Clinical trial NCT05956405: Retraining of the Amygdala and Insula for the Treatment of Persistent Covid
Official title: Retraining of the Amygdala and Insula for the Treatment of Persistent Covid
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Wellness
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Short Form de 36 items (SF-36)
timeFrame: Baseline
measure: Short Form de 36 items (SF-36)
timeFrame: Post-treatment 8 weeks from baseline
measure: Short Form de 36 items (SF-36)
timeFrame: Three-months follow-up
measure: Short Form de 36 items (SF-36)
timeFrame: Baseline
measure: Short Form de 36 items (SF-36)
timeFrame: Post-treatment 8 weeks from baseline
measure: Short Form de 36 items (SF-36)
timeFrame: Three-months follow-up
Secondary outcomes:
measure: Sociodemographic data Gender, age, marital status, education, occupation, economical level
timeFrame: Baseline
measure: Sociodemographic data Gender, age, marital status, education, occupation, economical level
timeFrame: Baseline
measure: Spanish Chronic Pain Grading Scale
timeFrame: Baseline
measure: Spanish Chronic Pain Grading Scale
timeFrame: Baseline
measure: Spanish Chronic Pain Grading Scale
timeFrame: Post-treatment 8 weeks from baseline
measure: Spanish Chronic Pain Grading Scale
timeFrame: Post-treatment 8 weeks from baseline
measure: Spanish Chronic Pain Grading Scale
timeFrame: Three-months follow-up
measure: Spanish Chronic Pain Grading Scale
timeFrame: Three-months follow-up
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Post-treatment 8 weeks from baseline
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Post-treatment 8 weeks from baseline
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Three-months follow-up
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Three-months follow-up
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Baseline
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Baseline
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Post-treatment 8 weeks from baseline
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Post-treatment 8 weeks from baseline
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Three-months follow-up
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Three-months follow-up
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline
measure: Insomnia Severity Index (ISI)
timeFrame: Post-treatment 8 weeks from baseline
measure: Insomnia Severity Index (ISI)
timeFrame: Post-treatment 8 weeks from baseline
measure: Insomnia Severity Index (ISI)
timeFrame: Three-months follow-up
measure: Insomnia Severity Index (ISI)
timeFrame: Three-months follow-up
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Post-treatment 8 weeks from baseline
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Post-treatment 8 weeks from baseline
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Three-months follow-up
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Three-months follow-up
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Post-treatment 8 weeks from baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Post-treatment 8 weeks from baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Three-months follow-up
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Three-months follow-up
measure: Memory failures of Everyday (MFE)
timeFrame: Baseline
measure: Memory failures of Everyday (MFE)
timeFrame: Baseline
measure: Memory failures of Everyday (MFE)
timeFrame: Post-treatment 8 weeks from baseline
measure: Memory failures of Everyday (MFE)
timeFrame: Post-treatment 8 weeks from baseline
measure: Memory failures of Everyday (MFE)
timeFrame: Three-months follow-up
measure: Memory failures of Everyday (MFE)
timeFrame: Three-months follow-up
measure: Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline
measure: Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline
measure: Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: Post-treatment 8 weeks from baseline
measure: Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: Post-treatment 8 weeks from baseline
measure: Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: Three-months follow-up
measure: Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: Three-months follow-up
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: Baseline
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: Baseline
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: Post-treatment 8 weeks from baseline
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: Post-treatment 8 weeks from baseline
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: Three-months follow-up
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: Three-months follow-up
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Baseline
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Baseline
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Post-treatment 8 weeks from baseline
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Post-treatment 8 weeks from baseline
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Three-months follow-up
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: In the relaxation program group
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Department of Psychiatry. Miguel Servet University Hospital
Study officials:
References: