Substance Use DisordersNCT07219056
Safe & Sound Protocol in Adults With Trauma and SUD
A study testing Safe and Sound Protocol in people with Substance Use Disorders and Posttraumatic Stress Symptom, run by Caron Treatment Centers at 1 site in United States.
Trial summary
This study will explore whether the use of the Safe and Sound Protocol (SSP) app is an effective adjunct to treatment as usual (TAU) in individuals with co-occurring substance use disorders and trauma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Substance Use Disorders, Posttraumatic Stress Symptom, Anxiety
- What is being tested?
- Safe and Sound Protocol
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 years old to 75 years old
- In residential treatment for substance use disorder.
- Has a history of trauma and is enrolled in Caron's trauma programming
- Is proficient in English
- Able to provide written informed consent.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
Who cannot join
- Does not speak English
- Age < 18 or > 75
- Does not have a history of trauma
- Active psychosis
- Active or uncontrolled seizures
- Tinnitus
Show all 11Show fewer
- Active suicidal ideation
- Actively engaging in self-injurious behavior
- Severe neurological condition
- Diagnosis of autism
- Has any serious medical disease or mental health condition which, in the judgment of the Principal Investigator or his/her designee, would make study participation unsafe, or would make intervention compliance difficult.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Caron Treatment Centers
Wernersville, Pennsylvania, 19565
Erin Takemoto, PhD, 484-345-2626, etakemoto@caron.org
Dean Stankoski, MS, 610-743-6224, DStankoski@caron.org
About this study
Official title: The Effect of the Safe and Sound Protocol on Emotional Regulation in Traumatized Adults With Substance Use Disorders
This study will explore whether the use of the Safe and Sound Protocol (SSP) app is an effective adjunct to treatment as usual (TAU) in individuals with co-occurring substance use disorders and trauma. This study will recruit 129 participants (100 completers) randomized to receive either active or sham SSP in addition to TAU. Participants will utilize the SSP for a minimum of three hours to a maximum of five hours for a total of seven days. Data will be collected at both pre- and post-test. Data to be collected will include measures on affect, anxiety, personality, mindfulness, and posttraumatic stress disorder symptoms. The SSP has shown effectiveness in reducing symptoms of anxiety, depression, and trauma symptoms in pilot studies conducted at other locations. This will be the first study to examine the effectiveness of SSP with individuals with co-occurring SUD and trauma.
Read the detailed description
The Safe and Sound Protocol (SSP) was developed by Dr. Stephen Porges based on his Polyvagal Theory that highlights the vagus nerve's influences on emotional and behavioral regulation, social connection, and fear/trauma responses.
Research examining the effectiveness of SSP with children and/or adults on the Autism Spectrum has shown improvement in social awareness and decline in auditory hypersensitivities and hypo-sensitivities, visual sensitivity, tactile hypersensitivities, selective eating and digestive problems. SSP has also been shown to reduce symptoms of anxiety, depression and autonomic reactivity in individuals engaged in speech therapy for voice and throat complaints.
There is on-going clinical research to examine the effectiveness of SSP in various populations, including those suffering from posttraumatic stress disorder (PTSD). In real-world data obtain through the SSP platform, just over half of individuals reporting clinical levels of PTSD symptoms as assessed on the Posttraumatic Checklist - 5 (PCL-5) had a reduction in symptoms to below the clinical threshold following the completion of SSP.
Safe and Sound Protocol (SSP) Core is five hours of music therapy that is progressively filtered through a patented algorithm that highlights middle sound frequencies, the frequency most associated with cues of safety from human speech. This is designed to stimulate the vagus nerve by engaging the middle ear muscles and nerves to move out of defensive state of activation and activate the social engagement and calming system of the nervous system. SSP is designed to help participants regulate their nervous system to support reduction in distress and increased social connection.
To date, there is no research underway to examine the effectiveness of SSP for individuals experiencing posttraumatic stress symptoms and a substance use disorder (SUD). Individuals experiencing posttraumatic stress symptoms and SUD are hypothesized to benefit from a non-invasive treatment designed to regulate their autonomic nervous system, such as SSP.
- Being tested
- Safe and Sound Protocol
- Keywords
- substance use disorders, posttraumatic stress symptoms, anxiety
- Medical subject headings
- Substance-Related Disorders, 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
Participants will complete a series of instruments after consenting to participate and have the SSP uploaded onto their mobile device or tablet. Participants will listen to the SSP for 3 to 5 hours over the course of 7 days. On the eighth day, participants will complete a follow-up set of instruments. The active arm will deliver the actual SSP intervention whereas the sham arm will deliver unfiltered music.
| Study group | Role | What they receive |
|---|---|---|
| Active SSP | Experimental | Participants will engage with the SSP for a minimum of 3 hours and a maximum of 5 hours over the course of seven days. Receives: Device: Safe and Sound Protocol |
| Sham SSP | Sham comparator | Participants will engage with the SSP for a minimum of 3 hours and a maximum of 5 hours over the course of seven days. The sham protocol will deliver unfiltered music. Receives: Device: Safe and Sound Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in posttraumatic stress symptom scores pre-post between groups as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in posttraumatic stress symptom outcomes as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) between treatment and sham group. The PCL-5 is a 20 item self-report questionnaire, with a minimum score of 0 and maximum of 80. A higher score indicates greater PTSD symptom severity.
Measured: Day 1 and Day 8
Difference in anxiety symptom scores pre-post between groups as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale.
Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in anxiety outcomes as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale, between treatment and sham group. The GAD-7 is a self-report screening tool with a minimum score of 0 and maximum of 21. Higher scores indicate greater anxiety symptom severity.
Measured: Day 1 and Day 8
Difference in autonomic arousal symptom scores pre-post between groups as measured by the Body Perception Questionnaire Autonomic Symptoms - short form (BPQ-20 ANS).
Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes autonomic arousal outcomes between treatment and sham group. The BPQ-20 ANS (Body Perception Questionnaire - 20 Item Autonomic Nervous System Scale) is a self-report measure of autonomic symptoms with a minimum score of 20 and maximum of 100. Higher scores indicate more frequent autonomic symptoms.
Measured: Day 1 and Day 8
Secondary outcomes (2)
Differences in positive and negative affect scores pre-post between groups as measured by the Positive and Negative Affect Schedule (PANAS).
Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in positive and negative affect outcomes between treatment and sham group. Positive and Negative Affect Schedule (PANAS) is a self-report screening tool with independent scores for positive affect and negative affect, both have a minimum score of 10 and maximum of 50. For positive affect, higher scores indicate greater positive mood, enthusiasm, engagement, and energy. For negative affect, higher scores indicate greater positive distress, anxiety, anger, guilt, and other negative emotional states.
Measured: Day 1 and Day 8
Changes in mindfulness scores pre-post between groups as measured by the Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in mindfulness outcomes, as measured by the CAMS-R, between treatment and sham group. The Cognitive and Affective Mindfulness Scale - Revised (10-item; CAMS-R) is a self-report measure of mindfulness with a minimum score of 10 and maximum of 40. Higher scores indicate greater mindfulness.
Measured: Day 1 and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start15 Dec 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-armed, prospective, randomized, double-blind, sham-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caron Treatment Centers
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Takemoto, Caron Treatment Centers
- Investigators
- Erin Takemoto, PhD, MPH, Principal investigator, Caron Treatment Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219056
- Sponsor's protocol ID
- Caron002
- Status last verified
- Sep 2026
- First submitted
- 14 Oct 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Safe and Sound Protocol on Emotional Regulation in Traumatized Adults With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT07219056
- Acronym / sponsor ID
- Caron002
- Keywords
- substance use disorders, posttraumatic stress symptoms, anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Caron Treatment CentersUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 21 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will explore whether the use of the Safe and Sound Protocol (SSP) app is an effective adjunct to treatment as usual (TAU) in individuals with co-occurring substance use disorders and trauma. This study will recruit 129 participants (100 completers) randomized to receive either active or sham SSP in addition to TAU. Participants will utilize the SSP for a minimum of three hours to a maximum of five hours for a total of seven days. Data will be collected at both pre- and post-test. Data to be collected will include measures on affect, anxiety, personality, mindfulness, and posttraumatic stress disorder symptoms. The SSP has shown effectiveness in reducing symptoms of anxiety, depression, and trauma symptoms in pilot studies conducted at other locations. This will be the first study to examine the effectiveness of SSP with individuals with co-occurring SUD and trauma.
Detailed description
The Safe and Sound Protocol (SSP) was developed by Dr. Stephen Porges based on his Polyvagal Theory that highlights the vagus nerve's influences on emotional and behavioral regulation, social connection, and fear/trauma responses.
