- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00667212
Psychotherapy for Intermittent Explosive Disorder
Individual Cognitive Behavioral Psychotherapy for Intermittent Explosive Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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 13 visits over approximately 4 months with a 3 follow-up session. 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Have problems with anger, temper outbursts, being irritable, getting in trouble at work or at home because of impulsive/aggressive behavior.
- Between the ages of 18 and 55.
- Meet other eligibility requirements as outlined by the research protocol.
Exclusion Criteria:
- Lifetime diagnosis of psychosis or bipolar disorder
- Current diagnosis of substance dependence or major depressive disorder.
- Current suicidal or homicidal ideation,
- Recent use of selective serotonin reuptake inhibitors (past month) or other psychotropic medication (past two months)
- Recent psychotherapy for aggression (past six months.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 2
Supportive Psychotherapy
|
Twelve weekly therapy sessions, approximately one hour each in duration
|
|
Active Comparator: 1
Cognitive Behavioral Therapy (Cognitive Restructuring, Relaxation, and Coping Skills Training: CRCST)
|
Twelve weekly therapy sessions, approximately one hour each in duration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Overt Aggression Scale - Modified (OASM) Score
Time Frame: Up to 12 months
|
Items are scored on a 5-point scale.
Higher scores indicate higher levels of aggression.
|
Up to 12 months
|
|
Change in State-Trait Anger Expression Inventory - Trait Anger Scale [STAXI-2]
Time Frame: Up to 12 months
|
Items are scored on a 4-point scale.
Higher scores indicate high levels of anger.
|
Up to 12 months
|
|
Change in Hostile Automatic Thoughts (HAT) Scale
Time Frame: Up to 12 months
|
Each item is answered on a 5-point Likert scale ranging from 0=not at all to 5=all the time.
Higher scores indicate higher frequency of hostile thoughts experienced.
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Self-Report of Aggression and Social Behavior Measure (SRASBM) Score
Time Frame: Up to 12 months
|
Items are scored on a 7-point scale to indicate how truthfully the statement describes personal experiences during the past year, ranging from 0=not at all true to 7=very true.
Higher scores indicate high levels of aggression
|
Up to 12 months
|
|
Change in Social Information Processing-Attribution and Emotional Response Questionnaire (SIP-AEQ) Score
Time Frame: Up to 12 months
|
Items are scored on a 0-3 Likert scale (0 = not at all likely to 3 = extremely likely).
Higher scores indicate higher levels of hostility.
|
Up to 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael McCloskey, PhD, University of Chicago
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15143A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.