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

July 25, 2025 updated by: HealthPartners Institute
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Placebo Comparator: Control Group
The control condition involves listening to music that is not filtered and modulated.
Other: Control
Listening to music that is not filtered and modulated for up to five hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PHQ-9
Time Frame: 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.
10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment
GAD-7
Time Frame: 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.
10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment.
BPQ-SF
Time Frame: 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.
10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment.
Heart Period and Respiratory Sinus Arrhythmia
Time Frame: 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.
10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Investigators

  • Principal Investigator: Michelle Leal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Actual)

November 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 28, 2025

Last Update Submitted That Met QC Criteria

July 25, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A24-341

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared with external entities outside of aggregate form for publication. Deidentified data will be shared with the study sponsor. Study identifiers will be destroyed after publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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