Research examining the effectiveness of SSP with children and/or adults on the Autism Spectrum has shown improvement in social awareness and decline in auditory hypersensitivities and hypo-sensitivities, visual sensitivity, tactile hypersensitivities, selective eating and digestive problems. SSP has also been shown to reduce symptoms of anxiety, depression and autonomic reactivity in individuals engaged in speech therapy for voice and throat complaints.
There is on-going clinical research to examine the effectiveness of SSP in various populations, including those suffering from posttraumatic stress disorder (PTSD). In real-world data obtain through the SSP platform, just over half of individuals reporting clinical levels of PTSD symptoms as assessed on the Posttraumatic Checklist - 5 (PCL-5) had a reduction in symptoms to below the clinical threshold following the completion of SSP.
Safe and Sound Protocol (SSP) Core is five hours of music therapy that is progressively filtered through a patented algorithm that highlights middle sound frequencies, the frequency most associated with cues of safety from human speech. This is designed to stimulate the vagus nerve by engaging the middle ear muscles and nerves to move out of defensive state of activation and activate the social engagement and calming system of the nervous system. SSP is designed to help participants regulate their nervous system to support reduction in distress and increased social connection.
To date, there is no research underway to examine the effectiveness of SSP for individuals experiencing posttraumatic stress symptoms and a substance use disorder (SUD). Individuals experiencing posttraumatic stress symptoms and SUD are hypothesized to benefit from a non-invasive treatment designed to regulate their autonomic nervous system, such as SSP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-armed, prospective, randomized, double-blind, sham-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Active SSP | Experimental | Device: Safe and Sound ProtocolParticipants will engage with the SSP for a minimum of 3 hours and a maximum of 5 hours over the course of seven days. |
| Sham SSP | Sham comparator | Device: Safe and Sound ProtocolParticipants will engage with the SSP for a minimum of 3 hours and a maximum of 5 hours over the course of seven days. The sham protocol will deliver unfiltered music. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 18 years old to 75 years old
- In residential treatment for substance use disorder.
- Has a history of trauma and is enrolled in Caron's trauma programming
- Is proficient in English
- Able to provide written informed consent.
Key exclusion criteria (11 listed)
- Does not speak English
- Age < 18 or > 75
- Does not have a history of trauma
- Active psychosis
- Active or uncontrolled seizures
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: SSPParticipants will complete a series of instruments after consenting to participate and have the SSP uploaded onto their mobile device or tablet. Participants will listen to the SSP for 3 to 5 hours over the course of 7 days. On the eighth day, participants will complete a follow-up set of instruments. The active arm will deliver the actual SSP intervention whereas the sham arm will deliver unfiltered music. | Device | Active SSP, Sham SSP |
Primary outcome
Difference in posttraumatic stress symptom scores pre-post between groups as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
Time frame: Day 1 and Day 8
Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in posttraumatic stress symptom outcomes as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) between treatment and sham group. The PCL-5 is a 20 item self-report questionnaire, with a minimum score of 0 and maximum of 80. A higher score indicates greater PTSD symptom severity.
Difference in anxiety symptom scores pre-post between groups as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale.
Time frame: Day 1 and Day 8
Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in anxiety outcomes as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale, between treatment and sham group. The GAD-7 is a self-report screening tool with a minimum score of 0 and maximum of 21. Higher scores indicate greater anxiety symptom severity.
Difference in autonomic arousal symptom scores pre-post between groups as measured by the Body Perception Questionnaire Autonomic Symptoms - short form (BPQ-20 ANS).
Time frame: Day 1 and Day 8
Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes autonomic arousal outcomes between treatment and sham group. The BPQ-20 ANS (Body Perception Questionnaire - 20 Item Autonomic Nervous System Scale) is a self-report measure of autonomic symptoms with a minimum score of 20 and maximum of 100. Higher scores indicate more frequent autonomic symptoms.
2 secondary outcomes
Differences in positive and negative affect scores pre-post between groups as measured by the Positive and Negative Affect Schedule (PANAS).
Time frame: Day 1 and Day 8
Changes in mindfulness scores pre-post between groups as measured by the Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
Time frame: Day 1 and Day 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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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.
Erin Takemoto, PhD, MPH principal investigator
Caron Treatment Centers
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 in people with Substance Use Disorders and Posttraumatic Stress Symptom, run by Caron Treatment Centers 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Takemoto, PhD, MPH (484-345-2626, etakemoto@caron.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in posttraumatic stress symptom scores pre-post between groups as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). (time frame: Day 1 and Day 8). The study lists 3 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 21 Sep 2026.