AnxietySSPNCT06701578
The Effect of the Safe and Sound Protocol on Depression and Anxiety Symptoms
A study testing Safe and Sound Protocol in people with Anxiety and Depression, run by HealthPartners Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Safe and Sound Protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2027to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Client of DayBridge
- 18 years old or older
- Meet the DMS-V diagnostic criteria of Major Depressive Disorder and/or Generalized Anxiety Disorder
Who cannot join
- Previous participation in the SSP
- Self-reported hearing loss
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Regions Hospital
Saint Paul, Minnesota, 55101
Peggy Ninow, 651-254-6836, Peggy.L.Ninow@healthpartners.com
Peggy Ninow
About this study
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.
Read the 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.
- Conditions
- Anxiety, Depression
- Being tested
- Safe and Sound Protocol, Control
- Keywords
- auditory, sound
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe and Sound ProtocolOther
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.
ControlOther
Listening to music that is not filtered and modulated for up to five hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Safe and Sound Protocol |
| Control Group | Placebo comparator | The control condition involves listening to music that is not filtered and modulated. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study startJun 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Leal, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701578
- Sponsor's protocol ID
- A24-341
- Acronym
- SSP
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 26890280Strawn 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.
PubMed 30056792Social 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.
PubMed 16717171A 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.
PubMed 36081005Plummer 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.
PubMed 26719105Meuret 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.
PubMed 32002933Mahlich 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.
PubMed 29185233Clinical effectiveness of the Safe and Sound Protocol in improving sensory processing: A pilot study. Frontiers in Psychiatry
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.
PubMed 36981773Harris 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.
PubMed 18929686Faul 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.
PubMed 19897823Domschke 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.
PubMed 19751958
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Safe and Sound Protocol on Depression and Anxiety Symptoms
- ClinicalTrials.gov ID
- NCT06701578
- Acronym / sponsor ID
- SSP / A24-341
- Conditions
- Anxiety, Depression
- Keywords
- auditory, sound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- Jun 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safe and Sound Protocol Group | Experimental | Other: Safe and Sound ProtocolThe 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. |
| Control Group | Placebo comparator | Other: ControlThe control condition involves listening to music that is not filtered and modulated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Client of DayBridge
- 18 years old or older
- Meet the DMS-V diagnostic criteria of Major Depressive Disorder and/or Generalized Anxiety Disorder
Key exclusion criteria (2 listed)
- Previous participation in the SSP
- Self-reported hearing loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe and Sound ProtocolListening 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. | Other | Safe and Sound Protocol Group |
| ControlListening to music that is not filtered and modulated for up to five hours. | Other | Control Group |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- BackgroundUsing 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: PubMed 26890280Vargas 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.
- Background: PubMed 30056792Strawn 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.
- BackgroundSocial Outcomes of a Child with Autism Spectrum Disorder Following a Listening Protocol. Journal of Occupational Therapy, Schools, & Early Intervention
- Background: PubMed 16717171Spitzer 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.
- BackgroundA Pilot Study of Integrated Listening Systems for Children With Sensory Processing Problems. Journal of Occupational Therapy, Schools, & Early Intervention
- Background: PubMed 36081005Schaffarczyk 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.
- Background: PubMed 26719105Plummer 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.
- Background: PubMed 32002933Meuret 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.
- Background: PubMed 29185233Mahlich 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.
- BackgroundClinical effectiveness of the Safe and Sound Protocol in improving sensory processing: A pilot study. Frontiers in Psychiatry
- Background: PubMed 36981773Kawai 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Leal principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe and Sound Protocol in people with Anxiety and Depression, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Leal (+27662496829, lealmic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PHQ-9 (time frame: 10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06701578, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.