Feasibility of a Digital Therapeutic for Adults With Posttraumatic Stress Disorder (PTSD)
Dosage, Feasibility, Acceptability and Usability of OTX-601
2 other identifiers
interventional
40
0 countries
N/A
Brief Summary
This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2025
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2025
CompletedFirst Posted
Study publicly available on registry
March 11, 2025
CompletedStudy Start
First participant enrolled
June 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2026
CompletedJune 19, 2025
June 1, 2025
7 months
March 5, 2025
June 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PTSD Checklist for DSM-V (PCL-5)
Change in PTSD symptoms will be ascertained with the PTSD Checklist for DSM-V (PCL-5). The PCL-5 total score ranges from 0 to 80, with higher scores indicating more severe symptoms.
Baseline, week 1, week 2, week 3, and week 7
System Usability Scale (SUS)
App usability will be ascertained with the System Usability Scale (SUS). The SUS provides a score from 0 to 100. An average SUS score equal to or greater than 68 is considered usable.
week 1, week 2, and week 3
Secondary Outcomes (1)
Anxiety Sensitivity Index 3 (ASI-3)
Baseline, week 1, week 2, week 3 and week 7
Study Arms (2)
OTX-601 Version 1
EXPERIMENTALA prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
OTX-601 Version 2
EXPERIMENTALIncreased dose of a prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
Interventions
Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
Prescription digital therapeutic (increased dose) designed to overcome existing barriers and deliver evidence-based treatment for PTSD
Treatment as usual may include psychotherapy and/or pharmacological interventions.
Eligibility Criteria
You may qualify if:
- Posttraumatic stress disorder (PTSD) diagnosis
- Anxiety Sensitivity Index 3 (ASI-3) scores above 24
- PTSD Checklist for DSM-V (PCL-5) scores above 30
- Understands and speaks English
- Access to a smartphone that is connected to the internet
You may not qualify if:
- Score of 24 or lower on the ASI-3
- Score of 30 and below on the PCL-5
- No PTSD diagnosis
- Active psychosis
- Acute intoxication during study baseline
- Enrolled in another treatment research study
- Medical illness that would prevent the completion of interoceptive exposure exercises
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oui Therapeutics, Inc.lead
- National Institute of Mental Health (NIMH)collaborator
- Florida State Universitycollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia Simon, PhD
Oui Therapeutics, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2025
First Posted
March 11, 2025
Study Start
June 30, 2025
Primary Completion
January 30, 2026
Study Completion
January 30, 2026
Last Updated
June 19, 2025
Record last verified: 2025-06