Trial Outcomes & Findings for Addressing Cognitive Fog in Long-COVID-19 Patients (NCT NCT05597722)
NCT ID: NCT05597722
Last Updated: 2024-07-22
Results Overview
The MOCA is a validated screening tool that provides a total score to assess for mild cognitive impairment.
TERMINATED
PHASE4
7 participants
Compare baseline to 12 weeks
2024-07-22
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
Study was terminated
|
6
|
1
|
Baseline Characteristics
Addressing Cognitive Fog in Long-COVID-19 Patients
Baseline characteristics by cohort
| Measure |
Digital Cognitive Behavioral Intervention- RxWell
n=6 Participants
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.
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.
|
Stimulant Medication
n=1 Participants
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.
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.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41 years
n=5 Participants
|
47 years
n=7 Participants
|
42 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Compare baseline to 12 weeksPopulation: The trial was terminated before the outcome measure data were collected. No follow-up data was collected for any participant.
The MOCA is a validated screening tool that provides a total score to assess for mild cognitive impairment.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Compare baseline to 12 weeksPopulation: The trial was terminated before the outcome measure data were collected. No follow-up data was collected for any participant.
BrainCheck is an FDA approved validated, automated, remote neurocognitive assessments in multiple domains.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Compare baseline to 12 weeksPopulation: The trial was terminated before the outcome measure data were collected. No follow-up data was collected for any participant.
ImPACT is an FDA approved computerized neurocognitive concussion assessment tool that provides composite sores to evaluate cognitive abilities.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Compare baseline up to 12 weeksPopulation: The trial was terminated before the outcome measure data were collected. No follow-up data was collected for any participant.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Compare baseline up to 12 weeksPopulation: The trial was terminated before the outcome measure data were collected. No follow-up data was collected for any participant.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Compare baseline up to 12 weeksPopulation: The trial was terminated before the outcome measure data were collected. No follow-up data was collected for any participant.
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).
Outcome measures
Outcome data not reported
Adverse Events
Digital Cognitive Behavioral Intervention- RxWell
Stimulant Medication
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place