Improving Attention in Individuals With Long COVID-19 (LongCovAtten)
Intensive Attention Training to Treat Brain Fog in Individuals With Long-Covid
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Kathryn Magee, MHS
- Phone Number: (312)238-6451
- Email: LongCovid@sralab.org
Study Locations
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-
Illinois
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Chicago, Illinois, United States, 60611
- Shirley Ryan Abilitylab
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18-65 years. Live in the Chicagoland area
- A history of confirmed SARS-CoV-2 infection.
- Subjective reports of cognitive symptoms that interfere with everyday activities, starting on or shortly after SARS-CoV-2 infection.
- Continuation or development of Long-Covid brain fog 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation.
- Objective attentional deficits as measured by the Conners CPT-312, and/or the Digit Span subtest (WAIS- III13).
- Able to use a keyboard.
- Able to understand and communicate in English.
- Able to consent independently.
Exclusion Criteria:
- Being hospitalized due to COVID-19 diagnosis for more than 3 days.
- Pre-morbid neurological conditions that could potentially affect cognition, such as Parkinson's Disease, Alzheimer's Dementia, acquired brain injury.
- Severe depression.
- Currently enrolled in cognitive training or physical exercise training.
- Receiving chemotherapy or radiation within last 6 months.
- Active substance abuse.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Attention Training
The computer based APT-3 intervention will be delivered in a hybrid model that will combine in-person therapy sessions at Shirley Ryan AbilityLab and practice sessions which will be completed remotely.
The dosing of each intervention training will be 30 minutes per day, 5 days a week, for 4 weeks (10 hours total over 4 weeks).
The difficulty of the tasks in both interventions will increase progressively as the participants improve in their skills.
APT-3 treatment will be administered by a trained and certified speech-language pathologist.
|
The APT-3 is an evidence-based, standardized computer-based training program that was designed to improve attention skills that underlie higher level cognitive processes (e.g., executive functions and memory).
Other Names:
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Experimental: Music Program
This group will receive an enhanced music experience.
They will listen to pre determined music for 30 minutes per day, 5 days a week, for 4 weeks (10 hours total over 4 weeks).
This will be delivered in a hybrid model that will combine, in person, remote, and independent sessions, similar to the Attention Training group.
Once they complete the music program, they will have the option to complete the Attention Training.
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This group will listen to a pre-determined playlist of music following the same dosing as the attention training group as stated in the arms.
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No Intervention: Delayed Attention Training
This group will not be provided any program for the initial 4 weeks.
After they complete the week 5 assessments, they will have the option to complete the Attention Training.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants who successfully completed at least 80% of the study tasks sessions
Time Frame: 2 years
|
Recording the number of participants who completed at least 80% of the study sessions out of the number of all participants who enrolled in the study.
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2 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of scores in objective attention tests (i.e, CPT 3), pre- and post -intervention
Time Frame: 2 year
|
The Conners Continuous Performance Test Third Edition™ (Conners CPT 3™)
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2 year
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of scores in objective attention tests (i.e, Digit Span), pre- and post -intervention
Time Frame: 2 year
|
Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) - Digit Span Subtest
|
2 year
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Elliot Roth, MD, Shirley Ryan Abilitylab
- Principal Investigator: Shira Cohen-Zimerman, PhD, Shirley Ryan Abilitylab
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Behavioral Symptoms
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Fatigue
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- COVID-19
- Post-Acute COVID-19 Syndrome
- Mental Fatigue
Other Study ID Numbers
Other Study ID Numbers
- STU00220499
- 90IFDV0033-01-00 (Other Grant/Funding Number: Department of Health and Human Services)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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