Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorMassachusetts General Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Transcranial Magnetic Stimulation (TMS)

    Device

    accelerated (multi-session) intermittent theta-burst transcranial magnetic stimulation (aiTBS)

  • Emotion Regulation Skills Training

    Behavioral

    Cognitive behavioral therapy based emotion regulation skills training using the Unified Protocol

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: TMS+UPExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Client Satisfaction Questionnaire (CSQ)

Self-report measure of participant satisfaction with the interventions

Time frame
From baseline to end of acute treatment at 8 weeks
2

UP Module Completion Rate

Measure of percentage of emotion skills training modules completed

Time frame
From enrollment to the end of treatment at 8 weeks
3

Session Completion Rate

Measure of percentage of study visits attended

Time frame
From baseline to end of acute treatment at 8 weeks

Secondary outcomes

1

Emotion Regulation Skills Questionnaire (ERSQ)

Self report measure of adaptive emotion regulation skills

Time frame
Baseline through acute treatment end at 8 weeks
2

Borderline Evaluation of Severity Over Time (BEST)

Self-report measure of severity of BPD symptoms

Time frame
Baseline through acute treatment end at 8 weeks
3

Affective Multi-Source Interference Task (MSIT-IAPS)

Computer-based behavioral task of emotion regulation

Time frame
Baseline through acute treatment end at 8 weeks
4

Delay-Discounting Task (DDT)

Computer-based behavioral task of decision making

Time frame
Baseline through acute treatment end at 8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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