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Safe & Sound Protocol in Adults With Trauma and SUD

Sponsor: Caron Treatment Centers • ClinicalTrials.gov ID: NCT07219056

Registry updated: 2026-09-21

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Description

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.

Interventions

Safe and Sound Protocol (Device)
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.

Eligibility criteria

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.

Conditions

Substance Use Disorders Posttraumatic Stress Symptom Anxiety

Locations

Caron Treatment Centers — Wernersville, Pennsylvania, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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