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A Pilot Study Comparing the Efficacy of Group Versus Individual Anger Management in Subjects With IED

Primary Purpose

Anger, Intermittent Explosive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
anger management therapy
Sponsored by
University of Chicago
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria: The subject meets research criteria for a lifetime diagnosis of intermittent explosive disorder (IED). The subject has a Trait Anger Score > 21 on the STAXI (see above). Subject is willing to be randomized to any one of the four conditions. The subject is willing and able to cooperate with study protocol (i.e., keep appointments, complete rating forms, etc.) Subject gives informed consent to participate in study. Exclusion Criteria: The subject has any history of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I bipolar mood disorder, schizophrenia, delusional disorder, organic brain disorder, mental retardation. The subject meets DSM-IV criteria for alcohol or drug dependence within 30 days prior to the start of any of the study conditions. The subject has a Beck Depression Inventory, 2nd Edition (BDI-II) score > 32. The subject has aggressive obsessions in the context of Obsessive Compulsive Disorder (OCD). Current suicidal behavior or homicidal ideation. The subject is not willing to be randomized to any one of the four conditions. The subject is not willing to cooperate with study protocol (i.e., keep appointments, complete rating forms, etc.). The subject, in the opinion of the principal investigator (PI), is not able or likely to cooperate with study protocol (i.e., keep appointments, complete rating forms, etc.) The subject is already engaged in an anger management program elsewhere. The subject does not give informed consent to participate in study

Sites / Locations

  • The University of Chicago

Outcomes

Primary Outcome Measures

Aggression interview (Overt Aggression Scale-Modified
[OASM]) at midpoint 1 week post-treatment, 3-month follow-up and 6-month follow-up
State-Trait Anxiety Inventory (STAXI) questionnaire at midpoint 1 week post-treatment, 3-month follow-up and 6-month follow-up

Secondary Outcome Measures

Behavioral aggression measures (Taylor Aggression Paradigm [TAP], Point Subtraction Aggression Paradigm [PSAP]) at 1 week post-treatment

Full Information

First Posted
August 3, 2005
Last Updated
September 4, 2013
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00127400
Brief Title
A Pilot Study Comparing the Efficacy of Group Versus Individual Anger Management in Subjects With IED
Official Title
A Pilot Study Comparing the Efficacy of Group Versus Individual Anger Management in Subjects With Intermittent Explosive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see how different forms of "Anger Management" compare in reducing anger and impulsive aggressive symptoms in people. "Anger Management" is a common form of "talk therapy" used to help people with anger problems. There are different types of "talk therapy" used to help people for anger problems and this study will compare two types of talk therapy in people with Intermittent Explosive Disorder (IED). IED is a disorder in which there are frequent and sudden outbursts of anger (yelling, throwing and breaking things, hitting people) that lead to problems with other people socially or at work.
Detailed Description
Intermittent Explosive Disorder (IED) is increasingly acknowledged as a common, potentially disabling psychiatric condition. Despite this, there are currently no empirically supported behavioral treatments for patients with IED. The purpose of the proposed study is to assess the short-term and long-term efficacy of a cognitive-behavioral treatment (CBT), previously found to be successful in treating dysfunctional anger, for treating IED. Secondary goals of the project are to: explore mechanisms involved in the successful treatment of IED, and examine individual differences associated with treatment response. Seventy-two subjects meeting for both research and DSM IED criteria will be randomly assigned to either 12 weeks of individual CBT, 12 weeks of group CBT or 12 weeks of a wait-list control condition. Subjects will be assessed before and after therapy/wait-list as well as at 3 month and 6 month follow-up. Primary outcome measures will assess aggressive behavior, anger, and the presence of an IED diagnosis at post-treatment, 6-month follow-up and 12-month follow-up. Social and emotional information processing will be evaluated as potential mechanism of change. Trait aggression will be assessed as a potential moderating variable.

