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临床试验/NCT05398627
NCT05398627进行中(未招募)不适用

Amygdala rtfMRI Neurofeedback for Borderline Personality Disorder

Kymberly Young2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年9月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
2
主要终点
Change from Baseline in Borderline Scale from the Personality Assessment Inventory at 12 weeks

研究概览

简要总结

The goal of this study is to evaluate whether rtfMRI-nf training to increase the amygdala response to positive memories may serve as an intervention for borderline personality disorder.

详细描述

We will assess the treatment effects of real-time fMRI neurofeedback in adults with borderline personality disorder. This is an experimental longitudinal design where participants will be followed every two weeks after receiving 2 sessions of neurofeedback from the amygdala . Procedures involve a battery of self-report measures, fMRI and psychophysiological indices (heart rate, respiration).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • right-handed adults (ages 18 - 55) with a primary diagnosis of Borderline Personality Disorder according to diagnostic criteria in the Structured Interview for DSM Personality Disorders
  • must be able to give written informed consent prior to participation
  • unmedicated or stable on an SSRI antidepressant regime (at least 3 weeks to ensure symptoms are stable)
  • English speaking

排除标准

  • have a clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
  • Current moderate or severe DSM-V alcohol or substance use disorder, with the exception of nicotine or caffeine. Clinician will access subjects' alcohol and substance use on a case-by-case to determine whether specific cases of mild alcohol or substance use would also interfere with the effects of the intervention.
  • have a history of traumatic brain injury
  • are unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
  • are currently pregnant or breast feeding
  • are unable to complete questionnaires written in English
  • current (within 3 weeks of testing) use of any antipsychotics, benzodiazepines, beta-blockers, or other medications (except SSRI antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study. Inclusion of patients on stable antidepressant medications was decided in order to allow generalization towards a real world population
  • have a DSM-5 diagnosis of psychotic or organic mental disorder
  • have any eye problems or difficulties in corrected vision.
  • Serious suidicial ideation

结局指标

主要结局

Change from Baseline in Borderline Scale from the Personality Assessment Inventory at 12 weeks

时间窗: Baseline vs 12 weeks

Assessment of severity of borderline symptoms. This scale contains 24 items rated on a four-point scale (0=false to 3=very true). Scores range from 0-72, and are converted to T scores, with higher scores indicating more borderline symptoms. Scores below 59 indicate healthy, scores at or above 70T indicate the respondent is likely to have borderline personality disorder.

次要结局

  • Change from Baseline in Beck Depression Inventory at 12 weeks(Baseline vs 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kymberly Young

Associate Professor

University of Pittsburgh

研究点 (2)

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