Cognitive Rehabilitation for Post-COVID-19 Cognitive Impairment

Mount Sinai Health System

Status: Completed

Conditions: Cognitive Impairment

Treatments: Behavioral: Cognitive Rehabilitation; Behavioral: Brain Health Education Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05498493

STUDY-20-00857

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 rehabilitation/training or daily meditative practices during study enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 2 patient groups

Cognitive Rehabilitation

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Rehabilitation

Brain Health Education Program

Active Comparator group

Description:

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).

Treatment:

Behavioral: Brain Health Education Program