Cognitive Rehabilitation for Post-COVID-19 Cognitive Impairment

NCT05498493 | Completed DMC

• 1 other identifier: STUDY-20-00857
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (8)

• Trail Making Test - Part B

  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

  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

  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

  Practicality measured by enrollment yield which is #enrolled/approached.

  end of study, at 12 months

• Dropout number

  Practicality measured by number of dropout

  end of study, at 12 months

• Staff Practicality

  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.

  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)

  Neuroimaging Outcomes: Resting state functional connectivity (rsFC) within the central executive network (CEN).

  end of study, at 12 months

Secondary Outcomes (8)

• National Alzheimer's Coordinating Center (NACC) battery's Number Span

  end of study, at 12 months

• Paced Auditory Serial Addition Task (PASAT)

  end of study, at 12 months

• Trail Making Test, Part A

  end of study, at 12 months

• The Symbol Digit Modalities Text (SDMT)

  end of study, at 12 months

• The Hopkins Verbal Learning Test-Revised (HVLT-R)

  end of study, at 12 months

Study Arms (2)

Cognitive Rehabilitation

EXPERIMENTAL

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

Brain Health Education Program

ACTIVE COMPARATOR

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

Interventions

Cognitive Rehabilitation BEHAVIORAL

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.

Cognitive Rehabilitation

Brain Health Education Program BEHAVIORAL

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.

Brain Health Education Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Becker JH, Watson E, Zubair N, Carnavali F, Bagiella E, Reich D, Wisnivesky JP. Preliminary evaluation of a cognitive rehabilitation intervention for post-COVID-19 cognitive impairment: A pilot randomized controlled trial. Neuropsychol Rehabil. 2025 Sep 24:1-12. doi: 10.1080/09602011.2025.2552154. Online ahead of print.

  PMID: 40991647 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Juan Wisnivesky, MD, DrPh

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of General Internal Medicine

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: September 19, 2022
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• 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).

Locations

US (1)