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

Conditions

• Adjustment Disorders

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Not accepted

Interventions

• SANA — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Oct 6, 2025

Status verified

Oct 2025

Primary completion

Jan 1, 2028

Completion

Jan 1, 2028

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: SANA + Standard of Care (SOC)
  Participants will be asked to use the SANA device and the Empatica monitoring bracelet for 28 days
• No Intervention: Standard of Care (SOC)
  Participants will be asked to use the Empatica monitoring bracelet for 28 days

Primary Outcome Measure

Adjustment Disorder-New Module 20 for Military (ADNM-20-Mil) [ Time Frame: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3 ]

Central Contacts

• Jouhayna Bajjani-Gebara, PhD
  301-295-1116
  [email protected]

Locations (3)

Find similar trials in San Diego, CA

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