rTMS-enhanced Psychotherapy for Borderline Personality Disorder
- Conditions
- Borderline Personality Disorder
- Interventions
- Behavioral: Dialectical behavioral therapy programDevice: Sham rTMS sessionsDevice: Prefrontal rTMS treatment
- Registration Number
- NCT06259851
- Lead Sponsor
- Masarykova Univerzita
- 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.
- Detailed Description
The proposed project aims to evaluate the effectiveness of combining Dialectical Behavioral Therapy (DBT) with prefrontal repetitive transcranial magnetic stimulation (rTMS) in individuals with borderline personality disorder (BPD). The study includes four groups of patients: 1) DBT combined with active prefrontal rTMS treatment (rTMS-DBT group), 2) DBT combined with sham rTMS treatment (sham-DBT group), 3) active prefrontal rTMS treatment only (rTMS-only group), and 4) sham rTMS treatment only (sham-only group). The study will include assessments conducted before (T1) and after the rTMS treatment (T2) composed of self-reported questionnaires, clinical interviews assessing self-harming behavior and healthcare utilization, ecological momentary assessment of emotional variability, functional magnetic resonance imaging (fMRI) during emotional task, and control clinical EEG measurements. Follow-up measurements will be conducted at T3 (three months after rTMS), and for DBT group also at T4 (six months after rTMS), and T5 (twelve months after rTMS) for to track long-term effects.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- 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
- neurological disorder
- comorbid affective disorder or schizophrenia-related disorder
- intelligence quotient<70
- contraindications for MRI measurement
- contraindication for rTMS treatment
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description rTMS-DBT group Dialectical behavioral therapy program Patients receiving combined DBT and active prefrontal rTMS treatment Sham-DBT group Dialectical behavioral therapy program Patients receiving combined DBT and sham rTMS treatment Sham-DBT group Sham rTMS sessions Patients receiving combined DBT and sham rTMS treatment rTMS-DBT group Prefrontal rTMS treatment Patients receiving combined DBT and active prefrontal rTMS treatment rTMS-only group Prefrontal rTMS treatment Patients receiving only active prefrontal rTMS treatment sham-only group Sham rTMS sessions Patients receiving only sham rTMS treatment
- Primary Outcome Measures
Name Time Method Decrease of borderline symptoms 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 significant decrease of symptoms measured by Borderline Symptoms List-23
Increase of emotion regulation 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 significant increase of emotion regulation measured by Difficulties in emotion regulation scale (minimum: 22, maximum: 87, higher score means better outcome)
Decrease of self-reported depression symptoms 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 significant decrease of depression symptoms measured by Beck Depression Inventory II
Decrease of dissociation symptoms 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 significant decrease of dissociation symptoms measured by Multiscale dissociation inventory
Decrease of depression symptoms clinical ranking 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 significant decrease of depression symptoms measured by Montgomery-Asberg Depression Rating Scale clinical rating
Decrease of anxiety 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 significant decrease of anxiety symptoms measured by Beck Anxiety Inventory
Decreased brain emotional reactivity Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3) in all groups and additionally 24 weeks after baseline (T4) in DBT group 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.
Decreased impulsivity in Go/No-Go task in fMRI Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3) in all groups and additionally 24 weeks after baseline (T4) in DBT group 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.
Decrease of impulsivity 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 significant decrease of impulsivity measured by UPPS-P questionnaire
Increased regulation of amygdala during fMRI neurofeedback Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3) in all groups and additionally 24 weeks after baseline (T4) in DBT group 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).
Decrease of emotional variability 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 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.
Decrease in sef-harming behavior and medical care usage 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) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Psychiatry, University Hospital Brno and Faculty of Medicine, Masaryk University
🇨🇿Brno, Czechia