CompletedPhase 2

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

United States72 participantsStarted 2002-02

Plain-language 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.

Who can participate

Age range

21 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 elsewher…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT00127400

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Anger trials