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

NCT06885554 | Recruiting FDA Device

• 2 other identifiers: USUHS.2024-132MO240171
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Adjustment Disorders

Keywords

Adjustment Disorders; Military

Outcome Measures

Primary Outcomes (4)

• Adjustment Disorder-New Module 20 for Military (ADNM-20-Mil)

  The ADNM-20-Mil assesses symptoms of AjDs. It consists of two parts: The first part lists a number of stressful life events from which the participant identifies the most distressing event, and the second part lists 20 symptoms that are grouped into six subscales. Each item is rated on a 4-point Likert type scale that rates symptom frequency ranging from 1 (never) to 4 (often) with higher scores indicating worst severity of symptoms. The ADNM-20-mil will be collected via self-report.

  Baseline/T1, 28days/T1a, 3months/T2, 6months/T3

• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

  The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a structured interview that assesses the severity of PTSD symptoms. The CAPS-5 will be administered to participants via a member of the CAPS-5 study team. This is not a scaled measure as it is a clinical interview.

  Baseline/T1, 3months/T2, 6months/T3

• PTSD Checklist for DSM-5 (PCL-5)

  The PCL-5 is a standard 20-item assessment that will be used to assess the presence and severity of PTSD symptoms. Items on the PCL-5 correspond with the DSM-5 criteria for PTSD. Items are rated on a 5-point scale and responses range from 0 (not at all) to 4 (extremely). A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. DSM-5 symptom cluster severity scores can be obtained by summing the scores for the items within a given cluster. The PCL-5 will be collected via self-report.

  Baseline/T1, 28days/T1a, 3months/T2, 6months/T3

• Adjustment Disorder Diagnosis

  License healthcare provider diagnosis of adjustment disorder from medical record assessed as the presence or absence of the affiliated ICD-10 or DSM-5 diagnostic code in the medical record. This will be collected retrospectively.

  Baseline/T1, 28days/T1a, 3months/T2, 6months/T3

Secondary Outcomes (5)

• General Well-Being Schedule (GWB)

  Baseline/T1, 28days/T1a, 3months/T2, 6months/T3

• Depression Anxiety Stress Scales 21 (DASS-21)

  Baseline/T1, 28days/T1a, 3months/T2, 6months/T3

• Clinical Global Impression (CGI)

  Baseline/T1, 3months/T2, 6months/T3

• Generalized Anxiety Disorder-7 items (GAD-7)

  Baseline/T1, 28days/T1a, 3months/T2, 6months/T3

• Patient Health Questionnaire-9 items (PHQ-9)

  Baseline/T1, 28days/T1a, 3months/T2, 6months/T3

Study Arms (2)

SANA + Standard of Care (SOC)

EXPERIMENTAL

Participants will be asked to use the SANA device and the Empatica monitoring bracelet for 28 days

Device: SANA

Standard of Care (SOC)

NO INTERVENTION

Participants will be asked to use the Empatica monitoring bracelet for 28 days

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.

SANA + Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (3)

Navy Medicine Readiness and Training Command San Diego

San Diego, California, 92134, United States

RECRUITING

Wright Patterson Air Force Base

Wright-Patterson Air Force Base, Ohio, 45433, United States

RECRUITING

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

RECRUITING

MeSH Terms

Conditions

Adjustment Disorders

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Jouhayna Bajjani-Gebara, PhD

CONTACT

301-295-1116; jouhayna.bajjani-gebara@usuhs.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment Randomized controlled trial

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-10

Locations

US (3)