Improving Attention in Individuals With Long COVID-19

NCT06503874 | Completed

• 2 other identifiers: STU0022049990IFDV0033-01-00
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Long Covid

Keywords

COVID-19; Brain Fog

Outcome Measures

Primary Outcomes (1)

• Number of participants who successfully completed at least 80% of the study tasks sessions

  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.

  2 years

Secondary Outcomes (1)

• Change of scores in objective attention tests (i.e, CPT 3), pre- and post -intervention

  2 year

Other Outcomes (1)

• Change of scores in objective attention tests (i.e, Digit Span), pre- and post -intervention

  2 year

Study Arms (3)

Attention Training

EXPERIMENTAL

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.

Other: Attention Training

Music Program

EXPERIMENTAL

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.

Other: Music Group

Delayed Attention Training

NO INTERVENTION

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.

Interventions

Attention Training 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).

Also known as: APT-3

Attention Training

Music Group 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.

Music Program

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19; Mental Fatigue

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatigue; Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Shira Cohen-Zimerman, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

• Elliot Roth, MD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: March 22, 2024
• Primary Completion: March 13, 2026
• Study Completion: March 13, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (1)