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

NCT ID: NCT04999852

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2023-12-07

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Psychotherapy + SSP

All subjects enrolled in this study will receive the SSP intervention

Group Type: EXPERIMENTAL

Safe and Sound Protocol

Intervention Type: 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.

Psychotherapy

Intervention Type: 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)

Subjects who are receiving psychotherapy but not the SSP intervention

Group Type: ACTIVE_COMPARATOR

Psychotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

SSP

Eligibility Criteria

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

1. 18 years of age or older

2. Active psychotherapy client at Spencer Psychology

3. Diagnosis of PTSD or trauma not otherwise specified

4. Match range of PCL-5 baseline scores with treatment arm during screener survey

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:

1. Currently using or have previously used the Safe and Sound Protocol (SSP) in therapy

2. Current therapy includes Eye Movement Desensitization and Reprocessing (EMDR)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spencer Psychology

UNKNOWN

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Jacek Kolacz

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacek Kolacz, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Spencer Psychology

Bloomington, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

11261, 14850

Identifier Type: -

Identifier Source: org_study_id