Cognitive Behavioral Aggression Treatment

Aggression Clinical Trial

Official title:

Cognitive Behavioral Aggression Treatment: Effects on Brain and Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264900
• Other study ID #: MH086525
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2010
• Last updated: March 3, 2016
• Start date: May 2010
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aggression

Intervention

Behavioral:
• Psychotherapy
Twelve weekly 50-minute sessions of individual cognitive behavioral aggression treatment or supportive psychotherapy

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aggressive Acts	Aggressive acts will be measured using electronic diaries and clinical interview	Pre-intervention thru 1 year post-intervention	No
Secondary	Brain activation to emotional stimuli	Brain response (as measured by fMRI)to emotional expressions and pictures	14 weeks	No