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Cognitive Behavioral Aggression Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01264900
First Posted: December 22, 2010
Last Update Posted: March 4, 2016
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.
Information provided by (Responsible Party):
Michael McCloskey, Temple University
  Purpose

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 Intervention Phase
Aggression Behavioral: Psychotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Aggression Treatment: Effects on Brain and Behavior

Further study details as provided by Michael McCloskey, Temple University:

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


Enrollment: 120
Study Start Date: May 2010
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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


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

Publications:
Responsible Party: Michael McCloskey, Associate Professor, Temple University
ClinicalTrials.gov Identifier: NCT01264900     History of Changes
Other Study ID Numbers: MH086525
First Submitted: December 20, 2010
First Posted: December 22, 2010
Last Update Posted: March 4, 2016
Last Verified: March 2016

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

Additional relevant MeSH terms:
Aggression
Behavioral Symptoms