Post-Traumatic Stress Disorder (PTSD) Clinical Trials

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The Effect of the Safe and Sound Protocol on Emotional Regulation in Traumatized Adults With Substance Use Disorders

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
Pennsylvania
Caron Treatment Centers
RECRUITING
Wernersville
Contact Information
Primary
Margaret King, Psy.D.
mking@caron.org
6107436503
Backup
Dean Stankoski, MS
dstankoski@caron.org
6107436224
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2027-03-15
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Caron Treatment Centers

This content was sourced from clinicaltrials.gov