The Effect of the Safe and Sound Protocol on Depression and Anxiety Symptoms
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Safe and Sound Protocol, Control.
- Кому может быть актуально
- Состояния в реестре: Anxiety, Depression. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Другое Safe and Sound Protocol
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 for up to five hours. - Другое Control
Listening to music that is not filtered and modulated for up to five hours.
Первичные конечные точки
- PHQ-9 [Срок оценки: 10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment]
- GAD-7 [Срок оценки: 10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment.]
- BPQ-SF [Срок оценки: 10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment.]
- Heart Period and Respiratory Sinus Arrhythmia [Срок оценки: 10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment.]
Критерии участия
Критерии включения
- Client of DayBridge
- 18 years old or older
- Meet the DMS-V diagnostic criteria of Major Depressive Disorder and/or Generalized Anxiety Disorder
Критерии исключения
- Previous participation in the SSP
- Self-reported hearing loss
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Regions Hospital — Saint Paul
Публикации
- Using the Safe and Sound Protocol (SSP) in clinical practice-Improving outcomes for clients with sensory processing difficulties and trauma-related challenges. International Journal of Environmental Research and Public Health
- Vargas S, Lucker JR. A Quantitative Summary of The Listening Program (TLP) Efficacy Studies: What Areas Were Found to Improve by TLP Intervention? Occup Ther Int. 2016 Jun;23(2):206-17. doi: 10.1002/oti.1425. Epub 2016 Feb 17. PMID 26890280
- Strawn JR, Geracioti L, Rajdev N, Clemenza K, Levine A. Pharmacotherapy for generalized anxiety disorder in adult and pediatric patients: an evidence-based treatment review. Expert Opin Pharmacother. 2018 Jul;19(10):1057-1070. doi: 10.1080/14656566.2018.1491966. PMID 30056792
- Social Outcomes of a Child with Autism Spectrum Disorder Following a Listening Protocol. Journal of Occupational Therapy, Schools, & Early Intervention
- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. PMID 16717171
- A Pilot Study of Integrated Listening Systems for Children With Sensory Processing Problems. Journal of Occupational Therapy, Schools, & Early Intervention
- Schaffarczyk M, Rogers B, Reer R, Gronwald T. Validity of the Polar H10 Sensor for Heart Rate Variability Analysis during Resting State and Incremental Exercise in Recreational Men and Women. Sensors (Basel). 2022 Aug 30;22(17):6536. doi: 10.3390/s22176536. PMID 36081005
- Plummer F, Manea L, Trepel D, McMillan D. Screening for anxiety disorders with the GAD-7 and GAD-2: a systematic review and diagnostic metaanalysis. Gen Hosp Psychiatry. 2016 Mar-Apr;39:24-31. doi: 10.1016/j.genhosppsych.2015.11.005. Epub 2015 Nov 18. PMID 26719105
Идентификаторы
NCT: NCT06701578 · A24-341