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

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ClinicalTrials.gov Identifier: NCT00127400
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : September 5, 2013
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE August 3, 2005
First Posted Date  ICMJE August 5, 2005
Last Update Posted Date September 5, 2013
Study Start Date  ICMJE February 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2005)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 4, 2005)
  • Aggression interview (OASM)at midpoint 1 week post-treatment, 3-month follow-up and 6-month follow-up
  • STAXI questionnaire at midpoint 1 week post-treatment, 3-month follow-up and 6-month follow-up
Change History Complete list of historical versions of study NCT00127400 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2005)
Behavioral aggression measures (Taylor Aggression Paradigm [TAP], Point Subtraction Aggression Paradigm [PSAP]) at 1 week post-treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2005)
Behavioral aggression measures (TAP PSAP)at 1 week post-treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study Comparing the Efficacy of Group Versus Individual Anger Management in Subjects With IED
Official Title  ICMJE A Pilot Study Comparing the Efficacy of Group Versus Individual Anger Management in Subjects With Intermittent Explosive Disorder
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:

  1. explore mechanisms involved in the successful treatment of IED, and
  2. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anger
  • Intermittent Explosive Disorder
Intervention  ICMJE Behavioral: anger management therapy
Study Arms  ICMJE Not Provided
Publications *
  • Deffenbacher, J. L., Filetti, L. B., Lynch, R. S., Dahlen, E.R., & Oetting, E. R. (2002). Cognitive-behavioral treatment of high anger. Behavioral Research Therapy, 34, 575-590.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • Deffenbacher JL, Oetting ER, Lynch RS, Morris CD. The expression of anger and its consequences. Behav Res Ther. 1996 Jul;34(7):575-90.
  • Deffenbacher, J. L., & Stark, R. S. (1992). Relaxation and cognitive-relaxation treatments of general anger. Journal of Counseling Psychology, 39, 158-167.
  • DiGiuseppe, R. & Tafrate, R. C. (2003). Anger Treatment for Adults: A Meta-Analytic Review. Clinical Psychology Science & Practice, 10, 70-84.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 4, 2005)
72
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE July 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00127400
Other Study ID Numbers  ICMJE 11487A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael McCloskey, Ph.D. University of Chicago
PRS Account University of Chicago
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP