Cognitive ImpairmentNCT05498493
Cognitive Rehabilitation for Post-COVID-19 Cognitive Impairment
A study testing Cognitive Rehabilitation and Brain Health Education Program in people with Cognitive Impairment, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Cognitive Rehabilitation and Brain Health Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2022to 20 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: 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.
- Conditions
- Cognitive Impairment
- Being tested
- Cognitive Rehabilitation, Brain Health Education Program
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RehabilitationBehavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Brain Health Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: end of study, at 12 months
Enrollment yield
Practicality measured by enrollment yield which is #enrolled/approached.
Measured: end of study, at 12 months
Dropout number
Practicality measured by number of dropout
Measured: 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%).
Measured: 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.
Measured: end of study, at 12 months
Resting state functional connectivity (rsFC)
Neuroimaging Outcomes: Resting state functional connectivity (rsFC) within the central executive network (CEN).
Measured: end of study, at 12 months
Secondary outcomes (8)
National Alzheimer's Coordinating Center (NACC) battery's Number Span
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.
Measured: end of study, at 12 months
Paced Auditory Serial Addition Task (PASAT)
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.
Measured: end of study, at 12 months
Trail Making Test, Part A
Requires participants to connect numbered dots in order as quickly as possible. A higher number of seconds implies worse performance.
Measured: end of study, at 12 months
The Symbol Digit Modalities Text (SDMT)
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.
Measured: end of study, at 12 months
The Hopkins Verbal Learning Test-Revised (HVLT-R)
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.
Measured: end of study, at 12 months
NACC battery's verbal phonemic and category fluency tests
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.
Measured: end of study, at 12 months
NACC battery's abbreviated Multilingual Naming Test (MINT)
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.
Measured: end of study, at 12 months
Wide Range Achievement Test, reading subtest, 4th edition (WRAT-4)
A measure of premorbid intellectual estimate. Scores range from 0-70, where a higher score indicates greater premorbid intellectual ability.
Measured: end of study, at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start19 Sep 2022
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Wisnivesky, Icahn School of Medicine at Mount Sinai
- Investigators
- Juan Wisnivesky, MD, DrPh, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498493
- Sponsor's protocol ID
- STUDY-20-00857
- Status last verified
- Sep 2024
- First submitted
- 10 Aug 2022
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
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. 2026 Jun;36(5):853-864. doi: 10.1080/09602011.2025.2552154. Epub 2025 Sep 24.
PubMed 40991647
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Cognitive Rehabilitation for Post-COVID-19 Cognitive Impairment: a Pilot Study
- ClinicalTrials.gov ID
- NCT05498493
- Acronym / sponsor ID
- STUDY-20-00857
- Conditions
- Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Rehabilitation | Experimental | Behavioral: Cognitive RehabilitationActive 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 | Active comparator | Behavioral: Brain Health Education ProgramThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive RehabilitationThe 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. | Behavioural | Cognitive Rehabilitation |
| Brain Health Education ProgramThe 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. | Behavioural | Brain Health Education Program |
Primary outcome
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.
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.
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.
Enrollment yield
Time frame: end of study, at 12 months
Practicality measured by enrollment yield which is #enrolled/approached.
Dropout number
Time frame: end of study, at 12 months
Practicality measured by number of dropout
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%).
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.
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).
8 secondary outcomes
National Alzheimer's Coordinating Center (NACC) battery's Number Span
Time frame: end of study, at 12 months
Paced Auditory Serial Addition Task (PASAT)
Time frame: end of study, at 12 months
Trail Making Test, Part A
Time frame: end of study, at 12 months
The Symbol Digit Modalities Text (SDMT)
Time frame: end of study, at 12 months
The Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: end of study, at 12 months
NACC battery's verbal phonemic and category fluency tests
Time frame: end of study, at 12 months
NACC battery's abbreviated Multilingual Naming Test (MINT)
Time frame: end of study, at 12 months
Wide Range Achievement Test, reading subtest, 4th edition (WRAT-4)
Time frame: end of study, at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Derived from this study: PubMed 40991647Becker 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. 2026 Jun;36(5):853-864. doi: 10.1080/09602011.2025.2552154. Epub 2025 Sep 24.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Wisnivesky, MD, DrPh principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Rehabilitation and Brain Health Education Program in people with Cognitive Impairment, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trail Making Test - Part B (time frame: end of study, at 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05498493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.