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Hostile Bias Modification Training (HBMT) Study

Primary Purpose

Anger, Stress, Aggression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hostile Bias Modification Training
Other training
Sponsored by
Walter Reed Army Institute of Research (WRAIR)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anger

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult male or female, ages 18-39 (inclusive)
  • Must confirm when asked by the experimenter that they are of normal hearing without the use of a hearing aid or have been diagnosed with any condition that produces a strong sensitivity to sound (e.g., misophonia, hyperacusis) to the best of their knowledge.
  • Must be able to provide written informed consent before commencing with experimental procedures and perform experimental writing and reading tasks (i.e., must be able to fluently read/write in English).
  • Must demonstrate satisfactory comprehension of the Informed Consent Document (ICD) by achieving a score of 100% correct on a short multiple-choice quiz .

Exclusion Criteria:

  • not between ages 18-39
  • not able to read/write fluently in English
  • not of normal hearing without use of a hearing aid
  • have been diagnosed with any condition that produces a strong sensitivity to sound (e.g., misophonia, hyperacusis)

Sites / Locations

  • Walter Reed Army Institute of Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Hostile Bias Modification (HBM) Training plus Unambiguous Feedback

Other training plus Unambiguous Feedback

Hostile Bias Modification (HBM) Training plus Ambiguous Feedback

Other training plus Ambiguous Feedback

Arm Description

Volunteers will complete a novel computer-based hostile bias modification training where they are instructed to respond to word fragments (words with missing letters) based on whether the word fragments can be completed to form aggressive or positive/neutral words. They are instructed not to respond if only an aggressive word can be formed. They will receive unambiguously hostile feedback to an essay.

Volunteers will complete a computer-based task where they are instructed to respond to word fragments (words with missing letters) regardless of whether the fragments can make hostile or ambiguous words. They will receive unambiguously hostile feedback to an essay.

Volunteers will complete a novel computer-based hostile bias modification training where they are instructed to respond to word fragments (words with missing letters) based on whether the word fragments can be completed to form aggressive or positive/neutral words. They are instructed not to respond if only an aggressive word can be formed. They will receive ambiguously hostile feedback to an essay.

Volunteers will complete a computer-based task where they are instructed to respond to word fragments (words with missing letters) regardless of whether the fragments can make hostile or ambiguous words. They will receive ambiguously hostile feedback to an essay.

Outcomes

Primary Outcome Measures

Essay Feedback Questionnaire
8-item self-reported hostile attribution bias to ambiguously hostile or unambiguously hostile feedback (0-4). Higher scores indicate more bias.
Taylor Aggression Paradigm (TAP)
The TAP objectively elicits and measures participant's aggression in response to provocation from an opponent. Aggression is operationalized as setting higher volumes and/or longer durations for tones (0-10). Higher scores indicate more aggression.

Secondary Outcome Measures

Full Information

First Posted
July 29, 2021
Last Updated
July 12, 2023
Sponsor
Walter Reed Army Institute of Research (WRAIR)
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1. Study Identification

Unique Protocol Identification Number
NCT04997356
Brief Title
Hostile Bias Modification Training (HBMT) Study
Official Title
Computer-Based Cognitive Games, Personality, and Behavior Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 12, 2021 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Walter Reed Army Institute of Research (WRAIR)

