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临床试验/NCT02465697
NCT02465697已完成不适用

An fMRI Study of the Enhancement of Emotion Regulation in Borderline Patients

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2011年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
169
试验地点
1
主要终点
Changes in BOLD signal in brain

研究概览

简要总结

Borderline Personality Disorder (BPD), a prevalent psychiatric disorder found in approximately 2% to 6% of the population and 20% of hospitalized psychiatric patients, has proven quite treatment resistant. This study is designed to determine whether patients with BPD can be trained to improve their ability to regulate their emotions and whether this leads to changes in how their brans regulate emotion.

详细描述

Borderline Personality Disorder (BPD) is a common psychiatric disorder found in approximately 2% to 6% of the population . It is characterized by intense and rapid mood changes, self-destructive behavior, suicidality, and tumultuous relationships. In additional to the emotional costs of the suffering experienced by borderline patients and their loved ones, BPD patients typically function at a level substantially below that of individuals with comparable intellect. The difficulty controlling emotion, so central to the disorder, has proved a particularly difficult to treat. The present study utilizes the latest neuroimaging findings in BPD to generate new ideas for the psychotherapy of the disorder.

This project builds upon our previous neuroimaging work, which has shown that when BPD patients try to control their emotions by employing a method that healthy people frequently use quite effectively -- taking an emotional distance from what is upsetting - BPD patients are not able to quiet down the part of their brain that sends out emotional alarm signals. The objective of the present study is to determine whether giving BPD patients special training in using this healthy distancing strategy can help them to improve their ability to regulate their emotions and return their brain activity to a more normal pattern. The investigators will do this by using fMRI to record brain activity as BPD subjects try to use distancing to reduce their emotional reactions to upsetting pictures before any training, then to have them receive specific training in the distancing strategy. After this training we will again obtain an fMRI scan to determine whether their pattern of brain activation has normalized and whether they have been able to better reduce their negative reactions to the pictures. If this is effective, it will show that such training may help BPD patients better regulate their emotions and would support a program to further develop and incorporate distancing training into the psychotherapy of BPD patients.

A second objective of the present study is to determine whether the tendency of BPD patients to become increasingly sensitized to negative situations when they are re-experienced (as shown by increased activity of the brain's emotional alarm system), will reduce with additional exposure, as it does in patients with phobias, or will continue to increase. Knowing this can help the therapist plan how to most therapeutically approach disturbing life experiences in the psychotherapy of BPD patients.

This project represents an important step in brain imaging research since it applies information learned about brain activity patterns to develop new approaches to psychotherapy. It addresses a serious, prevalent and difficult to treat disorder.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

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

  • BPD subjects 18 to 50 years old
  • Meet criteria for DSM-IV Borderline Personality Disorder, including the DSM-IV criteria for affective instability (criterion #6), and not meet criteria for Schizotypal Personality Disorder (SPD) or AvPD.
  • Subjects in the AvPD group meet DSM-IV criteria for AvPD and not for BPD or SPD.
  • All subjects will be free of psychotropic medications for 2 weeks (6 weeks for fluoxetine).
  • Subjects may be enrolled in psychotherapy

排除标准

  • BPD and AvPD subjects will not meet DSM-IV criteria for past or present PTSD, bipolar I disorder, schizophrenia, schizoaffective disorder, substance dependence, head trauma, CNS neurological disease, seizure disorder or current major depression.
  • Substance abuse disorder in the prior 6 months
  • Significant medical illness
  • Pregnancy
  • Metallic foreign-bodies that contraindicate MRI

研究组 & 干预措施

BPD Control

No Intervention

no training in reappraisal

APD Emotion Regulation Training

Experimental

Guided practice in reappraisal

干预措施: Reappraisal Training (Behavioral)

APD Controls

No Intervention

no training in reappraisal

Healthy Controls Emotion Regulation Training

Experimental

Guided practice in reappraisal

干预措施: Reappraisal Training (Behavioral)

Healthy Controls

No Intervention

no training in reappraisal

BPD Emotion Regulation Training

Experimental

Guided practice in reappraisal

干预措施: Reappraisal Training (Behavioral)

结局指标

主要结局

Changes in BOLD signal in brain

时间窗: baseline and 2 weeks

BOLD signal changes at 2 weeks compared to baseline to measure reappraisal success using fMRI to record brain activity.

次要结局

  • Perceived Stress Scale(baseline and 2 weeks)
  • State Trait Anger Expression Inventory (STAXI)(baseline and 2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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