Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT06870305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Mindfulness in PREventing Progression to Psychosis in Individuals With an Ultra High Risk for Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-03-06', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distress related to psychotic symptoms', 'timeFrame': '3 months', 'description': 'Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention'}, {'measure': 'Distress related to psychotic symptoms', 'timeFrame': '4 months', 'description': 'Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention'}, {'measure': 'Distress related to psychotic symptoms', 'timeFrame': '6 months', 'description': 'Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention'}, {'measure': 'Distress related to psychotic symptoms', 'timeFrame': '9 months', 'description': 'Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention'}], 'secondaryOutcomes': [{'measure': 'Intensity of psychotic symptoms', 'timeFrame': '3 months', 'description': 'Intensity of psychotic symptoms on the CAARMS scale'}, {'measure': 'Intensity of psychotic symptoms', 'timeFrame': '4 months', 'description': 'Intensity of psychotic symptoms on the CAARMS scale'}, {'measure': 'Intensity of psychotic symptoms', 'timeFrame': '6 months', 'description': 'Intensity of psychotic symptoms on the CAARMS scale'}, {'measure': 'Intensity of psychotic symptoms', 'timeFrame': '9 months', 'description': 'Intensity of psychotic symptoms on the CAARMS scale'}, {'measure': 'Distress related to psychotic symptoms', 'timeFrame': '3 months', 'description': 'Distress related to psychotic symptoms on the CAARMS scale'}, {'measure': 'Distress related to psychotic symptoms', 'timeFrame': '4 months', 'description': 'Distress related to psychotic symptoms on the CAARMS scale'}, {'measure': 'Distress related to psychotic symptoms', 'timeFrame': '6 months', 'description': 'Distress related to psychotic symptoms on the CAARMS scale'}, {'measure': 'Distress related to psychotic symptoms', 'timeFrame': '9 months', 'description': 'Distress related to psychotic symptoms on the CAARMS scale'}, {'measure': 'Number of patients making a transition to psychosis', 'timeFrame': '3 months', 'description': 'Number of patients making a transition to psychosis'}, {'measure': 'Number of patients making a transition to psychosis', 'timeFrame': '4 months', 'description': 'Number of patients making a transition to psychosis'}, {'measure': 'Number of patients making a transition to psychosis', 'timeFrame': '6 months', 'description': 'Number of patients making a transition to psychosis'}, {'measure': 'Number of patients making a transition to psychosis', 'timeFrame': '9 months', 'description': 'Number of patients making a transition to psychosis'}, {'measure': 'Cognitive functions', 'timeFrame': '3 months', 'description': 'Cognitive functions measured by the Attentional Performance Tests (APT)'}, {'measure': 'Cognitive functions', 'timeFrame': '4 months', 'description': 'Cognitive functions measured by the Attentional Performance Tests (APT)'}, {'measure': 'Cognitive functions', 'timeFrame': '6 months', 'description': 'Cognitive functions measured by the Attentional Performance Tests (APT)'}, {'measure': 'Cognitive functions', 'timeFrame': '9 months', 'description': 'Cognitive functions measured by the Attentional Performance Tests (APT)'}, {'measure': 'Cognitive functions', 'timeFrame': '3 months', 'description': 'Cognitive functions measured by the California Verbal Learning Test (CVLT)'}, {'measure': 'Cognitive functions', 'timeFrame': '4 months', 'description': 'Cognitive functions measured by the California Verbal Learning Test (CVLT)'}, {'measure': 'Cognitive functions', 'timeFrame': '6 months', 'description': 'Cognitive functions measured by the California Verbal Learning Test (CVLT)'}, {'measure': 'Cognitive functions', 'timeFrame': '9 months', 'description': 'Cognitive functions measured by the California Verbal Learning Test (CVLT)'}, {'measure': 'Anxiety', 'timeFrame': '3 months', 'description': 'Anxiety measured by the State Trait Anxiety Inventory (STAI)'}, {'measure': 'Anxiety', 'timeFrame': '4 months', 'description': 'Anxiety measured by the State Trait Anxiety Inventory (STAI)'}, {'measure': 'Anxiety', 'timeFrame': '6 months', 'description': 'Anxiety measured by the State Trait Anxiety Inventory (STAI)'}, {'measure': 'Anxiety', 'timeFrame': '9 months', 'description': 'Anxiety measured by the State Trait Anxiety Inventory (STAI)'}, {'measure': 'Functioning', 'timeFrame': '3 months', 'description': 'Functioning measured by the Personal and Social Performance Scale (PSP)'}, {'measure': 'Functioning', 'timeFrame': '4 months', 'description': 'Functioning measured by the Personal and Social Performance Scale (PSP)'}, {'measure': 'Functioning', 'timeFrame': '6 months', 'description': 'Functioning measured by the Personal and Social Performance Scale (PSP)'}, {'measure': 'Functioning', 'timeFrame': '9 months', 'description': 'Functioning measured by the Personal and Social Performance Scale (PSP)'}, {'measure': 'Health-related quality of life (HRQoL)', 'timeFrame': '3 months', 'description': 'Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire'}, {'measure': 'Health-related quality of life (HRQoL)', 'timeFrame': '4 months', 'description': 'Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire'}, {'measure': 'Health-related quality of life (HRQoL)', 'timeFrame': '6 months', 'description': 'Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire'}, {'measure': 'Health-related quality of life (HRQoL)', 'timeFrame': '9 months', 'description': 'Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire'}, {'measure': 'Health-related quality of life (HRQoL)', 'timeFrame': '3 months', 'description': 'Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire.'