Post-traumatic Stress DisorderNCT06734858
Pivotal Trial of SAT-014 for Trauma and Stressor-Related Disorder Symptoms
A study testing SAT014 in people with Post-traumatic Stress Disorder and Adjustment Disorders, run by S-Alpha Therapeutics, Inc. at 5 sites in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Post-traumatic Stress Disorder, Adjustment Disorders
- What is being tested?
- SAT014
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 9 Dec 2024to 29 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Kyung Hee University Hospital
Seoul
Samsung Medical Center
Seoul
Severance Hospital
Seoul
SMG-SNU Boramae Medical Center
Seoul
Wonju Severance Christian Hospital
Wŏnju
About this study
Official 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
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).
Read the 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.
- Being tested
- SAT014, Control
- Keywords
- post-traumatic stress disorder (PTSD), adjustment disorder (AD), SaMD
- Medical subject headings
- Stress Disorders, Post-Traumatic, Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAT014Device
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SAT014 study group | Experimental | 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) Receives: Device: SAT014 |
| Control group | Other | Conventional treatment*
*Conventional treatment: Pharmacological treatment received at baseline for the indication or simple counseling (excluding cognitive behavioral therapy and psychoanalytic counseling therapy) Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start9 Dec 2024
- Primary completion29 May 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- S-Alpha Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong, MD, Principal investigator, Samsumg Medical CenterKang, MD, Principal investigator, Severance HospitalSeo, MD, Principal investigator, Wonju Severance Christian HospitalLee, MD, Principal investigator, Kyung Hee University HospitalYoo, MD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734858
- Sponsor's protocol ID
- SAT014-KP-002
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06734858
- Acronym / sponsor ID
- SAT014-KP-002
- Keywords
- post-traumatic stress disorder (PTSD), adjustment disorder (AD), SaMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- S-Alpha Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAT014 study group | Experimental | Device: SAT014SAT-0014 + Conventional treatment* *Conventional treatment: Pharmacological treatment received at baseline for the indication or simple counseling (excluding cognitive behavioral therapy and psychoanalytic counseling therapy) |
| Control group | Other | Other: ControlConventional treatment* *Conventional treatment: Pharmacological treatment received at baseline for the indication or simple counseling (excluding cognitive behavioral therapy and psychoanalytic counseling therapy) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAT014SAT-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. | Device | SAT014 study group |
| ControlBaseline 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. | Other | Control group |
Primary outcome
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.
8 secondary outcomes
Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks
Change in Beck Anxiety Inventory (BAI) score
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks
Change in (Patient Health Questionnaire-9 (PHQ-9) score
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks
Change in Hamilton Anxiety Scale (HAM-A) score
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks
Change in Clinical Global Impression-Severity (CGI-S) score
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks
Clinical Global Impression-Improvement (CGI-I) score
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks
Change in Impact of Event Scale - Revised (IES-R) score
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
Time frame: Baseline, 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Post-traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong, MD principal investigator
Samsumg Medical Center
Kang, MD principal investigator
Severance Hospital
Seo, MD principal investigator
Wonju Severance Christian Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAT014 in people with Post-traumatic Stress Disorder and Adjustment Disorders, run by S-Alpha Therapeutics, Inc. at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) score (time frame: baseline, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.