rTMS-enhanced Psychotherapy for Borderline Personality Disorder

NCT06259851 | Active Not Recruiting

• 1 other identifier: NU23-04-00472
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This project assesses the effectiveness and lasting impact of combining Dialectical Behavioral Therapy (DBT) with prefrontal repetitive transcranial magnetic stimulation (rTMS) in patients with borderline personality disorder.

Conditions

Borderline Personality Disorder

Keywords

Dialectical behavioral therapy; Repetitive transcranial magnetic stimulation; Borderline personality disorder

Outcome Measures

Primary Outcomes (12)

• Decrease of borderline symptoms

  significant decrease of symptoms measured by Borderline Symptoms List-23

  Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group

• Decrease of impulsivity

  significant decrease of impulsivity measured by UPPS-P questionnaire

  Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group

• Increase of emotion regulation

  significant increase of emotion regulation measured by Difficulties in emotion regulation scale (minimum: 22, maximum: 87, higher score means better outcome)

  Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group

• Decrease of self-reported depression symptoms

  significant decrease of depression symptoms measured by Beck Depression Inventory II

  Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group

• Decrease of depression symptoms clinical ranking

  significant decrease of depression symptoms measured by Montgomery-Asberg Depression Rating Scale clinical rating

  Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group

• Decrease of anxiety

  significant decrease of anxiety symptoms measured by Beck Anxiety Inventory

  Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group

• Decrease of dissociation symptoms

  significant decrease of dissociation symptoms measured by Multiscale dissociation inventory

  Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group

• Increased regulation of amygdala during fMRI neurofeedback

  fMRI neurofeedback will be used to measure the participants' ability to influence their amygdala activity. fMRI neurofeedback is a method which enables measuring, computing, and displaying the current blood oxygen level-dependent (BOLD) signal level in a selected brain area. The ability of the participants to voluntarily regulate the target area activity using the feedback presentation is measured. Specifically, pictures arousing negative emotions will be presented to participants in the MR scanner together with a scale showing the current level of their right amygdala activity and participants will be instructed to decrease the scale as much as possible by regulating down their emotion (regulation condition). As a controlled condition to regulation condition, passive viewing of the negative pictures will be included (view condition).

  Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3) in all groups and additionally 24 weeks after baseline (T4) in DBT group

• Decreased brain emotional reactivity

  Hariri task (fMRI emotional processing task) in fMRI will be used to measure brain correlates of emotional reactivity. The task includes 2 experimental categories: 1. emotional faces and 2. emotional social scenes which reliably evoke emotional responses, and 1 control baseline condition of geometric shapes. Further, each experimental category will include three condition: negative pictures, positive pictures, and neutral pictures. Contrast of emotional conditions against neutral conditions of the same type and against control condition will be used to track the neural correlates of emotional reactivity and processing.

  Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3) in all groups and additionally 24 weeks after baseline (T4) in DBT group

• Decreased impulsivity in Go/No-Go task in fMRI

  fMRI Go/No-Go task will be displaying 2 experimental conditions (presenting letter A or X), where participant is asked to react with a button only in first condition (Go condition), while remain passive during the second condition (NoGo condition). The task is designed to measure impulsivity and brain correlates during inhibition.

  Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3) in all groups and additionally 24 weeks after baseline (T4) in DBT group

• Decrease of emotional variability

  Measured by ecological momentary assessment (EMA) implemented as an questionnaire accessible through participant's smartphone via application ExpiWell. Participants will receive notifications reminding to fill out the questionnaire every hour (in random times during the hour) between 9 am and 9 pm for two days. Participants will be asked about their current experienced emotion and its intensity. Additional questions on self-harm and suicidal thoughts intensity during the day and whether a self-harming incident has occurred during the day will be sent at 9 pm on both days.

  Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3), 24 weeks after baseline (T4) in all groups and additionally 48 weeks after baseline (T5) in DBT group

• Decrease in sef-harming behavior and medical care usage

  During an interview with a clinician, participants will be asked about the number of self-harming incidents and suicidal attempts and the number of crisis medical care usage and number of days spent in psychiatric hospitalization in the past 6 months or in the past three months.

  Recorded for the past 6 months (at the beginning and after 48 weeks) or in the past three months (after 12 weeks and after 24 weeks)

Study Arms (4)

rTMS-DBT group

EXPERIMENTAL

Patients receiving combined DBT and active prefrontal rTMS treatment

Behavioral: Dialectical behavioral therapy program; Device: Prefrontal rTMS treatment

Sham-DBT group

ACTIVE COMPARATOR

Patients receiving combined DBT and sham rTMS treatment

Behavioral: Dialectical behavioral therapy program; Device: Sham rTMS sessions

rTMS-only group

ACTIVE COMPARATOR

Patients receiving only active prefrontal rTMS treatment

Device: Prefrontal rTMS treatment

sham-only group

SHAM COMPARATOR

Patients receiving only sham rTMS treatment

Device: Sham rTMS sessions

Interventions

Dialectical behavioral therapy program BEHAVIORAL

Dialectical behavioral therapy (DBT) program with all the standard DBT modules (individual therapy 1 hour per week, skills group 3 hours per week, phone coaching, and therapist consultation team 1,5 hour per week). The program takes 24 weeks in total comprising two 12-week runs of skills training. The program will be precluded with 4 individual sessions of pretreatment before the start of the main program part.

Sham-DBT group; rTMS-DBT group

Prefrontal rTMS treatment DEVICE

rTMS will be performed by DuoMag XT with 70BF cool coil. Patients will undergo 15 daily stimulation sessions during a period of three weeks with one session each working day. Each session consists of 20 trains with 100 pulses (10 seconds for train). Inter-train interval will be 30 seconds. Gradual titration of the individual resting motor threshold (RMT) will apply, meaning probands will undergo first session with 90% RMT intensity, second session with 100% RMT intensity, third session with 110% RMT intensity. All the following sessions will use the final 120% RMT intensity. In case a session is left out because of any reason, the total duration of treatment will be prolonged by one day, so that the total number of sessions underwent is the same in all patients. Patients will receive 2000 pulses during one session (total 30000 pulses during the whole procedure) with 10 Hz frequency.

rTMS-DBT group; rTMS-only group

Sham rTMS sessions DEVICE

Sham TMS will be performed by sham coil that looks identical to DuoMag XT in the active group. Patients will undergo 15 daily sham stimulation sessions during a period of three weeks with one session each working day. Each session consists of 20 trains with 100 pulses (10 seconds for train). Inter-train interval will be 30 seconds.

Sham-DBT group; sham-only group

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: cisgender female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of borderline personality disorder according to Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria (rated by Structured Clinical Interview for DSM-5 for Personality Disorders, BPD section)
• minimum age 16, informed consent of the patient
• informed consent of patient's legal representative in case of patients under age 18

You may not qualify if:

• neurological disorder
• comorbid affective disorder or schizophrenia-related disorder
• intelligence quotient\<70
• contraindications for MRI measurement
• contraindication for rTMS treatment
• pregnancy

Sponsors & Collaborators

• Masarykova Univerzita: lead
• Brno University Hospital: collaborator
• Masaryk University: collaborator

Study Sites (1)

Department of Psychiatry, University Hospital Brno and Faculty of Medicine, Masaryk University

Brno, 62500, Czechia

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Libor Ustohal, prof, Ph.D.

  University Hospital Brno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Allocation to the Active rTMS/Sham rTMS group is randomized.

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: February 14, 2024
• Study Start: August 20, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: 1 year after publication of the results.
• Access Criteria: Access requests can be submitted by email to Central contact person: Pavla Linhartová.

Locations

CZ (1)