A Cognitive Bias Modification RCT for Aggression

Not Applicable

• Conditions: Intermittent Explosive Disorder

• Registration Number: NCT04819230
• Lead Sponsor: Temple University

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.

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-25
• Last Update Submitted: 2021-03-25
• Study First Posted: 2021-03-26
• Last Update Posted: 2021-03-26
• Study Start: 2021-05
• Primary Completion: 2023-05
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in a Aggression from pretreatment to end of treatment (4 weeks later) and 1-month follow-up	preatment, post-treatment (4 weeks later) and 1-month follow-up. Total of 2 months	Overt 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-up	pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months	State-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-up	pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months	Social Information Processing - Attribution and Emotional Response Questionnaire

Secondary Outcome Measures

Name	Time	Method
Change in Emotion Regulation from pretreatment to end of treatment (4 weeks later) and 1-month follow-up	pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months	Difficulty 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-up	pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months	Intermittent Explosive Disorder-Module (presence vs absence of current disorder)

Trial Locations

Locations (1)

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States