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Mental Flexibility (MFS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135001
Recruitment Status : Enrolling by invitation
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Walter Reed Army Institute of Research (WRAIR)

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.

Condition or disease Intervention/treatment Phase
Anger Hostility Behavioral: HBM Training Other: Placebo Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
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
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Mental Flexibility Study
Actual Study Start Date : August 6, 2019
Estimated Primary Completion Date : August 6, 2023
Estimated Study Completion Date : August 6, 2024

Arm Intervention/treatment
Experimental: HBM Training Behavioral: 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 Other: 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.




Primary Outcome Measures :
  1. 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.

  2. Workplace interpersonal conflict scale [ Time Frame: throughout study to completion, up to 1 year ]
    Workplace Interpersonal Conflict Scale. Adapted from Wright et al., 2017

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135001


Locations
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United States, Maryland
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
Walter Reed Army Institute of Research (WRAIR)
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Responsible Party: Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier: NCT04135001    
Other Study ID Numbers: WRAIR #2686
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No