Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04747405
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2021-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'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': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011615', 'term': 'Psychotherapy, Group'}], 'ancestors': [{'id': 'D012960', 'term': 'Socioenvironmental 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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2021-02-09', 'studyFirstSubmitQcDate': '2021-02-09', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of post traumatic stress syndrome', 'timeFrame': '12 months after intensive care hospitalization', 'description': 'the aim is to compare the prevalence of post traumatic stress syndrome between both groups 12 months after exiting intensive care unit'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intensive Care Unit Syndrome', 'Covid19', 'Anxiety', 'Depression']}, 'descriptionModule': {'briefSummary': 'Psychological impact of intensive care hospitalization for patients has been demonstrated during the last few years: anxiety, depression and post traumatic stress disorder. Hospitalizations during COVID-19 pandemic have been marked by factors such as confinement forbidding family members visits, stress on intensive care unit ...Those factors may have a psychological impact added to factors of long hospitalization and prolonged mechanical ventilation.\n\nFor all these reasons the investigators fear that patients hospitalized in intensive care during COVID-19 pandemic develop psychological trouble with an increased risk for those who experienced COVID-19 infection. The hypothesis therapy group added to standard care might have a positive impact on psychological troubles such as anxiety, depression and post traumatic stress disorder for patients who have been hospitalized in intensive care during COVID-19 pandemic.\n\nThe investigators will compare two groups:\n\n* group receiving standard of care\n* group receiving standard of care and therapy group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old and older\n* hospitalized at least 72h in intensive care during COVID-19 pandemic crisis\n* out of intensive care for at least 2 months and maximum 6 months\n* psychological evaluation done according to local practice and standard of care\n* speaking french\n* patient coming alone to the therapy group\n* patient agree to respect confidentiality rules and demonstrating goodwill with others participants\n* patient comite to respecting barriers rules against COVID-19\n* affiliated to social security system\n* no juridic protection engaged\n\nExclusion Criteria:\n\n* presenting psychological disease\n* drug addiction\n* participation to other interventional clinical trial'}, 'identificationModule': {'nctId': 'NCT04747405', 'acronym': 'GPR COVID', 'briefTitle': 'Evaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Metropole Savoie'}, 'officialTitle': 'Evaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study', 'orgStudyIdInfo': {'id': 'CHMS20009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'A standard', 'description': 'standard of care'}, {'type': 'EXPERIMENTAL', 'label': 'B therapy group', 'description': 'standard of care and therapy group', 'interventionNames': ['Other: therapy group']}], 'interventions': [{'name': 'therapy group', 'type': 'OTHER', 'description': 'therapy group of maximum 8 people repeated twice', 'armGroupLabels': ['B therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73000', 'city': 'Chambéry', 'country': 'France', 'facility': 'CH Métropole Savoie', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}], 'overallOfficials': [{'name': 'Romain PERCOT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cebtre Hospitalier Metropole Savoie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Metropole Savoie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}