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Completed

NCT Number: NCT06439407

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.

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Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

SAT-014(Software as Medical Device)

Device

SAT-014(Software as Medical Device) + maintain previous treatment

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

S-Alpha Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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