Clinical & Scientific Validity
Twenty years of
evidence.
Nine peer-reviewed studies.
Sharpen DTX was built on two decades of Community-Based Participatory Research — 50,000+ stakeholder surveys, 100+ documentary listening sessions, and real-world deployment across diverse clinical settings before a single line of commercial code was written.
9
Peer-reviewed & published studies across clinical populations
25+
Academic & research institution partnerships
56.84%
Average engagement rate vs. 4–11% industry benchmark
5
Formal FDA meetings held with CDRH & Digital Health CoE
Evidence-Based Framework
15 clinical frameworks. One platform.
Every Sharpen module incorporates evidence-based components derived from the field's most validated frameworks — not adapted from them, built from them from the ground up.
Mental Health Literacy
Kutcher et al. (2016) framework improving understanding of mental health, reducing stigma, and increasing help-seeking behaviors across populations.
Suicide Prevention
Zero Suicide framework and HHS safety planning interventions (2024), with integrated CAT-SS computerized adaptive screening and 988 crisis escalation.
CBT & DBT
Cognitive Behavioral and Dialectical Behavior Therapy techniques embedded across 700+ therapeutic modules and 4,000+ documentary-style peer videos.
Trauma-Informed Care
Burke Harris et al. (2020) principles addressing protective factors at individual, family, and community levels through the Social-Ecological Model.
Community-Based Research
20 years of CBPR through documentary listening sessions, with 50,000+ post-program surveys and 400+ community-based research surveys informing every module.
Digital Safety Planning
Stanley et al. (2014, 2015) digital safety planning protocols with computerized adaptive testing in mental health (CAT-MH®) and real-time alert systems.
Clinical Research Evidence
Nine studies. Multiple populations.
Consistent results.
01 · 2025
Clinical Waitlist Management
Prisma Children's Hospital
N=37 pediatric eating disorder patients · Pilot implementation · Cosgrove et al., 2025
Clinician-prescribed DTX interventions delivered via Epic integration. Director of Adolescent Medicine subsequently expanded implementation across inpatient, partial hospitalization, outpatient, and intensive outpatient levels of care.
02 · 2023–2025
Athlete Mental Health & Suicide Prevention
Division I Athletics
N=1,275 college athletes · 3-year longitudinal · Whelan et al., 2024; Davis et al., 2026
Universal CAT-MH® screening with real-time clinical triage via Sharpen DTX dashboard. 126 athletes (9.9%) flagged for elevated suicide risk across three years. 100% received same-day intervention — a rate impossible through traditional clinical workflows.
03 · 2024–2025
Medical Student Mental Health Literacy
Edward Via College of Osteopathic Medicine
N=54 medical students · Pre-post evaluation · Fadel et al., 2024; Magalhaes et al., 2025
Self-guided 5-hour SMHL course addressing a population where depression (28%), anxiety (33.8%), burnout (44.2%), and suicidal ideation (11.1%) substantially exceed general population rates.
04 · 2022–2025
Healthcare Provider Suicide Prevention Training
Social workers, nurses, case managers, MH professionals · Rios et al., 2024
Customized Sharpen professional development app with 9 evidence-based suicide prevention courses. Low provider confidence was completely eliminated following training. 200+ certifications issued to licensed clinicians and healthcare workers.
05 · 2020–2025
VNS Health Safe Pathways Suicide Prevention
New York City
5-year longitudinal · High-risk urban youth & families · NY OMH funded · Year 3 Eval, 2025
Multi-component program integrating professional development, parent mental health literacy, and youth peer resiliency (ages 10–25). Five-year longitudinal evidence of sustainable implementation for populations with complex psychosocial stressors.
06 · 2022–2025
Foster Parent Mental Health Literacy
SC Foster Parent Association
N=334 completers · 3-year IRB-approved longitudinal · Hussa Farrell, Farrell & Biber, forthcoming
First empirical evidence of statistically significant improvements in both resilience and self-compassion among foster parents following a digital mental health literacy intervention. 83.33% completion rate substantially exceeds digital intervention benchmarks. SC DSS certified.
