Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 6:04 PM
Study NCT ID:
NCT06263933
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Experience Sharing and Mutual Assistance on Insight and Recovery During the First Psychotic Episode
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A control group and a intervention group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2024-01-03', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The level of the increasing of The INSIGHT scale', 'timeFrame': "at baseline (T0) and at 5 days after the intervention's beginning (T1).", 'description': 'Used the "Echelle de conscience de trouble" - insight scale. There are 8 items, with 3 choices for each items : agree, disagree, unsure. The time is 5 minutes.\n\nMaximum score = 12, very good Insight Minimum score= 0, No Insight 9 and more= good insight'}], 'secondaryOutcomes': [{'measure': 'The increase of Recovery Scale', 'timeFrame': "At baseline (T0) and at 5 days after the intervention's beginning (T1).", 'description': 'Scale of recovery "Stage of recovery instrument" (STORI). The time is 25 minutes. There are 5 dimensions of recovery, with 10 groups of questions, with 50 items in total. There is 5 choices for each items, with "0" to "2" for "not at all true currently" and "3" to "5" is "completely true currently".'}, {'measure': 'The semi-structured interview', 'timeFrame': "At baseline (T0) and at 1 month after the hospitalization's end (T2).", 'description': 'For the first semi-structured interview, with 11 questions on 3 themes : the crisis course and the hospitalization, the role of peers during hospitalization and finally afterwards hospitalization. For the second semi-structured interview, there are 13 questions with 4 themes : the hospitalization living, psychosocial functioning, trouble awareness and management of symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['retablishment', 'insight', 'mutual assistance', 'peer helper', 'psychiatric hospitalization', 'first psychotic episode'], 'conditions': ['Psychotic Episode']}, 'referencesModule': {'references': [{'pmid': '14511087', 'type': 'BACKGROUND', 'citation': 'Andresen R, Oades L, Caputi P. The experience of recovery from schizophrenia: towards an empirically validated stage model. Aust N Z J Psychiatry. 2003 Oct;37(5):586-94. doi: 10.1046/j.1440-1614.2003.01234.x.'}, {'pmid': '30935486', 'type': 'BACKGROUND', 'citation': 'Courtet P. [Suicidal risk during the first psychotic episode]. Encephale. 2018 Dec;44(6S):S39-S43. doi: 10.1016/S0013-7006(19)30078-8. French.'}, {'pmid': '8037256', 'type': 'BACKGROUND', 'citation': 'Fennig S, Kovasznay B, Rich C, Ram R, Pato C, Miller A, Rubinstein J, Carlson G, Schwartz JE, Phelan J, et al. Six-month stability of psychiatric diagnoses in first-admission patients with psychosis. Am J Psychiatry. 1994 Aug;151(8):1200-8. doi: 10.1176/ajp.151.8.1200.'}, {'pmid': '27526987', 'type': 'BACKGROUND', 'citation': 'Franck N. [How to involve patients with schizophrenia in their treatment using psychoeducation]. Presse Med. 2016 Sep;45(9):742-8. doi: 10.1016/j.lpm.2016.07.012. Epub 2016 Aug 12. French.'}, {'pmid': '17551351', 'type': 'BACKGROUND', 'citation': 'Kessler RC, Amminger GP, Aguilar-Gaxiola S, Alonso J, Lee S, Ustun TB. Age of onset of mental disorders: a review of recent literature. Curr Opin Psychiatry. 2007 Jul;20(4):359-64. doi: 10.1097/YCO.0b013e32816ebc8c.'}, {'pmid': '31242015', 'type': 'BACKGROUND', 'citation': 'Malla A, McGorry P. Early Intervention in Psychosis in Young People: A Population and Public Health Perspective. Am J Public Health. 2019 Jun;109(S3):S181-S184. doi: 10.2105/AJPH.2019.305018.'}, {'pmid': '27161262', 'type': 'BACKGROUND', 'citation': 'Souaiby L, Gaillard R, Krebs MO. [Duration of untreated psychosis: A state-of-the-art review and critical analysis]. Encephale. 2016 Aug;42(4):361-6. doi: 10.1016/j.encep.2015.09.007. Epub 2016 May 6. French.'}, {'pmid': '11704943', 'type': 'BACKGROUND', 'citation': 'Thompson KN, McGorry PD, Harrigan SM. Reduced awareness of illness in first-episode psychosis. Compr Psychiatry. 2001 Nov-Dec;42(6):498-503. doi: 10.1053/comp.2001.27900.'