AngerMFSNCT04135001
Mental Flexibility
A study testing HBM Training in people with Anger and Hostility, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in United States.
Trial summary
The main purpose of this research is evaluate if HBMT reduces HAB in Soldiers, reduces intra-team conflict, improves trust, and improves unit cohesion. A secondary purpose of this research is to test Soldier acceptability and perception of the training. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- HBM Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2019to 6 Aug 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Soldiers assigned to the 1-128 IN BN / Wisconsin Army National Guard.
Who cannot join
- Soldiers not assigned to the 1-128 IN BN / Wisconsin Army National Guard.
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: Mental Flexibility Study
The main purpose of this research is evaluate if HBMT reduces HAB in Soldiers, reduces intra-team conflict, improves trust, and improves unit cohesion. A secondary purpose of this research is to test Soldier acceptability and perception of the training. Volunteers will be randomized to a training or placebo version of a computer task designed to reduce HAB and interpersonal conflict. Soldiers will then complete surveys at multiple time intervals before, during, and following deployment. If successful, this research would demonstrate the ability of a computer based training to improve unit cohesion and Soldier attitudes during pre-deployment training and deployment itself.
Read the detailed description
The study will consist of a double blind randomized controlled trial of HBMT (versus placebo) with subsequent pre-, during, and post-deployment surveys to assess the effectiveness of HBMT to influence relevant unit- and Soldier-level outcomes. Soldiers will be Command directed to participate. As such, all data will be used for briefing to unit leadership, however, participants will be asked to consent whether they allow their data to be used for research purposes. Subordinate units within the BN will be randomly assigned to complete either an active training or placebo version of the task. The individual briefing the Soldiers during training sessions will not know which version of the training the Soldiers are completing on the computer. Up to 40 Soldiers will complete HBMT at a time on individual study computers. Brief surveys will follow each training. There will also be a survey shortly before deployment, during deployment and shortly after deployment. See Appendix Q for tentative study timeline. For details on procedure see Section 9.8. Surveys completed during same day as HBMT training sessions will be completed on experimenter provided laptops, whereas surveys completed independent of an HBMT training session will be completed in pencil and paper format. See section 219.8 for details. The current protocol provides details for the first time point (initial HBMT training session). Additional amendments will be used to provide details and obtain approval for subsequent time points as these are coordinated with the unit. However, general information for follow-on time points is provided in this version of the protocol.
- Being tested
- HBM Training, Placebo Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBM TrainingBehavioural
A computer-based training to reduce hostile bias and interpersonal conflict as a mechanism to improve trust and cohesion within an operational military unit across the deployment cycle. The computer training is based on the Go/No-Go task (Fillmore et al., 2006) and Lexical Decision Task (Lepore \& Brown, 2002). The training reduces HAB by affecting two cognitive mechanisms: prime seeking non-hostile concepts when presented with ambiguous cues and conditioning inhibition in response to hostile cues. Thus, the training induces a non-hostile attribution bias while simultaneously training the inhibition of hostile attribution bias and aggressive behavior in response to ambiguous cues.
Placebo TrainingOther
Volunteers in the placebo condition will be told to complete the fragments with the first word that comes to mind. This placebo still exposes volunteers to the training stimuli and computer task, but does not train inhibition or selectively prime non-hostility, which are the hypothesized mechanisms of the training.
| Study group | Role | What they receive |
|---|---|---|
| HBM Training | Experimental | Not described Receives: Behavioral: HBM Training |
| Placebo Training | Placebo comparator | Not described Receives: Other: Placebo Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
attitudes about mission
Attitudes toward Mission. Nine items based on past WRAIR research that assess Soldiers attitudes about their mission.
Measured: throughout study to completion, up to 1 year
Workplace interpersonal conflict scale
Workplace Interpersonal Conflict Scale. Adapted from Wright et al., 2017
Measured: throughout study to completion, up to 1 year
unit cohesion measure
Three item measure used in past WRAIR research. Based on Podsakoff and MacKenzie (1994)
Measured: throughout study to completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start6 Aug 2019
- Primary completion6 Aug 2023 (estimated)
- Study completion6 Aug 2024 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Assignment to each condition (active vs. placebo) will be done by block assignment (by company) using the two versions of the HBMT program start code by study staff running participants
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135001
- Sponsor's protocol ID
- WRAIR #2686
- Acronym
- MFS
- Status last verified
- Apr 2021
- First submitted
- 25 Sep 2019
- Last updated
- 8 Apr 2021
- 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Flexibility Study
- ClinicalTrials.gov ID
- NCT04135001
- Acronym / sponsor ID
- MFS / WRAIR #2686
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)US federal agency
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 6 Aug 2023 (estimated)
- Study completion
- 6 Aug 2024 (estimated)
- First posted
- 22 Oct 2019 (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 main purpose of this research is evaluate if HBMT reduces HAB in Soldiers, reduces intra-team conflict, improves trust, and improves unit cohesion. A secondary purpose of this research is to test Soldier acceptability and perception of the training. Volunteers will be randomized to a training or placebo version of a computer task designed to reduce HAB and interpersonal conflict. Soldiers will then complete surveys at multiple time intervals before, during, and following deployment. If successful, this research would demonstrate the ability of a computer based training to improve unit cohesion and Soldier attitudes during pre-deployment training and deployment itself.
