Safe & Sound Protocol for Trauma and Substance Use
This study is looking into whether the Safe and Sound Protocol (SSP) app can help adults who are in residential treatment for substance use disorders and also have a history of trauma. The SSP is a music therapy that uses specially filtered music to help with emotional regulation and social connection. You would listen to the SSP for 3 to 5 hours over 7 days. Researchers will measure if your symptoms of post-traumatic stress, anxiety, and body sensations related to stress improve after using the SSP. To join, you need to be between 18 and 75 years old, in residential treatment for substance use, have a history of trauma, and be able to speak English. The study aims to enroll 100 participants.
- Study design
- This study will involve 100 participants who will be randomly assigned to receive either the active SSP or a sham (inactive) SSP, in addition to their usual treatment.
- What's involved
- You would listen to the SSP on your mobile device or tablet for 3 to 5 hours over 7 days. You would also complete surveys at the beginning and end of the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your symptoms will be measured at Day 1 and Day 8 to see if there are any changes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safe & Sound Protocol in Adults With Trauma and SUD
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Margaret King, Psy.D. · PRINCIPAL_INVESTIGATOR · Caron Treatment Centers
- Erin Takemoto, PhD · STUDY_DIRECTOR · Caron Treatment Centers
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Difference in posttraumatic stress symptom scores pre-post between groups as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).Day 1 and Day 8
Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in posttraumatic stress symptom outcomes as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) between treatment and sham group. The PCL-5 is a 20 item self-report questionnaire, with a minimum score of 0 and maximum of 80. A higher score indicates greater PTSD symptom severity.
- Difference in anxiety symptom scores pre-post between groups as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale.Day 1 and Day 8
Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in anxiety outcomes as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale, between treatment and sham group. The GAD-7 is a self-report screening tool with a minimum score of 0 and maximum of 21. Higher scores indicate greater anxiety symptom severity.
- Difference in autonomic arousal symptom scores pre-post between groups as measured by the Body Perception Questionnaire Autonomic Symptoms - short form (BPQ-20 ANS).Day 1 and Day 8
Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes autonomic arousal outcomes between treatment and sham group. The BPQ-20 ANS (Body Perception Questionnaire - 20 Item Autonomic Nervous System Scale) is a self-report measure of autonomic symptoms with a minimum score of 20 and maximum of 100. Higher scores indicate more frequent autonomic symptoms.