Safe & Sound Protocol in Adults With Trauma and SUD

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCaron Treatment Centers

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Does not speak English

Age < 18 or > 75

Does not have a history of trauma

Active psychosis

Trial design

Treatments tested in this trial

  • Safe and Sound Protocol

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators