A Cognitive Bias Modification RCT for Aggression

NCT ID: NCT04819230

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2023-06-30

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.

Conditions

Intermittent Explosive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Bias Modification

Intervention Type: BEHAVIORAL

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.)

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.

Group Type: PLACEBO_COMPARATOR

Cognitive Bias Control

Intervention Type: BEHAVIORAL

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.)

Interventions

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.)

Intervention Type: 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.)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Michael McCloskey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Temple University

Philadelphia, Pennsylvania, United States

Countries

United States

Facility Contacts

Michael S McCloskey, Ph.D

Role: primary

mikemccloskey@temple.edu

215-204-3738

Other Identifiers

27093

Identifier Type: -

Identifier Source: org_study_id