NCT07219056 Safe & Sound Protocol in Adults With Trauma and SUD
| NCT ID | NCT07219056 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Caron Treatment Centers |
| Condition | Substance Use Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-12-15 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Erin Takemoto, PhD, MPH
PRINCIPAL INVESTIGATOR
Caron Treatment Centers
Frequently Asked Questions
Who can join the NCT07219056 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Substance Use Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07219056 currently recruiting?
Yes, NCT07219056 is actively recruiting participants. Contact the research team at etakemoto@caron.org for enrollment information.
Where is the NCT07219056 trial being conducted?
This trial is being conducted at Wernersville, United States.
Who is sponsoring the NCT07219056 clinical trial?
NCT07219056 is sponsored by Caron Treatment Centers. The principal investigator is Erin Takemoto, PhD, MPH at Caron Treatment Centers. The trial plans to enroll 100 participants.