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NCT04999852 · ClinicalTrials.gov registry record · NA
The Effects of the Safe and Sound Protocol on PTSD Symptoms and Anxiety
A NA study of Anxiety and Post Traumatic Stress Disorder, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT04999852: Completed NA study of Anxiety and Post Traumatic Stress Disorder, sponsored by Indiana University.
NCT04999852 is a NA study of Anxiety and Post Traumatic Stress Disorder that has completed, run by Indiana University. The registered enrollment target is 45 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04999852, a NA study of Anxiety and Post Traumatic Stress Disorder, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- BEHAVIORAL Psychotherapy
- DEVICE Safe and Sound Protocol
Study Locations (1)
Indiana
- Spencer Psychology - Bloomington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2021-07-12 |
| Est. Completion | 2023-12-07 |
| Phase | NA |
What the finished NCT04999852 record still lists
NCT04999852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Anxiety appearing as the primary indexed condition, and to 2 interventions - of which Psychotherapy is the first listed.
NCT04999852 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT04999852 about?
NCT04999852 is a clinical study titled "The Effects of the Safe and Sound Protocol on PTSD Symptoms and Anxiety". 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 wi...
What is the current status of trial NCT04999852?
This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2021-07-12. Estimated completion is 2023-12-07.
What conditions does trial NCT04999852 study?
This clinical trial studies the following conditions: Anxiety, Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT04999852?
The interventions under investigation include: Psychotherapy (BEHAVIORAL), Safe and Sound Protocol (DEVICE).
Who is sponsoring clinical trial NCT04999852?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04999852 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04999852's enrollment target sits among peer trials
45 259th of 364 higher than 105 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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