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Adjustment DisordersNCT06885554

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

A study testing SANA in people with Adjustment Disorders, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Adjustment Disorders
What is being tested?
SANA
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesUnited States
Study dates
6 Oct 2025to 1 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jouhayna Bajjani-Gebara, PhD contact

301-295-1116

jouhayna.bajjani-gebara@usuhs.edu

United States3 sites, 3 recruiting
  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

    MAJ Elizabeth Johnson, PsyD, 210-510-9357, elizabeth.h.johnson30.mil@health.mil

    Recruiting
  • Navy Medicine Readiness and Training Command San Diego

    San Diego, California, 92134

    LTC Nathan Hydes, PhD, 619-532-8551, nathaniel.r.hydes.mil@health.mil

    Recruiting
  • Wright Patterson Air Force Base

    Wright-Patterson Air Force Base, Ohio, 45433

    MAJ Melissa Anderson, DNP, PMHNP-BC, PMH-C, 937-257-6877, melissa.g.anderson10.mil@health.mil

    Recruiting

Other trials in United States

About this study

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.

Read the 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).

Being tested
SANA
Keywords
Adjustment Disorders, Military
Medical subject headings
Adjustment Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SANADevice

    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 groups in NCT06885554
Study groupRoleWhat they receive
SANA + Standard of Care (SOC)ExperimentalParticipants will be asked to use the SANA device and the Empatica monitoring bracelet for 28 days
Receives: Device: SANA
Standard of Care (SOC)No interventionParticipants will be asked to use the Empatica monitoring bracelet for 28 days

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Secondary outcomes (5)
  1. General Well-Being Schedule (GWB)

    The GWB is a standard assessment that will be used to measure participants' selfreported positive well-being. The GWB consists of 18 items that are further organized into 6 domains. Out of 18 items, 14 use a 6-point Likert-type scale and represent either intensity or frequency. The four remaining items use a 0-to-10-point rating scale that has opposing adjectives at each end. The total possible scores on the GWB can range from 0 to 110, with higher scores indicating positive well-being. GWB scores can indicate three levels of well-being: score ranges from 0 to 60 indicate "severe distress", score ranges from 61 to 72 indicate "moderate distress", and score ranges from 73 to 110 indicate "positive well-being". The GWB will be collected via self-report.

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

  2. Depression Anxiety Stress Scales 21 (DASS-21)

    The DASS-21 is a standard assessment that will be used to measure participants' selfreported levels of depression, anxiety, and stress. The DASS-21 consists of 21 items and three scales: Depression, Anxiety, and Stress. Each scale has 7 items each rated on a 4-point Likerttype scale ranging from 0 (never) to 3 (almost always) with higher scores indicating greater severity. The DASS-21 will be collected via self-report.

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

  3. Clinical Global Impression (CGI)

    The CGI scale is a standard, well-validated measure that provides a clinician's view of the global assessment of how ill their patient is. It consists of 2 items: the CGI-Severity (CGI-S) which measures the severity of the patient's illness on a 7-point rating scale (ranging from normal to very severely ill) and the CGI-Improvement (CGI-I) which measures the patient's overall improvement from baseline also on a 7-point rating scale (ranging from very much worse to very much improved). The higher the scores indicate overall betterment in illness and improvement from baseline. The CGI will be administered to participants via a member of the study team.

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

  4. Generalized Anxiety Disorder-7 items (GAD-7)

    The GAD-7 is a standard assessment of anxiety and will be used to measure anxiety severity and identify participants with a probable actual diagnosis of generalized anxiety disorder. The GAD-7 is a standard clinical measure that is given to MHS patients by their behavioral health provider to complete at every visit. The GAD-7 consists of 7 items with scores that range from 0 to 4 and total score ranging between 0 and 21. The GAD-7 cutoff of >=10 indicates a probable GAD diagnosis. The GAD-7 will be collected retrospectively.

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

  5. Patient Health Questionnaire-9 items (PHQ-9)

    The PHQ-9 is a standard assessment that will be used to measure depression severity and identify participants with a probable actual diagnosis of major depression. The PHQ-9 is a standard clinical measure that is given to MHS patients by their behavioral health provider to complete at every visit. The PHQ-9 has a cutoff of >=10 for probable depression and its scores can range from 0-27, with higher scores indicating worse depression severity. The PHQ-9 will be collected retrospectively.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study start6 Oct 2025
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment Randomized controlled trial
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06885554
Sponsor's protocol ID
USUHS.2024-132
Other IDs
MO240171
Status last verified
Jul 2026
First submitted
13 Mar 2025
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing SANA in people with Adjustment Disorders, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jouhayna Bajjani-Gebara, PhD (301-295-1116, jouhayna.bajjani-gebara@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjustment Disorder-New Module 20 for Military (ADNM-20-Mil) (time frame: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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