Safe and Sound Protocol for Substance Abuse
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of the Safe and Sound Protocol (SSP) app when used alongside regular treatment for individuals with substance use issues and past trauma. Participants will use either the active SSP or a sham (placebo) version for three to five hours over seven days. Researchers will monitor changes in mood, anxiety, personality, mindfulness, and trauma symptoms before and after app use. The trial seeks participants currently in residential treatment for substance use disorders with a history of trauma. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve treatment options for others in similar situations.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual treatment, as the study involves using the SSP app alongside your regular care.
What prior data suggests that the Safe and Sound Protocol is safe for individuals with substance use disorders and trauma?
Research has shown that the Safe and Sound Protocol (SSP) is generally easy for people to handle. In earlier studies, some participants experienced mild side effects like headaches, but these were not serious. Most people using SSP felt calmer and more in control of their emotions. Additionally, 84% of participants noticed improvements in their symptoms. This suggests that SSP is safe to use and may help with anxiety, depression, and trauma symptoms. While this trial will examine its effects on individuals with substance use disorders and trauma more closely, current evidence is promising for its safety.12345
Why are researchers excited about this trial?
Researchers are excited about the Safe and Sound Protocol (SSP) for substance abuse because it offers a novel approach by using sound and music therapy, which is quite different from standard treatments like medication-assisted therapy or cognitive behavioral therapy. Unlike traditional methods that often rely on pharmaceuticals or talk therapy, SSP focuses on calming the nervous system through specific sound frequencies, potentially reducing cravings and anxiety. This non-invasive approach might offer a more holistic and accessible option for individuals who prefer alternative therapies or are looking to complement existing treatments.
What evidence suggests that the Safe and Sound Protocol is effective for substance use disorders and trauma?
Research has shown that the Safe and Sound Protocol (SSP) may help reduce symptoms of anxiety, depression, and trauma. These studies suggest that SSP can improve emotional management, which is crucial for individuals dealing with trauma and substance use disorders (SUD). The protocol involves music-based activities, linked to improved mood and reduced stress. This trial will compare the effects of the Active SSP, which participants will engage with for 3 to 5 hours over seven days, to a Sham SSP, which delivers unfiltered music. This study will be the first to examine SSP specifically in individuals with both SUD and trauma, but early results in other groups are promising. The researchers aim to determine if adding SSP to regular treatment can enhance outcomes for those facing these challenges.678910
Who Is on the Research Team?
Erin Deneke, PhD
Principal Investigator
Caron Treatment Centers
Are You a Good Fit for This Trial?
This trial is for adults with both substance use disorders (SUD) and trauma, such as PTSD or anxiety. Participants should be willing to use the Safe and Sound Protocol app alongside their usual treatment for a week.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants engage with the Safe and Sound Protocol (SSP) for a minimum of 3 hours and a maximum of 5 hours over the course of seven days
Follow-up
Participants are monitored for changes in posttraumatic stress, anxiety, mindfulness, and autonomic arousal symptoms
What Are the Treatments Tested in This Trial?
Interventions
- Safe and Sound Protocol
Trial Overview
The study tests if the Safe and Sound Protocol (SSP) app helps people with SUD and trauma when added to regular treatment. Half of the participants will get real SSP while the other half gets a sham version, decided randomly.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will engage with the SSP for a minimum of 3 hours and a maximum of 5 hours over the course of seven days.
Participants will engage with the SSP for a minimum of 3 hours and a maximum of 5 hours over the course of seven days. The sham protocol will deliver unfiltered music.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Caron Treatment Centers
Lead Sponsor
Citations
1.
trial.medpath.com
trial.medpath.com/clinical-trial/7999745a154958b9/nct07219056-safe-sound-protocol-emotional-regulation-trauma-substance-useSafe & Sound Protocol in Adults With Trauma and SUD
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 ...
Effects of music therapy and music-based interventions in the ...
We used the search term “(music therapy AND addiction) OR (music therapy AND substance use disorder) OR (music therapy AND substance abuse) OR ( ...
3.
researchgate.net
researchgate.net/publication/261568484_Indirect_effects_of_12-session_seeking_safety_on_substance_use_outcomes_Overall_and_attendance_class-specific_effectsIndirect effects of 12-session seeking safety on substance ...
Synergy between Seeking Safety and Twelve-Step Affiliation on Substance Use Outcomes for Women. April 2013 · Journal of Substance Abuse ...
Substance Abuse Intensive Outpatient Programs
Substance abuse intensive outpatient programs (IOPs) are direct services for people with substance use disorders or co-occurring mental and substance use ...
5.
library.samhsa.gov
library.samhsa.gov/sites/default/files/ebp-kit-building-your-program-10112019.pdfIntegrated Treatment for Co-Occurring Disorders
following positive outcomes: ▫ Reduced substance use ... Since effective treatment depends on integrating mental health and substance abuse.
Safe and Sound Protocol Study
Patients participating in SSP felt calmer, were less likely to get overwhelmed in treatment, and were better able to manage their emotions and ...
Safe & Sound Protocol in Adults With Trauma and SUD
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 ...
Initial Outcomes of the Safe and Sound Protocol on ...
The SSP was successfully administered to all participants according to the protocol. Some participants presented mild side effects, including headaches, ...
Real-World Evidence - Unyte Integrated ...
SSP CORE · 84% reported an improvement in symptoms. · 47% of clients moved from “impaired” to “not impaired” category (score less than 28). · The average score on ...
10.
hilltopbehavioralhealth.com
hilltopbehavioralhealth.com/certified-safe-and-sound-protocol-in-new-jersey/The Healing Power of Safe and Sound Protocol (SSP)
SSP improves people's ability to become more social, engaged, and responsive to their emotional and physical needs. SSP can benefit individuals experiencing ...
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