Addressing Cognitive Fog in Long-COVID-19 Patients

NCT ID: NCT05597722

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2023-05-18

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Digital cognitive behavioral intervention- RxWell

The mobile app provides users with brief skill building techniques such as relaxation, behavioral activation and exposure, distress tolerance, cognitive reframing, and mindfulness meditation, for anxiety and depression. The content of RxWell was developed based on standard CBT techniques for treating anxiety disorders and depression. The user will have the option to select either the depression or anxiety program, and the coach will have the ability to personalize the program so that the individual can utilize the proper CBT techniques that fits with their presentation.

The health coach communicates with RxWell users via asynchronous, secure within app messaging. They reinforce CBT principles, guide users through goal setting, and help users work through challenges and recognize successes. The coaches will also receive individualized cognitive rehabilitation tips from the speech therapist after their appointment with the participant.

Group Type: ACTIVE_COMPARATOR

Digital cognitive behavioral intervention-RxWell

Intervention Type: BEHAVIORAL

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.

Stimulant Medication

The other intervention is a stimulant medication known to reduce cognitive impairment in other chronic medical conditions, such as Inflammatory Bowel Disease. The Long-COVID psychiatrist will order the medication and the participant will be scheduled for a 6-week research tele visit with the psychiatrist to monitor for any medication side effects. Amphetamine-dextroamphetamine drug dose will be 10mg daily for 12 weeks, and no dose changes will be made. Amphetamine-dextroamphetamine is a Schedule II controlled substance that has a risk for abuse, tolerance, and psychological dependence, which can be associated with severe social disability.

Group Type: ACTIVE_COMPARATOR

Amphetamine-Dextroamphetamine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

Other Intervention Names

Adderall

Eligibility Criteria

Inclusion Criteria

• History of SARS-CoV-2 infection as defined as a positive PCR or home antigen test
• Patients with Long-COVID as defined as COVID symptoms that persist for three months or longer.
• Between the ages of 21 and 65
• Moderate cognitive impairment (MOCA score to meet criteria is < or =18) present for at least 3 months
• Response of "No" to the screening question, "Are you pregnant or do you plan to become pregnant in the next 3 months?"
• Access to a smartphone

Exclusion Criteria

• History of dementia, psychosis, mania, addiction or current conditions requiring immediate hospitalization
• Previous adverse or allergic reaction to Adderall or other amphetamines
• Pre-existing cardiac or kidney condition, severe hypertension, glaucoma, advanced arteriosclerosis, hyperthyroidism, and taking an MAOI within the past 14 days
• Current or past substance misuse
• Previous use of RxWell (completed 3 or more techniques)
• Current use of amphetamine-dextroamphetamine
• History of uncontrolled blood pressure
• Subjects taking Methylphenidate; Lisdexamfetamine; non-Adderall amphetamine products; Atomoxetine; Viloxazine; Modafinil; Armodafinil; Nortriptyline and other tricyclic drugs; Bupropion; Tramadol; and Monoamine Oxidase Inhibitor (MAOI) drugs (including Linezolid).
• Inability to pay for study medication.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Beckwith Institute

OTHER

Sponsor Role: collaborator

Eva Szigethy

OTHER

Sponsor Role: lead

Responsible Party

Eva Szigethy

Professor of Psychiatry Pediatrics and Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eva Szigethy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY22050191

Identifier Type: -

Identifier Source: org_study_id