Four Pillars of Defense: A Whole Health Approach to the Military

April 1, 2024 updated by: Tiffany Stewart, Pennington Biomedical Research Center
The overall objectives of this study are to better define the construct of psychological resilience in the military, to identify potential modifiable risk factors and trainable skills of psychological resilience in Soldiers, and provide a scalable, integrated physical and mental optimization training app to be integrated into relevant systems. The proposed work would be a first step in identifying predictive risk factors that can be modified to increase the future resilience of Soldiers. With this crucial information, the investigators aim to gather data that will inform the development of a resilience-focused intervention (e.g., a skills training program) and test the feasibility of that intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 21+ and either a Soldier in the NG or NG family member

Exclusion Criteria:

  • Under age 21 and not an NG Soldier or family member

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Program Users
Behavioral: Army Health
A whole health mobile application for Soldiers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resilience
Time Frame: 1 month
Connor Davidson Resilience Scale (CDRISC)
1 month
Resilience
Time Frame: 1 month
Brief Resilience Scale (BRS)
1 month
Emotion Regulation
Time Frame: 1 month
Difficulty in Emotion Regulation Scale (DERS)
1 month
Experiential Avoidance
Time Frame: 1 month
Multidimensional Experiential Avoidance Questionnaire (MEAQ-30)
1 month
Intolerance of Uncertainty
Time Frame: 1 month
Intolerance of Uncertainty Scale (IUS-12)
1 month
Coping
Time Frame: 1 month
Brief COPE
1 month
Positive and Negative Social Exchanges
Time Frame: 1 month
Positive and Negative Social Exchanges (PANSE)
1 month
Post Traumatic Stress Disorder (PTSD)
Time Frame: 1 month
PTSD Checklist (PCL-5)
1 month
Sleep
Time Frame: 1 month
Pittsburgh Sleep Quality Index (PSQI)
1 month
Social Support
Time Frame: 1 month
Social Support Survey (SSS)
1 month
Responses to Stressful Experiences
Time Frame: 1 month
Responses to Stressful Experiences Scale (RSES)
1 month
Unit Cohesion
Time Frame: 1 month
Questionnaire
1 month
Depression
Time Frame: 2 weeks
Patient Health Questionnaire (PHQ-8)
2 weeks
Anxiety
Time Frame: 2 weeks
Generalized Anxiety Disorder (GAD7)
2 weeks
Stress
Time Frame: 1 month
Perceived Stress Scale (PSS)
1 month
Drug Abuse
Time Frame: 12 months
Drug Abuse Screening Test (DAST-10)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Topics Ranking
Time Frame: 1 month
Questionnaire
1 month
Technology Use
Time Frame: 1 month
Questionnaire
1 month
Program Satisfaction
Time Frame: 6 Months
Questionnaire
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2024

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 15, 2027

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

January 3, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PBRC 2023-073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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