Cognitive Behavioral Aggression Treatment

NCT01264900 | Completed Phase 2 DMC

• 1 other identifier: MH086525
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Aggression

Keywords

Psychotherapy; Cognitive Behavioral Therapy; Aggression; fMRI; Behavioral Intervention

Outcome Measures

Primary Outcomes (1)

• Aggressive Acts

  Aggressive acts will be measured using electronic diaries and clinical interview

  Pre-intervention thru 1 year post-intervention

Secondary Outcomes (1)

• Brain activation to emotional stimuli

  14 weeks

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

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

Behavioral: Psychotherapy

Supportive Psychotherapy

ACTIVE COMPARATOR

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

Behavioral: Psychotherapy

Interventions

Psychotherapy BEHAVIORAL

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

Also known as: CBT

Cognitive Behavioral Therapy; Supportive Psychotherapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Related Publications (1)

• 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.

  PMID: 18837604 BACKGROUND

MeSH Terms

Conditions

Aggression

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Michael S McCloskey, Ph.D

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 22, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

US (1)