Psychotherapy for Intermittent Explosive Disorder - Full Text View

Sponsored by:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00667212

Purpose

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.

Condition	Intervention	Phase
Anger Intermittent Explosive Disorder	Behavioral: Cognitive Behavioral Therapy Behavioral: Supportive Psychotherapy	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Factorial Assignment, Efficacy Study
Official Title:	Individual Cognitive Behavioral Psychotherapy for Intermittent Explosive Disorder

Further study details as provided by University of Chicago:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
State-Trait Anger Expression Inventory - Trait Anger Scale [STAXI-T] [ Time Frame: Pre-Therapy visit, Therapy session 7, Post-Therapy visit ] [ Designated as safety issue: No ]
Intermittent Explosive Disorder Interview [ Time Frame: Diagnostic Interview, Post-Therapy Visit (Modified), 3, 6, and 12-month Follow-Up vists (modified) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	August 2006
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator Supportive Psychotherapy	Behavioral: Supportive Psychotherapy Twelve weekly therapy sessions, approximately one hour each in duration
1: Active Comparator Cognitive Behavioral Therapy (Cognitive Restructuring, Relaxation, and Coping Skills Training: CRCST)	Behavioral: Cognitive Behavioral Therapy Twelve weekly therapy sessions, approximately one hour each in duration

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).

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667212

Contacts

Contact: Adam M Strohm

773-834-5928

astrohm@yoda.bsd.uchicago.edu

Locations

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

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator:

Michael McCloskey, PhD

University of Chicago

More Information

Additional Information:

Study web page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Chicago ( Dr. Michael McCloskey )
Study ID Numbers:	15143A
Study First Received:	April 24, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00667212 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

anger
intermittent
explosive

Study placed in the following topic categories:

Impulse Control Disorders
Mental Disorders

Additional relevant MeSH terms:

Impulse Control Disorders
Pathologic Processes
Disease
Mental Disorders

ClinicalTrials.gov processed this record on May 07, 2009