A Cognitive Bias Modification RCT for Aggression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Attention and Interpretation Bias Modification for Aggression Difficulties

Conditions
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Intermittent Explosive Disorder

Intervention / Treatment
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* Behavioral: Cognitive Bias Modification
* Behavioral: Cognitive Bias Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bias Modification<br>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<br>* 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.)<br>|
| Placebo Comparator: Control Condition<br>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<br>* 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.)<br>|

What is the study measuring?
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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 |