AngerNCT04997356
Hostile Bias Modification Training (HBMT) Study
A study testing Hostile Bias Modification Training and Other training in people with Anger and Stress, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in United States.
Trial 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: 1. Investigate the role of individual difference variables on HAB, interpersonal aggression, and effects of HBMT. 2. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Anger, Stress, Aggression
- What is being tested?
- Hostile Bias Modification Training and Other training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2021to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 .
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Institute of Research
Silver Spring, Maryland, 20910
About this study
Official title: 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.
Read the 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.
- Conditions
- Anger, Stress, Aggression
- Being tested
- Hostile Bias Modification Training, Other training
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hostile Bias Modification TrainingBehavioural
Also called HBMT
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Hostile Bias Modification (HBM) Training plus Unambiguous Feedback | Experimental | 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. Receives: Behavioral: Hostile Bias Modification Training |
| Other training plus Unambiguous Feedback | Placebo comparator | 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. Receives: Behavioral: Other training |
| Hostile Bias Modification (HBM) Training plus Ambiguous Feedback | Experimental | 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. Receives: Behavioral: Hostile Bias Modification Training |
| Other training plus Ambiguous Feedback | Placebo comparator | 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. Receives: Behavioral: Other training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Essay Feedback Questionnaire
8-item self-reported hostile attribution bias to ambiguously hostile or unambiguously hostile feedback (0-4). Higher scores indicate more bias.
Measured: average of 30 minutes post-intervention
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.
Measured: average of 45 minutes post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start12 Aug 2021
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Margeaux V Auslander, PhD, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997356
- Sponsor's protocol ID
- 2637
- Status last verified
- Dec 2023
- First submitted
- 29 Jul 2021
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Based Cognitive Games, Personality, and Behavior Study
- ClinicalTrials.gov ID
- NCT04997356
- Acronym / sponsor ID
- 2637
- Conditions
- Anger, Stress, Aggression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)US federal agency
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hostile Bias Modification (HBM) Training plus Unambiguous Feedback | Experimental | Behavioral: Hostile Bias Modification TrainingVolunteers 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. |
| Other training plus Unambiguous Feedback | Placebo comparator | Behavioral: Other trainingVolunteers 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. |
| Hostile Bias Modification (HBM) Training plus Ambiguous Feedback | Experimental | Behavioral: Hostile Bias Modification TrainingVolunteers 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. |
| Other training plus Ambiguous Feedback | Placebo comparator | Behavioral: Other trainingVolunteers 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 .
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hostile Bias Modification TrainingAlso: HBMTVolunteers 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. | Behavioural | Hostile Bias Modification (HBM) Training plus Ambiguous Feedback, Hostile Bias Modification (HBM) Training plus Unambiguous Feedback |
| Other trainingVolunteers 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. | Behavioural | Other training plus Ambiguous Feedback, Other training plus Unambiguous Feedback |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margeaux V Auslander, PhD principal investigator
Walter Reed Army Institute of Research (WRAIR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hostile Bias Modification Training and Other training in people with Anger and Stress, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Essay Feedback Questionnaire (time frame: average of 30 minutes post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.