RecruitingNot ApplicableNCT07219056

Safe & Sound Protocol in Adults With Trauma and SUD

The Effect of the Safe and Sound Protocol on Emotional Regulation in Traumatized Adults With Substance Use Disorders

Sponsor

Caron Treatment Centers

Enrollment

100 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

Anxiety Substance Use Disorders Posttraumatic Stress Symptom

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

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 Criteria11

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.

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Interventions

DEVICESafe and Sound Protocol

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.