A Cognitive Bias Modification RCT for Aggression

Attention and Interpretation Bias Modification for Aggression Difficulties

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

Study Overview

• Status: Not yet recruiting
• Conditions: Intermittent Explosive Disorder
• Intervention / Treatment: Behavioral: Cognitive Bias Modification; Behavioral: Cognitive Bias Control

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19122
      • Temple University
      • Contact: Michael S McCloskey, Ph.D; Phone Number: 215-204-3738; Email: mikemccloskey@temple.edu
      • Principal Investigator: Michael S McCloskey, Ph.D
      • Sub-Investigator: Richard G Heimberg, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bias Modification; Attention (ATT) and interpretation (ITT) bias training. Participants complete the ATT and ITT tasks twice per week for four weeks. The ATT trains attention toward neutral stimuli and away from negative stimuli. On trials with one neutral and one threat word, the probe will always follow the location of the neutral word. Therefore, there is a contingency between the valence of the word and the location of the probe. Participants will be asked to indicate which type of probe had appeared in each trial by pressing a corresponding button as rapidly and accurately as possible. The ITT trains participants to make benign (vs. threatening) interpretations of socially-ambiguous scenarios. For each trial, a word suggesting a socially threatening or benign interpretation is presented then replaced by a sentence describing a socially-ambiguous scenario. Participants indicate if they thought the word and sentence were related. Participants will receive corrective feedback after each trial.	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.)
PLACEBO_COMPARATOR: Control Condition; A combination of attention (ATT-C) and interpretation (ITT-C) control tasks These tasks are identical to the experimental tasks (ATT and ITT) with the exceptions that: ATT-C: It is designed to train attention toward neither neutral nor the threat stimuli. This will be achieved by having an equal number of probes follow the location of the threatening word and the neutral word. ITT-C: It is not designed to train benign interpretations of ambiguous social scenarios. Thus, no feedback will be given during the inter-trial interval, rather participants will see a blank screen between trials. Participants will complete both the ATT-C and ITT-C tasks twice per week for four weeks, totaling to eight experimental sessions.	Behavioral: 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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Temple University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2021
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (ACTUAL): March 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Aggression; Disruptive, Impulse Control, and Conduct Disorders
• Other Study ID Numbers: 27093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No