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

Not Applicable

Recruiting

• Conditions: Mental Health Wellness
• Interventions: Behavioral: AIR + Mindfulness; Behavioral: Relaxation condition

• Registration Number: NCT05956405
• Lead Sponsor: Hospital Miguel Servet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-07-21
• Study Start: 2023-09-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amygdala & Insula Retraining + Mindfulness	AIR + Mindfulness	-
Relaxation condition	Relaxation condition	-

Primary Outcome Measures

Name	Time	Method
Short Form de 36 items (SF-36)	Three-months follow-up	In the relaxation program group

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Psychiatry. Miguel Servet University Hospital; 🇪🇸 Zaragoza, Spain