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

HealthPartners Institute

Status: Begins enrollment this month

Conditions: Depression; Anxiety

Treatments: Other: Control; Other: Safe and Sound Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06701578

A24-341

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Client of DayBridge
• 18 years old or older
• Meet the DMS-V diagnostic criteria of Major Depressive Disorder and/or Generalized Anxiety Disorder

Exclusion criteria

• Previous participation in the SSP
• Self-reported hearing loss

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

120 participants in 2 patient groups, including a placebo group

Safe and Sound Protocol Group

Experimental group

Description:

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.

Treatment:

Other: Safe and Sound Protocol

Control Group

Placebo Comparator group

Description:

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

Treatment:

Other: Control