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Unyte Health

Real-World Evidence

Real-world evidence (RWE) relies on health data from sources outside of clinical research settings, including electronic records, registries, and technology products, including personal devices and applications. This data can be used to better understand the safety and efficacy of health-related products and services (Sherman et al., 2016).

As compared to traditional clinical trials, real-world evidence has unique benefits and limitations.

Real-World Data

  • Settings are more representative of how people behave in the real world
  • Limits bias through very large sample sizes, transparency in reporting, and acknowledgement of mediating variables
  • Generates larger data sets more quickly
  • Easier to generalize to diverse populations
  • Can contribute to and/or inform clinical trials and professional use

Clinical Trials

  • Account for natural variation through highly controlled environments and procedures
  • Limits bias and chance by controlling variables and narrowing eligibility criteria
  • Longer timelines for completion
  • More difficult to generalize beyond study population
  • Can be include and/or be informed by real-world data

The real-world evidence reported by Unyte Health Inc. has been collected by SSP Providers who administer third-party developed, standardized assessments to their clients using the Unyte Assessments digital platform. Read full disclaimer →

SSP CORE

Many clients who experience the SSP report fewer symptoms of anxiety.

61%

of clients moved from clinical to
non-clinical level

5.6

point improvement in symptoms
of anxiety

In a real-world data sample, 313 clients reported at least moderate anxiety symptoms on the GAD-7 before starting the SSP Core program.

Following completion of 5 Hours of SSP Core:

  • 61% of clients moved from clinical to non-clinical level (score less than 10).
  • The average score on the GAD-7 decreased from 14.5 (high severity) to 8.8 (mild severity); an average decrease of 5.6 points

Case Study

Client’s severe anxiety declines in only a few months with the SSP 

Sophie’s score went from a 17/21 (severe anxiety) to a 4/21 (normal range) following the SSP Core.

“During the SSP process, it provided me with a safe place. I was constantly looking forward to the next session for the peace and quiet it brought me. After completing the protocol, I had tools to bring myself back into my safe place, and it really helped me with my anxiety issues.”

SSP CORE

Many clients who experience the SSP report fewer symptoms of depression.

54%

of clients moved from clinical to
non-clinical level

5.4

point improvement in symptoms
of depression

In a real-world data sample, 208 clients reported at least moderate depression symptoms on the PHQ-9 before starting the SSP Core program.

Following completion of 5 Hours of SSP Core:

  • 54% of clients moved from clinical to non-clinical level (score less than 10).
  • The average score on the PHQ-9 decreased from 15.2 (high severity) to 9.8 (mild severity); an average decrease of 5.4 points.

Case Study

 Safe and Sound Protocol (SSP) supports woman in achieving a ventral state after 31 years of depression

At hour two of listening, Jill realized she was waking up without the feeling of dread. She was in tears as she shared this news with her provider, and could not believe how quickly the change happened. During the same time, her motivation to move and accomplish tasks began to increase. Jill explained that her lingering depression just “slid away.” She began to notice and feel that she was in a ventral state for the first time in decades, possibly for the first time in her whole life.

SSP CORE

Many clients who experience the SSP report fewer trauma-related symptoms.

63%

of clients moved from clinical to
non-clinical level

17.5

point improvement in trauma-related symptoms

In a real-world data sample, 120 clients reported at least moderate trauma-related symptoms before starting the SSP Core program.

Following completion of 5 Hours of SSP Core:

  • 63% of clients moved from clinical to non-clinical level (score less than 30).
  • The average score on the PCL-5 decreased from 45.2 (severe) to 27.7 (moderate), a 17.5 point improvement in symptoms. 

Case Study

Using the SSP as part of holistic treatment for childhood trauma

Lucy’s PCL-5 scores went from 26 (severe) to 14 (moderate).
Lucy was living with her biological parents after years of drug use, homelessness, domestic violence, and having to put a child up for adoption. Following the SSP, Lucy reports feeling able to advocate for herself at work, take walks or meditate in her car instead of working through her breaks. She has purchased a condo and has communicated effectively with her parents about her plans to live on her own, including plans to maintain her sobriety. Lucy also began dating again, after having abstained from romantic relationships since she left her life of drug use.

