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NCT06701578 · ClinicalTrials.gov registry record · NA
The Effect of the Safe and Sound Protocol on Depression and Anxiety Symptoms
A NA study, sponsored by HealthPartners Institute.
- Not yet
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT06701578: Clinical Trial NA study, sponsored by HealthPartners Institute.
NCT06701578 is a NA study that has not yet begun recruiting, run by HealthPartners Institute. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06701578, a NA study, has not yet begun recruiting, sponsored by HealthPartners Institute.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study 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.
Primary Outcome
The 9-question Patient Health Questionnaire (PHQ-9) is a self-report screening tool for adults in primary care settings for assessing the presence and severity of depression symptoms. Items are aligned with the DSM-5 diagnostic criteria for MDD and queries the individual's experience in the past two weeks. Likert-type responses range from 0 ("Not at all") to 3 ("Nearly every day"). Good reliability and validity have been demonstrated. The PHQ-9 score is the key outcome variable for MDD symptoms.
Interventions
- OTHER Control
- OTHER Safe and Sound Protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2026-06 |
| Est. Completion | 2027-06 |
| Phase | NA |
What is known before NCT06701578 opens enrollment
NCT06701578 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT06701578 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06701578 about?
NCT06701578 is a clinical study titled "The Effect of the Safe and Sound Protocol on Depression and Anxiety Symptoms". 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.
What is the current status of trial NCT06701578?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2026-06. Estimated completion is 2027-06.
What interventions are being tested in trial NCT06701578?
The interventions under investigation include: Control (OTHER), Safe and Sound Protocol (OTHER).
Who is sponsoring clinical trial NCT06701578?
This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06701578's enrollment target sits among peer trials
120 762nd of 2000 higher than 1,198 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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