- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04997356
Hostile Bias Modification Training (HBMT) Study
Computer-Based Cognitive Games, Personality, and Behavior Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
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Silver Spring, Maryland, United States, 20910
- Walter Reed Army Institute of Research
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hostile Bias Modification (HBM) Training plus Unambiguous Feedback
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 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.
Other Names:
|
|
Placebo Comparator: Other training plus Unambiguous Feedback
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 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.
|
|
Experimental: Hostile Bias Modification (HBM) Training plus Ambiguous Feedback
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 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.
Other Names:
|
|
Placebo Comparator: Other training plus Ambiguous Feedback
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Essay Feedback Questionnaire
Time Frame: average of 30 minutes post-intervention
|
8-item self-reported hostile attribution bias to ambiguously hostile or unambiguously hostile feedback (0-4).
Higher scores indicate more bias.
|
average of 30 minutes post-intervention
|
|
Taylor Aggression Paradigm (TAP)
Time Frame: average of 45 minutes post-intervention
|
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.
|
average of 45 minutes post-intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Margeaux V Auslander, PhD, Walter Reed Army Institute of Research (WRAIR)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2637
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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