Clinical trial NCT01264900: Cognitive Behavioral Aggression Treatment
Official title: Cognitive Behavioral Aggression Treatment: Effects on Brain and Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aggression
Keywords: Psychotherapy
Cognitive Behavioral Therapy
Aggression
fMRI
Behavioral Intervention
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2010-12-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Aggressive Acts
timeFrame: Pre-intervention thru 1 year post-intervention
Secondary outcomes:
measure: Brain activation to emotional stimuli
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Michael S McCloskey, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCloskey MS, Noblett KL, Deffenbacher JL, Gollan JK, Coccaro EF. Cognitive-behavioral therapy for intermittent explosive disorder: a pilot randomized clinical trial. J Consult Clin Psychol. 2008 Oct;76(5):876-86. doi: 10.1037/0022-006X.76.5.876.