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Completed

NCT Number: NCT05956405

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

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.

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Key information

Conditions

Mental Health Wellness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry. Miguel Servet University Hospital

Zaragoza, 50009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Short Form de 36 items (SF-36)

    Time frame: Baseline

    In the AIR + Mindfulness program group

  2. Short Form de 36 items (SF-36)

    Time frame: Post-treatment 8 weeks from baseline

    In the AIR + Mindfulness program group

  3. Short Form de 36 items (SF-36)

    Time frame: Three-months follow-up

    In the AIR + Mindfulness program group

  4. Short Form de 36 items (SF-36)

    Time frame: Baseline

    In the relaxation program group

  5. Short Form de 36 items (SF-36)

    Time frame: Post-treatment 8 weeks from baseline

    In the relaxation program group

  6. Short Form de 36 items (SF-36)

    Time frame: Three-months follow-up

    In the relaxation program group

Secondary outcomes

  1. Sociodemographic data Gender, age, marital status, education, occupation, economical level

    Time frame: Baseline

    In the AIR + Mindfulness program group

  2. Sociodemographic data Gender, age, marital status, education, occupation, economical level

    Time frame: Baseline

    In the relaxation program group

  3. Spanish Chronic Pain Grading Scale

    Time frame: Baseline

    In the AIR + Mindfulness program group

  4. Spanish Chronic Pain Grading Scale

    Time frame: Baseline

    In the relaxation program group

  5. Spanish Chronic Pain Grading Scale

    Time frame: Post-treatment 8 weeks from baseline

    In the AIR + Mindfulness program group

  6. Spanish Chronic Pain Grading Scale

    Time frame: Post-treatment 8 weeks from baseline

    In the relaxation program group

  7. Spanish Chronic Pain Grading Scale

    Time frame: Three-months follow-up

    In the AIR + Mindfulness program group

  8. Spanish Chronic Pain Grading Scale

    Time frame: Three-months follow-up

    In the relaxation program group

  9. Pain Catastrophizing Scale (PCS)

    Time frame: Baseline

    In the AIR + Mindfulness program group

  10. Pain Catastrophizing Scale (PCS)

    Time frame: Baseline

    In the relaxation program group

  11. Pain Catastrophizing Scale (PCS)

    Time frame: Post-treatment 8 weeks from baseline

    In the AIR + Mindfulness program group

  12. Pain Catastrophizing Scale (PCS)

    Time frame: Post-treatment 8 weeks from baseline

    In the relaxation program group

  13. Pain Catastrophizing Scale (PCS)

    Time frame: Three-months follow-up

    In the AIR + Mindfulness program group

  14. Pain Catastrophizing Scale (PCS)

    Time frame: Three-months follow-up

    In the relaxation program group

  15. Modified Fatigue Impact Scale (MFIS)

    Time frame: Baseline

    In the AIR + Mindfulness program group

  16. Modified Fatigue Impact Scale (MFIS)

    Time frame: Baseline

    In the relaxation program group

  17. Modified Fatigue Impact Scale (MFIS)

    Time frame: Post-treatment 8 weeks from baseline

    In the AIR + Mindfulness program group

  18. Modified Fatigue Impact Scale (MFIS)

    Time frame: Post-treatment 8 weeks from baseline

    In the relaxation program group

  19. Modified Fatigue Impact Scale (MFIS)

    Time frame: Three-months follow-up

    In the AIR + Mindfulness program group

  20. Modified Fatigue Impact Scale (MFIS)

    Time frame: Three-months follow-up

    In the relaxation program group

  21. Insomnia Severity Index (ISI)

    Time frame: Baseline

    In the AIR + Mindfulness program group

  22. Insomnia Severity Index (ISI)

    Time frame: Baseline

    In the relaxation program group

  23. Insomnia Severity Index (ISI)

    Time frame: Post-treatment 8 weeks from baseline

    In the AIR + Mindfulness program group

  24. Insomnia Severity Index (ISI)

    Time frame: Post-treatment 8 weeks from baseline

    In the relaxation program group

  25. Insomnia Severity Index (ISI)

    Time frame: Three-months follow-up

    In the AIR + Mindfulness program group

  26. Insomnia Severity Index (ISI)

    Time frame: Three-months follow-up

    In the relaxation program group

  27. General Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline

    In the AIR + Mindfulness program group

  28. General Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline

    In the relaxation program group

  29. General Anxiety Disorder-7 (GAD-7)

    Time frame: Post-treatment 8 weeks from baseline

    In the AIR + Mindfulness program group

  30. General Anxiety Disorder-7 (GAD-7)

    Time frame: Post-treatment 8 weeks from baseline

    In the relaxation program group

  31. General Anxiety Disorder-7 (GAD-7)

    Time frame: Three-months follow-up

    In the AIR + Mindfulness program group

  32. General Anxiety Disorder-7 (GAD-7)

    Time frame: Three-months follow-up

    In the relaxation program group

  33. Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline

    In the AIR + Mindfulness program group

  34. Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline

    In the relaxation program group

  35. Patient Health Questionnaire (PHQ-9)

    Time frame: Post-treatment 8 weeks from baseline

    In the AIR + Mindfulness program group

  36. Patient Health Questionnaire (PHQ-9)

    Time frame: Post-treatment 8 weeks from baseline

    In the relaxation program group

  37. Patient Health Questionnaire (PHQ-9)

    Time frame: Three-months follow-up

    In the AIR + Mindfulness program group

  38. Patient Health Questionnaire (PHQ-9)

    Time frame: Three-months follow-up

    In the relaxation program group

  39. Memory failures of Everyday (MFE)

    Time frame: Baseline

    In the AIR + Mindfulness program group

  40. Memory failures of Everyday (MFE)

    Time frame: Baseline

    In the relaxation program group

  41. Memory failures of Everyday (MFE)

    Time frame: Post-treatment 8 weeks from baseline

    In the AIR + Mindfulness program group

  42. Memory failures of Everyday (MFE)

    Time frame: Post-treatment 8 weeks from baseline

    In the relaxation program group

  43. Memory failures of Everyday (MFE)

    Time frame: Three-months follow-up

    In the AIR + Mindfulness program group

  44. Memory failures of Everyday (MFE)

    Time frame: Three-months follow-up

    In the relaxation program group

  45. Five Facets of Mindfulness Questionnaire (FFMQ)

    Time frame: Baseline

    In the AIR + Mindfulness program group

  46. Five Facets of Mindfulness Questionnaire (FFMQ)

    Time frame: Baseline

    In the relaxation program group

  47. Five Facets of Mindfulness Questionnaire (FFMQ)

    Time frame: Post-treatment 8 weeks from baseline

    In the AIR + Mindfulness program group

  48. Five Facets of Mindfulness Questionnaire (FFMQ)

    Time frame: Post-treatment 8 weeks from baseline

    In the relaxation program group

  49. Five Facets of Mindfulness Questionnaire (FFMQ)

    Time frame: Three-months follow-up

    In the AIR + Mindfulness program group

  50. Five Facets of Mindfulness Questionnaire (FFMQ)

    Time frame: Three-months follow-up

    In the relaxation program group

  51. Emotional Regulation Questionnaire (ERQ)

    Time frame: Baseline

    In the AIR + Mindfulness program group

  52. Emotional Regulation Questionnaire (ERQ)

    Time frame: Baseline

    In the relaxation program group

  53. Emotional Regulation Questionnaire (ERQ)

    Time frame: Post-treatment 8 weeks from baseline

    In the AIR + Mindfulness program group

  54. Emotional Regulation Questionnaire (ERQ)

    Time frame: Post-treatment 8 weeks from baseline

    In the relaxation program group

  55. Emotional Regulation Questionnaire (ERQ)

    Time frame: Three-months follow-up

    In the AIR + Mindfulness program group

  56. Emotional Regulation Questionnaire (ERQ)

    Time frame: Three-months follow-up

    In the relaxation program group

  57. Acceptance and Action Questionnaire-II (AAQ-II)

    Time frame: Baseline

    In the AIR + Mindfulness program group

  58. Acceptance and Action Questionnaire-II (AAQ-II)

    Time frame: Baseline

    In the relaxation program group

  59. Acceptance and Action Questionnaire-II (AAQ-II)

    Time frame: Post-treatment 8 weeks from baseline

    In the AIR + Mindfulness program group

  60. Acceptance and Action Questionnaire-II (AAQ-II)

    Time frame: Post-treatment 8 weeks from baseline

    In the relaxation program group

  61. Acceptance and Action Questionnaire-II (AAQ-II)

    Time frame: Three-months follow-up

    In the AIR + Mindfulness program group

  62. Acceptance and Action Questionnaire-II (AAQ-II)

    Time frame: In the relaxation program group

    In the AIR + Mindfulness program group

Sponsors and collaborators

Lead sponsor

Hospital Miguel Servet

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2023
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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