Retraining of the Amygdala and Insula for the Treatment of Persistent Covid

Study Overview
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Brief Summary
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Prolonged COVID, also known as post-COVID or Sar-CoV-2 infection with post-acute sequelae, refers to a set of multi-organ symptoms that persist in patients who have suffered SARS-CoV-2 infection, even after of the acute phase of the disease. Approximately 10% of people experience this set of symptoms after their acute COVID has resolved. Such symptoms may include respiratory problems, myalgia, extreme fatigue, moodiness, cognitive impairment, and difficulty sleeping. Psychological therapies, such as mindfulness, have already demonstrated their effectiveness in pathologies of this type, improving mental health and physical function, as well as reinforcing acceptance and reducing symptoms. Specifically, amygdala-insula training was originally designed for patients with chronic fatigue syndrome as a method of reducing chronic over-sensitization and heightened fear response of the amygdala, which may be behind some of the symptoms related to both with this pathology as with fibromyalgia. A lot of research is currently being done on different types of treatments such as pharmaceutical, biological, dietary, homeopathic and rehabilitation for the treatment of persistent COVID; however, an effective treatment has not yet been found. Therefore, this study aims to evaluate the impact of a retraining intervention of the amygdala and insula for the improvement of the quality of life of patients with persistent COVID.

Official Title
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Retraining of the Amygdala and Insula for the Treatment of Persistent Covid

Conditions
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Mental Health Wellness

Intervention / Treatment
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* Behavioral: AIR + Mindfulness
* Behavioral: Relaxation condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-30 years old. Grant informed consent. Diagnosis of persistent COVID by primary care physicians. Exclusion Criteria: Age: <18 years old Serious medical or psychiatric illnesses

