protocolSection identificationModule nctId: NCT06367907, orgStudyIdInfo id: SM 68/6-1, briefTitle: Biological Effects of Schema Therapy, acronym: BE-ST, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-09-09, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Jena University Hospital, class: OTHER, descriptionModule briefSummary: Background: The major aim of this study is to compare the effects of emotion focused (experiential) and cognitive interventions of schema therapy (ST) on emotion regulation deficits in patients with borderline personality disorder (BPD) according to DSM-V (alternative model) criteria. In a randomized, single-blinded parallel-group design clinical effects as well as effects on neurotransmitter metabolism and connectivity will be compared.Method: While the 9-weeks treatment protocol of particular interest includes emotion focused interventions (ST-EF, n=60) such as chair dialogs, imagery rescripting or role play, the active control condition (ST-AC, n=60) is restricted to cognitive interventions, e.g. psychoeducation or pro/contra discussions. MEGA-PRESS 1H-MR spectroscopy and resting-state functional MR imaging (rs-fMRI) will be used before/after treatment protocols (T0-T1) and 6 months after the end of therapy (T2) to assess the effects on glutamate (Glx) and GABA metabolism in key regions of the target networks (executive control network, ECN: dorsolateral prefrontal cortex, DLPFC; salience network, SN: anteromedial cingulate cortex, aMCC; default mode network, DMN: pregenual cingulate cortex, pgACC) and to investigate the corresponding altered connectivity in these networks. The biological aberrations at T0 as compared to healthy controls (n=60) and treatment effects (at T1 and T2, n≥40 in each condition) on these aberrations will be linked to clinical effects measured by an extensive test battery with particular interest on emotion regulation, and specified by the Reliable Change Index (RCI). For longitudinal data mixed model analysis will be performed.The main questions are (1) whether the emotion regulation deficit and the pattern of BPD-specific symptomatology are associated with a specific pattern of Glx and GABA concentrations in the DLPFC, aMCC and pgACC and corresponding deviations of functional connectivity within the ECN, SN and DMN. Hypothesis: Depending on primary and secondary outcome measures at T0, altered RSFC in the DMN, SN and ECN and corresponding altered Glx or GABA concentrations are assumed. (2) whether both treatment conditions have different clinical effects on the ability to regulate emotions and whether the respective clinical effects are associated with the changes in neurobiological aberrations. Hypothesis: It is hypothesized that the ST-EF condition will improve emotion regulation skills more effectively than the control condition. Only in the ST-EF condition are higher response and remission rates expected in the primary and secondary outcome measures, as well as effects on the ECN, SN and DMN with corresponding changes in RSFC and Glx or GABA concentrations., conditionsModule conditions: Personality Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized, parallel-group, single-blinded, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Parallel-group: Both conditions (emotion focussed, ST-EF and active control, ST-AC) are highly standardized and active in terms of their expected clinical effect, which was a precondition for a positive ethics approval.Randomized: Patients are randomly assigned to the ST-EF or ST-AC condition according to a randomization list established by an independent statistician, and applied to incoming help-seeking patients by an independent admission management (managing nurse, not a member of the research team).Single-blinded: Researchers are blind as regards group belonging of participants., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: schema therapy, outcomesModule primaryOutcomes measure: Changes in emotion regulation capabilities, secondaryOutcomes measure: Improvement of BPD specific symptomatology, secondaryOutcomes measure: Change of personality traits, secondaryOutcomes measure: Changes of the intensity of early maladaptive schemas., secondaryOutcomes measure: Changes of the intensity of schema modes., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Jena, status: RECRUITING, city: Jena, zip: 07743, country: Germany, contacts name: Stefan Smesny, PhD, role: CONTACT, phone: +4936419390451, email: stefan.smesny@med.uni-jena.de, geoPoint lat: 50.92878, lon: 11.5899, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol: Study Protocol: Study design, date: 2018-06-04, uploadDate: 2024-04-12T04:07, filename: Prot_000.pdf, size: 653719, largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol: Study Protocol: Study design, date: 2018-06-04, uploadDate: 2024-04-12T04:14, filename: Prot_001.pdf, size: 454285, largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol: Information on reliability criteria of assessment tools, date: 2018-06-04, uploadDate: 2024-04-12T04:22, filename: Prot_002.pdf, size: 605787, largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol: Core aspects of therapy conditions, date: 2018-06-04, uploadDate: 2024-04-12T04:23, filename: Prot_003.pdf, size: 440449, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2018-06-04, uploadDate: 2024-04-12T04:10, filename: SAP_004.pdf, size: 692600, hasResults: False