AngerNCT00667212
Psychotherapy for Intermittent Explosive Disorder
A study testing Cognitive Behavioral Therapy and Supportive Psychotherapy in people with Anger and Intermittent Explosive Disorder, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anger, Intermittent Explosive Disorder
- What is being tested?
- Cognitive Behavioral Therapy and Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2010
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individual Cognitive Behavioral Psychotherapy for Intermittent Explosive Disorder
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.
Read the 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).
- Conditions
- Anger, Intermittent Explosive Disorder
- Being tested
- Cognitive Behavioral Therapy, Supportive Psychotherapy
- 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.
Cognitive Behavioral TherapyBehavioural
Also called Cognitive Restructuring, Relaxation, and Coping Skills Training
Twelve weekly therapy sessions, approximately one hour each in duration
Supportive PsychotherapyBehavioural
Twelve weekly therapy sessions, approximately one hour each in duration
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Supportive Psychotherapy Receives: Behavioral: Supportive Psychotherapy |
| 1 | Active comparator | Cognitive Behavioral Therapy (Cognitive Restructuring, Relaxation, and Coping Skills Training: CRCST) Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overt Aggression Scale - Modified (OASM) Score
Items are scored on a 5-point scale. Higher scores indicate higher levels of aggression.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Secondary outcomes (2)
Change in Self-Report of Aggression and Social Behavior Measure (SRASBM) Score
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
Measured: Up to 12 months
Change in Social Information Processing-Attribution and Emotional Response Questionnaire (SIP-AEQ) Score
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startAug 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael McCloskey, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667212
- Sponsor's protocol ID
- 15143A
- Status last verified
- Aug 2024
- First submitted
- 24 Apr 2008
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Cognitive Behavioral Psychotherapy for Intermittent Explosive Disorder
- ClinicalTrials.gov ID
- NCT00667212
- Acronym / sponsor ID
- 15143A
- Conditions
- Anger, Intermittent Explosive Disorder
- Keywords
- anger, intermittent, explosive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Behavioral: Supportive PsychotherapySupportive Psychotherapy |
| 1 | Active comparator | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy (Cognitive Restructuring, Relaxation, and Coping Skills Training: CRCST) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyAlso: Cognitive Restructuring, Relaxation, and Coping Skills TrainingTwelve weekly therapy sessions, approximately one hour each in duration | Behavioural | 1 |
| Supportive PsychotherapyTwelve weekly therapy sessions, approximately one hour each in duration | Behavioural | 2 |
Primary outcome
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.
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.
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.
2 secondary outcomes
Change in Self-Report of Aggression and Social Behavior Measure (SRASBM) Score
Time frame: Up to 12 months
Change in Social Information Processing-Attribution and Emotional Response Questionnaire (SIP-AEQ) Score
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael McCloskey, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Supportive Psychotherapy 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 3 inclusion and 5 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 19 Aug 2024. 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.
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?
Change in Overt Aggression Scale - Modified (OASM) Score (time frame: Up to 12 months). 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?
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 19 Aug 2024.