Cognitive Behavioral Aggression Treatment

March 3, 2016 updated by: Michael McCloskey, Temple University

Cognitive Behavioral Aggression Treatment: Effects on Brain and Behavior

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19122
        • Temple University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aggressive Acts
Time Frame: Pre-intervention thru 1 year post-intervention
Aggressive acts will be measured using electronic diaries and clinical interview
Pre-intervention thru 1 year post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain activation to emotional stimuli
Time Frame: 14 weeks
Brain response (as measured by fMRI)to emotional expressions and pictures
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Investigators

  • Principal Investigator: Michael S McCloskey, Ph.D, Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

December 20, 2010

First Submitted That Met QC Criteria

December 20, 2010

First Posted (ESTIMATE)

December 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH086525

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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