07 · 2023–2024
College Female Peer Mentoring Program
N=16 psychology students · Pilot qualitative evaluation · Biber & Rothman, 2024
Sharpen platform trained non-clinical peer mentors to provide evidence-based support within appropriate professional boundaries, demonstrating scalability of the platform beyond licensed clinical providers to community-level peer support roles.
08 · 2020–2025
College Mental Health Literacy
University of West Georgia
N=29 students · Mixed-methods semester-long evaluation · Levy et al., forthcoming 2026
SMHL course embedded in undergraduate health science curriculum over 16 weeks. Campus-specific video content featuring students, coaches, faculty, and counselors. Pending publication in Journal of American College Health.
09 · 2019–2026
Seamless Multi-Level Prevention Logic Model Validation
N=11,548+ users · Cross-toolkit synthesis · Hussa Farrell, 2026
Multi-year retrospective analysis validating the Sharpen System's social-ecological logic model across primary, secondary, and tertiary prevention — within a single user experience. 7,551+ documented transitions from education engagement to crisis resource activation.
Engagement Benchmarks
Why engagement matters in digital therapeutics.
A digital therapeutic that nobody uses is just software. Industry attrition rates for digital mental health interventions run 89–96%. Sharpen's engagement rates across every population studied are categorically different — and these numbers predate the AI personalization layer currently in development with UC Berkeley.
Engagement Rate Comparison
4,478+
Hours of user engagement across all implementations
7,551+
Documented transitions from education to crisis resource activation
10–44 min
Average session duration vs. 3–5 min industry standard
96%
Of users report the platform is effective; 96% would recommend
Regulatory Pathway
Five FDA meetings.
A clear path forward.
Resiliency Technologies has engaged FDA's Center for Devices and Radiological Health (CDRH) and Digital Health Center of Excellence through a structured pre-submission process. The agency has expressed active interest in Sharpen DTX filling a critical gap in pediatric mental health treatment access.
Meeting 1 · Completed
Platform Overview & Intended Use
Introductory meeting presenting platform architecture, clinical use case, and intended patient population to CDRH reviewers.
Meeting 2 · Completed
Full Product Demonstration
Comprehensive functionality review of the clinician portal, patient dashboard, EHR integration, and AI recommendation engine.
Meeting 3 · Completed
Pre-Sub Teleconference
Meeting minutes approved for formal pre-submission. Clinical trial design discussion aligned with FDA expectations for digital therapeutic evidence.
Meeting 4 · Completed
Clinical Trial Design Refinement
Follow-up session focused on real-world evidence generation requirements, safety monitoring protocols, and outcome measure selection.
Meeting 5 · Completed
AI Algorithm Discussion
Deep review of explainable AI recommendation engine architecture with CDRH and Digital Health Center of Excellence reviewers.
"FDA has expressed active interest in Sharpen DTX filling a critical gap in mental health treatment access — and anticipates the platform addressing an unmet need in pediatric digital therapeutics."
— FDA CDRH Pre-Submission Communications, 2024–2025
513(g) Request for Information recommended as next formal step
Clinical trial design aligned with FDA DTx evidence expectations
Post-clearance: RTM codes (98978/98975/98981) + DMHT + A9291
NIH R01 RCTs in development at Stanford and UCSF
Payer outcomes research: ED reduction & HEDIS quality measures
Research Collaboration Network
Built with the institutions
that set the standard.
25+
Academic institutions
250+
Researchers & collaborators
4
Medical school curricula
Clinical Research
Stanford Children's Hospital / Stanford University School of Medicine
Clinical Research
UC San Francisco (UCSF)
AI Development
UC Berkeley Center for Data Science and Society
Public Health
Emory University / Rollins School of Public Health
Clinical Deployment
Prisma Health Children's Hospital
State Agency
New York State Office of Mental Health
Medical Education
Edward Via College of Osteopathic Medicine
Public Health
San Diego State University School of Public Health
Social Services
South Carolina Department of Social Services
Validation
University of Washington SMART Center
Public Health
Georgia Health Policy Center
Clinical Research
Medical University of South Carolina
Selected Publications & White Papers
The evidence, cited.
Partner with Us
Interested in the clinical data or research collaboration?
We actively partner with academic medical centers, research institutions, and health systems. Download the full Clinical Overview or contact our research team directly.