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Cognitive Behavioral Aggression Treatment

Primary Purpose

Aggression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aggression focused on measuring Psychotherapy, Cognitive Behavioral Therapy, Aggression, fMRI, Behavioral Intervention

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Temple University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral Therapy

Supportive Psychotherapy

Arm Description

Twelve weekly 50-minute sessions of individual cognitive behavioral aggression treatment

Twelve weekly 50-minute sessions of individual supportive (client-centered) psychotherapy

Outcomes

Primary Outcome Measures

Aggressive Acts
Aggressive acts will be measured using electronic diaries and clinical interview

Secondary Outcome Measures

Brain activation to emotional stimuli
Brain response (as measured by fMRI)to emotional expressions and pictures

Full Information

First Posted
December 20, 2010
Last Updated
March 3, 2016
Sponsor
Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT01264900
Brief Title
Cognitive Behavioral Aggression Treatment
Official Title
Cognitive Behavioral Aggression Treatment: Effects on Brain and Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Temple University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: CBAT will reduce anger, aggression and hostile biases more than supportive therapy. CBAT will decrease limbic activation and increase prefrontal activation to emotional pictures more than supportive therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggression
Keywords
Psychotherapy, Cognitive Behavioral Therapy, Aggression, fMRI, Behavioral Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Twelve weekly 50-minute sessions of individual cognitive behavioral aggression treatment
Arm Title
Supportive Psychotherapy
Arm Type
Active Comparator
Arm Description
Twelve weekly 50-minute sessions of individual supportive (client-centered) psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Other Intervention Name(s)
CBT
Intervention Description
Twelve weekly 50-minute sessions of individual cognitive behavioral aggression treatment or supportive psychotherapy
Primary Outcome Measure Information:
Title
Aggressive Acts
Description
Aggressive acts will be measured using electronic diaries and clinical interview
Time Frame
Pre-intervention thru 1 year post-intervention
Secondary Outcome Measure Information:
Title
Brain activation to emotional stimuli
Description
Brain response (as measured by fMRI)to emotional expressions and pictures
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S McCloskey, Ph.D
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18837604
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.
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Cognitive Behavioral Aggression Treatment

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