rTMS-enhanced Psychotherapy for Borderline Personality Disorder (rTMS-DBT)

Masarykova Univerzita

Status: Active, not recruiting

Conditions: Borderline Personality Disorder

Treatments: Device: Prefrontal rTMS treatment; Behavioral: Dialectical behavioral therapy program; Device: Sham rTMS sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT06259851

NU23-04-00472

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

60 participants in 4 patient groups

rTMS-DBT group

Experimental group

Description:

Patients receiving combined DBT and active prefrontal rTMS treatment

Treatment:

Behavioral: Dialectical behavioral therapy program

Device: Prefrontal rTMS treatment

Sham-DBT group

Active Comparator group

Description:

Patients receiving combined DBT and sham rTMS treatment

Treatment:

Device: Sham rTMS sessions

Behavioral: Dialectical behavioral therapy program

rTMS-only group

Active Comparator group

Description:

Patients receiving only active prefrontal rTMS treatment

Treatment:

Device: Prefrontal rTMS treatment

sham-only group

Sham Comparator group

Description:

Patients receiving only sham rTMS treatment

Treatment:

Device: Sham rTMS sessions