Mental Flexibility

Anger Clinical Trial

— MFS  

Official title:

Mental Flexibility Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04135001
• Other study ID #: WRAIR #2686
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 6, 2019
• Est. completion date: August 6, 2024

Study information

• Verified date: April 2021
• Source: Walter Reed Army Institute of Research (WRAIR)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: August 6, 2024
• Est. primary completion date: August 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anger
• Hostility

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Walter Reed Army Institute of Research	Silver Spring	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed Army Institute of Research (WRAIR)

Country where clinical trial is conducted

United States, 

Outcome

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