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Behavioral Intervention
Amygdala Insula Retraining for Post-COVID Syndrome
N/A
Waitlist Available
Research Sponsored by Miami VA Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have no evidence of cardiac or pulmonary end organ damage, as per WHO definition. We will define not having end organ damage as a normal ejection fraction on echocardiogram and no pulmonary infiltrates on a non-contrast computed tomography (CT) of the chest during the work-up of the long COVID clinic.
A probable or confirmed diagnosis of acute COVID-19 infection as per WHO guidelines.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial will compare a mind-body intervention to usual care in people with long COVID to see if it helps reduce fatigue & improve lab markers.
Who is the study for?
This trial is for individuals who have had COVID-19 and are now experiencing long-term fatigue, without any heart or lung damage. Participants must have been diagnosed with post-COVID syndrome, be patients at the Miami VA post-COVID clinic, and have access to a computer or phone.Check my eligibility
What is being tested?
The study tests amygdala insula retraining as an additional treatment to usual care for managing fatigue in long COVID patients. It will also explore if this mind-body intervention can affect lab markers, heart rate variability, and dysautonomia.See study design
What are the potential side effects?
Since amygdala insula retraining is a non-invasive mind-body technique focusing on mental exercises and relaxation strategies, it typically does not cause physical side effects. However, individual experiences may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart and lungs are functioning normally according to tests.
Select...
I have been diagnosed with COVID-19 following WHO guidelines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Modified Yorkshire COVID-19 scale
Secondary outcome measures
COMPASS-31
Heart rate variability
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Mind body intervention + Usual care: The intervention will be delivered virtually
Group II: Control armActive Control1 Intervention
The participants in the comparator group will be wait listed for the intervention
Find a Location
Who is running the clinical trial?
Miami VA Healthcare SystemLead Sponsor
17 Previous Clinical Trials
2,271 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart and lungs are functioning normally according to tests.I have been diagnosed with COVID-19 following WHO guidelines.You have symptoms consistent with post-acute sequelae of SARS-CoV-2 infection.I have access to a computer or phone.I experience moderate fatigue after having COVID-19.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation currently enrolling participants?
"According to clinicialtrials.gov, this medical trial is not recruiting at this time; the first posting was on May 15th 2023 and the most recent update occurred eight days ago. Despite its lack of recruitment, there are still 47 other trials actively seeking patients right now."
Answered by AI
Who else is applying?
What site did they apply to?
Miami VAHS
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I still feel fatigue, headaches, loss of smell and taste.
PatientReceived 1 prior treatment
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