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

San Diego, CA
N/A
Waitlist Available
Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Age 18-64
* Serving as active duty in the US Military
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline/t1, 3months/t2, 6months/t3
Awards & highlights
No Placebo-Only Group

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.

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Eligible Conditions
  • Application Site Reaction
  • Adjustment Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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* Age 18-64
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* Serving as active duty in the US Military
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* Diagnosed with adjustment disorder (with or without depression and/or anxiety) within the last 3 months
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* No other mental health diagnosis (e.g., schizophrenia spectrum and other psychotic disorders, substance use disorder, bipolar and related disorders, TBI)
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* No current thoughts of or serious risk of suicide
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* 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
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* Any psychotropic drug therapy regimen must be stable (unchanging) for at least 4 weeks prior to enrollment and remain steady throughout the study
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* Must have and be willing to use an internet-enabled smartphone or tablet for the study
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* Provision of appropriate storage and charging for study equipment in a generally safe and dry condition
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* In treatment through the Military Health System for adjustment disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline/t1, 3months/t2, 6months/t3
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline/t1, 3months/t2, 6months/t3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adjustment Disorder Diagnosis
Adjustment Disorder-New Module 20 for Military (ADNM-20-Mil)
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
+1 more
Secondary study objectives
Clinical Global Impression (CGI)
Depression Anxiety Stress Scales 21 (DASS-21)
General Well-Being Schedule (GWB)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SANA + Standard of Care (SOC)Experimental Treatment1 Intervention
Participants will be asked to use the SANA device and the Empatica monitoring bracelet for 28 days
Group II: Standard of Care (SOC)Active Control1 Intervention
Participants will be asked to use the Empatica monitoring bracelet for 28 days

Find a Location

Closest Location:Navy Medicine Readiness and Training Command San Diego· San Diego, CA

Who is running the clinical trial?

Henry M. Jackson Foundation for the Advancement of Military MedicineLead Sponsor
102 Previous Clinical Trials
94,248 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
128 Previous Clinical Trials
90,966 Total Patients Enrolled
~40 spots leftby Jan 2028