Status:
NOT_YET_RECRUITING
Safe & Sound Protocol in Adults With Trauma and SUD
Lead Sponsor:
Caron Treatment Centers
Conditions:
Substance Use Disorders
Posttraumatic Stress Symptom
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
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 connecti...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Does not speak English
- Age \< 18 or \> 75
- Does not have a history of trauma
- Active psychosis
- Active or uncontrolled seizures
- Tinnitus
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07219056
Start Date
November 1 2025
End Date
March 15 2027
Last Update
October 21 2025
Active Locations (1)
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1
Caron Treatment Centers
Wernersville, Pennsylvania, United States, 19565