Safe and Sound Protocol for Depression and Anxiety

(SSP Trial)

Overseen By Michelle Leal

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Disqualifiers: Previous SSP, Hearing loss

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if specially designed music can reduce anxiety and depression more effectively than regular music. Participants will either experience the new music therapy, called the Safe and Sound Protocol, or listen to standard music for comparison. The trial seeks individuals diagnosed with major depression or generalized anxiety who are clients of DayBridge. This research could provide a new method to treat these conditions using sound therapy. As an unphased trial, it offers a unique opportunity to explore innovative sound therapy as a potential treatment option.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for reducing anxiety and depression?

Research shows that the Safe and Sound Protocol (SSP) is a treatment that most people tolerate well. It involves listening to specially designed music to help the brain process sounds better. Various studies have tested this treatment for conditions like PTSD and anxiety.

Early results suggest that SSP users feel more relaxed and connected with others. These studies have reported no major safety issues. Participants usually experience mild effects, such as increased awareness of their surroundings, indicating SSP's safety.

Since this trial is not in its early stages, some safety data is already available. The treatment aims to support well-being without causing harm. Overall, SSP appears to be a safe option for managing anxiety and depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Safe and Sound Protocol because it takes a novel approach to treating depression and anxiety by using specially designed filtered and modulated music. Unlike traditional treatments like medication or talk therapy, this protocol aims to enhance the auditory system's ability to process and respond to sound, potentially addressing underlying sensory processing issues related to these conditions. This innovative method could offer a non-invasive and potentially faster-acting alternative to existing treatments, which often focus on chemical imbalances in the brain.

What evidence suggests that the Safe and Sound Protocol is effective for reducing anxiety and depression?

Research has shown that the Safe and Sound Protocol (SSP), which participants in this trial may receive, might help reduce anxiety and depression. One study found that people who used SSP experienced a noticeable decrease in their anxiety and depression levels. Another report indicated that 81% of SSP users saw improvement in their symptoms. Specifically, 53% of these individuals went from having serious concerns to having no clinical concerns. These results suggest that SSP's unique use of filtered music could effectively manage anxiety and depression. ^{2 4 5 6 7}

Who Is on the Research Team?

Michelle Leal

Principal Investigator

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are clients at DayBridge and have been diagnosed with Major Depressive Disorder or Generalized Anxiety Disorder according to the DSM-V. It's not open to those who've done SSP before or have self-reported hearing loss.

Inclusion Criteria

Client of DayBridge

I have been diagnosed with Major Depressive Disorder or Generalized Anxiety Disorder.

Exclusion Criteria

I have noticed a decrease in my hearing.

Previous participation in the SSP

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive either modulated or non-modulated auditory stimulation therapy

3 weeks

1 enrollment visit, 1 final study visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Safe and Sound Protocol

Trial Overview The study is testing if the Safe and Sound Protocol (SSP), which uses modulated auditory stimulation, can better reduce symptoms of depression and anxiety compared to non-modulated sounds in a control group.

How Is the Trial Designed?

Group I: Safe and Sound Protocol Group Experimental Treatment 1 Intervention

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.

Group II: Control Group Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

Published Research Related to This Trial

In a study of 1324 discharged patients, 10.88% experienced adverse events (AEs), with medication-related AEs occurring in 90% of those affected, highlighting the significant risk of harm from neuropsychiatric treatments.

The neuropsychiatry trigger tool (NPTT) was highly effective, identifying 30 times more AEs than traditional reporting methods, suggesting it could be a valuable tool for improving patient safety and reducing harm in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. Sharma, S., Kapoor, K., Nasare, N., et al.[2023]

The safety of psychological interventions is critical, as adverse events (AEs) can occur and must be carefully evaluated to ensure that these interventions do not cause harm before being deemed beneficial.

There is a pressing need for standardized protocols for assessing and reporting AEs in psychological interventions to improve transparency, consistency, and ultimately enhance clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? Purgato, M., Cortese, S.[2023]

The comprehensive body system review (BSR) in the Safety Monitoring Uniform Report Form (SMURF) identified 129 additional adverse events (AEs) in pediatric patients, significantly more than the 48 AEs from the general inquiry and 16 from the drug-specific inquiry, highlighting its effectiveness in capturing important safety data.

