Clinical trial NCT04999852: The Effects of the Safe and Sound Protocol on PTSD Symptoms and Anxiety
Official title: The Effects of the Safe and Sound Protocol on PTSD Symptoms and Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Anxiety
Keywords: Post Traumatic Stress Disorder
Anxiety
PTSD treatment
Safe and Sound Protocol
SSP
auditory intervention
music intervention
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Spencer Psychology
First posted: 2021-08-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Post Traumatic Stress Disorder Symptoms
timeFrame: 2--4 months
measure: Anxiety
timeFrame: 2--4 months
Secondary outcomes:
measure: Self-reported disruption of autonomic reactivity
timeFrame: 2--4 months
measure: Mean heart period during posture shifts [SSP arm only]
timeFrame: 2--4 months
measure: Respiratory sinus arrhythmia (RSA) during posture shifts [SSP arm only]
timeFrame: 2--4 months
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Spencer Psychology
state: Indiana
Study officials:
affiliation: Indiana University
name: Jacek Kolacz, PhD
role: PRINCIPAL_INVESTIGATOR
References: