UnknownNot Applicable

A Cognitive Bias Modification RCT for Aggression

United States45 participantsStarted 2021-05

Plain-language summary

This randomized controlled trial will test a computerized cognitive bias modification program (CBM) to treat attention and interpretive biases in patients with primary aggression.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Meet DSM-5 criteria for current IED, as assessed via phone screen and confirmed during an in-person diagnostic interview conducted during visit one of the study * Are able and willing to cooperate with study protocol; i.e. keep appointments, read and understand consent form, etc. * Have written and verbal English proficiency for understanding consent and study materials Exclusion Criteria: * Have a lifetime history of psychosis * Have current moderate to severe substance use disorder * Have a history of bipolar disorder * Have current major depressive disorder * Are younger than 18 or older than 55 years old * Are currently (past month) receiving treatment for anger or aggression * Recently (past month) started or changed psychotropic medications

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in a Aggression from pretreatment to end of treatment (4 weeks later) and 1-month follow-up

Timeframe: preatment, post-treatment (4 weeks later) and 1-month follow-up. Total of 2 months

Change in a Anger from pretreatment to end of treatment (4 weeks later) and 1-month follow-up

Timeframe: pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months

Change in Social Information Processing from pretreatment to end of treatment (4 weeks later) and 1-month follow-up

Timeframe: pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months

Trial details

NCT IDNCT04819230

SponsorTemple University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05

View on ClinicalTrials.gov More Intermittent Explosive Disorder trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in a Aggression from pretreatment to end of treatment (4 weeks later) and 1-month follow-up

Timeframe: preatment, post-treatment (4 weeks later) and 1-month follow-up. Total of 2 months

Change in a Anger from pretreatment to end of treatment (4 weeks later) and 1-month follow-up

Timeframe: pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months

Change in Social Information Processing from pretreatment to end of treatment (4 weeks later) and 1-month follow-up

Timeframe: pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months