Cognitive Rehabilitation for Post-COVID-19 Cognitive Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-19

Study Completion Date

2024-08-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive Rehabilitation

Intervention Type 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.

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).

Group Type ACTIVE_COMPARATOR

Brain Health Education Program

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No