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临床试验/NCT01264900
NCT01264900已完成2 期

Cognitive Behavioral Aggression Treatment: Effects on Brain and Behavior

Temple University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
120
试验地点
2
主要终点
Aggressive Acts

研究概览

简要总结

Aggressive behavior is a leading worldwide public health problem. Despite this, relatively little is known about how to best treat individuals who are highly angry and aggressive. A rich literature suggests that aggression is associated with a tendency to interpret situations as threatening or hostile even when they are not. This process is governed by a prefrontal-limbic circuit in the brain. A goal of cognitive behavioral therapy is to reduce these kinds of hostile biases. Preliminary data by the PI suggests a 12- session cognitive behavioral aggression treatment (CBAT) may help reduce aggressive behavior and underlying hostile biases associated with affective aggression. To assess the efficacy of this treatment, 120 adults with high levels of anger and aggression will receive 12 sessions of either CBAT or supportive psychotherapy. All subjects will monitor their anger and aggressive behavior throughout the treatment electronic diaries. Subjects will also complete questionnaires and computer tasks to assess anger, hostile biases and related processes 1-week before treatment begins, and again 1-week, 6-months and 1-year after treatment ends. In addition, to understand the effects of CBAT on the brain, subjects will have their brains scanned (functional Magnetic Resonance Imaging) while they look at emotional pictures and complete computer tasks. The brain scans will occur once before treatment starts and once after treatment ends.

Our hypotheses are:

  1. CBAT will reduce anger, aggression and hostile biases more than supportive therapy.
  2. CBAT will decrease limbic activation and increase prefrontal activation to emotional pictures more than supportive therapy.

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
Single (Outcomes Assessor)

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

  • Three or more acts of physical aggression (assault / property destruction) in past six months
  • Aggression related distress and/or impairment
  • Meets Criteria for Intermittent Explosive Disorder

排除标准

  • Life History of DSM-IV Axis Bipolar disorder, Schizophrenia, Delusional disorder, Organic disorder, or Mental Retardation
  • Current DSM-IV Major Depressive Episode, Alcohol Dependence or other Drug Dependence
  • Current (past month) psychotropic medication use
  • Current severe suicidal or homicidal ideation necessitating immediate medical intervention
  • Current pregnancy or nursing, or existence of any medical condition that would deem the subject ineligible to undergo an fMRI (e.g., metal pins)
  • Two consecutive positive Expired Breathalyzer Alcohol or Urine Drug toxicological screens
  • Unable or unwilling to cooperate with study protocol (e.g., keep appointments, complete rating forms, read and understand informed consent).

结局指标

主要结局

Aggressive Acts

时间窗: Pre-intervention thru 1 year post-intervention

Aggressive acts will be measured using electronic diaries and clinical interview

次要结局

  • Brain activation to emotional stimuli(14 weeks)

研究者

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

Michael McCloskey

Associate Professor

Temple University

研究点 (2)

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