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

Part of paid clinical trials in Bloomington, Indiana.

Sponsor
Indiana University
Study ID
NCT04999852
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Jul 12, 2021
Status verified
Sep 2025
Primary completion
Dec 7, 2023
Completion
Dec 7, 2023

Study Design

Enrollment
45 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Psychotherapy + SSP
    All subjects enrolled in this study will receive the SSP intervention
  • Active Comparator: Psychotherapy (treatment as usual)
    Subjects who are receiving psychotherapy but not the SSP intervention

Primary Outcome Measure

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). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Spencer PsychologyBloomingtonIndiana47403-

Find similar trials in Bloomington, IN

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Spencer Psychology· Bloomington, IN

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