Adjustment disorder patterns and validation of the ADNM-20 for U.S. military members

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

This project tests whether adding the SANA audio-visual device to usual care helps active-duty U.S. military members with recent adjustment disorder and whether the ADNM-20-mil questionnaire tracks symptom changes over time.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine (other)
• Locations: 3 sites (San Diego, California and 2 other locations)
• Trial ID: NCT06885554 on ClinicalTrials.gov

What this trial studies

This randomized, two-arm longitudinal pilot assigns active-duty service members with recent adjustment disorder to receive standard of care (SOC) alone or SOC plus the SANA audio-visual device. The SANA arm uses the device twice daily for 22 minutes over 28 days while all participants wear an Emapatica monitor and complete measures at baseline, 28 days, 3 months, and 6 months. The primary aims are to test the ADNM-20-mil's sensitivity to change and to pilot the feasibility and preliminary efficacy of SANA as an adjunct to usual care. Outcomes include symptom change on the ADNM-20-mil, device adherence, and safety/tolerability signals.

Who should consider this trial

Good fit: Active-duty U.S. military members aged 18–64 diagnosed with adjustment disorder within the past three months, without other major psychiatric diagnoses, and able to complete study procedures are ideal candidates.

Not a fit: Patients with comorbid serious mental illness, substance use disorders, recent suicidal ideation, or unstable psychotropic regimens are unlikely to benefit from this pilot.

Why it matters

Potential benefit: If successful, this could provide a validated military-specific screening measure and a non-pharmacologic adjunct that reduces adjustment disorder symptoms and supports readiness.

How similar studies have performed: ADNM-20 instruments have shown promise in prior research, while use of audio-visual devices like SANA in this population is relatively novel and being pilot tested here.

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

Where this trial is running

San Diego, California and 2 other locations

• Navy Medicine Readiness and Training Command San Diego — San Diego, California, United States (RECRUITING)
• Wright Patterson Air Force Base — Wright-Patterson Air Force Base, Ohio, United States (RECRUITING)
• Brooke Army Medical Center — Fort Sam Houston, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Jouhayna Bajjani-Gebara, PhD

Conditions: Adjustment Disorders, Military