Actively Recruiting
Adjustment Disorders in the US Military: Disease Trajectories and ADNM-20-Mil Validation
Led by Henry M. Jackson Foundation for the Advancement of Military Medicine · Updated on 2025-11-21
60
Participants Needed
3
Research Sites
116 weeks
Total Duration
On this page
Sponsors
H
Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead Sponsor
U
Uniformed Services University of the Health Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Adjustment disorders (AjDs) - a group of mental health diagnosis given following exposure to a stressor that results in preoccupation, failure to adapt, and/or functional impairments - have consistently remained the most common mental health diagnoses in the US military across branches for more than a decade. AjDs can be dangerous and negatively affect military readiness by reducing availability of members and through use of resources to allow evacuations from combat. Diagnosing AjDs can be challenging as it is closely related to other well-defined mental health disorders and assessment and research on AjDs have historically been difficult due to the lack of clarity in the disorder's diagnostic criteria. However, the Adjustment Disorder New Module (ADNM-20) is a recently developed instrument that has shown promise. In previous work, our team adapted the ADNM-20 to the US military population after finding that there was a need for an AjD-specific diagnostic instrument in this population; this instrument is referred to as the ADNM-20-Mil. The principal focus of this study is the longitudinal psychometric validation of the ADNM-20-mil. However, another goal of the proposed study is to pilot test the audio-visual stimulation device SANA for AjD as pilot testing such a device for AjD is a needed next step. Furthermore, the proposed, longitudinal study provides an ideal platform to test the ADNM-20-Mil's sensitivity to change in the context of this pilot trial to address this critical area of need.
CONDITIONS
Official Title
Adjustment Disorders in the US Military: Disease Trajectories and ADNM-20-Mil Validation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 64 years
- Active duty service in the US Military
- Diagnosed with adjustment disorder (with or without depression and/or anxiety) within the past 3 months
- No other mental health diagnosis such as schizophrenia spectrum, substance use disorder, bipolar disorder, or traumatic brain injury
- No current suicidal thoughts or serious suicide risk
- Willing and available to participate in all study activities with no deployments or station changes planned for 6 months
- Stable psychotropic drug therapy for at least 4 weeks before enrollment and throughout the study
- Must have and be willing to use an internet-enabled smartphone or tablet
- Able to provide appropriate storage and charging for study devices in a safe, dry place
- Currently receiving treatment for adjustment disorder through the Military Health System
You will not qualify if you...
- Significant medical conditions or situations preventing study compliance or safe participation
- Does not meet other eligibility criteria
- Unable to read, speak, or understand English
- Unable or unwilling to give informed consent
- Current pregnancy, planned pregnancy during the study, or breastfeeding
- Participants of childbearing potential unwilling to use effective contraception while using the SANA device
- History or presence of photo-sensitive epilepsy or similar conditions
- History or presence of seizure disorders, vertigo, severe tinnitus, or migraine headaches
- Recent surgery or trauma requiring rehabilitation within 12 weeks
- Presence of cancer pain, acute injury pain, or other severe pain expected to change during the study
- Vision impairments affecting light or color perception or differences between eyes
- Deafness or hearing differences between ears
- Current ear or eye infections, untreated allergies, or acute illnesses affecting eyes or hearing
- Inflammation or broken skin around the eyes where the mask is worn
- Presence of narcolepsy or untreated sleep apnea (sleep apnea patients must be comfortable using both their apnea mask and the SANA device)
- Participation in other clinical studies with investigational drugs or devices in the last 30 days
- Current suicidal thoughts
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Navy Medicine Readiness and Training Command San Diego
San Diego, California, United States, 92134
Actively Recruiting
2
Wright Patterson Air Force Base
Wright-Patterson Air Force Base, Ohio, United States, 45433
Actively Recruiting
3
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Actively Recruiting
Research Team
J
Jouhayna Bajjani-Gebara, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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