Improving Attention in Individuals With Long COVID-19 (LongCovAtten)

Intensive Attention Training to Treat Brain Fog in Individuals With Long-Covid

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.

Study Overview

• Status: Completed
• Conditions: Long Covid
• Intervention / Treatment: Other: Attention Training; Other: Music Group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan AbilityLab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

3

Arms and Interventions

Participant Group / Arm	Intervention / 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.	Other: 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).; Other Names: APT-3
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.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of scores in objective attention tests (i.e, CPT 3), pre- and post -intervention	The Conners Continuous Performance Test Third Edition™ (Conners CPT 3™)	2 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of scores in objective attention tests (i.e, Digit Span), pre- and post -intervention	Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) - Digit Span Subtest	2 year

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• 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): March 22, 2024
• Primary Completion (Actual): March 13, 2026
• Study Completion (Actual): March 13, 2026

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: COVID-19; Brain Fog
• 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: 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: No
• Studies a U.S. FDA-regulated device product: No