Diagnostic Tool for Adjustment Disorder

Recruiting at 2 trial locations

Overseen By Jouhayna Bajjani-Gebara, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Must be taking: Psychotropic drugs

Disqualifiers: Epilepsy, Migraine, Tinnitus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new tool, the ADNM-20-Mil, developed to better diagnose adjustment disorders (AjDs) in active-duty U.S. military members. The study will also pilot a device named SANA, which uses audio-visual stimulation to potentially assist those with AjDs. Participants will be divided into two groups: one using SANA along with standard care, and the other receiving only standard care. Individuals diagnosed with an adjustment disorder in the last three months and currently receiving treatment through the Military Health System might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future diagnostic and treatment options.

Will I have to stop taking my current medications?

You don't have to stop taking your current medications, but any psychotropic medication (drugs affecting mood, perception, or behavior) must be stable for at least 4 weeks before joining the study and remain unchanged during the study.

What prior data suggests that the SANA device is safe for use in treating adjustment disorders?

Studies have shown that the SANA device is safe for humans. For example, research on individuals with PTSD, a stress-related mental health condition, found that those using the SANA device experienced fewer symptoms and felt better compared to those who did not use it. This suggests the device is not only effective but also easy to use without issues. No major safety concerns were reported.

While specific data on using SANA for adjustment disorders is not yet available, the positive results from PTSD studies provide some confidence in its safety. As this trial is in the early stages, the device continues to be tested for safety and effectiveness. However, the absence of serious side effects so far is encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new diagnostic tool for adjustment disorder using the SANA device. Unlike traditional methods that rely heavily on subjective assessments, this approach incorporates wearable technology to provide more objective, continuous monitoring of physiological data. The SANA device, in combination with the Empatica monitoring bracelet, offers a unique way to gather real-time insights into a patient's condition over 28 days. This could lead to more accurate diagnoses and personalized treatment plans, potentially transforming how adjustment disorder is managed.

What evidence suggests that the SANA device is effective for adjustment disorders?

Research shows that the SANA device, which participants in this trial may receive alongside standard care, may improve symptoms of stress-related conditions. Studies have found it can lessen symptoms of PTSD (post-traumatic stress disorder), anxiety, and depression when used with regular treatments. Early results also suggest it can enhance sleep and overall quality of life. While researchers have primarily tested the SANA device for PTSD, they are also exploring its potential to help with adjustment disorders (AjDs). These findings suggest that SANA could be a useful tool for managing stress-related mental health issues. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for US military members who may be experiencing adjustment disorders (AjDs), which are mental health issues that arise after stressful events and can hinder military readiness. Participants should not have other well-defined mental health disorders that could complicate the diagnosis of AjDs.

Inclusion Criteria

Willing and available to participate in all study activities if eligible and enrolled

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

Exclusion Criteria

Unwilling to use an effective method of contraception during the use of SANA device

I am experiencing severe pain from my cancer or injury.

Vision impairments that affect perception of light, color, or brightness in one or both eyes, and differences in visual perception between eyes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments and are randomized into study arms

1 week

1 visit (in-person)

Treatment

Participants use the SANA device and Empatica monitoring bracelet for 28 days

4 weeks

Daily device use

Post-Treatment Assessment

Participants complete assessments immediately after the treatment period

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 months

Assessments at 3 and 6 months post-baseline

What Are the Treatments Tested in This Trial?

Interventions

• SANA

Trial Overview The study aims to validate a diagnostic tool specifically for AjDs in the military, called ADNM-20-Mil. It also tests an audio-visual stimulation device named SANA as a potential treatment for AjD within this population over time.

How Is the Trial Designed?

Group I: SANA + Standard of Care (SOC) Experimental Treatment 1 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 Control 1 Intervention

Participants will be asked to use the Empatica monitoring bracelet for 28 days

Who Is Running the Clinical Trial?

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

Trials

103

Recruited

94,300+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

Citations

1. mtec-sc.org mtec-sc.org/technology-showcase/sana-health-publishes-first-peer-reviewed-article-exploring-the-effectiveness-of-sana-device-in-managing-ptsd-in-mtec-momrp-va-study

Sana Health publishes first peer-reviewed article exploring ... Researchers found that combining the Sana Device with standard PTSD treatments significantly improved symptoms, anxiety, depression, and quality ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05319405

Effectiveness of Sana Treatment in Post-Traumatic Stress ... This is a study designed to assess the effectiveness of the Sana Device when added to Treatment as Usual in participants with a diagnosis of post-traumatic ...

3. scitechnol.com scitechnol.com/peer-review/a-pilot-investigation-of-the-effectiveness-of-the-sana-device-in-management-of-ptsd-a-blinded-randomized-controlled-trial-LMUF.php?article_id=26757

A Pilot Investigation of the Effectiveness of the Sana Device ... Conclusion: The Sana Device + TAU was more effective than best practices TAU alone for improving PTSD symptoms, anxiety, depression, and quality of life for ...

4. sana.io sana.io/clinical

Clinical Preliminary results indicate that the device may help reduce PTSD symptoms, improve sleep quality, and lower anxiety levels. The findings support further ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/54/NCT06885554/ICF_000.pdf

Adjustment Disorders in the US Military The purpose of this research study is to develop a screening tool for adjustment disorder in military personnel and test the effectiveness of the Sana light ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06885554?term=William+Oh

Study Details | NCT06885554 | Adjustment Disorders in the ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10690536/

Assessing the Efficacy and Safety of a Digital Therapeutic ... Conclusions. We hypothesize that the results of this trial will support the efficacy and safety of SparkRx in attenuating symptoms of depression ...

8. withpower.com withpower.com/trial/diagnostic-tool-for-adjustment-disorder-538e3

Diagnostic Tool for Adjustment Disorder What data supports the effectiveness of the treatment SANA for adjustment disorder? The ZIEL study showed that an online self-help treatment for adjustment ...

9. sana.io sana.io/news/ptsd-publication

Journal of Traumatic Stress Disorders & Treatment ... In a blinded randomized controlled trial, participants using the Sana device showed significant improvement compared to the control group. Key ...