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A Cognitive Bias Modification RCT for Aggression

Primary Purpose

Intermittent Explosive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Bias Modification
Cognitive Bias Control
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Explosive Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Temple University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bias Modification

Control Condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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)
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

Secondary Outcome Measures

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)
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)

Full Information

First Posted
March 5, 2021
Last Updated
March 25, 2021
Sponsor
Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT04819230
Brief Title
A Cognitive Bias Modification RCT for Aggression
Official Title
Attention and Interpretation Bias Modification for Aggression Difficulties
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Temple University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Explosive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes 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)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael S McCloskey, Ph.D
Phone
215-204-3738
Email
mikemccloskey@temple.edu
First Name & Middle Initial & Last Name & Degree
Michael S McCloskey, Ph.D
First Name & Middle Initial & Last Name & Degree
Richard G Heimberg, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Cognitive Bias Modification RCT for Aggression

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