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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 5
- 主要终点
- Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score
时间窗: 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.
次要结局
- Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score(Baseline, 2 weeks, 4 weeks, 6 weeks)
- Change in Beck Anxiety Inventory (BAI) score(Baseline, 2 weeks, 4 weeks, 6 weeks)
- Change in (Patient Health Questionnaire-9 (PHQ-9) score(Baseline, 2 weeks, 4 weeks, 6 weeks)
- Change in Hamilton Anxiety Scale (HAM-A) score(Baseline, 2 weeks, 4 weeks, 6 weeks)
- Change in Clinical Global Impression-Severity (CGI-S) score(Baseline, 2 weeks, 4 weeks, 6 weeks)
- Clinical Global Impression-Improvement (CGI-I) score(Baseline, 2 weeks, 4 weeks, 6 weeks)
- Change in Impact of Event Scale - Revised (IES-R) score(Baseline, 2 weeks, 4 weeks, 6 weeks)
- Percentage of participants with a ≥10 point reduction in PTSD Checklist for DSM-5 (PCL-5) score(Baseline, 6 weeks)