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

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 psychoticdisorders, 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 thenext 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 4weeks prior to enrollment and remain steady throughout the study

• Must have and be willing to use an internet-enabled smartphone or tablet for thestudy

• Provision of appropriate storage and charging for study equipment in a generallysafe and dry condition

• In treatment through the Military Health System for adjustment disorder

Exclusion Criteria:

• Significant medical conditions or other circumstances which would precludecompliance with the protocol, adequate cooperation in the study or obtaininginformed 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, orlactation

• Study participants of childbearing potential who are unwilling to use an effectivemethod 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 seizuredisorders 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 wouldbe anticipated to change during the course of the study

• Vision impairments that affect perception of light, color, or brightness in one orboth 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 affecteyes 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 ispermitted, so long as patients feel comfortable to use both apnea mask and Sanadevice in conjunction.

• Participation in any other clinical study in which medication(s) are being deliveredor have used an investigational drug or device within the last 30 days.

• Current thoughts of suicide