Clinical trial NCT04135001: Mental Flexibility
Official title: Mental Flexibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anger
Hostility
Lead sponsor: Walter Reed Army Institute of Research (WRAIR)
Sponsor class: FED
First posted: 2019-10-22
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: attitudes about mission
timeFrame: throughout study to completion, up to 1 year
measure: Workplace interpersonal conflict scale
timeFrame: throughout study to completion, up to 1 year
measure: unit cohesion measure
timeFrame: throughout study to completion, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Walter Reed Army Institute of Research
state: Maryland
Study officials:
References: