Clinical trial NCT06503874: Improving Attention in Individuals With Long COVID-19
Official title: Intensive Attention Training to Treat Brain Fog in Individuals With Long-Covid
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long Covid
Keywords: COVID-19
Brain Fog
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants who successfully completed at least 80% of the study tasks sessions
timeFrame: 2 years
Secondary outcomes:
measure: Change of scores in objective attention tests (i.e, CPT 3), pre- and post -intervention
timeFrame: 2 year
Other outcomes:
measure: Change of scores in objective attention tests (i.e, Digit Span), pre- and post -intervention
timeFrame: 2 year
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Shira Cohen-Zimerman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shirley Ryan AbilityLab
name: Elliot Roth, MD
role: PRINCIPAL_INVESTIGATOR
References: