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

Mental Health Wellness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05956405
• Other study ID #: PI23/315
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: October 2023
• Source: Hospital Miguel Servet
• Contact: Javier García Campayo, PhD
• Phone: +34976506578
• Email: jgarcamp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Wellness

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Department of Psychiatry. Miguel Servet University Hospital	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Miguel Servet

Country where clinical trial is conducted

Spain, 

Outcome

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