Cognitive Behavioral Aggression Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2010 by Temple University
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT01264900
First received: December 20, 2010
Last updated: August 3, 2011
Last verified: December 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Aggression Treatment: Effects on Brain and Behavior

Further study details as provided by Temple University:

Primary Outcome Measures:
  • Aggressive Acts [ Time Frame: Pre-intervention thru 1 year post-intervention ] [ Designated as safety issue: No ]
    Agggressive acts will be measured using electronic diaries and clinical interview


Secondary Outcome Measures:
  • Brain activation to emotional stimuli [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    Brain response (as measured by fMRI)to emotional expressions and pictures


Estimated Enrollment: 120
Study Start Date: May 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264900

Contacts
Contact: Michael S McCloskey, Ph.D 215-204-3738 mikemccloskey@temple.edu

Locations
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19122
Contact: Michael S McCloskey, Ph.D    215-204-3738    mikemccloskey@temple.edu   
Principal Investigator: Michael S McCloskey, Ph.D         
Sub-Investigator: Feroze Mohammed, Ph.D         
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Michael S McCloskey, Ph.D Temple University
  More Information

Publications:
Responsible Party: Michael McCloskey, Ph.D./ Assistant Professor, Temple University
ClinicalTrials.gov Identifier: NCT01264900     History of Changes
Other Study ID Numbers: MH086525
Study First Received: December 20, 2010
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Aggression
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 20, 2014