Improving Attention in Individuals With Long COVID-19

NCT ID: NCT06503874

Last Updated: 2024-09-19

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-22

Study Completion Date

2027-03-01

Brief Summary

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This study is to find out if the Attention Processing Training program is a potential treatment for brain fog symptoms, reported by people with Long-Covid. Also investigating the feasibility of completing this program virtually.

Detailed Description

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The goal of this project is to test the feasibility, acceptability and efficacy of an attention training intervention (Attention Process Training; APT-3) as a potential treatment for brain fog symptoms experienced by people with Long-Covid. There already is good empirical evidence to support the idea that the APT-3 treatment is feasible and effective in improving attention in people with acquired brain injuries, but information about its efficacy and acceptability in people with Long-Covid brain fog is lacking.

Conditions

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Long Covid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

First, participants will complete the pre-treatment assessment. Participants then will be randomized to either immediate APT-3 group, delayed APT or Music activity group.

The interventions (APT-3 or Music activity) will last 4 weeks. At the end of the intervention participants will undergo another assessment battery, and once again at 1-month post intervention follow-up.

Following the maintenance assessment, participants from the Music activity group will have the option to receive the APT-3 intervention. If they accept, they will undergo another assessment battery at the end of the 4-week intervention.

Participants from the delayed APT-3 group will undergo the week 5 assessment and will then be offered to enroll in the APT-3 training. If they accept, they will undergo another assessment battery at the end of the 4-week intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Attention Training

Intervention Type OTHER

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).

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.

Group Type EXPERIMENTAL

Music Group

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Attention Training

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).

Intervention Type OTHER

Music Group

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.

Intervention Type OTHER

Other Intervention Names

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APT-3

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shirley Ryan AbilityLab

OTHER

Sponsor Role lead

Responsible Party

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Shira Cohen-Zimerman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shira Cohen-Zimerman, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Elliot Roth, MD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

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Shirley Ryan AbilityLab

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathryn Magee, MHS

Role: CONTACT

(312)238-6451

Facility Contacts

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Kathryn L Magee

Role: primary

312-238-6451

Other Identifiers

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90IFDV0033-01-00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STU00220499

Identifier Type: -

Identifier Source: org_study_id

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