- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04015440
Hostile Bias Modification Training Online Study II (HBMT II)
August 11, 2021 updated by: Walter Reed Army Institute of Research (WRAIR)
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
229
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Silver Spring, Maryland, United States, 20910
- Sleep Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult aged 18 and older
- Located in the United States or other primarily English speaking country.
- Active Amazon Account.
Exclusion Criteria:
- Less than 18 years old.
- Not located in the United States or other primarily English speaking country.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Alternative to HBMT training
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Experimental: HBMT
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Individual is presented with words with some letters missing and told to complete the word.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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24-96 hours post HBMT
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Driving Aggression
Time Frame: 24-96 hours post HBMT
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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.
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24-96 hours post HBMT
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Aggression On Social Media
Time Frame: 24-96 hours post treatment
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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.
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24-96 hours post treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anger
Time Frame: 24-96 hours post HBMT
|
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.
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24-96 hours post HBMT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2019
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
July 8, 2019
First Submitted That Met QC Criteria
July 8, 2019
First Posted (Actual)
July 11, 2019
Study Record Updates
Last Update Posted (Actual)
September 8, 2021
Last Update Submitted That Met QC Criteria
August 11, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WRAIR #2628
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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