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

September 10, 2025 updated by: Javier Garcia Campayo, Hospital Miguel Servet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50009
        • Department of Psychiatry. Miguel Servet University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amygdala & Insula Retraining + Mindfulness
Behavioral: AIR + Mindfulness
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.
Active Comparator: Relaxation condition
Behavioral: Relaxation condition
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Form de 36 items (SF-36)
Time Frame: Baseline
In the AIR + Mindfulness program group
Baseline
Short Form de 36 items (SF-36)
Time Frame: Post-treatment 8 weeks from baseline
In the AIR + Mindfulness program group
Post-treatment 8 weeks from baseline
Short Form de 36 items (SF-36)
Time Frame: Three-months follow-up
In the AIR + Mindfulness program group
Three-months follow-up
Short Form de 36 items (SF-36)
Time Frame: Baseline
In the relaxation program group
Baseline
Short Form de 36 items (SF-36)
Time Frame: Post-treatment 8 weeks from baseline
In the relaxation program group
Post-treatment 8 weeks from baseline
Short Form de 36 items (SF-36)
Time Frame: Three-months follow-up
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
Time Frame: Baseline
In the relaxation program group
Baseline
Emotional Regulation Questionnaire (ERQ)
Time Frame: Baseline
In the relaxation program group
Baseline
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Baseline
In the relaxation program group
Baseline
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: Baseline
In the relaxation program group
Baseline
Sociodemographic data Gender, age, marital status, education, occupation, economical level
Time Frame: Baseline
In the AIR + Mindfulness program group
Baseline
Spanish Chronic Pain Grading Scale
Time Frame: Baseline
In the AIR + Mindfulness program group
Baseline
Spanish Chronic Pain Grading Scale
Time Frame: Baseline
In the relaxation program group
Baseline
Spanish Chronic Pain Grading Scale
Time Frame: Post-treatment 8 weeks from baseline
In the AIR + Mindfulness program group
Post-treatment 8 weeks from baseline
Spanish Chronic Pain Grading Scale
Time Frame: Post-treatment 8 weeks from baseline
In the relaxation program group
Post-treatment 8 weeks from baseline
Spanish Chronic Pain Grading Scale
Time Frame: Three-months follow-up
In the AIR + Mindfulness program group
Three-months follow-up
Spanish Chronic Pain Grading Scale
Time Frame: Three-months follow-up
In the relaxation program group
Three-months follow-up
Pain Catastrophizing Scale (PCS)
Time Frame: Baseline
In the AIR + Mindfulness program group
Baseline
Pain Catastrophizing Scale (PCS)
Time Frame: Baseline
In the relaxation program group
Baseline
Pain Catastrophizing Scale (PCS)
Time Frame: Post-treatment 8 weeks from baseline
In the AIR + Mindfulness program group
Post-treatment 8 weeks from baseline
Pain Catastrophizing Scale (PCS)
Time Frame: Post-treatment 8 weeks from baseline
In the relaxation program group
Post-treatment 8 weeks from baseline
Pain Catastrophizing Scale (PCS)
Time Frame: Three-months follow-up
In the AIR + Mindfulness program group
Three-months follow-up
Pain Catastrophizing Scale (PCS)
Time Frame: Three-months follow-up
In the relaxation program group
Three-months follow-up
Modified Fatigue Impact Scale (MFIS)
Time Frame: Baseline
In the AIR + Mindfulness program group
Baseline
Modified Fatigue Impact Scale (MFIS)
Time Frame: Baseline
In the relaxation program group
Baseline
Modified Fatigue Impact Scale (MFIS)
Time Frame: Post-treatment 8 weeks from baseline
In the AIR + Mindfulness program group
Post-treatment 8 weeks from baseline
Modified Fatigue Impact Scale (MFIS)
Time Frame: Post-treatment 8 weeks from baseline
In the relaxation program group
Post-treatment 8 weeks from baseline
Modified Fatigue Impact Scale (MFIS)
Time Frame: Three-months follow-up
In the AIR + Mindfulness program group
Three-months follow-up
Modified Fatigue Impact Scale (MFIS)
Time Frame: Three-months follow-up
In the relaxation program group
Three-months follow-up
Insomnia Severity Index (ISI)
Time Frame: Baseline
In the AIR + Mindfulness program group
Baseline
Insomnia Severity Index (ISI)
Time Frame: Baseline
In the relaxation program group
Baseline
Insomnia Severity Index (ISI)
Time Frame: Post-treatment 8 weeks from baseline
In the AIR + Mindfulness program group
Post-treatment 8 weeks from baseline
Insomnia Severity Index (ISI)
Time Frame: Post-treatment 8 weeks from baseline
In the relaxation program group
Post-treatment 8 weeks from baseline
Insomnia Severity Index (ISI)
Time Frame: Three-months follow-up
In the AIR + Mindfulness program group
Three-months follow-up
Insomnia Severity Index (ISI)
