Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
More than 30 percent of the over 70 million individuals in the United States who experienced an acute COVID-19 infection as a result of severe acute respiratory coronavirus-2 (SARS-CoV2), have variety of lingering and disabling symptoms that last beyond the acute phase of the illness. [1]This condition is referred to as Post-Acute Sequalae SARS-CoV-2 infection (PASC). Symptoms (including fatigue, post-exertional malaise (PEM), cardiovascular dysfunction, respiratory distress, gastrointestinal disturbances, and dermatologic issues) associated with PASC vary and can affect multiple organ systems. These symptoms are similar to, in extent and degree, to other neuro-immune conditions such as Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). PASC, as with ME/CFS, is likely to pose a significant impact on the healthcare system and patient's quality of life. An unmet need exists as the susceptibility and pathogenesis of PASC remains yet to be fully elucidated. Emerging evidence suggests that existing interventions widely used for other neuro-immune conditions may prove equally effective in the treatment of PASC. Repurposing of drugs or identification of new drugs will take time. Still, there is growing evidence of the mind-body connection in modulating the autonomic, central and peripheral nervous systems as well as the immune system and the gastrointestinal tract. Recent studies have documented that holistic strategies such as mindfulness, meditation, and amygdala and insula retraining (AIR) have an objective measurable effect on heart rate variability, fatigue, pain, quality of life, depression, anxiety, and gastrointestinal symptoms. The mechanisms proposed include activation of vagus nerve, balancing the autonomic nervous system, reducing stress, and improving immune function. AIR is based on the principle that viral, bacterial, or environmental insults can sensitize the amygdala, which becomes hypervigilant and unleashes a cascade of hormonal responses that perpetuate a state of neuroinflammation and dysautonomia. AIR de-sensitizes the amygdala, breaking vicious cycles and reducing the maladaptive release of hormones and cytokines. Our clinical group has already recommended the use of AIR with great anecdotical response in clinical practice. This strategy is readily available and has no contraindications or risks. We aim to conduct a pilot study of AIR to generate preliminary data for a larger, federally funded trial. Our specific aims are:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Mind body intervention + Usual care: The intervention will be delivered virtually |
|
| Control arm | No Intervention | The participants in the comparator group will be wait listed for the intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amygdala insula retraining | Behavioral | Mind body intrevention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Yorkshire COVID-19 scale | Long COVID symptom scale | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability | SSDN | 3 months |
| COMPASS-31 | Dysautonomia scale | 3 months |
Not provided
Inclusion Criteria:
The inclusion criteria will be:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leonardo Tamariz, MD | Contact | 305-575-7000 | 4487 | leonardo.tamariz@va.gov |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Neuroimmune Medcince | Fort Lauderdale | Florida | 33314 | United States |
Not provided
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
Not provided
Not provided
What list of participants
Not provided
Not provided
Not provided
Not provided
| Miami VAHS | Miami | Florida | 33136 | United States |
|
| Institute for Neuroinmune medicine | Miami | Florida | 33183 | United States |
|
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |