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Completed

NCT Number: NCT04999852

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.

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Key information

Conditions

Post Traumatic Stress Disorder Anxiety Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spencer Psychology

Bloomington, Indiana, 47403, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: 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.

Primary outcomes

  1. Change From Baseline in Post Traumatic Stress Disorder Symptoms

    Time frame: 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 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. Change From Baseline in Anxiety Symptoms

    Time frame: 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, 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).

Secondary outcomes

  1. Change From Baseline in Self-reported Disruption of Autonomic Reactivity

    Time frame: 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 autonomic symptoms, measured using the Body Perception Questionnaire (BPQ), 20-item self-report. T Scores (M = 50, SD = 10) were used, with higher scores indicating greater level of symptoms.

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

    Time frame: 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 supine, sitting, and standing posture shifts. Data was 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.

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

    Time frame: 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) - a component of heart rate variability - measured during supine, sitting, and standing posture shifts. Measurements were conducted 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Spencer Psychology

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 11, 2021
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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