A Phase 4 interventional study of Digital cognitive behavioral intervention-RxWell and Amphetamine-Dextroamphetamine in Cognitive Impairment and Long COVID, sponsored by Eva Szigethy. Terminated at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-22.
Sponsored by Eva Szigethy · Phase 4, Interventional, and Treatment
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.
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.
520 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 186 are open to participants now.
This study's enrollment of 7 is below the median of 60 across 361 interventional studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →Eva Szigethy is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Digital cognitive behavioral intervention-RxWell
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.
Drug: Amphetamine-Dextroamphetamine
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.
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.
Also known as: Adderall
Change in Cognitive Impairment - MOCA
The MOCA is a validated screening tool that provides a total score to assess for mild cognitive impairment.
Time frame: Compare baseline to 12 weeks
Change in Cognitive Impairment - BrainCheck
BrainCheck is an FDA approved validated, automated, remote neurocognitive assessments in multiple domains.
Time frame: Compare baseline to 12 weeks
Change in Cognitive Impairment - ImPACT
ImPACT is an FDA approved computerized neurocognitive concussion assessment tool that provides composite sores to evaluate cognitive abilities.
Time frame: Compare baseline to 12 weeks
Change in Depression - PHQ8
Patient Health Questionnaire (PHQ8) will be utilized to measure change in depression severity from baseline up to 12 weeks after baseline. The PHQ-8 is an 8 item questionnaire. Scores can range from 0-24. A score of 0-4 indicates no depressive symptoms; 5-9 indicates mild depressive symptoms; 10-19 indicates moderate depressive symptoms; 20-24 indicates severe depressive symptoms.
Time frame: Compare baseline up to 12 weeks
Change in Quality of Life - SWLS
Satisfaction with Life Scale (SWLS) will be utilized to measure change in quality of life from baseline up to 12 weeks after baseline. SWLS is a five item measure with a maximum score of 35. Higher score correlate with higher satisfaction of life. Scores 31-35 extremely satisfied. Scores less than 9 indicate extremely dissatisfied.
Time frame: Compare baseline up to 12 weeks
Change in Disability
Sheehan Disability Scale assess functional impairment in three inter-related domains; work/school, social and family life. The three items are summed into a single measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).
Time frame: Compare baseline up to 12 weeks
| Milestone | Digital Cognitive Behavioral Intervention- RxWell | Stimulant Medication |
|---|---|---|
| Started | 6 | 1 |
| Completed | 0 | 0 |
| Not completed | 6 | 1 |
| Withdrew: Study was terminated | 6 | 1 |
The MOCA is a validated screening tool that provides a total score to assess for mild cognitive impairment.
No measurements were reported for this outcome.
BrainCheck is an FDA approved validated, automated, remote neurocognitive assessments in multiple domains.
No measurements were reported for this outcome.
ImPACT is an FDA approved computerized neurocognitive concussion assessment tool that provides composite sores to evaluate cognitive abilities.
No measurements were reported for this outcome.
Patient Health Questionnaire (PHQ8) will be utilized to measure change in depression severity from baseline up to 12 weeks after baseline. The PHQ-8 is an 8 item questionnaire. Scores can range from 0-24. A score of 0-4 indicates no depressive symptoms; 5-9 indicates mild depressive symptoms; 10-19 indicates moderate depressive symptoms; 20-24 indicates severe depressive symptoms.
No measurements were reported for this outcome.
Satisfaction with Life Scale (SWLS) will be utilized to measure change in quality of life from baseline up to 12 weeks after baseline. SWLS is a five item measure with a maximum score of 35. Higher score correlate with higher satisfaction of life. Scores 31-35 extremely satisfied. Scores less than 9 indicate extremely dissatisfied.
No measurements were reported for this outcome.
Sheehan Disability Scale assess functional impairment in three inter-related domains; work/school, social and family life. The three items are summed into a single measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).
No measurements were reported for this outcome.
Collected over Adverse event data were collected for the one month participants were involved in the study prior to the termination of the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Digital Cognitive Behavioral Intervention- RxWell | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Stimulant Medication | — | — | — |
The study was terminated prior to any baseline assessments being analyzed.
| Age, Categorical(Participants) | Digital Cognitive Behavioral Intervention- RxWell | Stimulant Medication | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 1 | 7 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Digital Cognitive Behavioral Intervention- RxWell | Stimulant Medication | Total |
|---|---|---|---|
| Mean | 41 (27 to 60) | 47 (47 to 47) | 42 (27 to 60) |
| Sex: Female, Male(Participants) | Digital Cognitive Behavioral Intervention- RxWell | Stimulant Medication | Total |
|---|---|---|---|
| Female | 6 | 1 | 7 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Digital Cognitive Behavioral Intervention- RxWell | Stimulant Medication | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 2 |
| White | 4 | 0 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Digital Cognitive Behavioral Intervention- RxWell | Stimulant Medication | Total |
|---|---|---|---|
| United States | 6 | 1 | 7 |
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Plan to share: No — Individual participant data will not be shared. Data is shared at the aggregate level.
This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Eva Szigethy