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Clinical Trial

Safe & Sound Protocol in Adults With Trauma and SUD

NCT: NCT07219056 · RECRUITING

NCT IDNCT07219056
StatusRECRUITING
Start Date2025-12-15
Completion2027-03-15
SponsorCaron Treatment Centers (OTHER)
First posted
Last updated

Brief 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.

Frequently Asked Questions

What is Safe & Sound Protocol in Adults With Trauma and SUD?

Safe & Sound Protocol in Adults With Trauma and SUD is a clinical trial registered under NCT07219056. Current status: RECRUITING.

What is the status of NCT07219056?

The current status of NCT07219056 (Safe & Sound Protocol in Adults With Trauma and SUD) is: RECRUITING.

When did Safe & Sound Protocol in Adults With Trauma and SUD start?

Safe & Sound Protocol in Adults With Trauma and SUD started on 2025-12-15.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.