Mental Flexibility (MFS)

Walter Reed Army Institute of Research (WRAIR)

Status: Invitation-only

Conditions: Hostility; Anger

Treatments: Other: Placebo Training; Behavioral: HBM Training

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04135001

WRAIR #2686

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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500 participants in 2 patient groups, including a placebo group

HBM Training

Experimental group

Treatment:

Behavioral: HBM Training

Placebo Training

Placebo Comparator group

Treatment:

Other: Placebo Training