Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT05956405
Status:
COMPLETED
Last Update Posted:
2025-09-16
First Post:
2023-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retraining of the Amygdala and Insula for the Treatment of Persistent Covid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000388', 'term': 'Air'}, {'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2023-07-20', 'studyFirstSubmitQcDate': '2023-07-20', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short Form de 36 items (SF-36)', 'timeFrame': 'Baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Short Form de 36 items (SF-36)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Short Form de 36 items (SF-36)', 'timeFrame': 'Three-months follow-up', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Short Form de 36 items (SF-36)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Short Form de 36 items (SF-36)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Short Form de 36 items (SF-36)', 'timeFrame': 'Three-months follow-up', 'description': 'In the relaxation program group'}], 'secondaryOutcomes': [{'measure': 'Sociodemographic data Gender, age, marital status, education, occupation, economical level', 'timeFrame': 'Baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Sociodemographic data Gender, age, marital status, education, occupation, economical level', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Spanish Chronic Pain Grading Scale', 'timeFrame': 'Baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Spanish Chronic Pain Grading Scale', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Spanish Chronic Pain Grading Scale', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Spanish Chronic Pain Grading Scale', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Spanish Chronic Pain Grading Scale', 'timeFrame': 'Three-months follow-up', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Spanish Chronic Pain Grading Scale', 'timeFrame': 'Three-months follow-up', 'description': 'In the relaxation program group'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'Baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'Three-months follow-up', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'Three-months follow-up', 'description': 'In the relaxation program group'}, {'measure': 'Modified Fatigue Impact Scale (MFIS)', 'timeFrame': 'Baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Modified Fatigue Impact Scale (MFIS)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Modified Fatigue Impact Scale (MFIS)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Modified Fatigue Impact Scale (MFIS)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Modified Fatigue Impact Scale (MFIS)', 'timeFrame': 'Three-months follow-up', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Modified Fatigue Impact Scale (MFIS)', 'timeFrame': 'Three-months follow-up', 'description': 'In the relaxation program group'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Three-months follow-up', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Three-months follow-up', 'description': 'In the relaxation program group'}, {'measure': 'General Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'General Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'General Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'General Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'General Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Three-months follow-up', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'General Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Three-months follow-up', 'description': 'In the relaxation program group'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Three-months follow-up', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Three-months follow-up', 'description': 'In the relaxation program group'}, {'measure': 'Memory failures of Everyday (MFE)', 'timeFrame': 'Baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Memory failures of Everyday (MFE)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Memory failures of Everyday (MFE)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Memory failures of Everyday (MFE)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Memory failures of Everyday (MFE)', 'timeFrame': 'Three-months follow-up', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Memory failures of Everyday (MFE)', 'timeFrame': 'Three-months follow-up', 'description': 'In the relaxation program group'}, {'measure': 'Five Facets of Mindfulness Questionnaire (FFMQ)', 'timeFrame': 'Baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Five Facets of Mindfulness Questionnaire (FFMQ)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Five Facets of Mindfulness Questionnaire (FFMQ)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Five Facets of Mindfulness Questionnaire (FFMQ)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Five Facets of Mindfulness Questionnaire (FFMQ)', 'timeFrame': 'Three-months follow-up', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Five Facets of Mindfulness Questionnaire (FFMQ)', 'timeFrame': 'Three-months follow-up', 'description': 'In the relaxation program group'}, {'measure': 'Emotional Regulation Questionnaire (ERQ)', 'timeFrame': 'Baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Emotional Regulation Questionnaire (ERQ)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Emotional Regulation Questionnaire (ERQ)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Emotional Regulation Questionnaire (ERQ)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Emotional Regulation Questionnaire (ERQ)', 'timeFrame': 'Three-months follow-up', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Emotional Regulation Questionnaire (ERQ)', 'timeFrame': 'Three-months follow-up', 'description': 'In the relaxation program group'}, {'measure': 'Acceptance and Action Questionnaire-II (AAQ-II)', 'timeFrame': 'Baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Acceptance and Action Questionnaire-II (AAQ-II)', 'timeFrame': 'Baseline', 'description': 'In the relaxation program group'}, {'measure': 'Acceptance and Action Questionnaire-II (AAQ-II)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Acceptance and Action Questionnaire-II (AAQ-II)', 'timeFrame': 'Post-treatment 8 weeks from baseline', 'description': 'In the relaxation program group'}, {'measure': 'Acceptance and Action Questionnaire-II (AAQ-II)', 'timeFrame': 'Three-months follow-up', 'description': 'In the AIR + Mindfulness program group'}, {'measure': 'Acceptance and Action Questionnaire-II (AAQ-II)', 'timeFrame': 'In the relaxation program group', 'description': 'In the AIR + Mindfulness program group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Health Wellness']}, 'referencesModule': {'references': [{'pmid': '37946190', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPsychological 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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-30 years old.\n* Grant informed consent.\n* Diagnosis of persistent COVID by primary care physicians.\n\nExclusion Criteria:\n\n* Age: \\<18 years old\n* Serious medical or psychiatric illnesses'}, 'identificationModule': {'nctId': 'NCT05956405', 'briefTitle': 'Retraining of the Amygdala and Insula for the Treatment of Persistent Covid', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Miguel Servet'}, 'officialTitle': 'Retraining of the Amygdala and Insula for the Treatment of Persistent Covid', 'orgStudyIdInfo': {'id': 'PI23/315'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amygdala & Insula Retraining + Mindfulness', 'interventionNames': ['Behavioral: AIR + Mindfulness']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Relaxation condition', 'interventionNames': ['Behavioral: Relaxation condition']}], 'interventions': [{'name': 'AIR + Mindfulness', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Amygdala & Insula Retraining + Mindfulness']}, {'name': 'Relaxation condition', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Relaxation condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Department of Psychiatry. Miguel Servet University Hospital', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Miguel Servet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Javier Garcia Campayo', 'investigatorAffiliation': 'Hospital Miguel Servet'}}}}