The Effect of the Safe and Sound Protocol on Depression and Anxiety Symptoms

Part of paid clinical trials in Saint Paul, Minnesota.

Sponsor
HealthPartners Institute
Study ID
NCT06701578
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Safe and Sound Protocol — OTHER
    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.
  • Control — OTHER
    Listening to music that is not filtered and modulated for up to five hours.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jul 2025
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Safe and Sound Protocol Group
    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.
  • Placebo Comparator: Control Group
    The control condition involves listening to music that is not filtered and modulated.

Primary Outcome Measure

PHQ-9 [ Time Frame: 10 minutes at enrollment visit and 10 minutes at final study visit 3 weeks after enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Regions HospitalSaint PaulMinnesota55101
Peggy Ninow
[email protected]
651-254-6836
Peggy Ninow (PRINCIPAL_INVESTIGATOR)

Find similar trials in Saint Paul, MN

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Regions Hospital· Saint Paul, MN

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