Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-22 @ 11:05 AM
Study NCT ID:
NCT01630005
Status:
TERMINATED
Last Update Posted:
2015-11-02
First Post:
2012-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Talk Therapy After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000219', 'term': 'Adams-Stokes Syndrome'}], 'ancestors': [{'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011613', 'term': 'Psychotherapy'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-30', 'studyFirstSubmitDate': '2012-02-20', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'acceptability', 'timeFrame': 'at 6 months', 'description': 'Participation rate in the study'}], 'secondaryOutcomes': [{'measure': 'Rates of anxiety and depression', 'timeFrame': 'at 3 and 6 months', 'description': 'Montgomery and Asberg Depression Rating Scale(depressive patients) and wide COVI (anxious patients)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': 'at 3 and 6 months', 'description': 'MM20-QOL scale'}, {'measure': 'Evaluation of functional recovery', 'timeFrame': 'at 3 and 6 months', 'description': '* Barthel index and Rankin score\n* NIHSS score'}, {'measure': 'Assessment of apathy', 'timeFrame': 'at 3 and 6 months', 'description': 'apathy index'}, {'measure': 'Categorization of patients', 'timeFrame': '6 months', 'description': 'according to their pattern of coping with specific scales and RWCQ (Revised Ways of Coping Questionnaire - stroke modified version) QSSP (Questionnaire de soutien social perçu)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adams-Stokes Syndrome']}, 'descriptionModule': {'briefSummary': 'Strokes are the first cause of acquired physical disability among adults. Some studies proved that depression is often an unrecognized complication from stroke, associated with a vital prognosis, functional and cognitive pejorative diagnosis. It led us to pose the hypothesis of the existence of a particular psychological state after stroke particularly favorable to a psychotherapeutic alliance. So, this longitudinal monocentric study aims to estimate the feasibility of a talk therapy and its impact on the anxio-depressive symptomatology after stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ischemic or aemoragic stroke minor 1 week, confirmed by cerebral imaging\n\nExclusion Criteria:\n\n* severe aphasia (NIHSS criteria 9: sup or egal: 2)\n* Chronic psychiatric preexistant desease.'}, 'identificationModule': {'nctId': 'NCT01630005', 'acronym': 'PS-POST AVC', 'briefTitle': 'Talk Therapy After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Talk Therapy After Stroke. PS-POST AVC', 'orgStudyIdInfo': {'id': '2010-A00905-34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Talk therapy', 'description': 'A cohort of 25 patients', 'interventionNames': ['Behavioral: talk therapy']}], 'interventions': [{'name': 'talk therapy', 'type': 'BEHAVIORAL', 'description': 'Psychotherapy', 'armGroupLabels': ['Talk therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06200', 'city': 'Nice', 'country': 'France', 'facility': 'CHU Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Hélène MAHAGNE, PH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}