BrainBoost - A Neurofeedback Booster for Emotion Regulation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in affective instability
研究概览
简要总结
This is a proof-of-concept study that aims to test the additional value of adjuvant neurofeedback treatment for psychotherapy. Three sessions of real-time fMRI neurofeedback will be administered to N=22 patients with BPD while they receive residential Dialectical Behavior Therapy treatment. In addition, outcomes are assessed from a control group with same sample size who do not receive the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-5 BPD diagnosis
- •informed consent
- •EtOH and tox negative on the day of neurofeedback
- •BSL-23 score >=1.87 at DBT halftime
排除标准
- •pharmacotherapy with opiates
- •standing benzodiazepines (bedtime-only benzodiazepines and anti-histamines allowed)
- •pregnancy
- •life-time diagnosis schizophrenia or bipolar disorder I
- •significant current or past neurological illness
- •BMI<16.5
- •usual safety criteria for magnetic resonance imaging
结局指标
主要结局
Change in affective instability
时间窗: Before treatment, immediately after treatment + follow-up measure (3 months)
Mean successive squared differences (MSSD) of six-item negative affect scale measured via behavioural sampling using ecological momentary assessment (EMA) over four days. MSSD will be compared between baseline and post-treatment timepoints.
次要结局
- Change in emotion regulation(Before treatment, immediately after treatment + follow-up measure (3 months))
- Change in borderline symptomatology(Before treatment, immediately after treatment + 2 follow-up measures (3 months, 6 months))
- Change in resting state brain connectivity(Before treatment, immediately after treatment + follow-up measure (3 months))
- Change in amygdala reactivity(Before treatment, immediately after treatment + follow-up measure (3 months))
- Structural changes in the brain(Before the first neurofeedback training and after the last neurofeedback training)
研究者
Christian Paret
Principal Investigator
Central Institute of Mental Health, Mannheim