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

U

University Hospital Miguel Servet

Status

Enrolling

Conditions

Mental Health Wellness

Treatments

Behavioral: AIR + Mindfulness
Behavioral: Relaxation condition

Study type

Interventional

Funder types

Other

Identifiers

NCT05956405
PI23/315

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Amygdala & Insula Retraining + Mindfulness
Experimental group
Treatment:
Behavioral: AIR + Mindfulness
Relaxation condition
Active Comparator group
Treatment:
Behavioral: Relaxation condition

Trial contacts and locations

1

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Central trial contact

Virginia Gasión; Javier García Campayo, PhD

Data sourced from clinicaltrials.gov

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