Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT03717818
Status:
UNKNOWN
Last Update Posted:
2018-10-25
First Post:
2018-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mechanisms of Change in Brief Treatment for Borderline Personality Disorder
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-23', 'studyFirstSubmitDate': '2018-10-22', 'studyFirstSubmitQcDate': '2018-10-22', 'lastUpdatePostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ZAN-BPD (Zanarini Borderline Personality Disorder Scale; Zanarini, 2003)', 'timeFrame': '4 months', 'description': 'measures borderline symptomatology from an dimensional perspective, ranges between 0 and 36 (36 being the most symptomatic), global score (sum of all 9 items coded between 0 and 4) used.'}], 'secondaryOutcomes': [{'measure': 'OQ-45 (Outcome Questionnaire-45.2, Lambert et al., 2004)', 'timeFrame': '4 months', 'description': 'measures the level of problems (distress, social and interpersonal) on a scale ranging from 0 to 180 (45 items coded between 0 and 4, 4 being the most symptomatic). A total sum score will be used'}, {'measure': 'BSL-23 (Borderline Symptom List, Short Version; Bohus et al., 2009)', 'timeFrame': '4 months', 'description': 'measures the intensity of borderline symptoms using a mean score of the 23 items ranging between 0 and 4 (4 being the most symptomatic), the mean score will be used.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Borderline Personality Disorder']}, 'referencesModule': {'references': [{'pmid': '30507735', 'type': 'RESULT', 'citation': 'Kramer U, Kolly S, Maillard P, Pascual-Leone A, Samson AC, Schmitt R, Bernini A, Allenbach G, Charbon P, de Roten Y, Conus P, Despland JN, Draganski B. Change in Emotional and Theory of Mind Processing in Borderline Personality Disorder: A Pilot Study. J Nerv Ment Dis. 2018 Dec;206(12):935-943. doi: 10.1097/NMD.0000000000000905.'}, {'pmid': '39696018', 'type': 'DERIVED', 'citation': 'Kramer U, Grandjean L, Machinea JB, Beuchat H, Ranjbar S, de Roten Y, Despland JN, Conus P, Kolly S. Emotional processing as mechanism of change in brief good psychiatric management for borderline personality disorder: results of a randomized controlled trial. BMC Psychiatry. 2024 Dec 18;24(1):921. doi: 10.1186/s12888-024-06370-2.'}, {'pmid': '32299512', 'type': 'DERIVED', 'citation': 'Kramer U, Grandjean L, Beuchat H, Kolly S, Conus P, de Roten Y, Draganski B, Despland JN. Mechanisms of change in brief treatments for borderline personality disorder: a protocol of a randomized controlled trial. Trials. 2020 Apr 16;21(1):335. doi: 10.1186/s13063-020-4229-z.'}]}, 'descriptionModule': {'briefSummary': 'The present two-arm randomized controlled study aims at testing the effects (i.e., symptom reduction) and the underlying mechanisms of change associated with a brief psychiatric treatment (10 sessions over 4 months), compared with treatment as usual. Participants undergo assessments at four points (intake, 2 months, discharge and 12 month follow-up). In addition to symptom measures, all individuals undergo a two-step assessment for the potential mechanisms of change (i.e., emotion and socio-cognitive processing): a) behavioural and b) neurofunctional. We hypothesize that change in the mechanisms explains the treatment effects. The present study uses an innovative treatment of BPD and at the same time a sophisticated assessment procedure to demonstrate the critical role of psychobiological change in emotion and sociocognitive processing in brief treatments. It will help increase the effectiveness of initial treatment phase for BPD and help diminish the societal burden of disease related with BPD. This study is funded by the Swiss National Science Foundation (SNSF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Borderline Personality Disorder\n* age between 18 and 35\n\nExclusion Criteria:\n\n* non-mastery in French\n* neurological disorders\n* schizophrenia (according to DSM-5)'}, 'identificationModule': {'nctId': 'NCT03717818', 'acronym': 'BPDCHANGE', 'briefTitle': 'Mechanisms of Change in Brief Treatment for Borderline Personality Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'Mechanisms of Change in Brief Treatment for Borderline Personality Disorder: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2017-02167'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Good Psychiatric Management-Brief', 'interventionNames': ['Behavioral: Good Psychiatric Management - Brief']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment as Usual-Brief', 'interventionNames': ['Behavioral: treatment as usual']}], 'interventions': [{'name': 'Good Psychiatric Management - Brief', 'type': 'BEHAVIORAL', 'description': 'specific interventions as defined by Gunderson and Links (2014)', 'armGroupLabels': ['Good Psychiatric Management-Brief']}, {'name': 'treatment as usual', 'type': 'BEHAVIORAL', 'description': 'non-specific intervention', 'armGroupLabels': ['Treatment as Usual-Brief']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1003', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Ueli Kramer, PhD PD', 'role': 'CONTACT', 'email': 'ueli.kramer@chuv.ch', 'phone': '+41 21 314 00 50'}], 'facility': 'Department of Psychiatry-CHUV, University of Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. phil. Head of Research', 'investigatorFullName': 'Ueli Kramer', 'investigatorAffiliation': 'University of Lausanne Hospitals'}}}}