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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06205186
• Other study ID #: PBRC 2023-073
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2024
• Est. completion date: January 15, 2027

Study information

• Verified date: April 2024
• Source: Pennington Biomedical Research Center
• Contact: Nicole Wesley
• Phone: 2257632721
• Email: nicole.wesley[@]pbrc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 15, 2027
• Est. primary completion date: January 15, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior

Intervention

Behavioral:
• Army Health
A whole health mobile application for Soldiers

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resilience	Connor Davidson Resilience Scale (CDRISC)	1 month
Primary	Resilience	Brief Resilience Scale (BRS)	1 month
Primary	Emotion Regulation	Difficulty in Emotion Regulation Scale (DERS)	1 month
Primary	Experiential Avoidance	Multidimensional Experiential Avoidance Questionnaire (MEAQ-30)	1 month
Primary	Intolerance of Uncertainty	Intolerance of Uncertainty Scale (IUS-12)	1 month
Primary	Coping	Brief COPE	1 month
Primary	Positive and Negative Social Exchanges	Positive and Negative Social Exchanges (PANSE)	1 month
Primary	Post Traumatic Stress Disorder (PTSD)	PTSD Checklist (PCL-5)	1 month
Primary	Sleep	Pittsburgh Sleep Quality Index (PSQI)	1 month
Primary	Social Support	Social Support Survey (SSS)	1 month
Primary	Responses to Stressful Experiences	Responses to Stressful Experiences Scale (RSES)	1 month
Primary	Unit Cohesion	Questionnaire	1 month
Primary	Depression	Patient Health Questionnaire (PHQ-8)	2 weeks
Primary	Anxiety	Generalized Anxiety Disorder (GAD7)	2 weeks
Primary	Stress	Perceived Stress Scale (PSS)	1 month
Primary	Drug Abuse	Drug Abuse Screening Test (DAST-10)	12 months
Secondary	Topics Ranking	Questionnaire	1 month
Secondary	Technology Use	Questionnaire	1 month
Secondary	Program Satisfaction	Questionnaire	6 Months