Clinical trial NCT06259851: rTMS-enhanced Psychotherapy for Borderline Personality Disorder
Official title: rTMS-enhanced Psychotherapy for Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Dialectical behavioral therapy
Repetitive transcranial magnetic stimulation
Borderline personality disorder
Lead sponsor: Masarykova Univerzita
Sponsor class: OTHER
Collaborators: name: Brno University Hospital
name: Masaryk University
First posted: 2024-02-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Allocation to the Active rTMS/Sham rTMS group is randomized.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Decrease of borderline symptoms
timeFrame: 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
measure: Decrease of impulsivity
timeFrame: 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
measure: Increase of emotion regulation
timeFrame: 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
measure: Decrease of self-reported depression symptoms
timeFrame: 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
measure: Decrease of depression symptoms clinical ranking
timeFrame: 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
measure: Decrease of anxiety
timeFrame: 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
measure: Decrease of dissociation symptoms
timeFrame: 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
measure: Increased regulation of amygdala during fMRI neurofeedback
timeFrame: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3) in all groups and additionally 24 weeks after baseline (T4) in DBT group
measure: Decreased brain emotional reactivity
timeFrame: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3) in all groups and additionally 24 weeks after baseline (T4) in DBT group
measure: Decreased impulsivity in Go/No-Go task in fMRI
timeFrame: Baseline (T1), after 3 weeks (T2), 12 weeks after baseline (T3) in all groups and additionally 24 weeks after baseline (T4) in DBT group
measure: Decrease of emotional variability
timeFrame: 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
measure: Decrease in sef-harming behavior and medical care usage
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Department of Psychiatry, University Hospital Brno and Faculty of Medicine, Masaryk University
Study officials:
affiliation: University Hospital Brno
name: Libor Ustohal, prof, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: