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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
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.
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.
Kyung Hee University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Severance Hospital
Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, South Korea
Wonju Severance Christian Hospital
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.
Time frame: baseline, 6 weeks
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.
Time frame: 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.
Time frame: 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.
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Wŏnju, South Korea
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 weeks