NCT00667212

Brief Summary

The goal of this study is to examine the effectiveness two forms of psychotherapy (also known as "talk therapy" ) for individuals with anger and aggression problems. Anger and aggression are everywhere - on the road, in the schools, at little league games, at home, and at work. In this study we are testing usefulness of anger management techniques in reducing symptoms of Intermittent Explosive Disorder (IED) and impulsive, aggressive behavior.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

4.3 years

First QC Date

April 24, 2008

Last Update Submit

August 14, 2024

Conditions

Keywords

angerintermittentexplosive

Outcome Measures

Primary Outcomes (3)

  • Change in Overt Aggression Scale - Modified (OASM) Score

    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]

    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

    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 Outcomes (2)

  • Change in Self-Report of Aggression and Social Behavior Measure (SRASBM) Score

    Up to 12 months

  • Change in Social Information Processing-Attribution and Emotional Response Questionnaire (SIP-AEQ) Score

    Up to 12 months

Study Arms (2)

2

ACTIVE COMPARATOR

Supportive Psychotherapy

Behavioral: Supportive Psychotherapy

1

ACTIVE COMPARATOR

Cognitive Behavioral Therapy (Cognitive Restructuring, Relaxation, and Coping Skills Training: CRCST)

Behavioral: Cognitive Behavioral Therapy

Interventions

Twelve weekly therapy sessions, approximately one hour each in duration

Also known as: Cognitive Restructuring, Relaxation, and Coping Skills Training
1

Twelve weekly therapy sessions, approximately one hour each in duration

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Disruptive, Impulse Control, and Conduct Disorders

Interventions

Cognitive Behavioral TherapyCognitive Restructuring

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michael McCloskey, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2008

First Posted

April 28, 2008

Study Start

August 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 19, 2024

Record last verified: 2024-08

Locations