}, {'measure': 'Health-related quality of life (HRQoL)', 'timeFrame': '4 months', 'description': 'Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire.'}, {'measure': 'Health-related quality of life (HRQoL)', 'timeFrame': '6 months', 'description': 'Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire.'}, {'measure': 'Health-related quality of life (HRQoL)', 'timeFrame': '9 months', 'description': 'Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire.'}, {'measure': 'Depressive symptoms', 'timeFrame': '3 months', 'description': 'Depressive symptoms measured by the Beck Depression Inventory (BDI)'}, {'measure': 'Depressive symptoms', 'timeFrame': '4 months', 'description': 'Depressive symptoms measured by the Beck Depression Inventory (BDI)'}, {'measure': 'Depressive symptoms', 'timeFrame': '6 months', 'description': 'Depressive symptoms measured by the Beck Depression Inventory (BDI)'}, {'measure': 'Depressive symptoms', 'timeFrame': '9 months', 'description': 'Depressive symptoms measured by the Beck Depression Inventory (BDI)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychosis', 'mindfulness'], 'conditions': ['Clinical High Risk for Psychosis (CHR)']}, 'descriptionModule': {'briefSummary': 'The main objective is to evaluate the efficacy of a group-based mindfulness therapy programme in reducing distress associated with symptoms of UHR (Ultra High Risk) or FEP (first psychotic episode) compared with usual treatment. The secondary objectives were to study the efficacy of a group-based mindfulness intervention: on the reduction of psychotic symptoms; on the maintenance over time (6 months of follow-up) of the efficacy of the intervention on the distress associated with the symptoms of the UHR or PEP state; and on various dimensions associated with care: cognitive functions, anxiety, quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People aged between 18 and 30 validating the criteria for UHR or PEP status on the CAARMS scale and having a social functional impact (SOFAS score below 50 or a reduction of more than 30% in the score)\n\nExclusion Criteria:\n\n* Previous episode of schizophrenic disorder, schizoaffective disorder or bipolar disorder\n* Previous antipsychotic treatment for more than 12 months\n* Organic mental disorder or intellectual disability\n* Serious suicidal/homicidal risk (but admissible if this risk has been resolved)\n* Insufficient French language skills\n* Adult incapable of giving consent and not under legal protection\n* Protection measure (guardianship/curatorship/court supervision) or under court supervision\n* Person deprived of liberty by judicial or administrative decision (including forced hospitalisation)\n* Persons in a life-threatening emergency\n* Not affiliated to a social security regime'}, 'identificationModule': {'nctId': 'NCT06870305', 'acronym': 'EM-PREPS', 'briefTitle': 'Efficacy of Mindfulness in PREventing Progression to Psychosis in Individuals With an Ultra High Risk for Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Psychothérapique de Nancy'}, 'officialTitle': 'Efficacy of Mindfulness in PREventing Progression to Psychosis in Individuals With an Ultra High Risk for Psychosis', 'orgStudyIdInfo': {'id': '2023-A02766-39'}, 'secondaryIdInfos': [{'id': 'RIPH 2023-04', 'type': 'OTHER', 'domain': 'centre Psychothérapique de Nancy CPN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MBTP group', 'interventionNames': ['Other: MBTP : Mindflulness based training for psychosis']}, {'type': 'NO_INTERVENTION', 'label': 'TAU group'}], 'interventions': [{'name': 'MBTP : Mindflulness based training for psychosis', 'type': 'OTHER', 'description': 'The group-based mindfulness programme is called MBTP (Mindfulness based training for psychosis). The MBTP programme consists of 5 sessions over a period of one month (2 sessions in the first week, then one session a week). Each session lasts approximately 1h30 and is carried out in a group of 5 participants. The sessions cover informal and formal mindfulness tasks, elements of psycho-education on emotions, meditation exercises on emotions, and thought defusion and acceptance tasks. Participants are encouraged to meditate at home between sessions.', 'armGroupLabels': ['MBTP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'country': 'France', 'contacts': [{'name': 'Christophe LEMEY, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire (CHU) de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '54520', 'city': 'Laxou', 'country': 'France', 'contacts': [{'name': 'William DALFIN, PU.PH', 'role': 'CONTACT', 'email': 'william.dalfin@cpn-laxou.com', 'phone': '03 83 92 68 22'}, {'name': 'vincent LAPREVOTE, PU.PH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'william DALFIN, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Psychothérapique de Nancy', 'geoPoint': {'lat': 48.68372, 'lon': 6.14929}}], 'centralContacts': [{'name': 'William DALFIN, MD', 'role': 'CONTACT', 'email': 'William.DALFIN@cpn-laxou.com', 'phone': '03 83 92 68 22'}, {'name': 'Naoual MELLOUKI BENDIMRED, PhD', 'role': 'CONTACT', 'email': 'unic@cpn-laxou.com', 'phone': '0383925267'}], 'overallOfficials': [{'name': 'Vincent Laprevote, PU.PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Psychothérapique de Nancy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Psychothérapique de Nancy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}