Feasibility of a Digital Therapeutic for Adults With Posttraumatic Stress Disorder (PTSD)
NCT ID: NCT06868446
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2025-06-30
2026-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
SINGLE
Study Groups
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OTX-601 Version 1
A prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
Digital Therapeutic (Version 1)
Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
Treatment as Usual (TAU)
Treatment as usual may include psychotherapy and/or pharmacological interventions.
OTX-601 Version 2
Increased dose of a prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
Digital Therapeutic (Version 2)
Prescription digital therapeutic (increased dose) designed to overcome existing barriers and deliver evidence-based treatment for PTSD
Treatment as Usual (TAU)
Treatment as usual may include psychotherapy and/or pharmacological interventions.
Interventions
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Digital Therapeutic (Version 1)
Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
Digital Therapeutic (Version 2)
Prescription digital therapeutic (increased dose) designed to overcome existing barriers and deliver evidence-based treatment for PTSD
Treatment as Usual (TAU)
Treatment as usual may include psychotherapy and/or pharmacological interventions.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Florida State University
OTHER
Oui Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Patricia Simon, PhD
Role: PRINCIPAL_INVESTIGATOR
Oui Therapeutics, Inc.
Central Contacts
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Other Identifiers
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2024-Oui-002
Identifier Type: -
Identifier Source: org_study_id
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