Detailed description
The study will consist of a double blind randomized controlled trial of HBMT (versus placebo) with subsequent pre-, during, and post-deployment surveys to assess the effectiveness of HBMT to influence relevant unit- and Soldier-level outcomes. Soldiers will be Command directed to participate. As such, all data will be used for briefing to unit leadership, however, participants will be asked to consent whether they allow their data to be used for research purposes. Subordinate units within the BN will be randomly assigned to complete either an active training or placebo version of the task. The individual briefing the Soldiers during training sessions will not know which version of the training the Soldiers are completing on the computer. Up to 40 Soldiers will complete HBMT at a time on individual study computers. Brief surveys will follow each training. There will also be a survey shortly before deployment, during deployment and shortly after deployment. See Appendix Q for tentative study timeline. For details on procedure see Section 9.8. Surveys completed during same day as HBMT training sessions will be completed on experimenter provided laptops, whereas surveys completed independent of an HBMT training session will be completed in pencil and paper format. See section 219.8 for details. The current protocol provides details for the first time point (initial HBMT training session). Additional amendments will be used to provide details and obtain approval for subsequent time points as these are coordinated with the unit. However, general information for follow-on time points is provided in this version of the protocol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Assignment to each condition (active vs. placebo) will be done by block assignment (by company) using the two versions of the HBMT program start code by study staff running participants
| Arm | Type | Receives |
|---|---|---|
| HBM Training | Experimental | Behavioral: HBM Training |
| Placebo Training | Placebo comparator | Other: Placebo Training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Soldiers assigned to the 1-128 IN BN / Wisconsin Army National Guard.
Key exclusion criteria (1 listed)
- Soldiers not assigned to the 1-128 IN BN / Wisconsin Army National Guard.
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 |
|---|---|---|
| HBM TrainingA computer-based training to reduce hostile bias and interpersonal conflict as a mechanism to improve trust and cohesion within an operational military unit across the deployment cycle. The computer training is based on the Go/No-Go task (Fillmore et al., 2006) and Lexical Decision Task (Lepore \& Brown, 2002). The training reduces HAB by affecting two cognitive mechanisms: prime seeking non-hostile concepts when presented with ambiguous cues and conditioning inhibition in response to hostile cues. Thus, the training induces a non-hostile attribution bias while simultaneously training the inhibition of hostile attribution bias and aggressive behavior in response to ambiguous cues. | Behavioural | HBM Training |
| Placebo TrainingVolunteers in the placebo condition will be told to complete the fragments with the first word that comes to mind. This placebo still exposes volunteers to the training stimuli and computer task, but does not train inhibition or selectively prime non-hostility, which are the hypothesized mechanisms of the training. | Other | Placebo Training |
Primary outcome
attitudes about mission
Time frame: throughout study to completion, up to 1 year
Attitudes toward Mission. Nine items based on past WRAIR research that assess Soldiers attitudes about their mission.
Workplace interpersonal conflict scale
Time frame: throughout study to completion, up to 1 year
Workplace Interpersonal Conflict Scale. Adapted from Wright et al., 2017
unit cohesion measure
Time frame: throughout study to completion, up to 1 year
Three item measure used in past WRAIR research. Based on Podsakoff and MacKenzie (1994)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Anger
Not yet recruiting
Implementing BEAM: A Scalable Digital Mental Health Program, for Families of Children Referred to Neurodevelopmental Services
Depression and Anxiety Symptom, Anger
Recruiting
Mobile Anger Reduction Intervention
Posttraumatic Stress Disorder, Anger
Not yet recruiting
QAIAx (AIhealth4U) - AI Smart Health Cities: Microcity Enclave Program (Quantum AI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360)
Asperger's Disorder, Asperger Disorder
Recruiting
Examining the Efficacy of the Man Therapy Platform in Reducing Problematic Anger Among Military Service Members With and Without a TBI History
Mild Traumatic Brain Injury (mTBI), Traumatic Brain Injury
Not yet recruiting
Digital Behavioral Parenting Programs With and Without Added Emotion Regulation Strategies to Manage Anger in Parenting
Parenting Intervention, Anger
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 HBM Training in people with Anger and Hostility, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Apr 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?
Results are not available in the source record.
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?
attitudes about mission (time frame: throughout study to completion, up to 1 year). 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 Apr 2021; AzTrials last refreshed its copy on 28 Oct 2026.