Mental Health Wellness
Conditions
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.
Interventions
BEHAVIORALAIR + 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.
BEHAVIORALRelaxation 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.
Sponsors
Hospital Miguel Servet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Form de 36 items (SF-36) | Baseline | In the AIR + Mindfulness program group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sociodemographic data Gender, age, marital status, education, occupation, economical level | Baseline | In the AIR + Mindfulness program group |
| Spanish Chronic Pain Grading Scale | Baseline | In the AIR + Mindfulness program group |
| Pain Catastrophizing Scale (PCS) | Baseline | In the AIR + Mindfulness program group |
| Modified Fatigue Impact Scale (MFIS) | Baseline | In the AIR + Mindfulness program group |
| General Anxiety Disorder-7 (GAD-7) | Baseline | In the AIR + Mindfulness program group |
| Insomnia Severity Index (ISI) | Baseline | In the AIR + Mindfulness program group |
| Memory failures of Everyday (MFE) | Baseline | In the AIR + Mindfulness program group |
| Five Facets of Mindfulness Questionnaire (FFMQ) | Baseline | In the AIR + Mindfulness program group |
| Emotional Regulation Questionnaire (ERQ) | Baseline | In the AIR + Mindfulness program group |
| Acceptance and Action Questionnaire-II (AAQ-II) | Baseline | In the AIR + Mindfulness program group |
| Patient Health Questionnaire (PHQ-9) | Baseline | In the AIR + Mindfulness program group |
Countries
Spain
Outcome results
None listed