Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT07219056
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-21
First Post:
2025-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safe & Sound Protocol in Adults With Trauma and SUD
Sponsor:
Caron Treatment Centers
Organization:
Study Overview
Official Title:
The Effect of the Safe and Sound Protocol on Emotional Regulation in Traumatized Adults With Substance Use Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: