The Effect of the Safe and Sound Protocol on Depression and Anxiety Symptoms

NCT06701578 | Not Yet Recruiting

• 1 other identifier: A24-341
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression

Keywords

auditory; sound

Outcome Measures

Primary Outcomes (4)

• PHQ-9

  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.

  10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment

• GAD-7

  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.

  10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment.

• BPQ-SF

  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.

  10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment.

• Heart Period and Respiratory Sinus Arrhythmia

  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.

  10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment.

Study Arms (2)

Safe and Sound Protocol Group

EXPERIMENTAL

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.

Other: Safe and Sound Protocol

Control Group

PLACEBO COMPARATOR

The control condition involves listening to music that is not filtered and modulated.

Other: Control

Interventions

Safe and Sound Protocol OTHER

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.

Safe and Sound Protocol Group

Control OTHER

Listening to music that is not filtered and modulated for up to five hours.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Related Publications (15)

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Social Outcomes of a Child with Autism Spectrum Disorder Following a Listening Protocol. Journal of Occupational Therapy, Schools, & Early Intervention

  BACKGROUND

• 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 BACKGROUND

• A Pilot Study of Integrated Listening Systems for Children With Sensory Processing Problems. Journal of Occupational Therapy, Schools, & Early Intervention

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 32002933 BACKGROUND

• 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.

  PMID: 29185233 BACKGROUND

• Clinical effectiveness of the Safe and Sound Protocol in improving sensory processing: A pilot study. Frontiers in Psychiatry

  BACKGROUND

• 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.

  PMID: 36981773 BACKGROUND

• 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.

  PMID: 18929686 BACKGROUND

• 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.

  PMID: 19897823 BACKGROUND

• 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.

  PMID: 19751958 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Michelle Leal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Leal

CONTACT

+27662496829; lealmic@gmail.com

Peggy Ninow

CONTACT

651-254-6836; Peggy.L.Ninow@healthpartners.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)