What this study is
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.
Front-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.
In 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.
What's being tested
- Transcranial Magnetic Stimulation (TMS)
Intervention · DEVICE
accelerated (multi-session) intermittent theta-burst transcranial magnetic stimulation (aiTBS)
- Emotion Regulation Skills Training
Intervention · BEHAVIORAL
Cognitive behavioral therapy based emotion regulation skills training using the Unified Protocol
Study details
- Sponsor
- Massachusetts General Hospital
- Conditions
- Borderline Personality Disorder (BPD)
- Enrolling
- 12 people
- Starts
- 2026-09-01
- Est. completion
- 2027-12-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 22 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- DSM-5 diagnosis of borderline personality disorder;
- Clinical levels of emotion dysregulation as determined by a score ≥ 80 on the DERS;
- Male and female sex as assigned at birth;
- Ages 22-65;
- Able to provide informed consent and provide verifiable contact information;
- Stable medication regimen.
You can't join if
- Current active suicidality (suicidal ideation with intent or plan)
- Current substance use disorder for the past 6 months (substance use disorder in remission permitted);
- History of psychosis;
- Dementia or other major neurological disorders
- Medical illness or non-psychiatric medical treatment that would likely interfere with study participation;
- 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;
- A clinical course of a neuromodulatory therapy (e.g. TMS, tDCS, ECT) within the past 6 months;
- Current use of benzodiazepines (can interfere with iTBS stimulation);
- Current pregnancy, to limit potential risks to an unborn child;
- Concurrent participation in cognitive behavioral therapy (CBT) or dialectical behavioral therapy (DBT) during participation ER-skills training portion of study.
- Non-English speaking (ER skills training delivered in English only)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMassachusetts General Hospital
Boston, Massachusetts, United States
- Kristen Ellard, PhD · Contact617-724-3221kellard@mgh.harvard.edu
Recruiting
Study team
Sponsor
Massachusetts General Hospital
Study ID 2026P001257
Principal investigator
Kristen K Ellard, Ph.D.
Massachusetts General Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.