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

120 Participants Needed

Trial Summary

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 data supports the effectiveness of the Safe and Sound Protocol treatment for depression and anxiety?

The Safe and Sound Protocol treatment may benefit from the general effectiveness of psychological therapies, as seen in the IAPT service, which shows positive outcomes for depression and anxiety. Additionally, monitoring and feedback methods in psychotherapy have been shown to improve recovery rates, suggesting that structured approaches can enhance treatment outcomes. ^{1 2 3 4 5}

Is the Safe and Sound Protocol generally safe for humans?

The safety of psychological interventions, like the Safe and Sound Protocol, is important, but there is a need for more standardized and comprehensive reporting of adverse events (unintended negative effects) in clinical trials. Current research highlights the importance of monitoring and reporting these events to ensure treatments are safe. ^{6 7 8 9 10}

How does the Safe and Sound Protocol treatment differ from other treatments for depression and anxiety?

The Safe and Sound Protocol is unique because it is a non-invasive treatment that uses specially designed music to stimulate the vagus nerve, which can help regulate the nervous system and improve emotional regulation, unlike traditional treatments that often involve medication or talk therapy. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Michelle Leal

Principal Investigator

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Quality assurance in inpatient treatment of depression. Aspects of quality monitoring and external quality assurance exemplified by a pilot project of inpatient treatment of depression]. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Transparency about the outcomes of mental health services (IAPT approach): an analysis of public data. [2023]

3. Spain pubmed.ncbi.nlm.nih.gov

Assessing a therapeutic exchange protocol for second-generation antidepressants: clinical results. [2013]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Pragmatic issues in design and implementation of a psychotherapy outcome study. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

A Proposed Algorithm for Improved Recognition and Treatment of the Depression/Anxiety Spectrum in Primary Care. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Implementing the evidence: Routine screening for depression and anxiety in primary care. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Can we distinguish anxiety from depression? [2022]

14. United States 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. [2023]

15. England pubmed.ncbi.nlm.nih.gov

Anxiety disorders: does one treatment fit all? [2014]