Cognitive Behavioral Aggression Treatment
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Aggression |
Behavioral: Psychotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Cognitive Behavioral Aggression Treatment: Effects on Brain and Behavior |
- Aggressive Acts [ Time Frame: Pre-intervention thru 1 year post-intervention ] [ Designated as safety issue: No ]Agggressive acts will be measured using electronic diaries and clinical interview
- Brain activation to emotional stimuli [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]Brain response (as measured by fMRI)to emotional expressions and pictures
| Estimated Enrollment: | 120 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: CBT
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| Contact: Michael S McCloskey, Ph.D | 215-204-3738 | mikemccloskey@temple.edu |
| United States, Pennsylvania | |
| Temple University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19122 | |
| Contact: Michael S McCloskey, Ph.D 215-204-3738 mikemccloskey@temple.edu | |
| Principal Investigator: Michael S McCloskey, Ph.D | |
| Sub-Investigator: Feroze Mohammed, Ph.D | |
| Principal Investigator: | Michael S McCloskey, Ph.D | Temple University |
More Information
Publications:
| Responsible Party: | Michael McCloskey, Ph.D./ Assistant Professor, Temple University |
| ClinicalTrials.gov Identifier: | NCT01264900 History of Changes |
| Other Study ID Numbers: | MH086525 |
| Study First Received: | December 20, 2010 |
| Last Updated: | August 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Temple University:
|
Psychotherapy Cognitive Behavioral Therapy Aggression fMRI Behavioral Intervention |
Additional relevant MeSH terms:
|
Aggression Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013