Post Traumatic Stress Disorder, PTSD
Conditions
Keywords
PTSD
Brief summary
This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.
Detailed description
The purpose of this study is to conduct a randomized controlled trial to evaluate the efficacy of OTX-601 (intervention) compared to OTX-003 (comparator) in reducing PTSD symptoms from baseline to 7 weeks.
Interventions
DEVICEOTX-601 Digital Therapeutic
Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
DEVICEOTX-003 Comparator app
Comparator designed to match interface of intervention while providing no active treatment.
Sponsors
Oui Therapeutics, Inc.
National Institute of Mental Health (NIMH)
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD symptoms between baseline and week 7 | Baseline, Week 7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD symptoms at weeks 15 and 27 | Week 15, Week 27 | 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. |
| Change in Anxiety Sensitivity at weeks 7, 15, and 27 | Week 7, Week 15, Week 27 | Change in Anxiety Sensitivity will be measured using 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. |
| Change in Generalized Anxiety Disorder at weeks 7, 15, and 27 | Week 7, Week 15, Week 27 | Change in Generalized Anxiety Disorder will be assessed with the Generalized Anxiety Disorder 7-item (GAD-7) assessment. GAD-7 total score for the seven items ranges from 0 to 21 where a score ranging from 0-4 indicates minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety. |
| Change in well-being at weeks 7, 15, and 27 | Week 7, Week 15, Week 27 | Change in well-being will be assessed through the General Life Satisfaction Scale (GLSS). The GLSS total score ranges from 5-35 with higher scores indicating greater life satisfaction. |
| Anxiety sensitivity as a mediator of treatment effects on PTSD symptoms at week 3 | Week 3 | Anxiety sensitivity 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. |
| App usability at week 3 | Week 3 | App usability which 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. |
Countries
United States
Outcome results
None listed