We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Cognitive Behavioral Aggression Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01264900
Recruitment Status : Completed
First Posted : December 22, 2010
Last Update Posted : March 4, 2016
Information provided by (Responsible Party):
Michael McCloskey, Temple University

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.

Condition or disease Intervention/treatment Phase
Aggression Behavioral: Psychotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Aggression Treatment: Effects on Brain and Behavior
Study Start Date : May 2010
Primary Completion Date : February 2016
Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy
Twelve weekly 50-minute sessions of individual cognitive behavioral aggression treatment
Behavioral: Psychotherapy
Twelve weekly 50-minute sessions of individual cognitive behavioral aggression treatment or supportive psychotherapy
Other Name: CBT
Active Comparator: Supportive Psychotherapy
Twelve weekly 50-minute sessions of individual supportive (client-centered) psychotherapy
Behavioral: Psychotherapy
Twelve weekly 50-minute sessions of individual cognitive behavioral aggression treatment or supportive psychotherapy
Other Name: CBT

Primary Outcome Measures :
  1. Aggressive Acts [ Time Frame: Pre-intervention thru 1 year post-intervention ]
    Aggressive acts will be measured using electronic diaries and clinical interview

Secondary Outcome Measures :
  1. Brain activation to emotional stimuli [ Time Frame: 14 weeks ]
    Brain response (as measured by fMRI)to emotional expressions and pictures

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264900

United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19122
Sponsors and Collaborators
Temple University
Principal Investigator: Michael S McCloskey, Ph.D Temple University

Responsible Party: Michael McCloskey, Associate Professor, Temple University
ClinicalTrials.gov Identifier: NCT01264900     History of Changes
Other Study ID Numbers: MH086525
First Posted: December 22, 2010    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016

Keywords provided by Michael McCloskey, Temple University:
Cognitive Behavioral Therapy
Behavioral Intervention

Additional relevant MeSH terms:
Behavioral Symptoms