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Safe & Sound Protocol in Adults With Trauma and SUD
Sponsor: Caron Treatment Centers
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.
Official title: The Effect of the Safe and Sound Protocol on Emotional Regulation in Traumatized Adults With Substance Use Disorders
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-11-01
Completion Date
2027-03-15
Last Updated
2025-10-21
Healthy Volunteers
No
Interventions
Safe 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.
Locations (1)
Caron Treatment Centers
Wernersville, Pennsylvania, United States