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

Anxiety

Depression

Trauma

Psychosocial

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:

• 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, translating to 39% improvement in symptoms.
• 61% of clients moved from clinical to non-clinical level (score less than 10).

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.”

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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:

• 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, translating to 36% improvement in symptoms.
• 54% of clients moved from clinical to non-clinical level (score less than 10).

 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.

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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:

• The average score on the PCL-5 decreased from 45.2 (severe) to 27.7 (moderate), translating to 39% improvement in symptoms. 
• 63% of clients moved from clinical to non-clinical level (score less than 30).

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.

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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:

• The average score on the PSC decreased from 35.9 to 29.2, translating to 19% improvement in psychosocial challenges. 
• 47% of clients moved from ‘impaired’, to ‘not-impaired’ category (score less than 28).

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.

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