Clinical Trial to Preliminarily Assess the Safety and Feasibility of SAT-014, a Software for Alleviating Symptoms of Trauma and Stress-related Disorders

NCT ID: NCT06439407

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-03
• Study Completion Date: 2024-08-30

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAT-014

Group Type: EXPERIMENTAL

SAT-014(Software as Medical Device)

Intervention Type: DEVICE

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

Maintain previous treatment

Group Type: OTHER

SAT-014(Software as Medical Device)

Intervention Type: DEVICE

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

Interventions

SAT-014(Software as Medical Device)

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

S-Alpha Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SAT014-KP-001

Identifier Type: -

Identifier Source: org_study_id