AggressionPhase 2NCT01264900
Cognitive Behavioral Aggression Treatment
A Phase 2 study testing Psychotherapy in people with Aggression, run by Temple University at 1 site in United States.
Trial summary
Aggressive behavior is a leading worldwide public health problem. Despite this, relatively little is known about how to best treat individuals who are highly angry and aggressive. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Aggression
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Feb 2016
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Three or more acts of physical aggression (assault / property destruction) in past six months
- Aggression related distress and/or impairment
- Meets Criteria for Intermittent Explosive Disorder
Who cannot join
- Life History of DSM-IV Axis Bipolar disorder, Schizophrenia, Delusional disorder, Organic disorder, or Mental Retardation
- Current DSM-IV Major Depressive Episode, Alcohol Dependence or other Drug Dependence
- Current (past month) psychotropic medication use
- Current severe suicidal or homicidal ideation necessitating immediate medical intervention
- Current pregnancy or nursing, or existence of any medical condition that would deem the subject ineligible to undergo an fMRI (e.g., metal pins)
- Two consecutive positive Expired Breathalyzer Alcohol or Urine Drug toxicological screens
- Unable or unwilling to cooperate with study protocol (e.g., keep appointments, complete rating forms, read and understand informed consent).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Behavioral Aggression Treatment: Effects on Brain and Behavior
Aggressive behavior is a leading worldwide public health problem. Despite this, relatively little is known about how to best treat individuals who are highly angry and aggressive. A rich literature suggests that aggression is associated with a tendency to interpret situations as threatening or hostile even when they are not. This process is governed by a prefrontal-limbic circuit in the brain. A goal of cognitive behavioral therapy is to reduce these kinds of hostile biases. Preliminary data by the PI suggests a 12- session cognitive behavioral aggression treatment (CBAT) may help reduce aggressive behavior and underlying hostile biases associated with affective aggression. To assess the efficacy of this treatment, 120 adults with high levels of anger and aggression will receive 12 sessions of either CBAT or supportive psychotherapy. All subjects will monitor their anger and aggressive behavior throughout the treatment electronic diaries. Subjects will also complete questionnaires and computer tasks to assess anger, hostile biases and related processes 1-week before treatment begins, and again 1-week, 6-months and 1-year after treatment ends. In addition, to understand the effects of CBAT on the brain, subjects will have their brains scanned (functional Magnetic Resonance Imaging) while they look at emotional pictures and complete computer tasks. The brain scans will occur once before treatment starts and once after treatment ends.
Our hypotheses are:
- CBAT will reduce anger, aggression and hostile biases more than supportive therapy.
- CBAT will decrease limbic activation and increase prefrontal activation to emotional pictures more than supportive therapy.
- Conditions
- Aggression
- Being tested
- Psychotherapy
- Keywords
- Psychotherapy, Cognitive Behavioral Therapy, Aggression, fMRI, Behavioral Intervention
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Also called CBT
Twelve weekly 50-minute sessions of individual cognitive behavioral aggression treatment or supportive psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Twelve weekly 50-minute sessions of individual cognitive behavioral aggression treatment Receives: Behavioral: Psychotherapy |
| Supportive Psychotherapy | Active comparator | Twelve weekly 50-minute sessions of individual supportive (client-centered) psychotherapy Receives: Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggressive Acts
Aggressive acts will be measured using electronic diaries and clinical interview
Measured: Pre-intervention thru 1 year post-intervention
Secondary outcomes (1)
Brain activation to emotional stimuli
Brain response (as measured by fMRI)to emotional expressions and pictures
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AggressionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael McCloskey, Temple University
- Investigators
- Michael S McCloskey, Ph.D, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264900
- Sponsor's protocol ID
- MH086525
- Status last verified
- Mar 2016
- First submitted
- 20 Dec 2010
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McCloskey MS, Noblett KL, Deffenbacher JL, Gollan JK, Coccaro EF. Cognitive-behavioral therapy for intermittent explosive disorder: a pilot randomized clinical trial. J Consult Clin Psychol. 2008 Oct;76(5):876-86. doi: 10.1037/0022-006X.76.5.876.
