Anxiety, Posttraumatic Stress Symptom, Substance Use Disorders
Conditions
Keywords
substance use disorders, posttraumatic stress symptoms, anxiety
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.
Detailed description
The Safe and Sound Protocol (SSP) was developed by Dr. Stephen Porges based on his Polyvagal Theory that highlights the vagus nerve's influences on emotional and behavioral regulation, social connection, and fear/trauma responses. Research examining the effectiveness of SSP with children and/or adults on the Autism Spectrum has shown improvement in social awareness and decline in auditory hypersensitivities and hypo-sensitivities, visual sensitivity, tactile hypersensitivities, selective eating and digestive problems. SSP has also been shown to reduce symptoms of anxiety, depression and autonomic reactivity in individuals engaged in speech therapy for voice and throat complaints. There is on-going clinical research to examine the effectiveness of SSP in various populations, including those suffering from posttraumatic stress disorder (PTSD). In real-world data obtain through the SSP platform, just over half of individuals reporting clinical levels of PTSD symptoms as assessed on the Posttraumatic Checklist - 5 (PCL-5) had a reduction in symptoms to below the clinical threshold following the completion of SSP. Safe and Sound Protocol (SSP) Core is five hours of music therapy that is progressively filtered through a patented algorithm that highlights middle sound frequencies, the frequency most associated with cues of safety from human speech. This is designed to stimulate the vagus nerve by engaging the middle ear muscles and nerves to move out of defensive state of activation and activate the social engagement and calming system of the nervous system. SSP is designed to help participants regulate their nervous system to support reduction in distress and increased social connection. To date, there is no research underway to examine the effectiveness of SSP for individuals experiencing posttraumatic stress symptoms and a substance use disorder (SUD). Individuals experiencing posttraumatic stress symptoms and SUD are hypothesized to benefit from a non-invasive treatment designed to regulate their autonomic nervous system, such as SSP.
Interventions
DEVICESafe 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.
Sponsors
Caron Treatment Centers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
This is a two-armed, prospective, randomized, double-blind, sham-controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in posttraumatic stress symptom scores pre-post between groups as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). | Day 1 and Day 8 | 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. |
| Difference in anxiety symptom scores pre-post between groups as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale. | Day 1 and Day 8 | 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. |
| Difference in autonomic arousal symptom scores pre-post between groups as measured by the Body Perception Questionnaire Autonomic Symptoms - short form (BPQ-20 ANS). | Day 1 and Day 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
Countries
United States
Contacts
CONTACTMargaret King, Psy.D.
CONTACTDean Stankoski, MS
PRINCIPAL_INVESTIGATORMargaret King, Psy.D.
Caron Treatment Centers
STUDY_DIRECTORErin Takemoto, PhD
Caron Treatment Centers
Outcome results
None listed