Pivotal Trial of SAT-014 for Trauma and Stressor-Related Disorder Symptoms

A Multicenter, Randomized, Open-label, Controlled, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of Software SAT-014 for the Alleviation of Symptoms Related to Trauma and Stressor-related Disorders

The aim of this study is to evaluate the efficacy of SAt-014, a software as a medical device (SaMD), in alleviating symptoms of trauma and stressor-related disorders in patients with post-traumatic stress disorder (PTSD) or adjustment disorder (AD), compared to standard treatment, and to assess its safety for regulatory approval by the Ministry of Food and Drug Safety (MFDS).

Study Overview

• Status: Completed
• Conditions: Post-traumatic Stress Disorder; Adjustment Disorders
• Intervention / Treatment: Device: SAT014; Other: Control

Detailed Description

Stress-related mental disorders, including Post-Traumatic Stress Disorder (PTSD) and Adjustment Disorder (AD), are caused by traumatic experiences or significant stressors. These conditions can lead to social dysfunction, decreased quality of life, and increased suicide risk if untreated. With high global prevalence and rising patient numbers, existing treatments such as psychotherapy and pharmacotherapy have limitations. Digital therapeutics (DTx) offer a more accessible, cost-effective solution with less external exposure. Based on studies showing the effectiveness of therapies like EMDR and MBCT, SAT-014, a cognitive therapy software, was developed. An exploratory clinical trial was conducted to assess its initial safety and efficacy for alleviating symptoms of PTSD and AD. This trial, involving 110 participants over 19 years old, aims to evaluate SAT-014's efficacy in comparison with conventional treatments and assess its safety. The primary efficacy endpoint is the change in PCL-5 score at Week 6 (Visit 7) compared to baseline, while secondary endpoints include changes in PCL-5, IES-R, BAI, PHQ-9, HAM-A, CGI, and SF-12 scores at various time points.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • SMG-SNU Boramae Medical Center
  • Seoul, Korea, Republic of
    • Kyung Hee University Hospital
  • Wonju, Korea, Republic of
    • WonJu Severance Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 19 years or older
• Diagnosed with Post-Traumatic Stress Disorder (PTSD) or Adjustment Disorder (AD) according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
• A score of 3 to 4 on the Clinical Global Impression-Severity (CGI-S) scale
• Able to access the internet and respond to app activity instructions
• Voluntarily decided to participate in this clinical trial and provided written consent by signing the participant information sheet and consent form

Exclusion Criteria:

