N/A
N=45
The Effects of the Safe and Sound Protocol on PTSD Symptoms and Anxiety
Post Traumatic Stress Disorder · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT04999852 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Change From Baseline in Post Traumatic Stress Disorder Symptoms — -9.9; -2.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Safe and Sound Protocol (Device); Psychotherapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Post Traumatic Stress Disorder Symptoms |
-9.9; -2.3 | — |
| PRIMARY Change From Baseline in Anxiety Symptoms |
-1.9; -0.8 | — |
| SECONDARY Change From Baseline in Self-reported Disruption of Autonomic Reactivity |
-1.7; -0.1 | — |
| SECONDARY Change From Baseline in Mean Heart Period During Posture Shifts [SSP Arm Only] |
-99.8; -90.0; -70.2 | — |
| SECONDARY Change From Baseline in Respiratory Sinus Arrhythmia (RSA) During Posture Shifts [SSP Arm Only] |
-.35; -.43; -.04 | — |
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.
Eligibility Criteria
SSP Intervention Arm:
Inclusion Criteria
- Client at Spencer Psychology in Bloomington, Indiana
- Diagnosed with PTSD or trauma not otherwise specified
- Already have agreed with therapist to administer SSP as a part of therapy
Exclusion Criteria
- Tinnitus or hearing loss
- Diagnosed with cardiac arrhythmia
- At high risk for 2019 novel coronavirus (COVID-19) complications based on Center for Disease Control (CDC) guidelines, unless vaccinated
Comparison (Treatment As Usual) Arm Additional Criteria:
Inclusion Criteria
- 18 years of age or older
- Active psychotherapy client at Spencer Psychology
- Diagnosis of PTSD or trauma not otherwise specified
- Match range of PCL-5 baseline scores with treatment arm during screener survey
Exclusion criteria
- Currently using or have previously used the Safe and Sound Protocol (SSP) in therapy
- Current therapy includes Eye Movement Desensitization and Reprocessing (EMDR)
Data sourced from ClinicalTrials.gov (NCT04999852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.