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AngerPhase 2NCT00127400

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

A Phase 2 study testing anger management therapy in people with Anger and Intermittent Explosive Disorder, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 55 years
Conditions the study is for
Anger, Intermittent Explosive Disorder
What is being tested?
anger management therapy
How many people
72 participants
Where
1 siteUnited States
Study dates
Feb 2002to Jul 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Chicago

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: A Pilot Study Comparing the Efficacy of Group Versus Individual Anger Management in Subjects With Intermittent Explosive Disorder

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.

Read the 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.

Being tested
anger management therapy
Keywords
anger, intermittent, explosive
Medical subject headings
Disruptive, Impulse Control, and Conduct Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anger management therapyBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aggression interview (Overt Aggression Scale-Modified

  2. [OASM]) at midpoint 1 week post-treatment, 3-month follow-up and 6-month follow-up

  3. State-Trait Anxiety Inventory (STAXI) questionnaire at midpoint 1 week post-treatment, 3-month follow-up and 6-month follow-up

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2005 (estimated)
  2. Study startFeb 2002
  3. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
72 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00127400
Sponsor's protocol ID
11487A
Status last verified
Sep 2013
First submitted
3 Aug 2005
Last updated
5 Sep 2013
Results posted
No

Publications

  • 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.

    PubMed 12186353

  • 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. doi: 10.1016/0005-7967(96)00018-6.

    PubMed 8826765

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anger management therapy in people with Anger and Intermittent Explosive Disorder, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aggression interview (Overt Aggression Scale-Modified. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00127400, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013.

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