Skip to main content
OpenTrials
Completed

NCT Number: NCT06734858

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post-traumatic Stress Disorder Adjustment Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyung Hee University Hospital, Seoul, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAT014

Device

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.

Control

Other

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.

Primary outcomes

  1. Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score

    Time frame: baseline, 6 weeks

    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.

Secondary outcomes

  1. Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score

    Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks

    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.

  2. Change in Beck Anxiety Inventory (BAI) score

    Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks

    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.

  3. Change in (Patient Health Questionnaire-9 (PHQ-9) score

    Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks

    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.

  4. Change in Hamilton Anxiety Scale (HAM-A) score

    Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks

    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.

  5. Change in Clinical Global Impression-Severity (CGI-S) score

    Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks

    The CGI-S scale ranges from 1 to 7, with each score representing a different level of illness. Higher scores reflect more serious illness.

  6. Clinical Global Impression-Improvement (CGI-I) score

    Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks

    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.

  7. Change in Impact of Event Scale - Revised (IES-R) score

    Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks

    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.

  8. Percentage of participants with a ≥10 point reduction in PTSD Checklist for DSM-5 (PCL-5) score

    Time frame: Baseline, 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

S-Alpha Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2024
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.