A Cognitive Bias Modification RCT for Aggression

Intermittent Explosive Disorder Clinical Trial

Official title:

Attention and Interpretation Bias Modification for Aggression Difficulties

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04819230
• Other study ID #: 27093
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2021
• Est. completion date: June 2023

Study information

• Verified date: March 2021
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Intermittent Explosive Disorder

Intervention

Behavioral:
• Cognitive Bias Modification
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.)
• Cognitive 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.)

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in a Aggression from pretreatment to end of treatment (4 weeks later) and 1-month follow-up	Overt Aggression Scale-Modified (higher score means more aggression)	preatment, post-treatment (4 weeks later) and 1-month follow-up. Total of 2 months
Primary	Change in a Anger from pretreatment to end of treatment (4 weeks later) and 1-month follow-up	State-Trait Anger Expression Inventory-2:state anger scale modified(higher score means more anger)	pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months
Primary	Change in Social Information Processing from pretreatment to end of treatment (4 weeks later) and 1-month follow-up	Social Information Processing - Attribution and Emotional Response Questionnaire	pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months
Secondary	Change in Emotion Regulation from pretreatment to end of treatment (4 weeks later) and 1-month follow-up	Difficulty in Emotion Regulation Scale (higher score means greater emotion dysregulation)	pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months
Secondary	Change in IED diagnosis from pretreatment to end of treatment (4 weeks later) and 1-month follow-up	Intermittent Explosive Disorder-Module (presence vs absence of current disorder)	pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months