NCT06885554

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The aim of this trial is to evaluate the sensitivity of the ADNM-20-mil to change via a prospective longitudinal 2-arm repeated measures design to pilot test the feasibility and efficacy of the audio-visual stimulation device SANA. SANA will be used twice daily as an adjunct to standard of care (SOC) within 4-time assessments compared to SOC. Participants will be randomized into a SOC or SOC+Sana group. Participants in the SOC+SANA arm will be expected to use the SANA device twice daily for 22 minutes per session, with one session just prior to bedtime, from day 1 through day 28 of the T1a period. Both arms of will be expected to wear the Emaptica device 22 hours per day from day 1 through day 28 of the T1a period. Participants will complete measures at Baseline/T1, 28days/T1a (immediately post-device use), 3months/T2 (2-months post-device use or 3-months post baseline), and 6months/T3 (5-months post device-use or 6-months post baseline).

Conditions

• Adjustment Disorders

Interventions

Type	Name	Description
DEVICE	SANA	SANA is an audio-visual stimulation device found to reduce symptoms commonly found in AjDs. SANA is an eye mask that delivers coordinated pulses of light and sound that facilitate relaxation in the wearer. The device's mechanism of action is neuromodulation through audiovisual stimulation (AVS). When the brain receives a stimulus through the eyes or ears, it emits a responsive electrical charge, called a Cortical Evoked Response (CER). The brain responds by synchronizing to it, a process known as Frequency Following Response (FFR). FFR can be used to trigger each electrical pattern to facilitate a state of relaxation. The Sana device utilizes AVS to induce FFR.

Timeline

• Start date: 2025-10-06
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-03-20
• Last updated: 2025-11-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study