Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT05815693
Status:
UNKNOWN
Last Update Posted:
2023-06-29
First Post:
2023-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive-behavioral Therapy for Mental Disorder in COVID-19 Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000099024', 'term': 'Mindfulness-Based Stress Reduction'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-28', 'studyFirstSubmitDate': '2023-04-11', 'studyFirstSubmitQcDate': '2023-04-13', 'lastUpdatePostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic pain', 'timeFrame': '6 months and 1 year', 'description': 'pain that persists or recurs for longer than 3 months, and it exerts an enormous personal and economic burden, affecting more than 30% of people worldwide'}, {'measure': 'Anxiety', 'timeFrame': '6 months and 1 year', 'description': 'an emotion characterized by feelings of tension, worried thoughts, and physical changes like increased blood pressure'}, {'measure': 'Depression', 'timeFrame': '6 months and 1 year', 'description': 'a depressed mood or loss of pleasure or interest in activities for long periods of time'}, {'measure': 'Insomnia', 'timeFrame': '6 months and 1 year', 'description': 'a common sleep disorder that can make it hard to fall asleep, hard to stay asleep, or cause you to wake up too early and not be able to get back to sleep'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Acute COVID-19 Syndrome']}, 'descriptionModule': {'briefSummary': 'The consequences of the Intensive Care Unit and the Covid-19 disease are still uncertain. However, many studies are bringing out often psychological and dramatic consequences for many COVID-survivor patients.\n\nAmong the ex-covid patients discharged from our Intensive Care Unit and with at least one covid-related psychological consequence, we want to evaluate the effectiveness for long-term consequences of COVID-19 of mindfulness-based stress reduction (MBSR) or usual care.', 'detailedDescription': 'Randomized controlled clinical study. All patients who survived COVID-19 and discharged from the intensive care unit of the Lecco hospital will be enrolled if present: chronic pain, anxiety, depression and/or insomnia in pharmacological therapy A group of patients will be observed during 12 months and evaluated with rating scales for chronic pain, anxiety, depression and insomnia.\n\nThe second (experimental) group will receive psychotherapy (mindfulness-based stress reduction and cognitive behavioral therapy) in addition to the pharmacological therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intensive care survivors\n* Surviving COVID-19 patients\n* Patients with Chronic Pain Anxiety Depression and/or Insomnia in drug therapy\n\nExclusion Criteria:\n\n* Patients with Chronic Pain Anxiety Depression and/or Insomnia NOT in drug therapy\n* Patients not hospitalized in intensive care for COVID-19'}, 'identificationModule': {'nctId': 'NCT05815693', 'acronym': 'LONGCOVID', 'briefTitle': 'Cognitive-behavioral Therapy for Mental Disorder in COVID-19 Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Socio Sanitaria Territoriale di Lecco'}, 'officialTitle': 'Evaluate the Effectiveness for Long-term Consequences of COVID-19 of Mindfulness-based Stress Reduction (MBSR)', 'orgStudyIdInfo': {'id': 'ASST LECCO, DEP. ICU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group 1', 'description': 'usual care for anxiety, depression, chronic pain and insomnia'}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'mindfulness-based stress reduction (MBSR) for anxiety, depression, chronic pain and insomnia', 'interventionNames': ['Behavioral: mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT)']}], 'interventions': [{'name': 'mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT)', 'type': 'BEHAVIORAL', 'description': 'Patients with long-term consequences of COVID-19 (Chronic pain, anxiety, depression or insomnia) enrolled and randomly assigned to receive MBSR (n = 63), or usual care (n = 62). MBSR (training in mindfulness meditation and yoga) were delivered in 12 months with 2-hour groups each 2 months. Usual care included anything care participants received such as drug therapy.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23814', 'city': 'Lecco', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'VINCENZO LC DAMICO', 'role': 'CONTACT', 'email': 'vi.damico@asst-lecco.it', 'phone': '3409297118', 'phoneExt': 'LC'}], 'facility': 'ASST Lecco', 'geoPoint': {'lat': 45.85589, 'lon': 9.39704}}], 'centralContacts': [{'name': 'Vincenzo LC Damico, PhD', 'role': 'CONTACT', 'email': 'vi.damico@asst-lecco.it', 'phone': '+39 3409297118', 'phoneExt': 'LC'}], 'overallOfficials': [{'name': 'Vincenzo Damico', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Socio Sanitaria Territoriale di Lecco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Socio Sanitaria Territoriale di Lecco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Registered Nurse (RN), Doctor of Philosophy (PhD), Department of Anesthesia and Critical Care', 'investigatorFullName': 'Vincenzo Damico', 'investigatorAffiliation': 'Azienda Socio Sanitaria Territoriale di Lecco'}}}}