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amygdala & Insula Retraining + Mindfulness<br> | Behavioral: AIR + Mindfulness<br>* AIR + Mindfulness program consists of 8 sessions of 120 minutes/session (10-12 people) Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months.<br>|
| Active Comparator: Relaxation condition<br> | Behavioral: Relaxation condition<br>* Relaxation program consists of 8 sessions of 120 minutes/session (10-12 people) Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form de 36 items (SF-36) | In the AIR + Mindfulness program group | Baseline | 
| Short Form de 36 items (SF-36) | In the AIR + Mindfulness program group | Post-treatment 8 weeks from baseline | 
| Short Form de 36 items (SF-36) | In the AIR + Mindfulness program group | Three-months follow-up | 
| Short Form de 36 items (SF-36) | In the relaxation program group | Baseline | 
| Short Form de 36 items (SF-36) | In the relaxation program group | Post-treatment 8 weeks from baseline | 
| Short Form de 36 items (SF-36) | In the relaxation program group | Three-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic data Gender, age, marital status, education, occupation, economical level | In the AIR + Mindfulness program group | Baseline | 
| Sociodemographic data Gender, age, marital status, education, occupation, economical level | In the relaxation program group | Baseline | 
| Spanish Chronic Pain Grading Scale | In the AIR + Mindfulness program group | Baseline | 
| Spanish Chronic Pain Grading Scale | In the relaxation program group | Baseline | 
| Spanish Chronic Pain Grading Scale | In the AIR + Mindfulness program group | Post-treatment 8 weeks from baseline | 
| Spanish Chronic Pain Grading Scale | In the relaxation program group | Post-treatment 8 weeks from baseline | 
| Spanish Chronic Pain Grading Scale | In the AIR + Mindfulness program group | Three-months follow-up | 
| Spanish Chronic Pain Grading Scale | In the relaxation program group | Three-months follow-up | 
| Pain Catastrophizing Scale (PCS) | In the AIR + Mindfulness program group | Baseline | 
| Pain Catastrophizing Scale (PCS) | In the relaxation program group | Baseline | 
| Pain Catastrophizing Scale (PCS) | In the AIR + Mindfulness program group | Post-treatment 8 weeks from baseline | 
| Pain Catastrophizing Scale (PCS) | In the relaxation program group | Post-treatment 8 weeks from baseline | 
| Pain Catastrophizing Scale (PCS) | In the AIR + Mindfulness program group | Three-months follow-up | 
| Pain Catastrophizing Scale (PCS) | In the relaxation program group | Three-months follow-up | 
| Modified Fatigue Impact Scale (MFIS) | In the AIR + Mindfulness program group | Baseline | 
| Modified Fatigue Impact Scale (MFIS) | In the relaxation program group | Baseline | 
| Modified Fatigue Impact Scale (MFIS) | In the AIR + Mindfulness program group | Post-treatment 8 weeks from baseline | 
| Modified Fatigue Impact Scale (MFIS) | In the relaxation program group | Post-treatment 8 weeks from baseline | 
| Modified Fatigue Impact Scale (MFIS) | In the AIR + Mindfulness program group | Three-months follow-up | 
| Modified Fatigue Impact Scale (MFIS) | In the relaxation program group | Three-months follow-up | 
| Insomnia Severity Index (ISI) | In the AIR + Mindfulness program group | Baseline | 
| Insomnia Severity Index (ISI) | In the relaxation program group | Baseline | 
| Insomnia Severity Index (ISI) | In the AIR + Mindfulness program group | Post-treatment 8 weeks from baseline | 
| Insomnia Severity Index (ISI) | In the relaxation program group | Post-treatment 8 weeks from baseline | 
| Insomnia Severity Index (ISI) | In the AIR + Mindfulness program group | Three-months follow-up | 
| Insomnia Severity Index (ISI) | In the relaxation program group | Three-months follow-up | 
| General Anxiety Disorder-7 (GAD-7) | In the AIR + Mindfulness program group | Baseline | 
| General Anxiety Disorder-7 (GAD-7) | In the relaxation program group | Baseline | 
| General Anxiety Disorder-7 (GAD-7) | In the AIR + Mindfulness program group | Post-treatment 8 weeks from baseline | 
| General Anxiety Disorder-7 (GAD-7) | In the relaxation program group | Post-treatment 8 weeks from baseline | 
| General Anxiety Disorder-7 (GAD-7) | In the AIR + Mindfulness program group | Three-months follow-up | 
| General Anxiety Disorder-7 (GAD-7) | In the relaxation program group | Three-months follow-up | 
| Patient Health Questionnaire (PHQ-9) | In the AIR + Mindfulness program group | Baseline | 
| Patient Health Questionnaire (PHQ-9) | In the relaxation program group | Baseline | 
| Patient Health Questionnaire (PHQ-9) | In the AIR + Mindfulness program group | Post-treatment 8 weeks from baseline | 
| Patient Health Questionnaire (PHQ-9) | In the relaxation program group | Post-treatment 8 weeks from baseline | 
| Patient Health Questionnaire (PHQ-9) | In the AIR + Mindfulness program group | Three-months follow-up | 
| Patient Health Questionnaire (PHQ-9) | In the relaxation program group | Three-months follow-up | 
| Memory failures of Everyday (MFE) | In the AIR + Mindfulness program group | Baseline | 
| Memory failures of Everyday (MFE) | In the relaxation program group | Baseline | 
| Memory failures of Everyday (MFE) | In the AIR + Mindfulness program group | Post-treatment 8 weeks from baseline | 
| Memory failures of Everyday (MFE) | In the relaxation program group | Post-treatment 8 weeks from baseline | 
| Memory failures of Everyday (MFE) | In the AIR + Mindfulness program group | Three-months follow-up | 
| Memory failures of Everyday (MFE) | In the relaxation program group | Three-months follow-up | 
| Five Facets of Mindfulness Questionnaire (FFMQ) | In the AIR + Mindfulness program group | Baseline | 
| Five Facets of Mindfulness Questionnaire (FFMQ) | In the relaxation program group | Baseline | 
| Five Facets of Mindfulness Questionnaire (FFMQ) | In the AIR + Mindfulness program group | Post-treatment 8 weeks from baseline | 
| Five Facets of Mindfulness Questionnaire (FFMQ) | In the relaxation program group | Post-treatment 8 weeks from baseline | 
| Five Facets of Mindfulness Questionnaire (FFMQ) | In the AIR + Mindfulness program group | Three-months follow-up | 
| Five Facets of Mindfulness Questionnaire (FFMQ) | In the relaxation program group | Three-months follow-up | 
| Emotional Regulation Questionnaire (ERQ) | In the AIR + Mindfulness program group | Baseline | 
| Emotional Regulation Questionnaire (ERQ) | In the relaxation program group | Baseline | 
| Emotional Regulation Questionnaire (ERQ) | In the AIR + Mindfulness program group | Post-treatment 8 weeks from baseline | 
| Emotional Regulation Questionnaire (ERQ) | In the relaxation program group | Post-treatment 8 weeks from baseline | 
| Emotional Regulation Questionnaire (ERQ) | In the AIR + Mindfulness program group | Three-months follow-up | 
| Emotional Regulation Questionnaire (ERQ) | In the relaxation program group | Three-months follow-up | 
| Acceptance and Action Questionnaire-II (AAQ-II) | In the AIR + Mindfulness program group | Baseline | 
| Acceptance and Action Questionnaire-II (AAQ-II) | In the relaxation program group | Baseline | 
| Acceptance and Action Questionnaire-II (AAQ-II) | In the AIR + Mindfulness program group | Post-treatment 8 weeks from baseline | 
| Acceptance and Action Questionnaire-II (AAQ-II) | In the relaxation program group | Post-treatment 8 weeks from baseline | 
| Acceptance and Action Questionnaire-II (AAQ-II) | In the AIR + Mindfulness program group | Three-months follow-up | 
| Acceptance and Action Questionnaire-II (AAQ-II) | In the AIR + Mindfulness program group | In the relaxation program group |