Psychotherapy for Intermittent Explosive Disorder

June 11, 2013 updated by: University of Chicago

Individual Cognitive Behavioral Psychotherapy for Intermittent Explosive Disorder

The goal of this study is to examine the effectiveness two forms of psychotherapy (also known as "talk therapy" ) for individuals with anger and aggression problems. Anger and aggression are everywhere - on the road, in the schools, at little league games, at home, and at work. In this study we are testing usefulness of anger management techniques in reducing symptoms of Intermittent Explosive Disorder (IED) and impulsive, aggressive behavior.

Study Overview

Detailed Description

Qualified participants will be randomly assigned to 12 1-hour sessions of either cognitive-behavioral therapy or supportive psychotherapy.

Participation in this study will require 16 visits over approximately 4 months with 3 follow-up sessions over a 12 month period. Therapy is provided at no cost and each study participant will receive a comprehensive psychological assessment. Two types of talk therapy are being offered in this study. One form of therapy focuses on thought and behaviors associated with anger and aggression. This type of therapy is known as cognitive behavioral therapy. The other type of therapy focuses on the individuals' feeling about their anger /aggression and the situations that lead to this anger. This is known as supportive therapy. The form of therapy you are given will be randomly determined (like by flipping of a coin).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have problems with anger, temper outbursts, being irritable, getting in trouble at work or at home because of impulsive/aggressive behavior.
  • Between the ages of 18 and 55.
  • Meet other eligibility requirements as outlined by the research protocol.

Exclusion Criteria:

  • CHECK ON THIS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Supportive Psychotherapy
Twelve weekly therapy sessions, approximately one hour each in duration
Active Comparator: 1
Cognitive Behavioral Therapy (Cognitive Restructuring, Relaxation, and Coping Skills Training: CRCST)
Twelve weekly therapy sessions, approximately one hour each in duration
Other Names:
  • Cognitive Restructuring, Relaxation, and Coping Skills Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overt Aggression Scale - Modified (OASM)
Time Frame: Screen Visit, Pre-Therapy visit, Therapy sessions 2, 4, 6, 8, 12, Post-Therapy Visit, 3, 6, and 12-month Follow-Up Vists
Screen Visit, Pre-Therapy visit, Therapy sessions 2, 4, 6, 8, 12, Post-Therapy Visit, 3, 6, and 12-month Follow-Up Vists
State-Trait Anger Expression Inventory - Trait Anger Scale [STAXI-T]
Time Frame: Pre-Therapy visit, Therapy session 7, Post-Therapy visit
Pre-Therapy visit, Therapy session 7, Post-Therapy visit
Intermittent Explosive Disorder Interview
Time Frame: Diagnostic Interview, Post-Therapy Visit (Modified), 3, 6, and 12-month Follow-Up vists (modified)
Diagnostic Interview, Post-Therapy Visit (Modified), 3, 6, and 12-month Follow-Up vists (modified)

Secondary Outcome Measures

Outcome Measure
Time Frame
Behavioral aggression measures (Taylor Aggression Paradigm [TAP], Point Subtraction Aggression Paradigm [PSAP])
Time Frame: Pre-Therapy Visit, Post-Therapy Visit, 3, 6, and 12-month Follow-Up visits
Pre-Therapy Visit, Post-Therapy Visit, 3, 6, and 12-month Follow-Up visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael McCloskey, PhD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 24, 2008

First Posted (Estimate)

April 28, 2008

Study Record Updates

Last Update Posted (Estimate)

June 13, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

December 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • 15143A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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