Post Traumatic Stress DisorderNCT04999852
The Effects of the Safe and Sound Protocol on PTSD Symptoms and Anxiety
A study testing Safe and Sound Protocol and Psychotherapy in people with Post Traumatic Stress Disorder and Anxiety, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder, Anxiety
- What is being tested?
- Safe and Sound Protocol and Psychotherapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2021to 7 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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:
- Currently using or have previously used the Safe and Sound Protocol (SSP) in therapy
- Current therapy includes Eye Movement Desensitization and Reprocessing (EMDR)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Post Traumatic Stress Disorder, Anxiety
- Being tested
- Safe and Sound Protocol, Psychotherapy
- Keywords
- Post Traumatic Stress Disorder, Anxiety, PTSD treatment, Safe and Sound Protocol, SSP, auditory intervention, music intervention
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe and Sound ProtocolDevice
Also called SSP
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.
PsychotherapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| Psychotherapy + SSP | Experimental | All subjects enrolled in this study will receive the SSP intervention Receives: Device: Safe and Sound Protocol; Behavioral: Psychotherapy |
| Psychotherapy (treatment as usual) | Active comparator | Subjects who are receiving psychotherapy but not the SSP intervention Receives: Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Post Traumatic Stress Disorder Symptoms
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).
Measured: 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
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).
Measured: 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).
Secondary outcomes (3)
Change From Baseline in Self-reported Disruption of Autonomic Reactivity
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.
Measured: 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]
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.
Measured: 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]
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start12 Jul 2021
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Spencer Psychology
- Responsible party
- Principal investigator, Jacek Kolacz, Indiana University
- Investigators
- Jacek Kolacz, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999852
- Sponsor's protocol ID
- 11261, 14850
- Status last verified
- Sep 2025
- First submitted
- 2 Aug 2021
- Last updated
- 5 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Researchers interested in using IPD collected or generated as part of this study may do so by contacting the study PI. Researchers will be asked to complete a Data Use Request Form, which includes contact information, description of the research project for which the data and/or code would be used, specification of which data and/or code would be needed for their proposed project, an approximate time line for their proposed project, and authorship on their proposed project.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Safe and Sound Protocol on PTSD Symptoms and Anxiety
- ClinicalTrials.gov ID
- NCT04999852
- Acronym / sponsor ID
- 11261, 14850
- Conditions
- Post Traumatic Stress Disorder, Anxiety
- Keywords
- Post Traumatic Stress Disorder, Anxiety, PTSD treatment, Safe and Sound Protocol, SSP, auditory intervention, music intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Spencer Psychology
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Posted 5 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy + SSP | Experimental | Device: Safe and Sound Protocol, Behavioral: PsychotherapyAll subjects enrolled in this study will receive the SSP intervention |
| Psychotherapy (treatment as usual) | Active comparator | Behavioral: PsychotherapySubjects who are receiving psychotherapy but not the SSP intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 18 years of age or older
- Active psychotherapy client at Spencer Psychology
Key exclusion criteria (6 listed)
- 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
- Currently using or have previously used the Safe and Sound Protocol (SSP) in therapy
- Current therapy includes Eye Movement Desensitization and Reprocessing (EMDR)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe and Sound ProtocolAlso: SSPSSP 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. | Device | Psychotherapy + SSP |
| PsychotherapyAll 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. | Behavioural | Psychotherapy (treatment as usual), Psychotherapy + SSP |
Primary outcome
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).
3 secondary outcomes
Change From Baseline in Self-reported Disruption of Autonomic Reactivity
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 Mean Heart Period During Posture Shifts [SSP Arm Only]
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 Respiratory Sinus Arrhythmia (RSA) During Posture Shifts [SSP Arm Only]
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Researchers interested in using IPD collected or generated as part of this study may do so by contacting the study PI. Researchers will be asked to complete a Data Use Request Form, which includes contact information, description of the research project for which the data and/or code would be used, specification of which data and/or code would be needed for their proposed project, an approximate time line for their proposed project, and authorship on their proposed project.
Related trials for Post Traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacek Kolacz, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe and Sound Protocol and Psychotherapy in people with Post Traumatic Stress Disorder and Anxiety, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.