NCT04135001

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2024

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

4 years

First QC Date

September 25, 2019

Last Update Submit

April 5, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • attitudes about mission

    Attitudes toward Mission. Nine items based on past WRAIR research that assess Soldiers attitudes about their mission.

    throughout study to completion, up to 1 year

  • Workplace interpersonal conflict scale

    Workplace Interpersonal Conflict Scale. Adapted from Wright et al., 2017

    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)

    throughout study to completion, up to 1 year

Study Arms (2)

HBM Training

EXPERIMENTAL
Behavioral: HBM Training

Placebo Training

PLACEBO COMPARATOR
Other: Placebo Training

Interventions

HBM TrainingBEHAVIORAL

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.

HBM Training

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.

Placebo Training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Soldiers assigned to the 1-128 IN BN / Wisconsin Army National Guard.

You may not qualify if:

  • Soldiers not assigned to the 1-128 IN BN / Wisconsin Army National Guard.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: 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
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2019

First Posted

October 22, 2019

Study Start

August 6, 2019

Primary Completion

August 6, 2023

Study Completion

August 6, 2024

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations