- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07286955
Life Skills Training for Soldiers Arriving at Their First Duty Location
SAFEGUARD: Life Skills Training for Soldiers Arriving at Their First Duty Location
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Suicide remains a leading cause of death among Soldiers, especially those 17-24 years old in their first year of military service. This time is also marked by high rates of other harmful behaviors and of early separation from the Army. The Army invests billions of dollars in recruiting and training, yet many new Soldiers leave the service early or experience serious events like suicidal behaviors. Exposure to situational stressors involving such areas of life as romantic relationships and finances increases risk for suicide and other harmful behaviors. Implementing universal training programs to prevent these types of negative outcomes before they arise have enormous potential to bolster the mental toughness of new Soldiers during this difficult transition. The proposed project aims to prevent suicide-related behaviors (SRBs) and other behaviors qualifying for a Serious Incident Report (SIR) through an innovative, universal life skills program delivered at a critical transition point in Soldiers' careers-their first duty assignment. By focusing on this particularly high-risk period, this project seeks to reduce SRBs and related harmful behaviors among U.S. Army Soldiers. The proposed project will test the effectiveness of a recently developed, evidence-based training program designed to build life skills and coping strategies that can protect against suicide, other harmful behaviors, poor work performance, and premature separation during a Soldier's first duty assignment.
This project will evaluate the effectiveness of Level Up, a strengths based, military-specific life skills training program. The goal is to determine whether Level Up can decrease suicidal thoughts and behaviors, improve mental health, enhance job performance, and reduce early military separation. Previous studies show that building skills like stress management, problem-solving, and healthy communication can protect against SRBs and related problem behaviors. However, many of these programs failed to show long-term impact, partly due to limited engagement. Level Up is designed to overcome these limitations by combining interactive learning, mobile technology, personalized coaching, and on-demand virtual booster sessions. This hybrid format is intended to help Soldiers refresh their skills and engage with content at their preferred pace and rhythm. The Level Up program components include: 1) a 90-minute live group session during Soldiers' in-processing week at their first duty station, 2) a mobile app/online platform/workbook with brief, interactive self-guided exercises in core skill areas (e.g., managing stress, tactical thinking, healthy relationships), 3) personalized coaching via messages from trained staff during the first month of app use, and 4) virtual booster sessions over one year, focused on practical domains like finances, leadership, promotion tips, and personal relationships. Soldiers will be randomized to receive either Level Up or Engage, an existing single session Army bystander intervention program that will serve as a comparison training.
The Level Up program content draws from evidence-based psychological methods such as Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, and motivational coaching adapted to fit military culture and tailored to be relevant, accessible, and engaging for newly assigned junior-ranking Soldiers, a group at high risk for suicide and other serious behavioral issues. By equipping them with essential life skills and support during their first year of service, the program aims to reduce SRBs and other behaviors qualifying for SIRs, develop psychosocial skills, and increase career success and satisfaction.
If effective, Level Up could be implemented Army-wide as a universal prevention program to improve mental health, readiness, and retention. There are minimal risks as the interventions are educational, although some participants may experience brief emotional discomfort during skill practice or reflection. All participants can opt out at any time, and all are provided with resources and additional support as needed. This study could have a transformative impact on military suicide prevention efforts, especially during early service when Soldiers are most vulnerable. By evaluating this scalable program in a large, real-world setting, the research will provide clear evidence about its benefits for reducing suicide and improving readiness. Results will also support development of predictive tools to identify which Soldiers may benefit most from added support. Findings will be shared across the Department of Defense to inform policy, training, and future resilience-building programs-ultimately improving the health, performance, and quality of life of Soldiers across the Force.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Life Skills Study Team
- Phone Number: 301-295-9711
- Email: life-skills-study-ggg@usuhs.edu
Study Locations
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Texas
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Fort Hood, Texas, United States, 76544
- Recruiting
- Fort Hood Installation Reception Center
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Contact:
- Fort Hood Installation Reception Center
- Phone Number: 254-449-3976
- Email: pcsfortcavazos@army.mil
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Active duty Soldiers arriving at a military installation located in the South Central U.S. for their first duty location who are attending reception center activities
Exclusion Criteria:
- Soldiers who are not available to attend the in-person training
- Soldiers who are under the age of 18 years old
- Soldiers who do not have a smart phone that supports installation of the mobile app
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Level Up Program
The Level Up program is a hybrid intervention combining interactive learning, mobile/online technology, personalized coaching, and on-demand virtual booster sessions.
The evidence-based training program was designed to build life skills and coping strategies that can protect against suicide, other harmful behaviors, poor work performance, and premature separation during a Soldier's first duty assignment.
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The Level Up program components include:
Other Names:
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Active Comparator: ENGAGE Training
ENGAGE is an existing single session Army bystander intervention program.
