Adjustment Disorders in the US Military: Disease Trajectories and ADNM-20-Mil Validation

Launched by HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE · Mar 13, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on studying adjustment disorders (AjDs) in active-duty members of the US military. Adjustment disorders are mental health conditions that can occur after experiencing stress, leading to difficulties in coping and functioning. The goal of the trial is to validate a new diagnostic tool specifically designed for military personnel, called the Adjustment Disorder New Module for Military (ADNM-20-Mil). The study will also test a device called SANA, which uses audio-visual stimulation to help manage symptoms of AjDs.

To be eligible for the trial, participants need to be active-duty military members aged 18 to 64 who have been diagnosed with an adjustment disorder in the last three months. They should not have other serious mental health conditions and must be stable in their medication for at least four weeks prior to joining. Participants will need to use an internet-enabled smartphone or tablet and be available for all study activities over the next six months. If eligible, participants can expect to contribute to important research that aims to improve the understanding and treatment of adjustment disorders in the military.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-64
• • Serving as active duty in the US Military
• • Diagnosed with adjustment disorder (with or without depression and/or anxiety) within the last 3 months
• • No other mental health diagnosis (e.g., schizophrenia spectrum and other psychotic disorders, substance use disorder, bipolar and related disorders, TBI)
• • No current thoughts of or serious risk of suicide
• • Willing and available (e.g., no upcoming deployments or station changes within the next 6 months) to be participate in all study activities if eligible and enrolled
• • Any psychotropic drug therapy regimen must be stable (unchanging) for at least 4 weeks prior to enrollment and remain steady throughout the study
• • Must have and be willing to use an internet-enabled smartphone or tablet for the study
• • Provision of appropriate storage and charging for study equipment in a generally safe and dry condition
• • In treatment through the Military Health System for adjustment disorder
• Exclusion Criteria:
• • Significant medical conditions or other circumstances which would preclude compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may prevent the patient from safely participating in study.
• • Does not meet the eligibility criteria
• • Unable to read, speak, or comprehend English
• • Unable or unwilling to give informed consent
• • No current pregnancy or intention/planned pregnancy during study duration, or lactation
• • Study participants of childbearing potential who are unwilling to use an effective method of contraception during the use of SANA device
• • History or presence of photo-sensitive epilepsy or other photo-sensitive condition
• • History or presence of condition(s) that may affect balance, such as seizure disorders or vertigo
• • History or presence of severe and continuous tinnitus
• • History or presence of migraine headaches
• • Surgery or trauma requiring rehabilitation within the last 12 weeks
• • Presence of cancer pain, acute pain following injury or other severe pain that would be anticipated to change during the course of the study
• • Vision impairments that affect perception of light, color, or brightness in one or both eyes, and differences in visual perception between eyes
• • Deafness in one or both ears, perceived differences in hearing between ears
• • Current ear or eye infection, untreated allergies, or acute illness that may affect eyes or hearing (e.g., due to congestion)
• • Presence of inflammation or broken skin around the eyes in the area of the mask
• • Presence of narcolepsy or untreated sleep apnea. Note: presence of sleep apnea is permitted, so long as patients feel comfortable to use both apnea mask and Sana device in conjunction.
• • Participation in any other clinical study in which medication(s) are being delivered or have used an investigational drug or device within the last 30 days.
• • Current thoughts of suicide