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临床试验/NCT06259851
NCT06259851进行中(未招募)不适用

rTMS-enhanced Psychotherapy for Borderline Personality Disorder

Masarykova Univerzita2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年8月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
2
主要终点
Decrease of borderline symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

rTMS-DBT group

Experimental

Patients receiving combined DBT and active prefrontal rTMS treatment

干预措施: Dialectical behavioral therapy program (Behavioral)

rTMS-DBT group

Experimental

Patients receiving combined DBT and active prefrontal rTMS treatment

干预措施: Prefrontal rTMS treatment (Device)

Sham-DBT group

Active Comparator

Patients receiving combined DBT and sham rTMS treatment

干预措施: Dialectical behavioral therapy program (Behavioral)

Sham-DBT group

Active Comparator

Patients receiving combined DBT and sham rTMS treatment

干预措施: Sham rTMS sessions (Device)

rTMS-only group

Active Comparator

Patients receiving only active prefrontal rTMS treatment

干预措施: Prefrontal rTMS treatment (Device)

sham-only group

Sham Comparator

Patients receiving only sham rTMS treatment

干预措施: Sham rTMS sessions (Device)

结局指标

主要结局

Decrease of borderline symptoms

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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