}]}, 'descriptionModule': {'briefSummary': "Controlled, prospective, qualitative and quantitative trial. The goal of this trial is to evaluate the mutual assistance early intervention device efficacy and its impact on insight and personal recovery of participants living with a first psychotic episode. This intervention lasts 5 days with 1 session per day of 1 hour 30 minutes. Three evaluations, before the intervention, after intervention and 1 month after the hospitalization's end."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man or woman between 18 and 40 years old\n* First psychotic episode under the guidance of a doctor\n* Brief psycotic trouble (SM-V)\n* Presenting a first psychiatry hospitalization (all modalities hospitalizations combined)\n* Fluent in French language (read and written)\n* Patient affiliated to a social protection system or beneficiary of Medical Aid of State\n* Patient having signed informed consent for his participation in the protocol\n\nExclusion Criteria:\n\n* Patients whose clinical condition does not allow them to participate in research\n* Patients placed in isolation rooms during the intervention'}, 'identificationModule': {'nctId': 'NCT06263933', 'acronym': 'DIPEM', 'briefTitle': 'Effect of Experience Sharing and Mutual Assistance on Insight and Recovery During the First Psychotic Episode', 'organization': {'class': 'OTHER', 'fullName': 'Centre hospitalier de Ville-Evrard, France'}, 'officialTitle': 'Effect of Experience Sharing and Mutual Assistance on Insight and Recovery During the First Psychotic Episode', 'orgStudyIdInfo': {'id': '2023-A01804-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Patients are followed in routine care.', 'interventionNames': ['Other: Insight Scale', 'Other: Semi-directional interviews', 'Other: routine care']}, {'type': 'EXPERIMENTAL', 'label': 'DIPEM group', 'description': 'Patients have 5 session of mutual assistance with a mediator psychologist, during five days, with 1 session per day. Each session lasts 1h30, with 45 min for atelier, 15 min for pause and 30 min about collective discussion.', 'interventionNames': ['Other: Insight Scale', 'Other: Semi-directional interviews', 'Other: session of mutual assistance with a mediator psychologist']}], 'interventions': [{'name': 'Insight Scale', 'type': 'OTHER', 'otherNames': ['stage of recovery scale'], 'description': 'Before the patient was in DIPEM or control group and after the patient is involved in DIPEM or control group', 'armGroupLabels': ['Control group', 'DIPEM group']}, {'name': 'Semi-directional interviews', 'type': 'OTHER', 'description': 'In the end of the intervention. In the end of DIPEM Or in the end of control group.\n\nThis intervention will be held after one month of hospitalization.', 'armGroupLabels': ['Control group', 'DIPEM group']}, {'name': 'routine care', 'type': 'OTHER', 'description': 'routine care', 'armGroupLabels': ['Control group']}, {'name': 'session of mutual assistance with a mediator psychologist', 'type': 'OTHER', 'description': 'session of mutual assistance with a mediator psychologist', 'armGroupLabels': ['DIPEM group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93330', 'city': 'Neuilly-sur-Marne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rusheenthira Thavaseelan', 'role': 'CONTACT', 'email': 'r.thavaseelan@epsve.fr', 'phone': '0143093232', 'phoneExt': '033'}, {'name': 'Dominique Januel', 'role': 'CONTACT', 'email': 'd.januel@epsve.fr', 'phone': '0143093232', 'phoneExt': '033'}, {'name': 'Dominique Januel, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ilona Arcomano, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Etablissement Public de Santé de Ville-Evrard', 'geoPoint': {'lat': 48.85373, 'lon': 2.54903}}], 'centralContacts': [{'name': 'Rusheenthira Thavaseelan', 'role': 'CONTACT', 'email': 'r.thavaseelan@epsve.fr', 'phone': '0143093232', 'phoneExt': '033'}, {'name': 'mathilde Pistre', 'role': 'CONTACT', 'email': 'm.pistre@epsve.fr', 'phone': '0143093232', 'phoneExt': '033'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre hospitalier de Ville-Evrard, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of research center and clinical professor', 'investigatorFullName': 'Dominique JANUEL', 'investigatorAffiliation': 'Centre hospitalier de Ville-Evrard, France'}}}}