AggressionHBMT IINCT04015440
Hostile Bias Modification Training Online Study II
A study testing HBMT and Other Training in people with Aggression and Anger, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in United States.
Trial summary
The purpose of this study is to see how people respond on a word completion task relates to how they behave and respond to situations in the real world. This is a two part research study. At time-point one, participants will fill out some brief personality surveys. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aggression, Anger, Emotion Regulation
- What is being tested?
- HBMT 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
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult aged 18 and older
- Located in the United States or other primarily English speaking country.
- Active Amazon Account.
Who cannot join
- Less than 18 years old.
- Not located in the United States or other primarily English speaking country.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sleep Research Center
Silver Spring, Maryland, 20910
About this study
The purpose of this study is to see how people respond on a word completion task relates to how they behave and respond to situations in the real world. This is a two part research study. At time-point one, participants will fill out some brief personality surveys. They will also read several short scenarios and imagine how they would react and/or interpret these situations in real life. They will also complete a vocabulary task where they will sort word fragments based on type as quickly as they are able. Participants will be asked to return in 24-96 hours for part two where they will repeat a similar scenario reading activity as during time one and fill out a brief questionnaire about your recent behaviors.
- Conditions
- Aggression, Anger, Emotion Regulation, Self-Control, Stress
- Being tested
- HBMT, Other Training
- Keywords
- attention bias, hostile attribution bias, hostile bias modification
- Medical subject headings
- Aggression, Emotional Regulation, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBMTBehavioural
Individual is presented with words with some letters missing and told to complete the word.
Other TrainingBehavioural
Alternative to HBMT training
| Study group | Role | What they receive |
|---|---|---|
| HBMT | Experimental | Not described Receives: Behavioral: HBMT |
| Placebo | Placebo comparator | Not described Receives: Behavioral: Other Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hostile Attribution Bias
Adapted from the "Angry Cognitions Scale" (Martin and Dahlen 2007). Volunteers read hypothetical scenarios where another person acted aggressively but with unclear intent (e.g., "You are driving through a residential area when someone backs their car out of a driveway and nearly hits you."). Volunteers respond to items (from "Very Unlikely" to "Very Likely") to indicate how they would think about the situation (e.g., "He/she did that just so I'd have to stop. He/she was trying to scare me."). Volunteers responded to one set (4 scenarios) at time point one and a second set (5 scenarios) at time point two. Reponses were summed within each scenario and averaged across scenarios to indicate level of hostile attribution bias. Individual scores at each time point could range from 0 (no hostile attribution bias) to 24 (high hostile attribution bias).
Measured: 24-96 hours post HBMT
Driving Aggression
State Aggression Survey: This survey is adapted from several others in the literature to measure variance along the normal spectrum of aggressive behaviors in daily life that the average person might display (Álvarez-García, et al., 2016; Deffenbacher, et al., 2001; Deffenbacher, J. et al., 2002). The survey specifically asks about driving behaviors (e.g., yelling at other drivers). Scoring is count of aggressive behaviors during reporting period.
Measured: 24-96 hours post HBMT
Aggression On Social Media
Seven items adapted from the Cyber-Aggression Questionnaire for Adolescents by Álvarez-García et al. (2016). Volunteers reported at time point two how often (during preceding 24 h) they engaged in various aggressive online behaviors (e.g., posted rude comments about someone on a social network). Response choices ranged from 1 = never to 4 = always. Scores were recorded dichotomously to represent whether a volunteer reported any online aggression during the reporting period (i.e. "never" was recoded as "0" to indicate no aggression, and all other responses were recoded as "1" to indicate at least some aggression. A higher percentage of volunteers in a study condition reporting usage of aggression on social media indicates a worse outcome for that study condition.
Measured: 24-96 hours post treatment
Secondary outcomes (1)
Anger
Trait Anger Scale: Brief measure of trait anger validated by Wilk et al., (2015). Scale (1-5, strongly disagree to strongly agree); Two questions regarding individual's perspective on their anger. Higher values indicate greater anger.
