NCT06868446

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2025

Completed
Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

March 5, 2025

Last Update Submit

July 24, 2026

Conditions

PTSDPost Traumatic Stress Disorder

Keywords

PTSD

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 Digital Therapeutic - Version 1

EXPERIMENTAL

A prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD

Device: OTX-601 Digital Therapeutic - Version 1Behavioral: Treatment as Usual (TAU)

OTX-601 Digital Therapeutic - Version 2

EXPERIMENTAL

Increased dose of a prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD

Device: OTX-601 Digital Therapeutic - Version 2Behavioral: Treatment as Usual (TAU)

Interventions

OTX-601 Digital Therapeutic - Version 1DEVICE

Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD

OTX-601 Digital Therapeutic - Version 1
OTX-601 Digital Therapeutic - Version 2DEVICE

Prescription digital therapeutic (increased dose) designed to overcome existing barriers and deliver evidence-based treatment for PTSD

OTX-601 Digital Therapeutic - Version 2
Treatment as Usual (TAU)BEHAVIORAL

Treatment as usual may include psychotherapy and/or pharmacological interventions.

OTX-601 Digital Therapeutic - Version 1OTX-601 Digital Therapeutic - Version 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Patricia Simon, PhD

    Oui Therapeutics, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
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

November 18, 2025

Study Completion

November 21, 2025

Last Updated

July 27, 2026

Record last verified: 2026-07

Locations

US(1)