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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

Who can join

Ages 18 to 75 · All sexes

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.

About the study

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.

What is being tested

• Safe and Sound Protocol (device)

Sponsor: Caron Treatment Centers · Participants: 100 · Started: Dec 15, 2025

Contact the study team

• Erin Takemoto, PhD, MPH · Phone: 484-345-2626
• Dean Stankoski, MS · Phone: 6107436224

Official record on ClinicalTrials.gov — NCT07219056

Locations in the U.S.

Conditions

• Drug Use and Addiction
• Anxiety

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.