Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT04746404
Status:
COMPLETED
Last Update Posted:
2021-10-25
First Post:
2021-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of a Positive Psychology Program for the Development of Emotional Skills in Prison
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001883', 'term': 'Borderline Personality Disorder'}], 'ancestors': [{'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-22', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2021-02-05', 'lastUpdatePostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of vompliance with the number of sessions', 'timeFrame': '1 day', 'description': "Achievement of the program's implementation and participation objectives : compliance with the number of sessions"}, {'measure': 'Rate of respect of the frequency of sessions', 'timeFrame': '1 day', 'description': "Achievement of the program's implementation and participation objectives : respect of the frequency of sessions: weekly"}, {'measure': 'rate of respect of the duration of each session', 'timeFrame': '1 day', 'description': "Achievement of the program's implementation and participation objectives : respect of the duration of each session"}, {'measure': 'rate of respect of the minimum number of participants', 'timeFrame': '1 day', 'description': "Achievement of the program's implementation and participation objectives : respect of the minimum number of participants"}], 'secondaryOutcomes': [{'measure': 'Respect of the duration of the theoretical/practical reminders', 'timeFrame': '1 day', 'description': "Achievement of the program's implementation and participation objectives : Respect of the duration of the theoretical/practical reminders"}, {'measure': 'respect of the frequency of theoretical/practical remote reminders', 'timeFrame': '1 day', 'description': "Achievement of the program's implementation and participation objectives : respect of the frequency of theoretical/practical remote reminders"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Borderline'], 'conditions': ['Borderline Personality Disorder']}, 'descriptionModule': {'briefSummary': 'Studies show that emotional competence plays a significant role in psychological and physical health, and that programs aimed at their development are effective. Can a positive psychology program aimed at the development of emotional competence be implemented as part of care in lieu of deprivation of liberty? The investigators hypothesize the interest and possibility of implementing an emotional skills development program in the specific context of custodial care.\n\nThe main expected outcome of this study is the identification of necessary adaptations of the emotional skills development program of Kotsou, I. et al (2011) for its implementation in remand homes.', 'detailedDescription': 'The expected secondary outcome is the identification of the interest of emotional skills development program (in prison) regarding :\n\n* Therapeutic support for patients meeting the criteria for borderline personality disorder\n* Participant satisfaction\n* The development of emotional skills'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Major patients followed up at the Health Unit of the Villeneuve-lès-Maguelone Remand Prison', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Meet the criteria for borderline personality disorder (DSM-V),\n* Interest in the issue of emotional skills development,\n* Comprehension and use of the French language adapted to the study,\n* Disposition to group practice,\n* Attentive disposition allowing to participate in a therapeutic activity for 3 hours.\n* Psychological/psychiatrical follow-up at the Health Unit of the Villeneuve-lès-Maguelone prison\n\nExclusion criteria:\n\n* Minor patients\n* Releasable before July 2021,\n* Decompensated psychiatric disorders,\n* Patient in withdrawal syndrome.'}, 'identificationModule': {'nctId': 'NCT04746404', 'briefTitle': 'Application of a Positive Psychology Program for the Development of Emotional Skills in Prison', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Application of a Positive Psychology Program for the Development of Emotional Skills in Prison : Feasibility Study', 'orgStudyIdInfo': {'id': 'RECHMPL21_0017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'Control group : Major borderline patients followed up at the Health Unit of the Villeneuve-lès-Maguelone Remand Prison'}, {'label': 'Test group', 'description': 'Test group : Major borderline patients followed up at the Health Unit of the Villeneuve-lès-Maguelone Remand Prison', 'interventionNames': ['Behavioral: Emotional Skills Development Program']}], 'interventions': [{'name': 'Emotional Skills Development Program', 'type': 'BEHAVIORAL', 'description': 'Emotional Skills Development Program (positive psychology)', 'armGroupLabels': ['Test group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Magali RUBIO, Psychologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}