Neural Mechanisms of Dialectical Behavioral Therapy in Patients with Borderline Personality Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Decrease of borderline symptoms
研究概览
简要总结
This research examines the behavioral and neural mechanisms of dialectical behavior therapy (DBT) effect in patients with borderline personality disorder (BPD).
详细描述
This project aims to evaluate the behavioral and neural mechanisms of dialectical behavior therapy (DBT) effect in patients with borderline personality disorder (BPD). The project includes three subject groups: patients with BPD undergoing the DBT program (BPD-DBT), control patients with BPD on the waiting list for the program (BPD-control), and healthy controls (HC). Patients in the BPD-DBT group undergo a 24-week DBT program in an outpatient setting. All participants undergo a test battery comprising of self-report measures, clinical evaluation and fMRI and EEG measurement in the week before the DBT program beginning (T1), after 24 weeks (follow-up, T3), and at 24 weeks after T3 (follow-up, T4). The BPD-DBT group undergoes another assessment at T2 (after 12 weeks) to monitor selected symptoms during the DBT program by a short set of questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BPD-DBT group:
- •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
- •more than one self-injury incident and/or suicidal attempt in the past six months
排除标准
- •neurological disorder
- •comorbid affective disorder or schizophrenia-related disorder
- •intelligence quotient<70
- •contraindications for MRI measurement
- •pregnancy
- •body mass index under 15
- •BPD-C group:
- •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
- •more than one self-injury incident and/or suicidal attempt in the past six months
- •Exclusion Criteria:
- •completing a DBT program or attending DBT-based therapy
- •neurological disorder
- •comorbid affective disorder or schizophrenia-related disorder
- •intelligence quotient<70
- •contraindications for MRI measurement
- •pregnancy
- •body mass index under 15
- •Inclusion criteria:
- •minimum age 16, informed consent of the patient
- •informed consent of patient's legal representative in case of patients under age 18
- •Exclusion criteria:
- •mental health problems
- •history of self-injury or/and suicidal attempt
- •neurological disorder
- •intelligence quotient<70
- •contraindications for MRI measurement
- •pregnancy
- •body mass index under 15
研究组 & 干预措施
BPD-DBT group - patients undergoing DBT program.
Patients with BPD undergoing Dialectical behavioral therapy (DBT) program with all the standard DBT modules (individual therapy 1 hour per week, skill groups 1.5 hours twice per week, phone coaching as needed, and consultation team 1.5 hours per week). The program lasts a total of 24 weeks in total including two 12-week runs of skills training. Four individual pretreatment sessions precede the program before the start of the main program part.
干预措施: Dialectical behavior therapy (Behavioral)
BPD-C group - patients undergoing treatment as usual (TAU)
Patients with BPD who are on the waiting list and who receive treatment as usual (typically standard individual psychotherapy not specifically focused on BPD treatment and/or psychiatric treatment).
HC group: healthy controls
Healthy controls matched to the BPD-DBT group for age and education. Participants without mental health problems and/or a history of self-harm or suicidal behavior. This group receives no psychotherapy or psychiatric treatment.
结局指标
主要结局
Decrease of borderline symptoms
时间窗: From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).
significant decrease of symptoms measured by Borderline Symptoms List-23
Decrease of self-injury incidents and suicidal attempts
时间窗: From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.
significant decrease of self-injury incidents and suicidal attempts assessed by semi-structured interview Lifetime - Suicide Attempt Self-Injury Count
次要结局
- Decrease in the number of days spent in the hospital(From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.)
- Ecological momentary assessment of emotional variability(From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.)
- Increase in reasons for living(From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).)
- Decrease of impulsivity(From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).)
- Increase of mindfulness(From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).)
- Decrease of rejection sensitivity(From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).)
- Decrease of dissociation symptoms(From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).)
- Decrease of anxiety(From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).)
- Decrease of depression ranking(From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).)
- Increase of emotion regulation(From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).)
- Changes in fMRI neural activity during "Faces task"(From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.)
- Changes in fMRI neural activity during fMRI neurofeedback(From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.)
- Changes in fMRI neural activity during Cyberball task(From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.)
- Changes in frontal asymmetry during social exclusion measured by EEG(From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.)
- Changes in ECG during fMRI(From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.)
- Changes in skin conductance during fMRI(From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.)