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| ID | Type | Description | Link |
|---|---|---|---|
| R44MH136888 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Florida State University | OTHER |
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This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTX-601 | Experimental | A prescription digital therapeutic designed to overcome existing barriers and deliver evidence based treatment for PTSD |
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| OTX-003 | Sham Comparator | OTX-003 is a smartphone application developed as a comparator to OTX-601 and designed to match its interface while providing no active PTSD treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTX-601 Digital Therapeutic | Device | Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD symptoms between baseline and 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. | Baseline, Week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD symptoms at weeks 15 and 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. | Week 15, Week 27 |
| Change in Anxiety Sensitivity at weeks 7, 15, and 27 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian Keenaghan | Contact | 203-200-0482 | brian@ouitherapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Recruiting | Tallahassee | Florida | 32306 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| OTX-003 Comparator app | Device | Comparator designed to match interface of intervention while providing no active treatment. |
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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. |
| Week 7, Week 15, Week 27 |
| Change in Generalized Anxiety Disorder at weeks 7, 15, and 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. | Week 7, Week 15, Week 27 |
| Change in well-being at weeks 7, 15, and 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. | Week 7, Week 15, Week 27 |
| Anxiety sensitivity as a mediator of treatment effects on PTSD symptoms at 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. | Week 3 |
| App usability at 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. | Week 3 |