Text (SDMT)
Time Frame: 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.
end of study, at 12 months
The Hopkins Verbal Learning Test-Revised (HVLT-R)
Time Frame: 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.
end of study, at 12 months
NACC battery's verbal phonemic and category fluency tests
Time Frame: 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.
end of study, at 12 months
NACC battery's abbreviated Multilingual Naming Test (MINT)
Time Frame: 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.
end of study, at 12 months
Wide Range Achievement Test, reading subtest, 4th edition (WRAT-4)
Time Frame: 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.
end of study, at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Juan Wisnivesky, MD, DrPh, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2022

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

August 10, 2022

First Posted (Actual)

August 12, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY-20-00857

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (Link to be included in the URL field below).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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