Safe & Sound Protocol in Adults With Trauma and SUD

Part of paid clinical trials in Wernersville, Pennsylvania.

Sponsor
Caron Treatment Centers
Study ID
NCT07219056
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Posttraumatic Stress Symptom
  • Substance Use Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Safe and Sound Protocol — DEVICE
    Participants will complete a series of instruments after consenting to participate and have the SSP uploaded onto their mobile device or tablet. Participants will listen to the SSP for 3 to 5 hours over the course of 7 days. On the eighth day, participants will complete a follow-up set of instruments. The active arm will deliver the actual SSP intervention whereas the sham arm will deliver unfiltered music.

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
Oct 2025
Primary completion
Dec 30, 2026
Completion
Mar 15, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active SSP
    Participants will engage with the SSP for a minimum of 3 hours and a maximum of 5 hours over the course of seven days.
  • Sham Comparator: Sham SSP
    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.

Primary Outcome Measure

Difference in posttraumatic stress symptom scores pre-post between groups as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). [ Time Frame: Day 1 and Day 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Caron Treatment CentersWernersvillePennsylvania19565-

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