[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647895":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":35,"centralContacts":39,"locations":43,"responsibleParty":48,"collaborators":43,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":43,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":43,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":73,"whyStopped":43,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":43},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TMS+UP","EXPERIMENTAL","Combined accelerated TMS and emotion regulation skills training",[13,14],"Device: Transcranial Magnetic Stimulation (TMS)","Behavioral: Emotion Regulation Skills Training",[16,25],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","Transcranial Magnetic Stimulation (TMS)","accelerated (multi-session) intermittent theta-burst transcranial magnetic stimulation (aiTBS)",[9],[22,23,24],"TMS","iTBS","aiTBS",{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","Emotion Regulation Skills Training","Cognitive behavioral therapy based emotion regulation skills training using the Unified Protocol",[9],[31,32,33,34],"Unified Protocol","UP","cognitive behavioral therapy","CBT",[36],{"name":37,"affiliation":5,"role":38},"Kristen K Ellard, Ph.D.","PRINCIPAL_INVESTIGATOR",[40,45],{"name":37,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","617-724-3221",null,"kellard@mgh.harvard.edu",{"name":46,"role":41,"phone":43,"phoneExt":43,"email":47},"Chandler Carr","ccarr16@mgh.harvard.edu",{"type":38,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Kristen K. Ellard, Ph.D.","Assistant Professor of Psychiatry","100647895","combining-transcranial-magnetic-stimulation-with-emotion-regulation-skills-training-in-borderline-personality-disorder-100647895",false,"NCT07714005","Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder","Inclusion Criteria:\n\n* DSM-5 diagnosis of borderline personality disorder;\n* Clinical levels of emotion dysregulation as determined by a score ≥ 80 on the DERS;\n* Male and female sex as assigned at birth;\n* ages 22-65;\n* able to provide informed consent and provide verifiable contact information;\n* stable medication regimen.\n\nExclusion Criteria:\n\n* current active suicidality (suicidal ideation with intent or plan)\n* current substance use disorder for the past 6 months (substance use disorder in remission permitted);\n* history of psychosis;\n* dementia or other major neurological disorders\n* medical illness or non-psychiatric medical treatment that would likely interfere with study participation;\n* contraindications for MRI or TMS, including the presence of metallic implants that would interfere with safety (i.e. cardiac pacemaker, metal plates, non-removable body piercings, etc.), history of seizure disorder, history of head trauma;\n* a clinical course of a neuromodulatory therapy (e.g. TMS, tDCS, ECT) within the past 6 months;\n* current use of benzodiazepines (can interfere with iTBS stimulation);\n* current pregnancy, to limit potential risks to an unborn child;\n* concurrent participation in cognitive behavioral therapy (CBT) or dialectical behavioral therapy (DBT) during participation ER-skills training portion of study.\n* non-English speaking (ER skills training delivered in English only)","ALL","22 Years","65 Years",{"count":61,"type":62},12,"ESTIMATED","INTERVENTIONAL",[65],"NA","Impaired emotion regulation is a core feature of borderline personality disorder (BPD) and a known driver of functional impairment, interpersonal difficulties, self-harm, and suicidality. Emotion regulation refers to the ways in which people influence and control which emotions they have, when they have them, and how they experience and express them. Effective emotion regulation is a precursor to success in a range of adaptive processes including decision making, impulse control, communication and social interaction, work performance and productivity, and goal achievement, with subsequent positive effects on mood stability and well-being.\n\nFront-line behavioral approaches to teach effective emotion regulation skills in BPD (e.g. DBT) have been moderately successful, but outcomes are limited by high dropout rates due to lengthy treatment protocols and pre-existing deficits in the neurocircuitry supporting engagement in emotion regulation, with poorer outcomes in individuals with more severe emotion dysregulation.\n\nIn this pilot feasibility trial, we aim to test an approach to improving emotion dysregulation in BPD by combining neuromodulation using transcranial magnetic stimulation (TMS), to improve functioning of emotion regulation related neurocircuitry, with an intensive, brief emotion regulation skills training protocol. Through this combined approach, we hypothesize increased gains in emotion regulation ability, decreased treatment dropout rates, and improved positive outcomes in patients with BPD.",[68],"Borderline Personality Disorder (BPD)",[70,71,72,27],"Borderline Personality Disorder","Transcranial Magnetic Stimulation","Emotion Regulation","NOT_YET_RECRUITING","2026-07-15",{"date":76,"type":77},"2026-07-20","ACTUAL",{"date":79,"type":62},"2026-08-01",{"date":81,"type":62},"2027-12-01",{"name":5,"class":6}]