The Effect of the Safe and Sound Protocol on Emotional Regulation in Traumatized Adults With Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Difference in posttraumatic stress symptom scores pre-post between groups as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Does not speak English
- •Age < 18 or > 75
- •Does not have a history of trauma
- •Active psychosis
- •Active or uncontrolled seizures
- •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.
研究组 & 干预措施
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.
干预措施: Safe and Sound Protocol (Device)
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.
干预措施: Safe and Sound Protocol (Device)
结局指标
主要结局
Difference in posttraumatic stress symptom scores pre-post between groups as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
时间窗: 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.
时间窗: 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).
时间窗: 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.
次要结局
- 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)
- 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)
研究者
Erin Takemoto
Research Director
Caron Treatment Centers