Safe & Sound Protocol in Adults With Trauma and SUD

NCT07219056 | Recruiting

• 1 other identifier: Caron002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders; Posttraumatic Stress Symptom; Anxiety

Keywords

substance use disorders; posttraumatic stress symptoms; anxiety

Outcome Measures

Primary Outcomes (3)

• Difference in posttraumatic stress symptom scores pre-post between groups as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).

  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.

  Day 1 and Day 8

• Difference in anxiety symptom scores pre-post between groups as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale.

  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.

  Day 1 and Day 8

• Difference in autonomic arousal symptom scores pre-post between groups as measured by the Body Perception Questionnaire Autonomic Symptoms - short form (BPQ-20 ANS).

  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.

  Day 1 and Day 8

Secondary Outcomes (2)

• Differences in positive and negative affect scores pre-post between groups as measured by the Positive and Negative Affect Schedule (PANAS).

  Day 1 and Day 8

• Changes in mindfulness scores pre-post between groups as measured by the Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)

  Day 1 and Day 8

Study Arms (2)

Active SSP

EXPERIMENTAL

Participants will engage with the SSP for a minimum of 3 hours and a maximum of 5 hours over the course of seven days.

Device: Safe and Sound Protocol

Sham SSP

SHAM COMPARATOR

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.

Device: Safe and Sound Protocol

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.

Also known as: SSP

Active SSP; Sham SSP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Caron Treatment Centers: lead

Study Sites (1)

Caron Treatment Centers

Wernersville, Pennsylvania, 19565, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Margaret King, Psy.D.

  Caron Treatment Centers

  PRINCIPAL INVESTIGATOR

• Erin Takemoto, PhD

  Caron Treatment Centers

  STUDY DIRECTOR

Central Study Contacts

Margaret King, Psy.D.

CONTACT

6107436503; mking@caron.org

Dean Stankoski, MS

CONTACT

6107436224; dstankoski@caron.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, all study staff including the PI, and clinical staff will be blinded to the group assignment. The PI will remain unblinded as they created the randomization design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Model Details: This is a two-armed, prospective, randomized, double-blind, sham-controlled clinical trial

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 21, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)