SSP CORE

Caregivers of children who experience the SSP report fewer psychosocial challenges.

47%

of clients moved from impaired to
not-impaired level

6.7

point improvement in psychosocial challenges

In a real-world data sample, caregivers of 94 children reported at least some challenges with psychosocial functioning before starting the SSP Core program.

Following completion of 5 Hours of SSP Core:

  • 47% of clients moved from ‘impaired’, to ‘not-impaired’ category (score less than 28).
  • The average score on the PSC decreased from 35.9 to 29.2, a 6.7 point improvement in psychosocial challenges. 

Case Study

SSP supports social-emotional learning goals for special education students, ages 6 to 12

Group study consisting of 10 children in a school setting.

Six-year-old Boy with Autism: He was unable to use an unfamiliar restroom, eat with his peers and was rigid in group play. Post-SSP, Sharon reports he “became able to eat in proximity [to] peers and use [an] unfamiliar restroom with shaping.” He started reading joke books for fun while eating lunch, and improved his peer-to-peer play with negotiation.

White paper

Nervous system regulation through listening: The science and applications

It is with great enthusiasm that we present to you the white paper, Nervous system regulation through listening: The science and applications, in which we dive into the profound impact of music-based interventions, sound therapies and listening therapies.

In an exploration of science, clinical research and real-world evidence, we aim to enrich your familiarity with bottom-up therapies and how they can complement traditional, top-down approaches to create holistic healing strategies grounded in physiological safety and autonomic regulation.


Disclaimer

The real-world evidence reported by Unyte Health Inc. has been collected by SSP Providers who administer third-party developed, standardized assessments to their clients using the Unyte Assessments digital platform. All reported data is de-identified (does not contain PHI), and only reported in aggregate. Consistent with best practices for real world evidence generation, these reports do not control for other therapies, medications, or contextual variables that may influence outcomes. These data are representative of real-world settings.

The reported data have not been evaluated by the FDA, and the products and services are not intended to diagnose, treat, cure, or prevent any disease. Unyte products are not medical devices or medical instruments. It is solely the responsibility of each user (whether a professional user or personal user) to determine whether the products and/or services may be beneficial for their patients/clients or themselves.

References

Pediatric Symptom Checklist (PSC)

Jellinek, M. & Murphy, J.M. (2020). Screening for psychosocial functioning as the eighth vital sign. JAMA Pediatrics. doi:10.1001/jamapediatrics.2020.2005

Generalized Anxiety Disorder 7 (GAD-7)

Spitzer, R. L., Kroenke, K., Williams, J. B., & Löwe, B. (2006). A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of internal medicine, 166(10), 1092–1097. https://doi.org/10.1001/archinte.166.10.1092

GAD-7 © Pfizer Inc. all rights reserved; used with permission.

Patient Health Questionnaire (PHQ-9)

Kroenke, K., Spitzer, R. L., & Williams, J. B. (2001). The PHQ-9: validity of a brief depression severity measure. Journal of general internal medicine, 16(9), 606–613. https://doi.org/10.1046/j.1525-1497.2001.016009606.x

PHQ9 Copyright © Pfizer Inc. All rights reserved. Reproduced with permission. 

PTSD Checklist for DSM-5 (PCL-5)

Weathers, F.W., Litz, B.T., Keane, T.M., Palmieri, P.A., Marx, B.P., & Schnurr, P.P. (2013). The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.

This measure was developed by staff at VA’s National Center for PTSD and is in the public domain and not copyrighted.

Real World Evidence

Sherman, R. E., Anderson, S. A., Dal Pan, G. J., Gray, G. W., Gross, T., Hunter, N. L., LaVange, L., Marinac-Dabic, D., Marks, P. W., Robb, M. A., Shuren, J., Temple, R., Woodcock, J., Yue, L. Q., & Califf, R. M. (2016). Real-World Evidence – What Is It and What Can It Tell Us?. The New England journal of medicine, 375(23), 2293–2297. https://doi.org/10.1056/NEJMsb1609216

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