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

Indiana University

Status: Completed

Conditions: Post Traumatic Stress Disorder; Anxiety

Treatments: Behavioral: Psychotherapy; Device: Safe and Sound Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04999852

11261, 14850

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Psychotherapy + SSP

Experimental group

Description:

All subjects enrolled in this study will receive the SSP intervention

Treatment:

Device: Safe and Sound Protocol

Behavioral: Psychotherapy

Psychotherapy (treatment as usual)

Active Comparator group

Description:

Subjects who are receiving psychotherapy but not the SSP intervention

Treatment:

Behavioral: Psychotherapy