Health TrialsbyHealthPanel

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

ConditionsPTSDPost Traumatic Stress Disorder
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOui Therapeutics, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Score of 24 or lower on the ASI-3

Score of 30 and below on the PCL-5

No PTSD diagnosis

Active psychosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Digital Therapeutic (Version 1)

    Device

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

  • Digital Therapeutic (Version 2)

    Device

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

  • Treatment as Usual (TAU)

    Behavioral

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: OTX-601 Version 1Experimental treatment 2 interventions
Group B: OTX-601 Version 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, week 1, week 2, week 3, and week 7
2

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.

Time frame
week 1, week 2, and week 3

Secondary outcomes

1

Anxiety Sensitivity Index 3 (ASI-3)

Change in anxiety sensitivity level will be ascertained with the Anxiety Sensitivity Index 3 (ASI-3). The ASI-3 total score ranges from 0 to 72 with a higher score indicating greater anxiety sensitivity.

Time frame
Baseline, week 1, week 2, week 3 and week 7

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oui Therapeutics, Inc.

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Florida State University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: