Clinical Trial to Preliminarily Assess the Safety and Feasibility of SAT-014, a Software for Alleviating Symptoms of Trauma and Stress-related Disorders
Key facts
- Who runs it
- S-Alpha Therapeutics, Inc.
- Where
- South Korea1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 20 people enrolled
- Started
- 3 Jan 2024
- Ended
- 30 Aug 2024
- Type of study
- Interventional, 2 groups
- Treatments tested
- SAT-014(Software as Medical Device)
- Record updated
- 20 December 2024
Who can take part
- Age
- 19 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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 take part
- Have been diagnosed with schizophrenia, bipolar disorder, and psychotic disorder
- Have been diagnosed with neurodevelopmental disorder, neurocognitive disorder, or organic mental disorder
- Comorbid with severe personality disorder
- Diagnosed with substance use disorder excluding nicotine and caffeine and with severe alcohol use disorder
- Severe depression (PHQ-9 score of 20 or greater)
- Have made a suicide attempt within 3 months and are judged to be at high risk for suicide by a psychiatrist
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- SAT-014Treatment being tested
Treatment: SAT-014(Software as Medical Device)
- Maintain previous treatmentOther group
Treatment: SAT-014(Software as Medical Device)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 20 December 2024