Safe & Sound Protocol in Adults With Trauma and SUD
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Safe and Sound Protocol
DeviceParticipants 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Active SSPExperimental treatment 1 intervention
Group B: Sham SSPSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 1 and Day 82
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.
Time frame
Day 1 and Day 83
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.
Time frame
Day 1 and Day 8Secondary outcomes
1
Differences in positive and negative affect scores pre-post between groups as measured by the Positive and Negative Affect Schedule (PANAS).
Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in positive and negative affect outcomes between treatment and sham group. Positive and Negative Affect Schedule (PANAS) is a self-report screening tool with independent scores for positive affect and negative affect, both have a minimum score of 10 and maximum of 50. For positive affect, higher scores indicate greater positive mood, enthusiasm, engagement, and energy. For negative affect, higher scores indicate greater positive distress, anxiety, anger, guilt, and other negative emotional states.
Time frame
Day 1 and Day 82
Changes in mindfulness scores pre-post between groups as measured by the Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in mindfulness outcomes, as measured by the CAMS-R, between treatment and sham group. The Cognitive and Affective Mindfulness Scale - Revised (10-item; CAMS-R) is a self-report measure of mindfulness with a minimum score of 10 and maximum of 40. Higher scores indicate greater mindfulness.
Time frame
Day 1 and Day 8Sponsors and contacts
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Source ClinicalTrials.gov