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Trial - NCT05498493


Column Value
Trial registration number NCT05498493
Full text link
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : March 14, 2023, midnight
Source : ClinicalTrials.gov

Nadia Zubair

Contact
Last imported at : March 14, 2023, midnight
Source : ClinicalTrials.gov

nadia.zubair@mountsinai.org

Registration date
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

2022-08-12

Recruitment status
Last imported at : Aug. 23, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

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
Last imported at : March 14, 2023, midnight
Source : ClinicalTrials.gov

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

Number of arms
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Icahn School of Medicine at Mount Sinai

Inclusion age min
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

60

primary outcome
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Acceptability Scale;Dropout number;Enrollment yield;Resting state functional connectivity (rsFC);Staff Practicality;Trail Making Test - Part B;Treatment Credibility and Expectancy Questionnaire.;Wisconsin Card Sorting Task (WCST)-64

Notes
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Aug. 13, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2109, "treatment_name": "Cognitive rehabilitation exercises", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Control", "treatment_id": 961, "treatment_name": "Patient education", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}]