NCT04999852

The Effects of the Safe and Sound Protocol on PTSD Symptoms and Anxiety

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Safe and Sound Protocol (SSP) is a passive acoustic intervention that is designed as a "neural exercise" to promote efficient regulation of autonomic state. Prior research has shown that the SSP can improve autonomic function, auditory hypersensitivities, and emotion regulation in individuals with Autism Spectrum Disorders. This observational pilot study is being conducted to establish methods for an upcoming randomized controlled trial to test the utility of the SSP for trauma treatment. This study will enroll clients at the Spencer Psychology clinic who are set to take part in SSP under the supervision of their therapist. Because the therapists have participated in the design of the protocol and will participate in data collection and analysis, SSP will be considered a research procedure. In addition to taking part in SSP, subjects complete a set of questionnaires and have their pulse measured before starting the SSP intervention, after having completed 2/5 hours of the SSP, one week after completing all 5 hours of the SSP, and one month after completing the SSP intervention. The investigators will also pull relevant information from Spencer Psychology's medical records to document diagnosis, track client progress during study, and augment self-reported demographics. Clients who are receiving psychotherapy but not the SSP will be recruited as a comparison group.

Conditions

• Post Traumatic Stress Disorder
• Anxiety

Interventions

Type	Name	Description
DEVICE	Safe and Sound Protocol	SSP is a non-invasive acoustic vagus nerve stimulator consisting of 5 hours of filtered and processed music designed to promote efficient regulation of autonomic state, and available through an app. The SSP is delivered via a mobile app and may fall under the heading of medical devices under the category of software functions/mobile medical applications.
BEHAVIORAL	Psychotherapy	All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively recieving psychotherapy. Participants will continue to recieve psychotherapy during the course of the study.

Timeline

• Start date: 2021-07-12
• Primary completion: 2023-12-07
• Completion: 2023-12-07
• First posted: 2021-08-11
• Last updated: 2025-09-05
• Results posted: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study