Measured: 24-96 hours post HBMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start30 Jul 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AggressionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an online study. Volunteer assignment to each of the two experimental conditions is semi-randomized (i.e. random except that computer ensure equal sample sizes across experimental conditions). The randomized assigning of participants is done by the study web-page/program at volunteerscience.com. The computer program randomly assigned volunteers to one of the two conditions when they begin the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)
- Sponsor type
- US federal agency
- Collaborators
- Army Research Laboratory
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015440
- Sponsor's protocol ID
- WRAIR #2628
- Acronym
- HBMT II
- Status last verified
- Aug 2021
- First submitted
- 8 Jul 2019
- Last updated
- 8 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hostile Bias Modification Training Online Study II
- ClinicalTrials.gov ID
- NCT04015440
- Acronym / sponsor ID
- HBMT II / WRAIR #2628
- Conditions
- Aggression, Anger, Emotion Regulation, Self-Control, Stress
- Keywords
- attention bias, hostile attribution bias, hostile bias modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)US federal agency
- Collaborators
- Army Research Laboratory
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Posted 8 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see how people respond on a word completion task relates to how they behave and respond to situations in the real world. This is a two part research study. At time-point one, participants will fill out some brief personality surveys. They will also read several short scenarios and imagine how they would react and/or interpret these situations in real life. They will also complete a vocabulary task where they will sort word fragments based on type as quickly as they are able. Participants will be asked to return in 24-96 hours for part two where they will repeat a similar scenario reading activity as during time one and fill out a brief questionnaire about your recent behaviors.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is an online study. Volunteer assignment to each of the two experimental conditions is semi-randomized (i.e. random except that computer ensure equal sample sizes across experimental conditions). The randomized assigning of participants is done by the study web-page/program at volunteerscience.com. The computer program randomly assigned volunteers to one of the two conditions when they begin the study.
| Arm | Type | Receives |
|---|---|---|
| HBMT | Experimental | Behavioral: HBMT |
| Placebo | Placebo comparator | Behavioral: Other Training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult aged 18 and older
- Located in the United States or other primarily English speaking country.
- Active Amazon Account.
Key exclusion criteria (2 listed)
- Less than 18 years old.
- Not located in the United States or other primarily English speaking country.
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 |
|---|---|---|
| HBMTIndividual is presented with words with some letters missing and told to complete the word. | Behavioural | HBMT |
| Other TrainingAlternative to HBMT training | Behavioural | Placebo |
Primary outcome
Hostile Attribution Bias
Time frame: 24-96 hours post HBMT
Adapted from the "Angry Cognitions Scale" (Martin and Dahlen 2007). Volunteers read hypothetical scenarios where another person acted aggressively but with unclear intent (e.g., "You are driving through a residential area when someone backs their car out of a driveway and nearly hits you."). Volunteers respond to items (from "Very Unlikely" to "Very Likely") to indicate how they would think about the situation (e.g., "He/she did that just so I'd have to stop. He/she was trying to scare me."). Volunteers responded to one set (4 scenarios) at time point one and a second set (5 scenarios) at time point two. Reponses were summed within each scenario and averaged across scenarios to indicate level of hostile attribution bias. Individual scores at each time point could range from 0 (no hostile attribution bias) to 24 (high hostile attribution bias).
Driving Aggression
Time frame: 24-96 hours post HBMT
State Aggression Survey: This survey is adapted from several others in the literature to measure variance along the normal spectrum of aggressive behaviors in daily life that the average person might display (Álvarez-García, et al., 2016; Deffenbacher, et al., 2001; Deffenbacher, J. et al., 2002). The survey specifically asks about driving behaviors (e.g., yelling at other drivers). Scoring is count of aggressive behaviors during reporting period.
Aggression On Social Media
Time frame: 24-96 hours post treatment
Seven items adapted from the Cyber-Aggression Questionnaire for Adolescents by Álvarez-García et al. (2016). Volunteers reported at time point two how often (during preceding 24 h) they engaged in various aggressive online behaviors (e.g., posted rude comments about someone on a social network). Response choices ranged from 1 = never to 4 = always. Scores were recorded dichotomously to represent whether a volunteer reported any online aggression during the reporting period (i.e. "never" was recoded as "0" to indicate no aggression, and all other responses were recoded as "1" to indicate at least some aggression. A higher percentage of volunteers in a study condition reporting usage of aggression on social media indicates a worse outcome for that study condition.
1 secondary outcome
Anger
Time frame: 24-96 hours post HBMT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBMT and Other Training in people with Aggression and Anger, 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 3 inclusion and 2 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 8 Sep 2021. 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?
Yes. Results are posted in the registry (first posted 8 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hostile Attribution Bias (time frame: 24-96 hours post HBMT). The study lists 3 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 8 Sep 2021.