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

Обзор

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.

Подробное описание

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).

Вмешательства

• Устройство SANA
  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 a

Первичные конечные точки

• Adjustment Disorder-New Module 20 for Military (ADNM-20-Mil) [Срок оценки: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3]
• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [Срок оценки: Baseline/T1, 3months/T2, 6months/T3]
• PTSD Checklist for DSM-5 (PCL-5) [Срок оценки: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3]
• Adjustment Disorder Diagnosis [Срок оценки: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3]

Вторичные конечные точки (5)

• General Well-Being Schedule (GWB) [Срок оценки: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3]
• Depression Anxiety Stress Scales 21 (DASS-21) [Срок оценки: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3]
• Clinical Global Impression (CGI) [Срок оценки: Baseline/T1, 3months/T2, 6months/T3]
• Generalized Anxiety Disorder-7 items (GAD-7) [Срок оценки: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3]
• Patient Health Questionnaire-9 items (PHQ-9) [Срок оценки: Baseline/T1, 28days/T1a, 3months/T2, 6months/T3]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Navy Medicine Readiness and Training Command San Diego — San Diego
• Wright Patterson Air Force Base — Wright-Patterson Air Force Base
• Brooke Army Medical Center — Fort Sam Houston

Идентификаторы

NCT: NCT06885554 · USUHS.2024-132 · MO240171

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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