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
The primary objective of the present protocol is to evaluate the effectiveness of real HBMT versus placebo on reducing HAB and aggression. The secondary objectives of the present protocol are: Investigate the role of individual difference variables on HAB, interpersonal aggression, and effects of HBMT. Collect vocal recording data to inform the development of algorithms to predict emotional stress from changes in speech.
Detailed Description
Aggression refers to causing harm to someone who is motivated to avoid that harm (Anderson & Bushman, 2002). Many Soldiers report heightened levels of anger and display elevated rates of aggressive behavior following combat deployments (Adler et al., 2011; Jakupcak et al., 2007; Novaco & Chemtob, 2015; Orth & Wieland, 2006; Thomas et al., 2010). Treating and addressing anger and aggression in combat Veterans can improve Soldier health as well as promote force readiness and lethality. One key predictor of anger and aggression when responding to the actions of other people is the extent to which the victim believes that the provocateur acted in an intentionally hostile manner (e.g., being shoved on purpose) versus not intending to be hostile (e.g., being shoved by mistake; De Castro, Veerman, Koops, Bosch, & Monshouwer, 2002). This is called "hostile attributional bias" (HAB). Interpretation and attribution biases toward perceiving threats and danger are elevated in individuals with posttraumatic stress symptoms (Bonyea, Johnson, and Lang, 2017). In the present study, the investigators test the effectiveness of a computer-based training called Hostile Bias Modification Training (HBMT) to reduce HAB and aggressive behavior in response to an ambiguous provocation (ambiguously hostile comments). Volunteers will complete a real or placebo version of a computer training designed to reduce HAB, then receive and react to either unambiguously hostile or ambiguously hostile feedback. The feedback is in regards to an essay the volunteer was asked to write as part of the study. The investigators predict that receiving the real (vs. placebo) computer training will reduce HAB in response to the ambiguous feedback, but not the unambiguous feedback. Volunteers will then partake in a second computer task, which involves a reaction time competition against the same confederate where the loser receives a penalty in the form of a short, unpleasant, acoustic tone delivered via headphones. The volunteer is told they can set the volume and duration of unpleasant acoustic tones that would be administered to the confederate. Aggression is operationalized as setting higher volumes and/or longer durations for tones. This will allow us to measure how aggressive volunteers are in response to ambiguous provocations and determine if the computer training is effective in reducing aggression to ambiguous provocations and if reduced HAB is the underlying mechanism of this effect. Finally, volunteers will complete a set of personality measures so we can determine if the effects of the computer training are contingent on individual differences. If successful, this research would add validity to a potential intervention to help people suffering from anger and aggression management issues to reduce their symptoms. The investigators are also using this experiment as an opportunity to collect vocal pattern data to inform the development of algorithms to predict emotional stress from changes in vocal patterns. As such, voice recordings of volunteers reading standardized scripts will be made at three points in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anger, Stress, Aggression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants are blinded to study condition.
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hostile Bias Modification (HBM) Training plus Unambiguous Feedback
Arm Type
Experimental
Arm Description
Volunteers will complete a novel computer-based hostile bias modification training where they are instructed to respond to word fragments (words with missing letters) based on whether the word fragments can be completed to form aggressive or positive/neutral words. They are instructed not to respond if only an aggressive word can be formed. They will receive unambiguously hostile feedback to an essay.
Arm Title
Other training plus Unambiguous Feedback
Arm Type
Placebo Comparator
Arm Description
Volunteers will complete a computer-based task where they are instructed to respond to word fragments (words with missing letters) regardless of whether the fragments can make hostile or ambiguous words. They will receive unambiguously hostile feedback to an essay.
Arm Title
Hostile Bias Modification (HBM) Training plus Ambiguous Feedback
Arm Type
Experimental
Arm Description
Volunteers will complete a novel computer-based hostile bias modification training where they are instructed to respond to word fragments (words with missing letters) based on whether the word fragments can be completed to form aggressive or positive/neutral words. They are instructed not to respond if only an aggressive word can be formed. They will receive ambiguously hostile feedback to an essay.
Arm Title
Other training plus Ambiguous Feedback
Arm Type
Placebo Comparator
Arm Description
Volunteers will complete a computer-based task where they are instructed to respond to word fragments (words with missing letters) regardless of whether the fragments can make hostile or ambiguous words. They will receive ambiguously hostile feedback to an essay.
Intervention Type
Behavioral
Intervention Name(s)
Hostile Bias Modification Training
Other Intervention Name(s)
HBMT
Intervention Description
Volunteers will complete a novel computer-based hostile bias modification training where they are instructed to respond to word fragments (words with missing letters) based on whether the word fragments can be completed to form aggressive or positive/neutral words. They will refrain from making words that can only form aggressive words.
Intervention Type
Behavioral
Intervention Name(s)
Other training
Intervention Description
Volunteers will complete a computer-based task where they are instructed to respond to word fragments (words with missing letters) regardless of whether the fragments can make hostile or ambiguous words.
Primary Outcome Measure Information:
Title
Essay Feedback Questionnaire
Description
8-item self-reported hostile attribution bias to ambiguously hostile or unambiguously hostile feedback (0-4). Higher scores indicate more bias.
Time Frame
average of 30 minutes post-intervention
Title
Taylor Aggression Paradigm (TAP)
Description
The TAP objectively elicits and measures participant's aggression in response to provocation from an opponent. Aggression is operationalized as setting higher volumes and/or longer durations for tones (0-10). Higher scores indicate more aggression.
Time Frame
average of 45 minutes post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult male or female, ages 18-39 (inclusive) Must confirm when asked by the experimenter that they are of normal hearing without the use of a hearing aid or have been diagnosed with any condition that produces a strong sensitivity to sound (e.g., misophonia, hyperacusis) to the best of their knowledge. Must be able to provide written informed consent before commencing with experimental procedures and perform experimental writing and reading tasks (i.e., must be able to fluently read/write in English). Must demonstrate satisfactory comprehension of the Informed Consent Document (ICD) by achieving a score of 100% correct on a short multiple-choice quiz . Exclusion Criteria: not between ages 18-39 not able to read/write fluently in English not of normal hearing without use of a hearing aid have been diagnosed with any condition that produces a strong sensitivity to sound (e.g., misophonia, hyperacusis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margeaux V Auslander, PhD
Organizational Affiliation
Walter Reed Army Institute of Research (WRAIR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Institute of Research
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Hostile Bias Modification Training (HBMT) Study

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