PubMed 18837604
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Aggression Treatment: Effects on Brain and Behavior
- ClinicalTrials.gov ID
- NCT01264900
- Acronym / sponsor ID
- MH086525
- Conditions
- Aggression
- Keywords
- Psychotherapy, Cognitive Behavioral Therapy, Aggression, fMRI, Behavioral Intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 22 Dec 2010 (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.
Aggressive behavior is a leading worldwide public health problem. Despite this, relatively little is known about how to best treat individuals who are highly angry and aggressive. A rich literature suggests that aggression is associated with a tendency to interpret situations as threatening or hostile even when they are not. This process is governed by a prefrontal-limbic circuit in the brain. A goal of cognitive behavioral therapy is to reduce these kinds of hostile biases. Preliminary data by the PI suggests a 12- session cognitive behavioral aggression treatment (CBAT) may help reduce aggressive behavior and underlying hostile biases associated with affective aggression. To assess the efficacy of this treatment, 120 adults with high levels of anger and aggression will receive 12 sessions of either CBAT or supportive psychotherapy. All subjects will monitor their anger and aggressive behavior throughout the treatment electronic diaries. Subjects will also complete questionnaires and computer tasks to assess anger, hostile biases and related processes 1-week before treatment begins, and again 1-week, 6-months and 1-year after treatment ends. In addition, to understand the effects of CBAT on the brain, subjects will have their brains scanned (functional Magnetic Resonance Imaging) while they look at emotional pictures and complete computer tasks. The brain scans will occur once before treatment starts and once after treatment ends.
Our hypotheses are:
- CBAT will reduce anger, aggression and hostile biases more than supportive therapy.
- CBAT will decrease limbic activation and increase prefrontal activation to emotional pictures more than supportive therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: PsychotherapyTwelve weekly 50-minute sessions of individual cognitive behavioral aggression treatment |
| Supportive Psychotherapy | Active comparator | Behavioral: PsychotherapyTwelve weekly 50-minute sessions of individual supportive (client-centered) psychotherapy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Three or more acts of physical aggression (assault / property destruction) in past six months
- Aggression related distress and/or impairment
- Meets Criteria for Intermittent Explosive Disorder
Key exclusion criteria (7 listed)
- Life History of DSM-IV Axis Bipolar disorder, Schizophrenia, Delusional disorder, Organic disorder, or Mental Retardation
- Current DSM-IV Major Depressive Episode, Alcohol Dependence or other Drug Dependence
- Current (past month) psychotropic medication use
- Current severe suicidal or homicidal ideation necessitating immediate medical intervention
- Current pregnancy or nursing, or existence of any medical condition that would deem the subject ineligible to undergo an fMRI (e.g., metal pins)
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 |
|---|---|---|
| PsychotherapyAlso: CBTTwelve weekly 50-minute sessions of individual cognitive behavioral aggression treatment or supportive psychotherapy | Behavioural | Cognitive Behavioral Therapy, Supportive Psychotherapy |
Primary outcome
Aggressive Acts
Time frame: Pre-intervention thru 1 year post-intervention
Aggressive acts will be measured using electronic diaries and clinical interview
1 secondary outcome
Brain activation to emotional stimuli
Time frame: 14 weeks
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 4 Mar 2016.
- Background: PubMed 18837604McCloskey MS, Noblett KL, Deffenbacher JL, Gollan JK, Coccaro EF. Cognitive-behavioral therapy for intermittent explosive disorder: a pilot randomized clinical trial. J Consult Clin Psychol. 2008 Oct;76(5):876-86. doi: 10.1037/0022-006X.76.5.876.
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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 S McCloskey, Ph.D principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psychotherapy in people with Aggression, run by Temple University 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 7 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 4 Mar 2016. 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?
Aggressive Acts (time frame: Pre-intervention thru 1 year post-intervention). 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 NCT01264900, which also lists 1 linked publication.
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 4 Mar 2016.