NCT06701578

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

A protocol has been developed that provides patients an intervention of listening to specifically designed filtered and modulated music that stimulates the part of the nervous system that induces a calm physiological (bodily) state. This enhancement may help re-establish nerve pathways between auditory processing and emotional regulation systems which promotes improved emotional regulation in regards to depression and anxiety. For this study, participants will either be assigned to the active group who receives the therapy with auditory stimulation that is modulated, or be assigned to the control group who will receive the same interventions without the modulated auditory stimuli.

Conditions

• Anxiety
• Depression

Interventions

Type	Name	Description
OTHER	Safe and Sound Protocol	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.
OTHER	Control	Listening to music that is not filtered and modulated for up to five hours.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-03-01
• Completion: 2027-06-01
• First posted: 2024-11-22
• Last updated: 2025-07-28

Locations

1 site across 1 country: United States