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Stimulant

Digital cognitive behavioral intervention- RxWell for Cognitive Impairment

Phase 4
Waitlist Available
Led By Eva Szigethy, MD, PhD
Research Sponsored by Eva Szigethy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up compare baseline to 12 weeks
Awards & highlights

Study Summary

This trial will test two strategies to help people with long-term COVID-related issues like cognitive fog and emotional distress. One uses medication, the other a digital tool with a health coach.

Eligible Conditions
  • Cognitive Impairment
  • COVID-19

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~compare baseline to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and compare baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Cognitive Impairment - BrainCheck
Change in Cognitive Impairment - ImPACT
Change in Cognitive Impairment - MOCA
Secondary outcome measures
Mental Depression
Change in Disability
Change in Quality of Life - SWLS

Trial Design

2Treatment groups
Active Control
Group I: Digital cognitive behavioral intervention- RxWellActive Control1 Intervention
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 II: Stimulant MedicationActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Eva SzigethyLead Sponsor
1 Previous Clinical Trials
99 Total Patients Enrolled
The Beckwith InstituteUNKNOWN
1 Previous Clinical Trials
609 Total Patients Enrolled
Eva Szigethy, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh
5 Previous Clinical Trials
964 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for participants in this experiment?

"As per clinicaltrials.gov, this trial is not actively seeking participants at the moment. The study was initially posted on November 15th 2022 and last updated on October 27th 2022. Although no longer recruiting patients, there are 632 other medical studies that are presently open for enrollment."

Answered by AI

Is there an age limit to participation in this research endeavor?

"The inclusion criteria for this research requires that recruits must be of legal age (21+) and not past their senior years (65-)."

Answered by AI

Who meets the criteria for entry into this clinical experiment?

"This research initiative is looking to enroll 120 individuals aged 21-65 suffering from cognitive impairment (ci). Furthermore, these participants must also have a history of SARS-CoV-2 infection attested by either a positive PCR or home antigen test, respond in the negative to any potential pregnancy plans for the following three months and display lingering Long COVID symptoms. Additionally, they need to obtain a score within 18 on the MOCA assessment as well as access to a smartphone device."

Answered by AI

Has the Food and Drug Administration sanctioned any Stimulant Medication?

"This medication already has official approval, so it scored a 3 on our scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Addressing Cognitive Fog in Long-COVID-19 Patients
Eva Szigethy 2023. "Addressing Cognitive Fog in Long-COVID-19 Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05597722.
~3 spots leftby Apr 2025
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