The purpose of this study is to assess the effectiveness of the Sana Device when added to Treatment as Usual in participants with a diagnosis of post-traumatic stress disorder (PTSD)
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 stress disorder (PTSD) on severity of symptoms as measured by CAPS-5. We will use a 2-arm repeated measures randomized controlled design in which participants will be randomly assigned to either Sana plus Treatment as Usual (Sana+TAU) or Treatment as Usual (TAU).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
46
Externally worn mask that physically contacts the skin of the face. The Sana Device delivers Audio Visual Stimulation (AVS) in the form of coordinated pulses of light (through closed eyelids) and sound at various frequencies.
Ralph H. Johnson Veteran Affairs Medical Center/Lowcountry Center for Veterans Research
Charleston, South Carolina, United States
To examine the difference between Sana plus Treatment as Usual (Sana+TAU) and Treatment as Usual (TAU) on changes in PTSD symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) after 28 days.
A 30-item structured interview that can be used to diagnosis and assess PTSD symptoms and severity.
Time frame: Baseline and Day 28
To examine the difference between Sana+TAU and TAU on changes in PTSD symptoms as measured by the PTSD Checklist - 20-item scale for DSM-5 (PCL-5) after 28 days.
A 20-item self-reported measure that assesses the 20 DSM-5 symptoms of PTSD.
Time frame: Baseline, Days 14 and 28
To examine the difference between Sana+TAU and TAU on anxiety symptoms as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7) after 28 days.
The GAD-7 is a self-reported questionnaire for screening and measuring severity of generalized anxiety disorder.
Time frame: Baseline, Days 14 and 28
To examine the difference between Sana+TAU and TAU on depression symptoms as measured by the Patient Health Questionnaire 9 (PHQ-9) after 28 days.
A self-reported questionnaire for screening and measuring severity of generalized anxiety disorder.
Time frame: Baseline, Days 14 and 28
To examine the difference between Sana+TAU compared to TAU on perceived change in quality of life over TAU as measured by the Patient Global Impression of Change scale (PGIC) after 28 days.
A validated tool for screening, diagnosing, monitoring and measuring depression severity and scores each of the 9 Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM-IV) related criteria.
Time frame: Baseline, Days 14 and 28
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