• Those diagnosed with schizophrenia, bipolar disorder type 1, or psychotic disorders
• Those diagnosed with neurodevelopmental disorders, neurocognitive disorders, or organic mental disorders
• Those with severe depression (Patient Health Questionnaire-9 (PHQ-9) ≥ 20)
• Those with severe personality disorders
• Those diagnosed with substance use disorders (excluding nicotine and caffeine) or severe alcohol use disordes
• Those exhibiting active suicidal tendencies (suicidal thoughts, suicide attempts, or suicidal behavior)
• Those who have had a change in the type, dosage, or regimen of anxiolytics or antidepressants within 4 weeks of baseline
• Those currently participating in another clinical trial or who have participated in a clinical trial within 90 days prior to the screening visit
• Those deemed unsuitable for participation in the trial at the discretion of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAT014 study group; SAT-0014 + Conventional treatment* *Conventional treatment: Pharmacological treatment received at baseline for the indication or simple counseling (excluding cognitive behavioral therapy and psychoanalytic counseling therapy)	Device: SAT014; SAT-014 in Combination with Baseline Conventional Treatment Participants in this arm will use the SAT-014 application for 6 weeks in combination with their baseline conventional treatment, which may include pharmacological therapy or simple counseling (excluding cognitive behavioral therapy and psychoanalytic counseling therapy). The aim of this study is to assess the efficacy and safety of SAT-014 for alleviating symptoms of trauma and stressor-related disorders, such as PTSD and adjustment disorder.
Other: Control group; Conventional treatment* *Conventional treatment: Pharmacological treatment received at baseline for the indication or simple counseling (excluding cognitive behavioral therapy and psychoanalytic counseling therapy)	Other: Control; Baseline Conventional Treatment Participants in this arm will receive only conventional treatment, which includes the medication they were taking at baseline for the indication or the basic counseling therapy they were receiving at baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score	The PTSD Checklist for DSM-5 (PCL-5) consist of 20 items, with a scale ranging from 0 to 4. Each item evaluates the frequency or intensity of specific symptoms over the past month. The scores are summed to produce a total severity score that ranges from 0 (minimum score) to 80 (maximum score). A higher scores indicate greater distress due to symptoms to past stressful experiences and a worse outcome.	baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score	PCL-5 consists of 20 items, with a scale ranging from 0 to 4. The scores range from 0 to 80, with higher scores indicating greater frequency and severity of PTSD symptoms.	Baseline, 2 weeks, 4 weeks, 6 weeks
Change in Beck Anxiety Inventory (BAI) score	The Beck Anxiety Inventory (BAI) consists of 21 items, each assessing the intensity of anxiety symptoms experienced over the past week. Each item is rated on a 4-point scale, ranging from 0 (not at all) to 3 (severely-I could barely stand it). The total score can range from 0 to 63. Scores between 0 and 7 indicate minimal anxiety, while scores from 8 to 15 reflect mild anxiety. A score between 16 and 25 suggests moderate anxiety, and scores from 26 to 63 indicate severe anxiety. A higher score correlates with more severe anxiety.	Baseline, 2 weeks, 4 weeks, 6 weeks
Change in (Patient Health Questionnaire-9 (PHQ-9) score	Change in PHQ-9 (Patient Health Questionnaire-9) score at each time point compared to baseline. The PHQ-9 (Patient Health Questionnaire-9) consists of 9 questions. Each question is scored on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day), resulting in a total score ranging from 0 to 27. The PHQ-9 score quantitatively reflects the severity of depressive symptoms, with higher scores indicating more severe depression.	Baseline, 2 weeks, 4 weeks, 6 weeks
Change in Hamilton Anxiety Scale (HAM-A) score	The HAM-A (Hamilton Anxiety Rating Scale) consists of 14 items, with each item scored on a scale from 0 (not present) to 4 (extremely severe). The total score can range from 0 to 56. The HAM-A score reflects the severity of a patient's anxiety symptoms, with higher scores indicating more severe anxiety.	Baseline, 2 weeks, 4 weeks, 6 weeks
Change in Clinical Global Impression-Severity (CGI-S) score	The CGI-S scale ranges from 1 to 7, with each score representing a different level of illness. Higher scores reflect more serious illness.	Baseline, 2 weeks, 4 weeks, 6 weeks
Clinical Global Impression-Improvement (CGI-I) score	The CGI-I scale uses a 7-point rating system to assess improvement in a patient's condition. The CGI-I score ranges from 1 point (very much improved) to 7 points (very much worse). A higher score indicates that the symptoms have worsened.	Baseline, 2 weeks, 4 weeks, 6 weeks
Change in Impact of Event Scale - Revised (IES-R) score	The Impact of Event Scale - Revised (IES-R) consists of 22 items, with each item rated on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The total score can range from 0 to 88. The IES-R total score reflects the severity of PTSD symptoms, with higher scores indicating a greater level of psychological distress and more intense post-traumatic stress responses.	Baseline, 2 weeks, 4 weeks, 6 weeks
Percentage of participants with a ≥10 point reduction in PTSD Checklist for DSM-5 (PCL-5) score	The percentage of participants showing a greater than or equal to a 10-point reduction in their PTSD Checklist for DSM-5 (PCL-5) score will be measured at Week 6 (Visit 7) compared to baseline. PCL-5 consists of 20 items, each rated on a scale from 0 to 4. The total score ranges from 0 to 80, with higher scores indicating a worse outcome.	Baseline, 6 weeks

Collaborators and Investigators

• Sponsor: S-Alpha Therapeutics, Inc.
• Investigators: Principal Investigator: Hong, MD, Samsumg Medical Center; Principal Investigator: Kang, MD, Severance Hospital; Principal Investigator: Seo, MD, WonJu Severance Christian Hospital; Principal Investigator: Lee, MD, Kyung Hee University Hospital; Principal Investigator: Yoo, MD, SMG-SNU Boramae Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2024
• Primary Completion (Actual): May 29, 2025
• Study Completion (Actual): May 29, 2025

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 2, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: post-traumatic stress disorder (PTSD); SaMD; adjustment disorder (AD)
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Adjustment Disorders
• Other Study ID Numbers: SAT014-KP-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No