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

NCT05956405 | Completed

• 1 other identifier: PI23/315
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Wellness

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (62)

• Sociodemographic data Gender, age, marital status, education, occupation, economical level

  Baseline

• Sociodemographic data Gender, age, marital status, education, occupation, economical level

  Baseline

• Spanish Chronic Pain Grading Scale

  Baseline

• Spanish Chronic Pain Grading Scale

  Baseline

• Spanish Chronic Pain Grading Scale

  Post-treatment 8 weeks from baseline

Study Arms (2)

Amygdala & Insula Retraining + Mindfulness

EXPERIMENTAL

Behavioral: AIR + Mindfulness

Relaxation condition

ACTIVE COMPARATOR

Behavioral: Relaxation condition

Interventions

AIR + Mindfulness BEHAVIORAL

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.

Amygdala & Insula Retraining + Mindfulness

Relaxation condition BEHAVIORAL

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.

Relaxation condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-30 years old.
• Grant informed consent.
• Diagnosis of persistent COVID by primary care physicians.

You may not qualify if:

• Age: \<18 years old
• Serious medical or psychiatric illnesses

Sponsors & Collaborators

• Hospital Miguel Servet: lead

Study Sites (1)

Department of Psychiatry. Miguel Servet University Hospital

Zaragoza, 50009, Spain

Location

Related Publications (1)

• Gasion V, Barcelo-Soler A, Beltran-Ruiz M, Hijar-Aguinaga R, Camarero-Grados L, Lopez-Del-Hoyo Y, Garcia-Campayo J, Montero-Marin J. Effectiveness of an amygdala and insula retraining program combined with mindfulness training to improve the quality of life in patients with long COVID: a randomized controlled trial protocol. BMC Complement Med Ther. 2023 Nov 9;23(1):403. doi: 10.1186/s12906-023-04240-0.

  PMID: 37946190 DERIVED

MeSH Terms

Interventions

Air; Mindfulness

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 21, 2023
• Study Start: September 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

ES (1)