Measuring the Impact of Real Time fMRI Neurofeedback in Borderline Personality Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change in Affective Lability
研究概览
简要总结
This study will test the impacts of real time fMRI neurofeedback in patients with Borderline Personality Disorder. This is a pilot study in a small number of people enrolled in clinical programs at Yale New Haven Hospital.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •enrolled in YNHH DBT-IOP
- •must meet specific clinical criteria
- •Inclusion in Experimental group requires participants meet standard safety and quality control requirements for MR scanning
- •For female participants, not pregnant and willing to use a reliable method of contraception during the study
排除标准
- •vision problem not able to be corrected to normal range
- •medication changes w/in one month
- •Lifetime hx of schizophrenia, schizoaffective d/o, bipolar I disorder.
- •illicit substance use within 7 days of MRI scans
- •taking scheduled opiates
- •taking scheduled benzodiazepines
- •taking scheduled anti-histamines
- •history of seizures
- •significant current or past neurologic illness
- •BMI < 16.5
结局指标
主要结局
Change in Affective Lability
时间窗: Baseline compared to the week after intervention
This outcome will be measured by the change in variance of negative emotions measured using ecologic momentary assessment (EMA: surveys sent to participants by smartphone app) repeatedly over a four-day period at each timepoint. The variance between measurements at each timepoint will be calculated, and compared to the other timepoints. There will be 5 negative emotion items at each timepoint, and a higher score indicates more negative emotion.
次要结局
- Change in Mean Negative Affect(Baseline compared to the week after intervention)
- Change in Amygdala Regulation(Baseline compared to the week after intervention)
- Change in Borderline Personality Disorder Symptoms(Baseline compared to the week after intervention)