Recruiting

Safe and Sound Protocol

Sponsor:

Caron Treatment Centers

Code:

NCT07219056

Conditions

Substance Use Disorders

Posttraumatic Stress Symptom

Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Safe and Sound Protocol

Study Details

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

Study ID

NCT07219056

Start date

Dec 15, 2025

Status verified date

Jul, 2026

Completion date

Mar 15, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 procedures and availability for the duration of the study.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Safe and Sound Protocol

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.

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 ]
  • Difference in anxiety symptom scores pre-post between groups as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale. [ Time Frame: 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). [ Time Frame: Day 1 and Day 8 ]

Central Contacts and Locations

Central contacts

Margaret King, Psy.D.

6107436503mking@caron.org

Dean Stankoski, MS

6107436224dstankoski@caron.org

Locations

Caron Treatment Centers

Recruiting

Wernersville, Pennsylvania, United States, 19565

Contacts

Erin Takemoto, PhD

484-345-2626etakemoto@caron.org

Dean Stankoski, MS

610-743-6224DStankoski@caron.org

More Information

Sponsor

Caron Treatment Centers

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • substance use disorders
  • posttraumatic stress symptoms
  • anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Caron Treatment Centers on 2026-08-03.