A Cognitive Bias Modification RCT for Aggression

Sponsor
Temple University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04819230
Collaborator
(none)
45
1
2
25
1.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Bias Modification
  • Behavioral: Cognitive Bias Control
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants in the control condition will see the same stimuli with a different contingency for correct vs incorrect response on the computerized training task (participant masking) Outcome assessors will not be involved in administration of the intervention and will not be informed of participant condition (outcomes assessor masking)
Primary Purpose:
Treatment
Official Title:
Attention and Interpretation Bias Modification for Aggression Difficulties
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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.)

Outcome Measures

Primary Outcome Measures

  1. Change in a Aggression from pretreatment to end of treatment (4 weeks later) and 1-month follow-up [preatment, post-treatment (4 weeks later) and 1-month follow-up. Total of 2 months]

    Overt Aggression Scale-Modified (higher score means more aggression)

  2. Change in a Anger from pretreatment to end of treatment (4 weeks later) and 1-month follow-up [pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months]

    State-Trait Anger Expression Inventory-2:state anger scale modified(higher score means more anger)

  3. Change in Social Information Processing from pretreatment to end of treatment (4 weeks later) and 1-month follow-up [pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months]

    Social Information Processing - Attribution and Emotional Response Questionnaire

Secondary Outcome Measures

  1. Change in Emotion Regulation from pretreatment to end of treatment (4 weeks later) and 1-month follow-up [pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months]

    Difficulty in Emotion Regulation Scale (higher score means greater emotion dysregulation)

  2. Change in IED diagnosis from pretreatment to end of treatment (4 weeks later) and 1-month follow-up [pretreatment, posttreatment (4 weeks later) and 1-month follow-up. Total of 2 months]

    Intermittent Explosive Disorder-Module (presence vs absence of current disorder)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Temple University Philadelphia Pennsylvania United States 19122

Sponsors and Collaborators

  • Temple University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael McCloskey, Professor, Temple University
ClinicalTrials.gov Identifier:
NCT04819230
Other Study ID Numbers:
  • 27093
First Posted:
Mar 26, 2021
Last Update Posted:
Mar 26, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 26, 2021