The training program is based on bystander intervention and prosocial behavior research.
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ENGAGE training is a single 90-minute workshop aimed at developing leadership skills and confidence in handling professional and personal confrontations.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The occurrence of any harmful behavior
Time Frame: Within the 12 months after intervention randomization
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The occurrence of any harmful behavior, either self-reported in follow up surveys or administratively reported
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Within the 12 months after intervention randomization
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The occurrence of any suicide-related behavior
Time Frame: Within the 12 months after intervention randomization
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The occurrence of any suicide-related behavior, either self-reported in follow up surveys or administratively reported
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Within the 12 months after intervention randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The occurrence of any premature separations from service
Time Frame: Within the 12 months after intervention randomization
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Within the 12 months after intervention randomization
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Poor performance as indicated either by written reprimands, designations in the NCOER, a corrective action plan, remedial training, flagging actions, demotion, Article 15, or barred reenlistment
Time Frame: Within the 12 months after intervention randomization
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Within the 12 months after intervention randomization
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Personal deployment readiness
Time Frame: Within the 6 months after intervention randomization
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Walter Reed Army Institute of Research Land Combat Survey; Scale ranges from 4-20; Higher scores indicate higher perceived readiness
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Within the 6 months after intervention randomization
|
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Emotionality
Time Frame: Within the 6 months after intervention randomization
|
Emotion Reactivity Scale (ERS) ; Scale ranges from0-4; Higher scores indicate higher of each maladaptive trait
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Within the 6 months after intervention randomization
|
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Job satisfaction
Time Frame: Within the 6 months after intervention randomization
|
3-item Job Satisfaction Scale; Scale ranges from 3-15; Higher scores indicate higher perceived job satisfaction
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Within the 6 months after intervention randomization
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Depression symptom severity
Time Frame: Within the 6 months after intervention randomization
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Patient Health Questionnaire-2 (PHQ-2); Scale ranges from 0-8; Higher scores indicate more severe symptoms
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Within the 6 months after intervention randomization
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Anxiety symptom severity
Time Frame: Within the 6 months after intervention randomization
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Generalized Anxiety Disorder-2 (GAD-2); Scale ranges from 0-8; Higher scores indicate more severe symptoms
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Within the 6 months after intervention randomization
|
|
Incidence of traumatic brain injuries
Time Frame: Within the 6 months after intervention randomization
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Number of traumatic brain injuries; based on the Army STARRS Surveys; No scale range; number indicates greater number of traumatic brain injuries
|
Within the 6 months after intervention randomization
|
|
Lifetime history of various mental/emotional health problems
Time Frame: Within the 6 months after intervention randomization
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Family History Screen (FHS); Scale ranges from 0-1; 0=No; 1=Yes
|
Within the 6 months after intervention randomization
|
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Chronic stress severity
Time Frame: Within the 6 months after intervention randomization
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Personal Life Stress Scale (PLS); Scale ranges from 0-50; Higher scores indicate greater chronic stress severity
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Within the 6 months after intervention randomization
|
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Mental toughness
Time Frame: Within the 6 months after intervention randomization
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Sports Mental Toughness Questionnaire (SMTQ); Scale ranges from 5-25; Higher scores indicate higher confidence & constancy
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Within the 6 months after intervention randomization
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History of suicidal ideation, plan, & attempt
Time Frame: Within the 6 months after intervention randomization
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Columbia-Suicide Severity Rating Scale (C-SSRS) Full scale Baseline/Screening; Scale ranges from 0-1 0=No; 1=Yes
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Within the 6 months after intervention randomization
|
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Positive social networks
Time Frame: Within the 6 months after intervention randomization
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Supportive & Negative Social Interaction Scale (SIS); Scale ranges from 0-8; Higher scores indicate more positive/negative social support
|
Within the 6 months after intervention randomization
|
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Negative social networks
Time Frame: Within the 6 months after intervention randomization
|
Supportive & Negative Social Interaction Scale (SIS); Scale ranges from 0-8; Higher scores indicate more positive/negative social support
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Within the 6 months after intervention randomization
|
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Mattering/belonging
Time Frame: Within the 6 months after intervention randomization
|
General Mattering Scale; Scale ranges from 0-20; Higher scores indicate higher perceived mattering to others
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Within the 6 months after intervention randomization
|
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Loneliness
Time Frame: Within the 6 months after intervention randomization
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3-Item Loneliness Screener; Scale ranges from 0-16; Higher scores indicate more frequency-severity of loneliness
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Within the 6 months after intervention randomization
|
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Adverse childhood events & trauma
Time Frame: Within the 6 months after intervention randomization
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Childhood Trauma Questionnaire - Short Form (CTQ-SF) ; Scale ranges from 0-44; Higher scores indicate more childhood maltreatment
