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

NCT04999852 | Completed Results FDA Device

• 1 other identifier: 11261, 14850
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Post Traumatic Stress Disorder; Anxiety; PTSD treatment; Safe and Sound Protocol; SSP; auditory intervention; music intervention

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Post Traumatic Stress Disorder Symptoms

  Change in PTSD symptoms from baseline, measured using the Post Traumatic Stress Disorder Checklist for the DSM-5 (PCL-5), a 20-item self report. Total symptom severity scores range from 0 to 80, with higher scores indicating higher symptomology (poorer outcome).

  2-4 months. SSP Arm/Group assessed at baseline and 1 week after completion of the SSP intervention; Psychotherapy (Treatment as Usual) Arm/Group assessed at 3 months post-baseline (estimated average time to complete listening in SSP arm).

• Change From Baseline in Anxiety Symptoms

  Change from baseline in anxiety symptoms, measured using the Generalized Anxiety Disorder scale (GAD-7), 7-item self report. Scores range from 0-21 points, with higher scores indicating greater anxiety symptoms (poorer outcome).

  2-4 months. SSP Arm/Group assessed at baseline and 1 week after completion of the SSP intervention; Psychotherapy (Treatment as Usual) Arm/Group assessed at 3 months post-baseline (estimated average time to complete listening in SSP arm).

Secondary Outcomes (3)

• Change From Baseline in Self-reported Disruption of Autonomic Reactivity

  2-4 months. SSP Arm/Group assessed at baseline and 1 week after completion of the SSP intervention; Psychotherapy (Treatment as Usual) Arm/Group assessed at 3 months post-baseline (estimated average time to complete listening in SSP arm).

• Change From Baseline in Mean Heart Period During Posture Shifts [SSP Arm Only]

  2-4 months. SSP Arm/Group assessed at baseline and 1 week after completion of the SSP intervention; Psychotherapy (Treatment as Usual) Arm/Group assessed at 3 months post-baseline (estimated average time to complete listening in SSP arm).

• Change From Baseline in Respiratory Sinus Arrhythmia (RSA) During Posture Shifts [SSP Arm Only]

  2-4 months. SSP Arm/Group assessed at baseline and 1 week after completion of the SSP intervention; Psychotherapy (Treatment as Usual) Arm/Group assessed at 3 months post-baseline (estimated average time to complete listening in SSP arm).

Study Arms (2)

Psychotherapy + SSP

EXPERIMENTAL

All subjects enrolled in this study will receive the SSP intervention

Device: Safe and Sound Protocol; Behavioral: Psychotherapy

Psychotherapy (treatment as usual)

ACTIVE COMPARATOR

Subjects who are receiving psychotherapy but not the SSP intervention

Behavioral: Psychotherapy

Interventions

Safe and Sound Protocol DEVICE

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.

Also known as: SSP

Psychotherapy + SSP

Psychotherapy BEHAVIORAL

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.

Psychotherapy (treatment as usual); Psychotherapy + SSP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• Currently using or have previously used the Safe and Sound Protocol (SSP) in therapy
• Current therapy includes Eye Movement Desensitization and Reprocessing (EMDR)

Sponsors & Collaborators

• Indiana University: lead
• Spencer Psychology: collaborator

Study Sites (1)

Spencer Psychology

Bloomington, Indiana, 47403, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Results Point of Contact

• Title: Clarissa Tokash
• Organization: Indiana University

catokash@iu.edu

(812) 855-7686

Study Officials

• Jacek Kolacz, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 11, 2021
• Study Start: July 12, 2021
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: September 5, 2025
• Results First Posted: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication of primary results
• Access Criteria: All requests for data will be reviewed by the PIs and co-Is and a majority vote will be used to determine whether the request is approved or not. If the request is approved, Dr. Kolacz will inform the requestor, return a signed copy of the completed Data Use Request Form to the requestor, and let the requestor know that written IRB approval of the requestor's proposed study from the requestor's home institution will be required before data and/or code will be shared with the requestor. If a request is approved pending revision to the Data Use Request Form, Dr. Kolacz will work with requestors to revise sections of their Data Use Request Forms in order to obtain approval. If the request is not approved, Dr. Kolacz will inform the requestor and returned a signed copy of the completed Data Use Request Form to the requestor that includes an explanation for the denial.

Locations

US (1)