Safe & Sound Protocol for Trauma and Substance Use Disorders
Safe & Sound Protocol in Adults With Trauma and SUD
Recruiting
N/A
Interventional Study
Substance Use Disorders
Posttraumatic Stress Symptom
Anxiety
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Caron Treatment Centers · Other
Who this trial is looking for
This trial is looking for adults who are in treatment for substance use and have a history of trauma. Participants will use the Safe and Sound Protocol app for about 3 to 5 hours over a week while continuing their usual treatment.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 18 and 75 years old.
- I am currently in residential treatment for substance use disorder.
- I have a history of trauma.
- I am enrolled in trauma programming at Caron.
- I can speak and understand English.
- I can provide written consent.
- I am willing to follow all study procedures.
You may not be able to join if
- I do not speak English.
- I am under 18 or over 75 years old.
- I do not have a history of trauma.
- I have active psychosis.
- I have uncontrolled seizures.
- I have tinnitus.
- I have active suicidal thoughts.
- I am engaging in self-harm.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 maxi…
Trial Locations
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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…
Contacts