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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00667212
Other study ID # 15143A
Secondary ID
Status Completed
Phase Phase 2
First received April 24, 2008
Last updated June 11, 2013
Start date August 2006
Est. completion date December 2010

Study information

Verified date December 2010
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

Behavioral:
Cognitive Behavioral Therapy
Twelve weekly therapy sessions, approximately one hour each in duration
Supportive Psychotherapy
Twelve weekly therapy sessions, approximately one hour each in duration

Locations

Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overt Aggression Scale - Modified (OASM) Screen Visit, Pre-Therapy visit, Therapy sessions 2, 4, 6, 8, 12, Post-Therapy Visit, 3, 6, and 12-month Follow-Up Vists No
Primary State-Trait Anger Expression Inventory - Trait Anger Scale [STAXI-T] Pre-Therapy visit, Therapy session 7, Post-Therapy visit No
Primary Intermittent Explosive Disorder Interview Diagnostic Interview, Post-Therapy Visit (Modified), 3, 6, and 12-month Follow-Up vists (modified) No
Secondary Behavioral aggression measures (Taylor Aggression Paradigm [TAP], Point Subtraction Aggression Paradigm [PSAP]) Pre-Therapy Visit, Post-Therapy Visit, 3, 6, and 12-month Follow-Up visits No
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