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临床试验/NCT04967222
NCT04967222已完成不适用

Cognitive Reappraisal Training Targeting Emotion Circuits As a Therapeutic Intervention 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 60 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in PINES Network Activity

研究概览

简要总结

Previous work by the study group convinced the study team to pursue development of focused cognitive reappraisal training as a novel approach to treatment of BPD, either as stand-alone treatment or in concert with evidence-based treatments of BPD. The present proposal aims to refine and test a proposed clinical intervention for BPD patients, training in reappraisal-by-distancing, in terms of its ability to influence hypothesized neural and behavioral targets and, once that is established, to demonstrate its ability improve clinically relevant outcome measures.

详细描述

Borderline Personality Disorder (BPD) is a prevalent, enduring and disabling psychiatric condition found in approximately 2% to 5.9% of the population and 20% of hospitalized psychiatric patients. Suicide rates of approximately 10% have been reported. One of the most prominent clinical features of BPD is extreme mood shifts occurring in response to external social/emotional events. The emotional instability in BPD contributes to many of the most disabling, even life-threatening, symptoms of the disorder, including suicidality, outbursts of intense anger, and seriously impaired role functioning. The severity of the BPD symptom profile, its prevalence, chronicity and high burden upon health care services make the development of effective and accessible treatment for BPD a high priority. Yet there is no current medication treatment indicated for BPD and the psychotherapies recognized for the disorder have been shown to have small effect sizes and are of limited availability.

The present study builds upon work by the study group that has shown that deficiencies in the ability to regulate emotion by engaging typically adaptive cognitive strategies (cognitive reappraisal, CR) and to effectively activate associated neural systems can be corrected by focused training in CR. The R61 phase of this study examines a manualized intensive training program in CR, tests that it effects target neural systems implicated in emotional processing and enhances behavioral reappraisal success. It examines 2-, 4- and 6- weeks of twice a week treatment to identify the optimal dose. Measures include fMRI imaging and clinical ratings at baseline and each of these subsequent time points. Upon demonstrating that CR training is superior to a control condition in enhancing performance in the neural target at one or more of these dose durations, the study team will proceed to the R33 phase. In the R33 phase the study team will treat a larger sample of BPD patients at the optimal dose defined in the R61 phase to 1) demonstrate reproducibility of the R61 findings, 2) to demonstrate that CR training is superior to control in improving BPD clinical outcomes at the end of treatment and at 1- and 4- month follow-up, and 3) that change in activity at the neural targets is associated with clinical improvement.

The results of this study can support the introduction of CR training as a new psychosocial approach for the treatment of BPD, either as stand-alone treatment or as an augmenting strategy. It may, moreover, have application to a range of psychiatric disorders characterized by severe emotional instability.

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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Medically healthy men and women with Borderline Personality Disorder who are mentally competent and give informed voluntary written consent.
  • Subjects who are being treated with psychotherapy or psychopharmacotherapy will be included so long as there has been no change in that treatment over the preceding 2 months.

排除标准

  • Age > 55
  • Criteria for Schizotypal Personality Disorder or Avoidant Personality Disorder. SPD is excluded to avoid possible confound from the restricted affect that characterizes SPD and co-morbid AvPD subjects will be excluded because the researchers have shown that their patterns of neural activity in emotion processing are distinct from BPD subjects.

结局指标

主要结局

Change in PINES Network Activity

时间窗: Baseline and up to 6 weeks of treatment

BOLD signal change in Picture Induced Negative Emotion Signature (PINES) network activity that includes the amygdala, insula, and other regions by measuring neural activation using fMRI.

Change in Zanarini Rating Scale for Borderline Personality (ZAN-BPD)

时间窗: Baseline and up to 6 weeks of treatment

Zanarini Rating Scale for Borderline Personality, self-report. Full scale from 0-36. Higher score indicates poorer health outcomes.

次要结局

  • Change in ZAN-BPD Sector Scores(Baseline and at 2-,4-, and 6-weeks)
  • Change in Affective Lability Scale Total (ALS)(Baseline and at 2-,4-, and 6-weeks)
  • Change in Perceived Stress Scale (PSS)(Baseline and at 2-,4-, and 6-weeks)
  • Change in Difficulty in Emotion Regulation Scale Scores (DERS)(Baseline and at 2-,4-, and 6-weeks)
  • Change in Beck Depression Scale Score (BDI)(Baseline and at 2-,4-, and 6-weeks)
  • Change in State-Trait Anxiety Scale Score (STAXI)(Baseline and at 2-,4-, and 6-weeks)

研究者

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

Harold W Koenigsberg, MD

Professor of Psychiatry

Icahn School of Medicine at Mount Sinai

研究点 (1)

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