- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04135001
Mental Flexibility (MFS)
April 5, 2021 updated by: Walter Reed Army Institute of Research (WRAIR)
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.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
500
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
-
-
Maryland
-
Silver Spring, Maryland, United States, 20910
- Walter Reed Army Institute of Research
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Soldiers assigned to the 1-128 IN BN / Wisconsin Army National Guard.
Exclusion Criteria:
- Soldiers not assigned to the 1-128 IN BN / Wisconsin Army National Guard.
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: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HBM Training
|
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 Comparator: Placebo 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
throughout study to completion, up to 1 year
|
Workplace interpersonal conflict scale
Time Frame: throughout study to completion, up to 1 year
|
Workplace Interpersonal Conflict Scale.
Adapted from Wright et al., 2017
|
throughout study to completion, up to 1 year
|
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)
|
throughout study to completion, up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
August 6, 2019
Primary Completion (Anticipated)
August 6, 2023
Study Completion (Anticipated)
August 6, 2024
Study Registration Dates
First Submitted
September 25, 2019
First Submitted That Met QC Criteria
October 18, 2019
First Posted (Actual)
October 22, 2019
Study Record Updates
Last Update Posted (Actual)
April 8, 2021
Last Update Submitted That Met QC Criteria
April 5, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- WRAIR #2686
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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