An interventional study of SAT-014(Software as Medical Device) in Posttraumatic Stress Disorder, sponsored by S-Alpha Therapeutics, Inc.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by S-Alpha Therapeutics, Inc. · Not applicable, Interventional, and Treatment
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.
2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.
This study's enrollment of 20 is below the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →S-Alpha Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: SAT-014(Software as Medical Device)
Device: SAT-014(Software as Medical Device)
SAT-014(Software as Medical Device) + maintain previous treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3weeks, 6weeks, 10weeks
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stress Disorders, Post-Traumatic→
S-Alpha Therapeutics, Inc.