Expired Study
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Chicago, Illinois 60637


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.


Study summary:

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).


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


Study is Available At:


Original ID:

15143A


NCT ID:

NCT00667212


Secondary ID:


Study Acronym:


Brief Title:

Psychotherapy for Intermittent Explosive Disorder


Official Title:

Individual Cognitive Behavioral Psychotherapy for Intermittent Explosive Disorder


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Chicago


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael McCloskey, PhD
Principal Investigator
University of Chicago

Study Dates

Start Date:August 2006
Completion Date:December 2010
Completion Type:Actual
Primary Completion Date:December 2010
Primary Completion Type:Actual
Verification Date:December 2010
Last Changed Date:June 11, 2013
First Received Date:April 24, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Intermittent Explosive Disorder Interview
Time Frame:Diagnostic Interview, Post-Therapy Visit (Modified), 3, 6, and 12-month Follow-Up vists (modified)
Safety Issues:False
Outcome Type:Primary Outcome
Measure:State-Trait Anger Expression Inventory - Trait Anger Scale [STAXI-T]
Time Frame:Pre-Therapy visit, Therapy session 7, Post-Therapy visit
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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-m
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Cognitive Behavioral Therapy
Description:Twelve weekly therapy sessions, approximately one hour each in duration
Arm Name:1
Other Name:Cognitive Restructuring, Relaxation, and Coping Sk
Intervention Type:Behavioral
Name:Supportive Psychotherapy
Description:Twelve weekly therapy sessions, approximately one hour each in duration
Arm Name:2

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Description:Cognitive Behavioral Therapy (Cognitive Restructuring, Relaxation, and Coping Skills Training: CRCST)
Study Arm Type:Active Comparator
Arm Name:2
Description:Supportive Psychotherapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Chicago

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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