Psychotherapy for Intermittent Explosive Disorder
| Tracking Information | |||||
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| First Received Date ICMJE | April 24, 2008 | ||||
| Last Updated Date | December 20, 2010 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00667212 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Psychotherapy for Intermittent Explosive Disorder | ||||
| Official Title ICMJE | Individual Cognitive Behavioral Psychotherapy for Intermittent Explosive Disorder | ||||
| 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. |
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| 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). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00667212 | ||||
| Other Study ID Numbers ICMJE | 15143A | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. Michael McCloskey, University of Chicago | ||||
| Study Sponsor ICMJE | University of Chicago | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Chicago | ||||
| Verification Date | December 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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