An interventional study of SANA in Adjustment Disorders, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine · Not applicable, Interventional, and Treatment
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.
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).
63 studies on the registry are indexed under Adjustment Disorders; 13 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 52 interventional studies indexed under Adjustment Disorders.
Browse Adjustment Disorders studies →Henry M. Jackson Foundation for the Advancement of Military Medicine is the lead sponsor of 86 studies on the registry; 18 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be asked to use the SANA device and the Empatica monitoring bracelet for 28 days
Device: SANA
Participants will be asked to use the Empatica monitoring bracelet for 28 days
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3
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.
Time frame: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3
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.
Time frame: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3
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.
Time frame: Baseline/T1, 3months/T2, 6months/T3
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.
Time frame: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3
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.
Time frame: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3
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Henry M. Jackson Foundation for the Advancement of Military Medicine