Amygdala Insula Retraining in the Management of Long COVID Symptoms

NCT05851846 | Unknown

• 1 other identifier: 1677529-1
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of the study is to compare a mind body intervention against usual care in patients with fatigue with long COVID. Our research questions include

1. 1.Is the mind body intervention additive to usual care in long COVID
2. 2.Can the mind body intervention change laboratory markers, heart rate variability and dysautonomia.

Conditions

Long COVID

Outcome Measures

Primary Outcomes (1)

• Modified Yorkshire COVID-19 scale

  Long COVID symptom scale

  3 months

Secondary Outcomes (2)

• Heart rate variability

  3 months

• COMPASS-31

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Mind body intervention + Usual care: The intervention will be delivered virtually

Behavioral: Amygdala insula retraining

Control arm

NO INTERVENTION

The participants in the comparator group will be wait listed for the intervention

Interventions

Amygdala insula retraining BEHAVIORAL

Mind body intrevention

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfill the definition of PASC
• Be a patient in the Miami VA post COVID clinic
• Have access to a computer or phone
• A probable or confirmed diagnosis of acute COVID-19 infection as per WHO guidelines.
• 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.

Sponsors & Collaborators

• Miami VA Healthcare System: lead

Study Sites (3)

Institute for Neuroimmune Medcince

Fort Lauderdale, Florida, 33314, United States

Location

Miami VAHS

Miami, Florida, 33136, United States

Location

Institute for Neuroinmune medicine

Miami, Florida, 33183, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Leonardo Tamariz, MD

CONTACT

305-575-7000; leonardo.tamariz@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff physician

Model Details: What list of participants

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 10, 2023
• Study Start: May 15, 2023
• Primary Completion: May 15, 2024
• Study Completion: June 15, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

US (3)