About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Transcranial Magnetic Stimulation (TMS)
Deviceaccelerated (multi-session) intermittent theta-burst transcranial magnetic stimulation (aiTBS)
Emotion Regulation Skills Training
BehavioralCognitive behavioral therapy based emotion regulation skills training using the Unified Protocol
Treatment groups
Trial outcomes
Primary outcomes
Client Satisfaction Questionnaire (CSQ)
Self-report measure of participant satisfaction with the interventions
UP Module Completion Rate
Measure of percentage of emotion skills training modules completed
Session Completion Rate
Measure of percentage of study visits attended
Secondary outcomes
Emotion Regulation Skills Questionnaire (ERSQ)
Self report measure of adaptive emotion regulation skills
Borderline Evaluation of Severity Over Time (BEST)
Self-report measure of severity of BPD symptoms
Affective Multi-Source Interference Task (MSIT-IAPS)
Computer-based behavioral task of emotion regulation
Delay-Discounting Task (DDT)
Computer-based behavioral task of decision making
Locations
Sponsors and contacts
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