Evaluating the ADNM-20-Mil Tool and SANA Device for Treating Adjustment Disorders in Active US Military Adults Aged 18-64

What this Trial Is About

Adjustment disorders AjDs are common mental health diagnoses in the US military, characterized by difficulty adapting to stressors, which can impair function and readiness. Diagnosing AjDs is challenging due to overlaps with other disorders and unclear criteria. This research evaluates the Adjustment Disorder New Module for Military ADNM-20-Mil, a recently adapted diagnostic tool designed specifically for the military population. The study also pilots the use of the audio-visual stimulation device SANA to explore its potential as an adjunctive treatment. The trial randomly assigns participants to either standard care alone or standard care plus the SANA device, which delivers coordinated light and sound pulses to promote relaxation through neuromodulation. Those in the SANA group use the device twice daily for 22 minutes each session over 28 days while all participants wear the Empatica monitoring bracelet daily during this period. The study follows participants over multiple time points to assess changes in symptoms and device feasibility. Participants complete assessments at baseline, immediately after the 28-day device use, at 3 months, and at 6 months. These include diagnostic interviews, symptom scales, and well-being questionnaires to measure adjustment disorder symptoms, PTSD symptoms, anxiety, depression, and overall clinical impression. The study monitors participants adherence to device use and collects continuous physiological data from the bracelet. Total participation spans approximately 6 months, allowing evaluation of the ADNM-20-Mils sensitivity to change and the SANA devices impact in this context.

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