Feasibility of a Digital Therapeutic for Adults With Posttraumatic Stress Disorder (PTSD)

Oui Therapeutics

Status and phase: Not yet enrolling; Phase 1

Conditions: Post Traumatic Stress Disorder; PTSD

Treatments: Device: Digital Therapeutic (Version 2); Behavioral: Treatment as Usual (TAU); Device: Digital Therapeutic (Version 1)

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06868446

R44MH136888 (U.S. NIH Grant/Contract)

2024-Oui-002

Details and patient eligibility

About

This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.

Full description

The purpose of this study is to conduct a randomized controlled trial to evaluate the usability and feasibility as well as the safety and effectiveness of OTX-601 (version 1) + TAU compared to OTX-601 (version 2) + TAU in reducing PTSD symptoms from baseline to 7 weeks.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

OTX-601 Version 1

Experimental group

Description:

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

Treatment:

Device: Digital Therapeutic (Version 1)

Behavioral: Treatment as Usual (TAU)

OTX-601 Version 2

Experimental group

Description:

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

Treatment:

Behavioral: Treatment as Usual (TAU)

Device: Digital Therapeutic (Version 2)