Parents found the detailed BSR acceptable and satisfactory, while clinicians did not share the same level of acceptance, indicating a potential gap in the perceived utility of detailed adverse event reporting methods in pediatric psychopharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill, LL., Vitiello, B., Fisher, P., et al.[2007]

A systematic review of 115 psychotherapy study protocols revealed that while 77 protocols explicitly addressed harm, there was a lack of standardization in how harm was conceptualized and assessed, particularly regarding adverse events.

The review highlighted that although serious adverse events were defined consistently, the definitions and considerations for adverse events varied widely, suggesting a need for more standardized approaches in clinical research to effectively monitor and report harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

In clinical trials, 30% of patients do not respond to psychotherapy, and up to 65% leave treatment without any benefit, highlighting the need for better monitoring of patient progress.

Using computer-assisted feedback methods can significantly improve treatment outcomes, reducing deterioration rates in at-risk patients from 21% to 13% and increasing recovery rates from 20% to 35%, with even better results when combined with problem-solving strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing Psychotherapy Outcome beyond Evidence-Based Medicine. Lambert, MJ.[2017]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

The Improving Access to Psychological Therapies (IAPT) service in the UK effectively monitors and reports clinical outcomes for over 537,000 patients annually, revealing that specific organizational factors, such as the number of treatment sessions and timely access to care, significantly predict better mental health outcomes.

Improvements in service organization could enhance clinical outcomes by 11-42%, indicating that how psychological therapies are delivered is as crucial as the treatments themselves, and this model could be beneficial for mental health services globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transparency about the outcomes of mental health services (IAPT approach): an analysis of public data. Clark, DM., Canvin, L., Green, J., et al.[2023]

The ADAPT program is a new collaborative care model aimed at improving outcomes for patients with mild to moderate-severe depression and anxiety, utilizing evidence-based practices like measurement-based care and accurate diagnosis.

This study will compare the effectiveness of the ADAPT program against traditional outpatient psychiatric care, potentially providing valuable insights into the implementation and outcomes of collaborative care in a large health system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Implementation and Outcomes of the Achieving Depression and Anxiety Patient-Centered Treatment Collaborative Care Program in a Large, Integrated Health Care System: A Mixed Methods Observational Study Protocol. Ridout, KK., Ridout, SJ., Alavi, M., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04999852

The Effects of the Safe and Sound Protocol on PTSD ... The Safe and Sound Protocol (SSP) is a passive acoustic intervention that is designed as a "neural exercise" to promote efficient regulation of autonomic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10049251/

Initial Outcomes of the Safe and Sound Protocol on ... In this study, only the Social Awareness scale of the SRS-2 Family-Report showed a significant improvement after the intervention. In addition, it was ...

3. integratedlistening.com integratedlistening.com/resources/real-world-evidence/

Real-World Evidence - Unyte Integrated ... SSP CORE · 81% reported an improvement in symptoms. · 53% of clients moved from clinical to non-clinical level (score less than 10). · The average score on the PHQ ...

4. withpower.com withpower.com/trial/phase-depressive-disorder-11-2024-9a597

Safe and Sound Protocol for Depression and Anxiety (SSP ... In clinical trials, 30% of patients do not respond to psychotherapy, and up to 65% leave treatment without any benefit, highlighting the need for better ...

5. integratedlistening.com integratedlistening.com/research/study-shows-the-safe-and-sound-protocols-potential-to-help-individuals-with-voice-and-throat-complaints/

Study shows the Safe and Sound Protocol's potential to ... Participants demonstrated a significant decrease in anxiety, depression and autonomic reactivity post-SSP. As measured using the Hospital Anxiety and Depression ...

6. integratedlistening.com integratedlistening.com/products/ssp-safe-sound-protocol/clinical-resources/

Safe and Sound Protocol (SSP): Clinical Information and ... The purpose of the Safe & Sound Protocol (SSP) is to initiate and access a physiological state conducive to well-being, positive engagement with others, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07219056

Safe & Sound Protocol in Adults With Trauma and SUD Data to be collected will include measures on affect, anxiety, personality, mindfulness, and posttraumatic stress disorder symptoms. The SSP has ...