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

Trial Summary

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 data supports the effectiveness of the treatment SANA for adjustment disorder?

The ZIEL study showed that an online self-help treatment for adjustment disorder helped reduce depressive symptoms and improve quality of life, suggesting that similar treatments like SANA might also be effective. ^{1 2 3 4 5}

How is this treatment for adjustment disorder different from other treatments?

This treatment is unique because it involves a diagnostic tool that is still being validated to assist with diagnosing adjustment disorder, which is not commonly available with other treatments. Unlike other conditions, adjustment disorder lacks robust studies demonstrating benefits from antidepressants, and treatments mainly consist of brief interventions and symptomatic management of anxiety or insomnia. ^{3 5 6 7 8}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

ZIEL: Internet-Based Self-Help for Adjustment Problems: Results of a Randomized Controlled Trial. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Association of Early Treatment With Chronicity and Hazard of Hospitalization After New Adjustment Disorder. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Adjustment disorder: A diagnosis whose time has come. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Psychotherapy of adjustment disorders: Current state and future directions. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

A controlled prospective study of DSM-III adjustment disorder in childhood. Short-term prognosis and long-term predictive validity. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Adjustment Disorder: Diagnosis and Treatment in Primary Care. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Psychometric and factorial validity of the International Adjustment Disorder Questionnaire (IADQ) in an Italian sample: A validation and prevalence estimate study. [2023]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Adjustment disorder: epidemiology, diagnosis and treatment. [2021]