MFS: Mental Flexibility

Sponsor

Walter Reed Army Institute of Research (WRAIR) (U.S. Fed)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04135001

Collaborator

(none)

500

Enrollment

Location

Arms

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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 participantsAssignment 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 :

Aug 6, 2019

Anticipated Primary Completion Date :

Aug 6, 2023

Anticipated Study Completion Date :

Aug 6, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

attitudes about mission [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.
Workplace interpersonal conflict scale [throughout study to completion, up to 1 year]
Workplace Interpersonal Conflict Scale. Adapted from Wright et al., 2017
unit cohesion measure [throughout study to completion, up to 1 year]
Three item measure used in past WRAIR research. Based on Podsakoff and MacKenzie (1994)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Walter Reed Army Institute of Research	Silver Spring	Maryland	United States	20910

Sponsors and Collaborators

Walter Reed Army Institute of Research (WRAIR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Walter Reed Army Institute of Research (WRAIR)

ClinicalTrials.gov Identifier:

NCT04135001

Other Study ID Numbers:

WRAIR #2686

First Posted:

Oct 22, 2019

Last Update Posted:

Apr 8, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 8, 2021