Safe & Sound Protocol as an add-on for adults with trauma and substance use disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study randomizes 129 adults in residential treatment for substance use disorders and with a trauma history to either active or sham Safe and Sound Protocol (SSP) in addition to treatment as usual. Participants will use the SSP for 3 to 5 hours over seven days, and outcomes will be collected before and after the intervention, focusing on affect, anxiety, personality, mindfulness, and PTSD symptoms. The SSP is based on polyvagal theory and aims to modulate autonomic regulation through targeted music, with prior pilot data suggesting reductions in anxiety and trauma-related symptoms. This will be the first study to examine SSP effectiveness specifically in individuals with co-occurring SUD and trauma. Real-world data from SSP users indicate potential symptom reductions, though evidence in this population is still developing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Caron Treatment Centers
  Wernersville, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Erin Takemoto, PhD, MPH — Caron Treatment Centers
• Study coordinator: Erin Takemoto, PhD, MPH
• Email: etakemoto@caron.org
• Phone: 484-345-2626

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.