Clinical trial NCT04819230: A Cognitive Bias Modification RCT for Aggression
Official title: Attention and Interpretation Bias Modification for Aggression Difficulties
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intermittent Explosive Disorder
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: 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
measure: 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
Secondary outcomes:
measure: Change in Emotion Regulation 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
measure: Change in IED diagnosis 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
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
References: