The Effects of the Safe and Sound Protocol on PTSD Symptoms and Anxiety
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Post Traumatic Stress Disorder Symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •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)
Arms & Interventions
Psychotherapy + SSP
All subjects enrolled in this study will receive the SSP intervention
Intervention: Safe and Sound Protocol (Device)
Psychotherapy + SSP
All subjects enrolled in this study will receive the SSP intervention
Intervention: Psychotherapy (Behavioral)
Psychotherapy (treatment as usual)
Subjects who are receiving psychotherapy but not the SSP intervention
Intervention: Psychotherapy (Behavioral)
Outcomes
Primary Outcomes
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).
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
- Change From Baseline in Self-reported Disruption of Autonomic Reactivity(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 Posture Shifts [SSP Arm Only](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) During Posture Shifts [SSP Arm Only](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).)
Investigators
Jacek Kolacz
Research Fellow
Indiana University