Clinical trial NCT06439407: Clinical Trial to Preliminarily Assess the Safety and Feasibility of SAT-014, a Software for Alleviating Symptoms of Trauma and Stress-related Disorders
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Lead sponsor: S-Alpha Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-03
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Adults (19 years and older)
2. Have experienced clinically significant psychological trauma within the 6 months prior to screening visit
3. Met the diagnostic criteria for Post-Traumatic Stress Disorder (PTSD) or Adjustment Disorder (AD) category as evaluated by MINI (Mini-International Neuropsychiatric Interview)
4. Score between 17 and 38 points on the IES-R (Impact of Event Scale-Revised)
5. Score of 4 or less on CGI (Clinical Global Impression)
6. Capable of complying the activity instructions provided the app

Exclusion Criteria:

1. Have been diagnosed with schizophrenia, bipolar disorder, and psychotic disorder
2. Have been diagnosed with neurodevelopmental disorder, neurocognitive disorder, or organic mental disorder
3. Severe depression (PHQ-9 score of 20 or greater)
4. Comorbid with severe personality disorder
5. Diagnosed with substance use disorder excluding nicotine and caffeine and with severe alcohol use disorder
6. Have made a suicide attempt within 3 months and are judged to be at high risk for suicide by a psychiatrist
7. Pregnant or lactating
8. Currently participating in another clinical trial or have participated in another trial within 90 days from screening
9. 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

Primary outcomes:
measure: Change in IES-R (Impact Event Scale-Revised) score
timeFrame: Baseline, 3weeks, 6weeks, 10weeks
measure: Change in PCL-5 (PTSD Checklist-5) score
timeFrame: Baseline, 3weeks, 6weeks, 10weeks
measure: Change in GAD-7 (Generalized Anxiety Disorder 7 item scale) score
timeFrame: Baseline, 3weeks, 6weeks, 10weeks
measure: Change in BAI (Beck Anxiety Inventory) score
timeFrame: Baseline, 3weeks, 6weeks, 10weeks
measure: Change in PHQ-9 (Patient Health Questionnaire-9; depression screening tool) score
timeFrame: Baseline, 3weeks, 6weeks, 10weeks
measure: Change in QIDS-SR (Quick Inventory of Depressive Symptomatology-Self Report) score
timeFrame: Baseline, 3weeks, 6weeks, 10weeks
measure: Change in CGI (Clinical Global Impression) score
timeFrame: Baseline, 3weeks, 6weeks, 10weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: