Safe & Sound Protocol in Adults With Trauma and SUD

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.

NCT Number	NCT07219056
Lead Sponsor	Caron Treatment Centers
Conditions	Substance Use Disorders, Posttraumatic Stress Symptom, Anxiety
Enrollment	100 participants
Start Date	2025-12-15
Primary Completion	2026-12-30 (estimated)
Study Completion	2027-03-15 (estimated)
Updated on ClinicalTrials.gov	2026-08-03