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Behavioural Intervention
Safe and Sound Protocol for Depression and Anxiety (SSP Trial)
N/A
Waitlist Available
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 belowSelect...
I am 18 years old or older.
Select...
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:Select...
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.
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 moreTrial 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.
Find a Location
Who is running the clinical trial?
HealthPartners InstituteLead Sponsor
194 Previous Clinical Trials
3,721,287 Total Patients Enrolled
6 Trials studying Depression
23,730 Patients Enrolled for Depression