Posttraumatic Stress DisorderNCT06439407
Clinical Trial to Preliminarily Assess the Safety and Feasibility of SAT-014, a Software for Alleviating Symptoms of Trauma and Stress-related Disorders
A study testing SAT-014(Software as Medical Device) in people with Posttraumatic Stress Disorder, run by S-Alpha Therapeutics, Inc. at 1 site in South Korea.
Trial summary
Failure to adapt to stress leads to functional impairments in various areas, including social, occupational, educational, and other significant domains, necessitating therapeutic intervention. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- SAT-014(Software as Medical Device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jan 2024to 30 Aug 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (19 years and older)
- Have experienced clinically significant psychological trauma within the 6 months prior to screening visit
- Met the diagnostic criteria for Post-Traumatic Stress Disorder (PTSD) or Adjustment Disorder (AD) category as evaluated by MINI (Mini-International Neuropsychiatric Interview)
- Score between 17 and 38 points on the IES-R (Impact of Event Scale-Revised)
- Score of 4 or less on CGI (Clinical Global Impression)
- Capable of complying the activity instructions provided the app
Who cannot join
- Have been diagnosed with schizophrenia, bipolar disorder, and psychotic disorder
- Have been diagnosed with neurodevelopmental disorder, neurocognitive disorder, or organic mental disorder
- Severe depression (PHQ-9 score of 20 or greater)
- Comorbid with severe personality disorder
- Diagnosed with substance use disorder excluding nicotine and caffeine and with severe alcohol use disorder
- Have made a suicide attempt within 3 months and are judged to be at high risk for suicide by a psychiatrist
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- Pregnant or lactating
- Currently participating in another clinical trial or have participated in another trial within 90 days from screening
- Others deemed unsuitable for participation in this clinical trial at the discretion of the investigator due to ethical concerns or potential impact on the trial outcome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Controlled, Exploratory Clinical Trial to Preliminarily Assess the Safety and Feasibility of SAT-014, a Software for Alleviating Symptoms of Trauma and Stress-related Disorders
Failure to adapt to stress leads to functional impairments in various areas, including social, occupational, educational, and other significant domains, necessitating therapeutic intervention. Interventions through mobile app in the form of software can provide a new alternative for alleviating symptoms caused by psychological trauma by increasing accessibility to early intervention for trauma patients. This study aims to preliminarily assess the safety and feasibility of a psychological traum intervention by developing SAT-014 to help patients with trauma and stress-related disorder continue effective treatment in a stable environment.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- SAT-014(Software as Medical Device)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAT-014(Software as Medical Device)Device
SAT-014(Software as Medical Device) + maintain previous treatment
| Study group | Role | What they receive |
|---|---|---|
| SAT-014 | Experimental | Not described Receives: Device: SAT-014(Software as Medical Device) |
| Maintain previous treatment | Other | Not described Receives: Device: SAT-014(Software as Medical Device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IES-R (Impact Event Scale-Revised) score
The Korean version of the Impact Event Scale-Revised (IES-R) consists of 22 items each rated on a 5-point scale ranging from 0 to 4. The total score ranges from 0 to 88, with higher scores indicating a greater risk of post-traumatic stress disorder and a worse outcome.
Measured: Baseline, 3weeks, 6weeks, 10weeks
Change in PCL-5 (PTSD Checklist-5) score
The PTSD Checklist for DSM-5 (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 greater distress due to symptoms related to past stressful experiences and a worse outcome.
Measured: Baseline, 3weeks, 6weeks, 10weeks
Change in GAD-7 (Generalized Anxiety Disorder 7 item scale) score
The Generalized Anxiety Disorder 7-item scale (GAD-7) consists of 7 items, each rated on a scale from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms and a worse outcome.
Measured: Baseline, 3weeks, 6weeks, 10weeks
Change in BAI (Beck Anxiety Inventory) score
The Beck Anxiety Inventory (BAI) consists of 21 items, each rated on a scale from 0 to 3. The total score ranges from 0 to 63, with higher scores indicating more severe anxiety symptoms and a worse outcome.
Measured: Baseline, 3weeks, 6weeks, 10weeks
Change in PHQ-9 (Patient Health Questionnaire-9; depression screening tool) score
The Patient Health Questionnaire-9 (PHQ-9) consists of 9 items, each rated on a scale of 0 to 3. The total score ranges from 0 to 27, with higher scores indicating more severe symptoms and a worse outcome.
Measured: Baseline, 3weeks, 6weeks, 10weeks
Change in QIDS-SR (Quick Inventory of Depressive Symptomatology-Self Report) score
The Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) consist of 16 items, each rated on a scale of 0 to 3. It evaluates responses to 16 items based on criteria for nine depressive symptoms. The total score ranges from 0 to 27, with higher scores indicating more severe symptoms and a worse outcome.
Measured: Baseline, 3weeks, 6weeks, 10weeks
Change in CGI (Clinical Global Impression) score
The CGI consists of two items: (a) the clinician's overall impression of the patient's severity of illness and (b) global improvement over time. The severity of illness is rated on a scale from 1 to 7, with a higher score indicating more severe illness and a worse outcome. Global improvement is also rated on a scale from 1 to 7, with a higher score indicating a worse outcome.
Measured: Baseline, 3weeks, 6weeks, 10weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start3 Jan 2024
- Primary completion28 Jun 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- S-Alpha Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439407
- Sponsor's protocol ID
- SAT014-KP-001
- Status last verified
- Aug 2024
- First submitted
- 27 May 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Controlled, Exploratory Clinical Trial to Preliminarily Assess the Safety and Feasibility of SAT-014, a Software for Alleviating Symptoms of Trauma and Stress-related Disorders
- ClinicalTrials.gov ID
- NCT06439407
- Acronym / sponsor ID
- SAT014-KP-001
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- S-Alpha Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 3 Jun 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.
Failure to adapt to stress leads to functional impairments in various areas, including social, occupational, educational, and other significant domains, necessitating therapeutic intervention. Interventions through mobile app in the form of software can provide a new alternative for alleviating symptoms caused by psychological trauma by increasing accessibility to early intervention for trauma patients. This study aims to preliminarily assess the safety and feasibility of a psychological traum intervention by developing SAT-014 to help patients with trauma and stress-related disorder continue effective treatment in a stable environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAT-014 | Experimental | Device: SAT-014(Software as Medical Device) |
| Maintain previous treatment | Other | Device: SAT-014(Software as Medical Device) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (19 years and older)
- Have experienced clinically significant psychological trauma within the 6 months prior to screening visit
- Met the diagnostic criteria for Post-Traumatic Stress Disorder (PTSD) or Adjustment Disorder (AD) category as evaluated by MINI (Mini-International Neuropsychiatric Interview)
- Score between 17 and 38 points on the IES-R (Impact of Event Scale-Revised)
- Score of 4 or less on CGI (Clinical Global Impression)
Key exclusion criteria (9 listed)
- Have been diagnosed with schizophrenia, bipolar disorder, and psychotic disorder
- Have been diagnosed with neurodevelopmental disorder, neurocognitive disorder, or organic mental disorder
- Severe depression (PHQ-9 score of 20 or greater)
- Comorbid with severe personality disorder
- Diagnosed with substance use disorder excluding nicotine and caffeine and with severe alcohol use disorder
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 |
|---|---|---|
| SAT-014(Software as Medical Device)SAT-014(Software as Medical Device) + maintain previous treatment | Device | Maintain previous treatment, SAT-014 |
Primary outcome
Change in IES-R (Impact Event Scale-Revised) score
Time frame: Baseline, 3weeks, 6weeks, 10weeks
The Korean version of the Impact Event Scale-Revised (IES-R) consists of 22 items each rated on a 5-point scale ranging from 0 to 4. The total score ranges from 0 to 88, with higher scores indicating a greater risk of post-traumatic stress disorder and a worse outcome.
Change in PCL-5 (PTSD Checklist-5) score
Time frame: Baseline, 3weeks, 6weeks, 10weeks
The PTSD Checklist for DSM-5 (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 greater distress due to symptoms related to past stressful experiences and a worse outcome.
Change in GAD-7 (Generalized Anxiety Disorder 7 item scale) score
Time frame: Baseline, 3weeks, 6weeks, 10weeks
The Generalized Anxiety Disorder 7-item scale (GAD-7) consists of 7 items, each rated on a scale from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms and a worse outcome.
Change in BAI (Beck Anxiety Inventory) score
Time frame: Baseline, 3weeks, 6weeks, 10weeks
The Beck Anxiety Inventory (BAI) consists of 21 items, each rated on a scale from 0 to 3. The total score ranges from 0 to 63, with higher scores indicating more severe anxiety symptoms and a worse outcome.
Change in PHQ-9 (Patient Health Questionnaire-9; depression screening tool) score
Time frame: Baseline, 3weeks, 6weeks, 10weeks
The Patient Health Questionnaire-9 (PHQ-9) consists of 9 items, each rated on a scale of 0 to 3. The total score ranges from 0 to 27, with higher scores indicating more severe symptoms and a worse outcome.
Change in QIDS-SR (Quick Inventory of Depressive Symptomatology-Self Report) score
Time frame: Baseline, 3weeks, 6weeks, 10weeks
The Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) consist of 16 items, each rated on a scale of 0 to 3. It evaluates responses to 16 items based on criteria for nine depressive symptoms. The total score ranges from 0 to 27, with higher scores indicating more severe symptoms and a worse outcome.
Change in CGI (Clinical Global Impression) score
Time frame: Baseline, 3weeks, 6weeks, 10weeks
The CGI consists of two items: (a) the clinician's overall impression of the patient's severity of illness and (b) global improvement over time. The severity of illness is rated on a scale from 1 to 7, with a higher score indicating more severe illness and a worse outcome. Global improvement is also rated on a scale from 1 to 7, with a higher score indicating a worse outcome.
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 20 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAT-014(Software as Medical Device) in people with Posttraumatic Stress Disorder, run by S-Alpha Therapeutics, Inc. at 1 site 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 6 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 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 IES-R (Impact Event Scale-Revised) score (time frame: Baseline, 3weeks, 6weeks, 10weeks). The study lists 7 primary outcomes in all. 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 20 Dec 2024.