Adjustment disorder patterns and validation of the ADNM-20 for U.S. military members

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, two-arm longitudinal pilot assigns active-duty service members with recent adjustment disorder to receive standard of care (SOC) alone or SOC plus the SANA audio-visual device. The SANA arm uses the device twice daily for 22 minutes over 28 days while all participants wear an Emapatica monitor and complete measures at baseline, 28 days, 3 months, and 6 months. The primary aims are to test the ADNM-20-mil's sensitivity to change and to pilot the feasibility and preliminary efficacy of SANA as an adjunct to usual care. Outcomes include symptom change on the ADNM-20-mil, device adherence, and safety/tolerability signals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Navy Medicine Readiness and Training Command San Diego
  San Diego, California, United States Recruiting
• Wright Patterson Air Force Base
  Wright-Patterson Air Force Base, Ohio, United States Recruiting
• Brooke Army Medical Center
  Fort Sam Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Jouhayna Bajjani-Gebara, PhD
• Email: jouhayna.bajjani-gebara@usuhs.edu
• Phone: 301-295-1116

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating Ranquilon for Anxiety Disorders Related to Neurasthenia and Adaptation Issues

  This study is testing if a new medication called Ranquilon can help people with anxiety related to neurasthenia and adaptation issues feel better compared to another medication called Afobazole.

  Recruiting at 6 sites Phase 4 Valenta Pharm JSC · Engel's and 5 other locations · NCT06843044

• Comparing Transdiagnostic Behavior Therapy to Standard Treatment for Adjustment Disorder in Veterans

  This study is testing whether a new type of therapy called Transdiagnostic Behavior Therapy can help veterans with Adjustment Disorder feel better compared to standard problem-solving therapy.

  Recruiting The University of Texas Health Science Center, Houston · Charleston, South Carolina · NCT06433271

• MDMA-assisted therapy for cancer patients with adjustment disorder and their partners

  This study is testing whether MDMA-assisted therapy can help cancer patients and their partners cope better with adjustment disorder.

  Recruiting Phase 2 Sunstone Medical · Rockville, Maryland · NCT05584826

• Evaluating the impact of self-help CBT in primary care behavioral health

  This study is testing if adding guided self-help therapy to regular mental health care can help patients feel better and improve their daily lives.

  Recruiting at 2 sites Linnaeus University · Varberg, Halland County and 3 other locations · NCT04900064

• Health and Work Ability After Inpatient Treatment for Stress-Related Disorders: Follow-Up of the HARMODI Cohort

  This study follows people who had inpatient treatment for stress-related disorders to see how their health and ability to work change over the next three years and what factors help them return to work.

  Recruiting Clinica Holistica Engiadina · Süs and 1 other locations · NCT07757997

• Virtual reality to reduce psychological symptom burden during cancer treatment

  This trial will try virtual reality sessions to reduce anxiety, depression, and adjustment symptoms for adults receiving cancer treatment.

  Recruiting Mayo Clinic · Jacksonville, Florida · NCT07221409

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.