NCT05597722

Addressing Cognitive Fog in Long-COVID-19 Patients

Randomized Study to Evaluate Strategies to Address Cognitive Fog in Long-COVID-19 Patients

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Eva Szigethy · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will assess two options to help patients better manage the cognitive fog and emotional distress that may be associated with having Long-COVID. Long-COVID is post-COVID conditions or symptoms lasting more than four weeks after infection. Clinicians from the UPMC Long-COVID Clinic leading this study are evaluating the utility of computer-based evaluation of COVID-related cognitive fog and the helpfulness of two intervention strategies to treat moderate cognitive impairment using a randomized trial. The two intervention strategies include 1) a standardized dosing of amphetamine/dextroamphetamine medication that has been used to improve cognitive fog; and 2) a digital behavioral tool with an embedded health coach that is used on a mobile phone.

Detailed description

Eligible participants will be randomized to one of two arms. One intervention targets cognitive fog associated with depression (RxWell mobile app), the other the cognitive fog directly (Amphetamine-dextroamphetamine medication). Two weeks after randomization, participants are contacted by study staff to complete the GAD7. Participants who are randomized to RxWell will be offered assistance if they were not able to download the app on their own. Participants who are randomized to receive the stimulant will also complete a stimulant drug side effect rating scale to determine if the participant has any effects from the medication. All participants will complete computerized neurocognitive assessments (ImPACT, and BrainCheck) and other study measures (MOCA (Screen, 1.5 and 3 months), Patient Health Questionnaire, Generalized Anxiety Disorder Measure, Satisfaction with Life Scale, PCL-5 Post Traumatic Stress Disorder checklist, ADHD Symptom Screener, and Sheehan Disability Scale) at baseline, 1.5 (interim) and 3 months after randomization. The study measures, other than the neuro-cognitive assessments, will be completed via REDCap.

Conditions

• Cognitive Impairment
• Long COVID

Interventions

Type	Name	Description
BEHAVIORAL	Digital cognitive behavioral intervention-RxWell	RxWell is a coach enhanced digital behavioral health intervention that teaches techniques to help manage emotional distress, which may improve cognitive fog and/or depression. Participants will have access to this app for three months.
DRUG	Amphetamine-Dextroamphetamine	Participants randomized to this arm will be prescribed 10mg of amphetamine-dextroamphetamine to take as needed to help with cognitive fog. Participants in this arm will be contacted at 2 and 6 weeks to assess for any side effects from taking the medication.

Timeline

• Start date: 2023-04-04
• Primary completion: 2023-05-18
• Completion: 2023-05-18
• First posted: 2022-10-28
• Last updated: 2024-07-22
• Results posted: 2024-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study