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Safe & Sound Protocol in Adults With Trauma and SUD

RecruitingNAAges 18 Years - 75 YearsAllCaron Treatment Centers
NCT07219056 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Safe and Sound Protocol
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Where

1 site
Caron Treatment Centers
Wernersville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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