Evaluating a digital therapy for PTSD and adjustment disorders
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
This study is testing a new digital therapy to see if it can help people aged 19 and older with PTSD and adjustment disorders feel better compared to standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | S-Alpha Therapeutics, Inc. Industry-sponsored |
| Locations | 5 sites (Seoul and 4 other locations) |
| Trial ID | NCT06734858 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy of SAT-014, a software as a medical device, in reducing symptoms of trauma and stressor-related disorders such as PTSD and adjustment disorder. The study compares SAT-014 to standard treatment methods and evaluates its safety for regulatory approval. Participants aged 19 and older will be monitored over a period of time, with primary and secondary endpoints focusing on various psychological assessment scores. The trial seeks to provide a more accessible and cost-effective therapeutic option for individuals suffering from these conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older diagnosed with PTSD or adjustment disorder.
Not a fit: Patients with severe mental health conditions such as schizophrenia, bipolar disorder, or severe personality disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a novel digital therapeutic option for patients with PTSD and adjustment disorders, potentially improving their quality of life.
How similar studies have performed: Previous studies have shown promise in digital therapeutics for mental health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul and 4 other locations
- Kyung Hee University Hospital — Seoul, Korea, Republic of (Recruiting)
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
- Severance Hospital — Seoul, Korea, Republic of (Recruiting)
- SMG-SNU Boramae Medical Center — Seoul, Korea, Republic of (Recruiting)
- Wonju Severance Christian Hospital — Wonju, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Hong, MD — Samsumg Medical Center
- Study coordinator: J Lee, MSc
- Email: sophie@salphadtx.com
- Phone: 82-2-3487-3923
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.