Clinical trial NCT06701578: The Effect of the Safe and Sound Protocol on Depression and Anxiety Symptoms
Official title: The Effect of the Safe and Sound Protocol on Depression and Anxiety Symptoms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Keywords: auditory
sound
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Client of DayBridge
* 18 years old or older
* Meet the DMS-V diagnostic criteria of Major Depressive Disorder and/or Generalized Anxiety Disorder

Exclusion Criteria:

* Previous participation in the SSP
* Self-reported hearing loss

Primary outcomes:
measure: PHQ-9
timeFrame: 10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment
measure: GAD-7
timeFrame: 10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment.
measure: BPQ-SF
timeFrame: 10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment.
measure: Heart Period and Respiratory Sinus Arrhythmia
timeFrame: 10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
Study officials:
name: Michelle Leal
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Social Outcomes of a Child with Autism Spectrum Disorder Following a Listening Protocol. Journal of Occupational Therapy, Schools, & Early Intervention
citation: 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.
citation: A Pilot Study of Integrated Listening Systems for Children With Sensory Processing Problems. Journal of Occupational Therapy, Schools, & Early Intervention
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citation: 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.
citation: Meuret AE, Tunnell N, Roque A. Anxiety Disorders and Medical Comorbidity: Treatment Implications. Adv Exp Med Biol. 2020;1191:237-261. doi: 10.1007/978-981-32-9705-0_15.
citation: Mahlich J, Tsukazawa S, Wiegand F. Estimating Prevalence and Healthcare Utilization for Treatment-Resistant Depression in Japan: A Retrospective Claims Database Study. Drugs Real World Outcomes. 2018 Mar;5(1):35-43. doi: 10.1007/s40801-017-0126-5.
citation: Clinical effectiveness of the Safe and Sound Protocol in improving sensory processing: A pilot study. Frontiers in Psychiatry
citation: Kawai H, Kishimoto M, Okahisa Y, Sakamoto S, Terada S, Takaki M. Initial Outcomes of the Safe and Sound Protocol on Patients with Adult Autism Spectrum Disorder: Exploratory Pilot Study. Int J Environ Res Public Health. 2023 Mar 9;20(6):4862. doi: 10.3390/ijerph20064862.
citation: Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
citation: Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.
citation: Domschke K, Stevens S, Pfleiderer B, Gerlach AL. Interoceptive sensitivity in anxiety and anxiety disorders: an overview and integration of neurobiological findings. Clin Psychol Rev. 2010 Feb;30(1):1-11. doi: 10.1016/j.cpr.2009.08.008.