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

Not Applicable

Completed

• Conditions: Anxiety; Post Traumatic Stress Disorder
• Interventions: Device: Safe and Sound Protocol; Behavioral: Psychotherapy

• Registration Number: NCT04999852
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-12
• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-11
• Primary Completion: 2023-12-07
• Study Completion: 2023-12-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-03
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psychotherapy + SSP	Safe and Sound Protocol	All subjects enrolled in this study will receive the SSP intervention
Psychotherapy + SSP	Psychotherapy	All subjects enrolled in this study will receive the SSP intervention
Psychotherapy (treatment as usual)	Psychotherapy	Subjects who are receiving psychotherapy but not the SSP intervention

Primary Outcome Measures

Name	Time	Method
Post Traumatic Stress Disorder Symptoms	2--4 months	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).
Anxiety	2--4 months	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).

Secondary Outcome Measures

Name	Time	Method
Self-reported disruption of autonomic reactivity	2--4 months	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).
Mean heart period during posture shifts [SSP arm only]	2--4 months	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.
Respiratory sinus arrhythmia (RSA) during posture shifts [SSP arm only]	2--4 months	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.

Trial Locations

Locations (1)

Spencer Psychology; 🇺🇸 Bloomington, Indiana, United States