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NCT01264900 · ClinicalTrials.gov registry record · Phase 2
Cognitive Behavioral Aggression Treatment
A Phase 2 study, sponsored by Temple University.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT01264900: Completed Phase 2 study, sponsored by Temple University.
NCT01264900 is a Phase 2 study that has completed, run by Temple University. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01264900, a Phase 2 study, has completed, sponsored by Temple University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study 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. 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: 1. CBAT will reduce anger, aggression and hostile biases more than supportive therapy. 2. CBAT will decrease limbic activation and increase prefrontal activation to emotional pictures more than supportive therapy.
Primary Outcome
Aggressive acts will be measured using electronic diaries and clinical interview
Interventions
- BEHAVIORAL Psychotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2010-05 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
What the finished NCT01264900 record still lists
NCT01264900 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 1 intervention - of which Psychotherapy is the first listed.
NCT01264900 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01264900 about?
NCT01264900 is a clinical study titled "Cognitive Behavioral Aggression Treatment". 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 hosti...
What is the current status of trial NCT01264900?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2010-05. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01264900?
The interventions under investigation include: Psychotherapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01264900?
This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01264900's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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