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A Cognitive Bias Modification RCT for Aggression

Attention and Interpretation Bias Modification for Aggression Difficulties

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04819230
Enrollment
45
Registered
2021-03-26
Start date
2021-05-31
Completion date
2023-06-30
Last updated
2021-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Explosive Disorder

Brief 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.

Detailed description

The objective of the proposed study is to test a computerized cognitive bias modification program (CBM) to treat attention and interpretive biases in patients with Intermittent Explosive Disorder, a disorder characterized by habitual engagement in aggressive behavior. Efficacy of the CBM program will be assessed via a small randomized controlled trial comparing CBM to a computerized control condition. This training program would consist of a four-week regimen of twice-weekly 30-minute sessions (8 sessions total) during which individuals would learn to: (a) focus attention away from threatening words toward neutral words \[attention bias\], and (b) to disambiguate ambiguous interpersonal scenarios using more benign, rather than threatening, interpretations \[interpretive bias\]. Participants will be asked to complete behavioral measures of attention bias and interpretive bias, as well as self-report measures of anger / aggression, interpretive bias, emotion regulation and life satisfaction at baseline (pre-training), post-training, and 1-month follow-up.

Interventions

A four-week computerized attentional and interpretive bias modification protocol in which participants complete both ATT and ITT tasks twice per week, totaling to eight experimental sessions (see experimental arm for more detail.)

BEHAVIORALCognitive Bias Control

A four-week computerized attentional and interpretive stimuli protocol in which participants complete both ATT-C and ITT-C tasks twice per week, totaling to eight control sessions (see placebo control arm for more detail.)

Sponsors

Temple University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants in the control condition will see the same stimuli with a different contingency for correct vs incorrect response on the computerized training task (participant masking) Outcome assessors will not be involved in administration of the intervention and will not be informed of participant condition (outcomes assessor masking)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in a Aggression from pretreatment to end of treatment (4 weeks later) and 1-month follow-uppreatment, post-treatment (4 weeks later) and 1-month follow-up. Total of 2 monthsOvert Aggression Scale-Modified (higher score means more aggression)
Change in a Anger from pretreatment to end of treatment (4 weeks later) and 1-month follow-uppretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 monthsState-Trait Anger Expression Inventory-2:state anger scale modified(higher score means more anger)
Change in Social Information Processing from pretreatment to end of treatment (4 weeks later) and 1-month follow-uppretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 monthsSocial Information Processing - Attribution and Emotional Response Questionnaire

Secondary

MeasureTime frameDescription
Change in Emotion Regulation from pretreatment to end of treatment (4 weeks later) and 1-month follow-uppretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 monthsDifficulty in Emotion Regulation Scale (higher score means greater emotion dysregulation)
Change in IED diagnosis from pretreatment to end of treatment (4 weeks later) and 1-month follow-uppretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 monthsIntermittent Explosive Disorder-Module (presence vs absence of current disorder)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026