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Psychotherapy for Intermittent Explosive Disorder

Primary Purpose

Anger, Intermittent Explosive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Supportive Psychotherapy
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anger focused on measuring anger, intermittent, explosive

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

2

1

Arm Description

Supportive Psychotherapy

Cognitive Behavioral Therapy (Cognitive Restructuring, Relaxation, and Coping Skills Training: CRCST)

Outcomes

Primary Outcome Measures

Overt Aggression Scale - Modified (OASM)
State-Trait Anger Expression Inventory - Trait Anger Scale [STAXI-T]
Intermittent Explosive Disorder Interview

Secondary Outcome Measures

Behavioral aggression measures (Taylor Aggression Paradigm [TAP], Point Subtraction Aggression Paradigm [PSAP])

Full Information

First Posted
April 24, 2008
Last Updated
June 11, 2013
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00667212
Brief Title
Psychotherapy for Intermittent Explosive Disorder
Official Title
Individual Cognitive Behavioral Psychotherapy for Intermittent Explosive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anger, Intermittent Explosive Disorder
Keywords
anger, intermittent, explosive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
Supportive Psychotherapy
Arm Title
1
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy (Cognitive Restructuring, Relaxation, and Coping Skills Training: CRCST)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
Cognitive Restructuring, Relaxation, and Coping Skills Training
Intervention Description
Twelve weekly therapy sessions, approximately one hour each in duration
Intervention Type
Behavioral
Intervention Name(s)
Supportive Psychotherapy
Intervention Description
Twelve weekly therapy sessions, approximately one hour each in duration
Primary Outcome Measure Information:
Title
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
Title
State-Trait Anger Expression Inventory - Trait Anger Scale [STAXI-T]
Time Frame
Pre-Therapy visit, Therapy session 7, Post-Therapy visit
Title
Intermittent Explosive Disorder Interview
Time Frame
Diagnostic Interview, Post-Therapy Visit (Modified), 3, 6, and 12-month Follow-Up vists (modified)
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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: CHECK ON THIS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael McCloskey, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Psychotherapy for Intermittent Explosive Disorder

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