- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00667212
Psychotherapy for Intermittent Explosive Disorder
Individual Cognitive Behavioral Psychotherapy for Intermittent Explosive Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
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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
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Pre-Therapy Visit, Post-Therapy Visit, 3, 6, and 12-month Follow-Up visits
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael McCloskey, PhD, University of Chicago
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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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