Trial Outcomes & Findings for The Effects of the Safe and Sound Protocol on PTSD Symptoms and Anxiety (NCT NCT04999852)
NCT ID: NCT04999852
Last Updated: 2025-09-05
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
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).
Results posted on
2025-09-05
Participant Flow
Participant milestones
| Measure |
Psychotherapy + SSP
All subjects enrolled in this study will receive the SSP intervention
Safe and Sound Protocol: 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: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
Psychotherapy (Treatment as Usual)
Subjects who are receiving psychotherapy but not the SSP intervention
Psychotherapy: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
13
|
|
Overall Study
COMPLETED
|
19
|
12
|
|
Overall Study
NOT COMPLETED
|
13
|
1
|
Reasons for withdrawal
| Measure |
Psychotherapy + SSP
All subjects enrolled in this study will receive the SSP intervention
Safe and Sound Protocol: 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: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
Psychotherapy (Treatment as Usual)
Subjects who are receiving psychotherapy but not the SSP intervention
Psychotherapy: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
1
|
|
Overall Study
Switched to different psychotherapy that was ineligible for study
|
2
|
0
|
Baseline Characteristics
The Effects of the Safe and Sound Protocol on PTSD Symptoms and Anxiety
Baseline characteristics by cohort
| Measure |
Psychotherapy + SSP
n=32 Participants
Safe and Sound Protocol: 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: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
Psychotherapy (Treatment as Usual)
n=13 Participants
Subjects who are receiving psychotherapy but not the SSP intervention
Psychotherapy: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.3 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
36.2 years
STANDARD_DEVIATION 8.72 • n=7 Participants
|
35.6 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).Population: Results are change scores from intent-to-treat analysis in which the last observed value is carried forward
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).
Outcome measures
| Measure |
Psychotherapy + SSP
n=32 Participants
All subjects enrolled in this study will receive the SSP intervention
Safe and Sound Protocol: 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: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
Psychotherapy (Treatment as Usual)
n=13 Participants
Subjects who are receiving psychotherapy but not the SSP intervention
Psychotherapy: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
|---|---|---|
|
Change From Baseline in Post Traumatic Stress Disorder Symptoms
|
-9.9 score on a scale
Standard Deviation 11.1
|
-2.3 score on a scale
Standard Deviation 12.2
|
PRIMARY outcome
Timeframe: 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).Population: Intent to treat analysis with last observed value carried forward
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).
Outcome measures
| Measure |
Psychotherapy + SSP
n=32 Participants
All subjects enrolled in this study will receive the SSP intervention
Safe and Sound Protocol: 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: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
Psychotherapy (Treatment as Usual)
n=13 Participants
Subjects who are receiving psychotherapy but not the SSP intervention
Psychotherapy: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
|---|---|---|
|
Change From Baseline in Anxiety Symptoms
|
-1.9 score on a scale
Standard Deviation 3.5
|
-0.8 score on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: 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 autonomic symptoms, measured using the Body Perception Questionnaire (BPQ), 20-item self-report. T Scores (M = 50, SD = 10) were used, with higher scores indicating greater level of symptoms.
Outcome measures
| Measure |
Psychotherapy + SSP
n=32 Participants
All subjects enrolled in this study will receive the SSP intervention
Safe and Sound Protocol: 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: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
Psychotherapy (Treatment as Usual)
n=13 Participants
Subjects who are receiving psychotherapy but not the SSP intervention
Psychotherapy: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
|---|---|---|
|
Change From Baseline in Self-reported Disruption of Autonomic Reactivity
|
-1.7 score on a scale
Standard Deviation 5.5
|
-0.1 score on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: 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 supine, sitting, and standing posture shifts. Data was measured using an earlobe pulse sensor (Photoplethysmography). Longer heart period (higher values, reported in milliseconds) are indicative of lower autonomic arousal states. This metric is intended as a measure of mechanism and and high values may be associated with a better outcome.
Outcome measures
| Measure |
Psychotherapy + SSP
n=29 Participants
All subjects enrolled in this study will receive the SSP intervention
Safe and Sound Protocol: 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: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
Psychotherapy (Treatment as Usual)
Subjects who are receiving psychotherapy but not the SSP intervention
Psychotherapy: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
|---|---|---|
|
Change From Baseline in Mean Heart Period During Posture Shifts [SSP Arm Only]
Supine
|
-99.8 milliseconds
Standard Deviation 117.0
|
—
|
|
Change From Baseline in Mean Heart Period During Posture Shifts [SSP Arm Only]
Sitting
|
-90.0 milliseconds
Standard Deviation 134.0
|
—
|
|
Change From Baseline in Mean Heart Period During Posture Shifts [SSP Arm Only]
Standing
|
-70.2 milliseconds
Standard Deviation 142.
|
—
|
SECONDARY outcome
Timeframe: 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) - a component of heart rate variability - measured during supine, sitting, and standing posture shifts. Measurements were conducted using an earlobe pulse sensor (Photoplethysmography). Greater RSA (higher values, reported in ln\[milliseconds\]\^2) is associated with greater parasympathetic activity, which can help reduce physiological threat responses. This metric is intended to measure mechanism and high values may be associated with a better outcome.
Outcome measures
| Measure |
Psychotherapy + SSP
n=29 Participants
All subjects enrolled in this study will receive the SSP intervention
Safe and Sound Protocol: 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: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
Psychotherapy (Treatment as Usual)
Subjects who are receiving psychotherapy but not the SSP intervention
Psychotherapy: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
|---|---|---|
|
Change From Baseline in Respiratory Sinus Arrhythmia (RSA) During Posture Shifts [SSP Arm Only]
Supine
|
-.35 ln[milliseconds]^2
Standard Deviation 1.00
|
—
|
|
Change From Baseline in Respiratory Sinus Arrhythmia (RSA) During Posture Shifts [SSP Arm Only]
Sit
|
-.43 ln[milliseconds]^2
Standard Deviation 1.44
|
—
|
|
Change From Baseline in Respiratory Sinus Arrhythmia (RSA) During Posture Shifts [SSP Arm Only]
Stand
|
-.04 ln[milliseconds]^2
Standard Deviation 1.33
|
—
|
Adverse Events
Psychotherapy + SSP
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Psychotherapy (Treatment as Usual)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Psychotherapy + SSP
n=32 participants at risk
All subjects enrolled in this study will receive the SSP intervention
Safe and Sound Protocol: 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: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
Psychotherapy (Treatment as Usual)
n=13 participants at risk
Subjects who are receiving psychotherapy but not the SSP intervention
Psychotherapy: All participants, regardless of study arm, will be recruited from the pool of Spencer Psychology clients who are actively receiving psychotherapy. Participants will continue to receive psychotherapy during the course of the study.
|
|---|---|---|
|
General disorders
Other (Not Including Serious) Adverse Event
|
3.1%
1/32 • Number of events 1 • Adverse events were tracked over the course of participation in the study (SSP+Psychotherapy Median Length = 145 days, Control Arm Median length = 122 days)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Terms
|
0.00%
0/13 • Adverse events were tracked over the course of participation in the study (SSP+Psychotherapy Median Length = 145 days, Control Arm Median length = 122 days)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Terms
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place