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Within the 6 months after intervention randomization
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Conscientiousness
Time Frame: Within the 6 months after intervention randomization
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Big Five Inventory (BFI)16 & Personality Inventory for DSM-5 Brief Form (PID-5-BF); Scale ranges from 0-8; Higher scores indicate lower of each adaptive trait
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Within the 6 months after intervention randomization
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Mastery
Time Frame: Within the 6 months after intervention randomization
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Pearlin & Schooler's Psychological Coping Resources Measure; Scale ranges from 0-8; Higher scores indicate lower of each adaptive trait
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Within the 6 months after intervention randomization
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Openness
Time Frame: Within the 6 months after intervention randomization
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120-item International Personality Item Pool (IPIP); Scale ranges from 0-4; Higher scores indicate lower of each adaptive trait
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Within the 6 months after intervention randomization
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Problem-solving ability
Time Frame: Within the 6 months after intervention randomization
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Social Problem Solving Inventory-Revised (SPSI-R); Scale ranges from 0-8; Higher scores indicate lower of each adaptive trait
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Within the 6 months after intervention randomization
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Psychological well-being
Time Frame: Within the 6 months after intervention randomization
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Flourishing Scale; Scale ranges from 0-12; Higher scores indicate lower of each adaptive trait
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Within the 6 months after intervention randomization
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Resilience
Time Frame: Within the 6 months after intervention randomization
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Army STARRS Resilience Scale; Scale ranges from 0-16; Higher scores indicate lower of each adaptive trait
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Within the 6 months after intervention randomization
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Self-esteem
Time Frame: Within the 6 months after intervention randomization
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Rosenberg Self-Esteem Scale; Scale ranges from 0-8; Higher scores indicate lower of each adaptive trait
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Within the 6 months after intervention randomization
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Anxious, Cyclothymic, Depressive, & Hyperthymic temperament
Time Frame: Within the 6 months after intervention randomization
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Revised NEO Personality Inventory (NEO-PI-R) & the Temperament Evaluation of Memphis, Pisa, Paris & San Diego-autoquestionnaire version (TEMPS-A); Scale ranges from 0-8 for each temperament; Higher scores indicate higher of each maladaptive trait
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Within the 6 months after intervention randomization
|
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Borderline personality
Time Frame: Within the 6 months after intervention randomization
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McLean Screening Instrument for Borderline Personality Disorder; Scale ranges from 0-16; Higher scores indicate higher of each maladaptive trait
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Within the 6 months after intervention randomization
|
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Anger-hostility
Time Frame: Within the 6 months after intervention randomization
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Big Five Inventory (BFI)16 & Personality Inventory for DSM-5 Brief Form (PID-5-BF); Scale ranges from 0-8; Higher scores indicate higher of each maladaptive trait
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Within the 6 months after intervention randomization
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Impulsivity/negative urgency
Time Frame: Within the 6 months after intervention randomization
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Impulsive Behavior Scale - Short Form (SUPPS-P); Scale ranges from 0-8; Higher scores indicate higher of each maladaptive trait
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Within the 6 months after intervention randomization
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Introversion
Time Frame: Within the 6 months after intervention randomization
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Eysenck Personality Questionnaire - Brief Version (EPQ-BV)28 & Revised NEO Personality Inventory (NEO-PI-R); Scale ranges from 0-8; Higher scores indicate higher of each maladaptive trait
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Within the 6 months after intervention randomization
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Fearlessness about death
Time Frame: Within the 6 months after intervention randomization
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Acquired Capability for Suicide Scale; Scale ranges from 0-4; Higher scores indicate higher of each maladaptive trait
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Within the 6 months after intervention randomization
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Self-conscious
Time Frame: Within the 6 months after intervention randomization
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Widiger Five-Factor Rating Form - Revised31 & NEO Five-Factor Inventory (NEO-FFI); Scale ranges from 0-8; Higher scores indicate higher of each maladaptive trait
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Within the 6 months after intervention randomization
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Vulnerability
Time Frame: Within the 6 months after intervention randomization
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NEO Five-Factor Inventory (NEO-FFI); Scale ranges from 0-4; Higher scores indicate higher of each maladaptive trait
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Within the 6 months after intervention randomization
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Frequency of risky behaviors
Time Frame: Within the 6 months after intervention randomization
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Unit Risk Inventory (URI); Scale ranges from 0-1; 0=Never; 1=At least less than once a month
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Within the 6 months after intervention randomization
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Thomas H Nassif, PhD, Uniformed Services University of the Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USUHS.2025-162
- Federal Award # HU00012520025 (Other Grant/Funding Number: Office of the Assistant Secretary of Defense for Health Affairs)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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