Time Frame: Three-months follow-up
In the relaxation program group
Three-months follow-up
General Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline
In the AIR + Mindfulness program group
Baseline
General Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline
In the relaxation program group
Baseline
General Anxiety Disorder-7 (GAD-7)
Time Frame: Post-treatment 8 weeks from baseline
In the AIR + Mindfulness program group
Post-treatment 8 weeks from baseline
General Anxiety Disorder-7 (GAD-7)
Time Frame: Post-treatment 8 weeks from baseline
In the relaxation program group
Post-treatment 8 weeks from baseline
General Anxiety Disorder-7 (GAD-7)
Time Frame: Three-months follow-up
In the AIR + Mindfulness program group
Three-months follow-up
General Anxiety Disorder-7 (GAD-7)
Time Frame: Three-months follow-up
In the relaxation program group
Three-months follow-up
Memory failures of Everyday (MFE)
Time Frame: Baseline
In the AIR + Mindfulness program group
Baseline
Memory failures of Everyday (MFE)
Time Frame: Baseline
In the relaxation program group
Baseline
Memory failures of Everyday (MFE)
Time Frame: Post-treatment 8 weeks from baseline
In the AIR + Mindfulness program group
Post-treatment 8 weeks from baseline
Memory failures of Everyday (MFE)
Time Frame: Post-treatment 8 weeks from baseline
In the relaxation program group
Post-treatment 8 weeks from baseline
Memory failures of Everyday (MFE)
Time Frame: Three-months follow-up
In the AIR + Mindfulness program group
Three-months follow-up
Memory failures of Everyday (MFE)
Time Frame: Three-months follow-up
In the relaxation program group
Three-months follow-up
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: Baseline
In the AIR + Mindfulness program group
Baseline
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: Post-treatment 8 weeks from baseline
In the AIR + Mindfulness program group
Post-treatment 8 weeks from baseline
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: Post-treatment 8 weeks from baseline
In the relaxation program group
Post-treatment 8 weeks from baseline
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: Three-months follow-up
In the AIR + Mindfulness program group
Three-months follow-up
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: Three-months follow-up
In the relaxation program group
Three-months follow-up
Emotional Regulation Questionnaire (ERQ)
Time Frame: Baseline
In the AIR + Mindfulness program group
Baseline
Emotional Regulation Questionnaire (ERQ)
Time Frame: Post-treatment 8 weeks from baseline
In the AIR + Mindfulness program group
Post-treatment 8 weeks from baseline
Emotional Regulation Questionnaire (ERQ)
Time Frame: Post-treatment 8 weeks from baseline
In the relaxation program group
Post-treatment 8 weeks from baseline
Emotional Regulation Questionnaire (ERQ)
Time Frame: Three-months follow-up
In the AIR + Mindfulness program group
Three-months follow-up
Emotional Regulation Questionnaire (ERQ)
Time Frame: Three-months follow-up
In the relaxation program group
Three-months follow-up
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Baseline
In the AIR + Mindfulness program group
Baseline
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Post-treatment 8 weeks from baseline
In the AIR + Mindfulness program group
Post-treatment 8 weeks from baseline
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Post-treatment 8 weeks from baseline
In the relaxation program group
Post-treatment 8 weeks from baseline
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Three-months follow-up
In the AIR + Mindfulness program group
Three-months follow-up
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: In the relaxation program group
In the AIR + Mindfulness program group
In the relaxation program group
Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline
In the AIR + Mindfulness program group
Baseline
Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline
In the relaxation program group
Baseline
Patient Health Questionnaire (PHQ-9)
Time Frame: Post-treatment 8 weeks from baseline
In the AIR + Mindfulness program group
Post-treatment 8 weeks from baseline
Patient Health Questionnaire (PHQ-9)
Time Frame: Post-treatment 8 weeks from baseline
In the relaxation program group
Post-treatment 8 weeks from baseline
Patient Health Questionnaire (PHQ-9)
Time Frame: Three-months follow-up
In the AIR + Mindfulness program group
Three-months follow-up
Patient Health Questionnaire (PHQ-9)
Time Frame: Three-months follow-up
In the relaxation program group
Three-months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Miguel Servet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI23/315

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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