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Behavioural Intervention

Safe and Sound Protocol for Depression and Anxiety (SSP Trial)

N/A

Waitlist Available

Led By Michelle Leal

Research Sponsored by HealthPartners Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years old or older

Meet the DMS-V diagnostic criteria of Major Depressive Disorder and/or Generalized Anxiety Disorder

Must not have

Self-reported hearing loss

Timeline

Screening 3 weeks

Treatment Varies

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

Summary

This trial aims to see if a new method of using sound can help reduce anxiety and depression in people better than the traditional method.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves auditory stimulation, potential side effects may include discomfort from wearing headphones, fatigue from listening sessions, or temporary changes in mood or stress levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have noticed a decrease in my hearing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

BPQ-SF

GAD-7

Heart Period and Respiratory Sinus Arrhythmia

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Safe and Sound Protocol GroupExperimental Treatment1 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 GroupPlacebo Group1 Intervention

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

0 / 3Eligibility criteria met