Cognitive Behavioral Aggression Treatment

NCT ID: NCT01264900

Last Updated: 2016-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Aggression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive Behavioral Therapy

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

Group Type EXPERIMENTAL

Psychotherapy

Intervention Type BEHAVIORAL

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

Supportive Psychotherapy

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

Group Type ACTIVE_COMPARATOR

Psychotherapy

Intervention Type BEHAVIORAL

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

Interventions

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Psychotherapy

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

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Temple University

OTHER

Sponsor Role lead

Responsible Party

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Michael McCloskey

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael S McCloskey, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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Temple University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18837604 (View on PubMed)

Other Identifiers

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MH086525

Identifier Type: -

Identifier Source: org_study_id

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