The Effect of the Safe and Sound Protocol on Depression and Anxiety Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- PHQ-9
研究概览
简要总结
The goal of this study is to determine if a developed protocol involving modulated auditory stimulation is better than non-modulated auditory stimulation in reducing anxiety and depression in human subjects.
详细描述
A protocol has been developed that provides patients an intervention of listening to specifically designed filtered and modulated music that stimulates the part of the nervous system that induces a calm physiological (bodily) state. This enhancement may help re-establish nerve pathways between auditory processing and emotional regulation systems which promotes improved emotional regulation in regards to depression and anxiety. For this study, participants will either be assigned to the active group who receives the therapy with auditory stimulation that is modulated, or be assigned to the control group who will receive the same interventions without the modulated auditory stimuli.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Client of DayBridge
- •18 years old or older
- •Meet the DMS-V diagnostic criteria of Major Depressive Disorder and/or Generalized Anxiety Disorder
排除标准
- •Previous participation in the SSP
- •Self-reported hearing loss
研究组 & 干预措施
Safe and Sound Protocol Group
The intervention involves listening to specially designed filtered and modulated music that is tailored to enhance the individual's auditory system's ability to process and respond to auditory stimuli.
干预措施: Safe and Sound Protocol (Other)
Control Group
The control condition involves listening to music that is not filtered and modulated.
干预措施: Control (Other)
结局指标
主要结局
PHQ-9
时间窗: 10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment
The 9-question Patient Health Questionnaire (PHQ-9) is a self-report screening tool for adults in primary care settings for assessing the presence and severity of depression symptoms. Items are aligned with the DSM-5 diagnostic criteria for MDD and queries the individual's experience in the past two weeks. Likert-type responses range from 0 ("Not at all") to 3 ("Nearly every day"). Good reliability and validity have been demonstrated. The PHQ-9 score is the key outcome variable for MDD symptoms. The total score is obtained by summing the values of the seven items. The total score ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
GAD-7
时间窗: 10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment.
The Generalized Anxiety Disorder 7 (GAD 7) is a self-administered measure of the frequency and severity of generalized anxiety disorder symptoms based on seven DSM-5 diagnostic criteria for GAD. It is typically used in outpatient and primary care settings. Response options are a Likert-type scale ranging from 0 ("Not at all") to 3 ("Nearly every day"). An additional question is a global rating of the severity of the patient's anxiety over the past 2 weeks. The measure is considered sensitive and has shown adequate internal consistency reliability and validity for assessing anxiety across a wide range of samples and settings. The GAD-7 score is the key outcome variable for GAD symptoms. The scoring involved summing the values of all seven items to obtain a score between 0 and 21. Higher scores indicate greater severity of anxiety symptoms.
BPQ-SF
时间窗: 10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment.
The Body Perception Questionnaire - Short Form (BPQ-SF) is an abbreviated version of the original self-report measure of body awareness and autonomic reactivity. The questionnaire consists of two subscales, Body Awareness (26 items) and Autonomic Nervous System Reactivity (20 items). The Likert-type scale answers range from 1 ("Never") to 5 ("Always"). Total scores for each subscale, which are key outcome variables, are summed and compared to T-scores in the BPQ Manual.
Heart Period and Respiratory Sinus Arrhythmia
时间窗: 10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment.
Heart period will be recorded at 1000 Hz using a Polar H10 chest strap device. This device has shown strong agreement and small bias compared to electrocardiogram (ECG) recordings. It has been chosen as it is minimally invasive and easy for participants to put on. RSA and heart period will be used to calculate the vagal contribution to regulation of the heart, i.e., vagal tone.
次要结局
未报告次要终点