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
None (Open Label)
Allocation
Randomized
Enrollment
72 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
anger management therapy
Primary Outcome Measure Information:
Title
Aggression interview (Overt Aggression Scale-Modified
Title
[OASM]) at midpoint 1 week post-treatment, 3-month follow-up and 6-month follow-up
Title
State-Trait Anxiety Inventory (STAXI) questionnaire at midpoint 1 week post-treatment, 3-month follow-up and 6-month follow-up
Secondary Outcome Measure Information:
Title
Behavioral aggression measures (Taylor Aggression Paradigm [TAP], Point Subtraction Aggression Paradigm [PSAP]) at 1 week post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject meets research criteria for a lifetime diagnosis of intermittent explosive disorder (IED). The subject has a Trait Anger Score > 21 on the STAXI (see above). Subject is willing to be randomized to any one of the four conditions. The subject is willing and able to cooperate with study protocol (i.e., keep appointments, complete rating forms, etc.) Subject gives informed consent to participate in study. Exclusion Criteria: The subject has any history of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I bipolar mood disorder, schizophrenia, delusional disorder, organic brain disorder, mental retardation. The subject meets DSM-IV criteria for alcohol or drug dependence within 30 days prior to the start of any of the study conditions. The subject has a Beck Depression Inventory, 2nd Edition (BDI-II) score > 32. The subject has aggressive obsessions in the context of Obsessive Compulsive Disorder (OCD). Current suicidal behavior or homicidal ideation. The subject is not willing to be randomized to any one of the four conditions. The subject is not willing to cooperate with study protocol (i.e., keep appointments, complete rating forms, etc.). The subject, in the opinion of the principal investigator (PI), is not able or likely to cooperate with study protocol (i.e., keep appointments, complete rating forms, etc.) The subject is already engaged in an anger management program elsewhere. The subject does not give informed consent to participate in study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael McCloskey, Ph.D.
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12186353
Citation
Deffenbacher JL, Filetti LB, Lynch RS, Dahlen ER, Oetting ER. Cognitive-behavioral treatment of high anger drivers. Behav Res Ther. 2002 Aug;40(8):895-910. doi: 10.1016/s0005-7967(01)00067-5.
Results Reference
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Citation
Deffenbacher, J. L., & McKay, M. (2000). Overcoming Situational and General Anger: A protocol for the treatment of anger based on relaxation, cognitive restructuring, and coping skills training. New Harbinger Publication: Oakland
Results Reference
background
Citation
Deffenbacher, J. L., McNamara, K., Stark, R. S., & Sabadell, P. M. (1990a). A comparison of cognitive-behavioral and process-oriented group counseling for general anger reduction. Journal of Counseling & Development, 69, 167-69.
Results Reference
background
Citation
Deffenbacher, J. L., McNamara, K., Stark, R. S., & Sabadell, P. M. (1990b). A combination of cognitive, relaxation, and behavioral coping skills in the reduction of general anger. Journal of College Student Development, 31, 351-358.
Results Reference
background
Citation
Deffenbacher, J. L., Oetting, E. R., Huff, M. E., Cornell, G. R., & Dallager, C. J. (1996a). Evaluation of two cognitive-behavioral approaches to general anger reduction. Cognitive Therapy and Research, 20, 551-573.
Results Reference
background
Citation
Deffenbacher, J. L., Oetting, E. R., Huff, M. E., & Thwaites, G. A. (1995). Fifteen-month follow-up of social skills and cognitive-relaxation approaches to general anger reduction. Journal of Counseling Psychology, 42, 400-405.
Results Reference
background
PubMed Identifier
8826765
Citation
Deffenbacher JL, Oetting ER, Lynch RS, Morris CD. The expression of anger and its consequences. Behav Res Ther. 1996 Jul;34(7):575-90. doi: 10.1016/0005-7967(96)00018-6.
Results Reference
background
Citation
Deffenbacher, J. L., & Stark, R. S. (1992). Relaxation and cognitive-relaxation treatments of general anger. Journal of Counseling Psychology, 39, 158-167.
Results Reference
background
Citation
DiGiuseppe, R. & Tafrate, R. C. (2003). Anger Treatment for Adults: A Meta-Analytic Review. Clinical Psychology Science & Practice, 10, 70-84.
Results Reference
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A Pilot Study Comparing the Efficacy of Group Versus Individual Anger Management in Subjects With IED

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