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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Post Traumatic Stress Disorder
• Intervention / Treatment: Device: Safe and Sound Protocol; Behavioral: Psychotherapy

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47403
      • Spencer Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

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:

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychotherapy + SSP; All subjects enrolled in this study will receive the SSP intervention	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.; Other Names: SSP; 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.
Active Comparator: Psychotherapy (treatment as usual); Subjects who are receiving psychotherapy but not the SSP intervention	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Traumatic Stress Disorder Symptoms	Post Traumatic Stress Disorder Checklist for the DSM-5 (PCL-5), a 20-item self report, will be used. Total symptom severity scores range from 0 to 80, with higher scores indicating higher symptomology (poorer outcome).	2--4 months
Anxiety	Generalized Anxiety Disorder scale (GAD-7), 7-item self report will be used. Scores range from 0-21 points, with higher scores indicating greater anxiety symptoms (poorer outcome).	2--4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported disruption of autonomic reactivity	Body Perception Questionnaire (BPQ), 20-item self-report, be used. Raw scores range from 0-100, with higher scores indicating greater level of symptoms associated with autonomic activity (poorer outcome).	2--4 months
Mean heart period during posture shifts [SSP arm only]	Mean heart period during supine, sitting, and standing posture shifts will be measured using an earlobe pulse sensor (Photoplethysmography). Longer heart period (higher values, reported in milliseconds) are indicative of lower autonomic arousal states. This metric is intended as a measure of mechanism and and high values may be associated with a better outcome.	2--4 months
Respiratory sinus arrhythmia (RSA) during posture shifts [SSP arm only]	Respiratory sinus arrhythmia (RSA) - a component of heart rate variability - will be measured during supine, sitting, and standing posture shifts using an earlobe pulse sensor (Photoplethysmography). Greater RSA (higher values, reported in ln[milliseconds]^2) is associated with greater parasympathetic activity, which can help reduce physiological threat responses. This metric is intended to measure mechanism and high values may be associated with a better outcome.	2--4 months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Spencer Psychology
• Investigators: Principal Investigator: Jacek Kolacz, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Actual): December 7, 2023
• Study Completion (Actual): December 7, 2023

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; Post Traumatic Stress Disorder; music intervention; PTSD treatment; Safe and Sound Protocol; SSP; auditory intervention
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Anxiety Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 11261, 14850

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No