SoundBridge Health Research Program

Working title↑ top

A Pilot Study of Usability, Safety, and Engagement With the SoundBridge Personalized Music-Guided Breathing Protocol

Why start here↑ top

Before measuring clinical effectiveness, SoundBridge should establish that people can understand the experience, select emotionally safe music, use the breathing guidance comfortably, and return to the practice over time. This pilot is designed to improve the product and identify safety issues before a larger controlled trial.

Study question↑ top

Can adults with mild to moderate anxiety and/or depressive symptoms safely use and engage with SoundBridge across the full 10-week protocol?

Proposed design↑ top

• Design: Single-arm mixed-methods feasibility study
• Participants: 20–30 adults
• Duration: 10 weeks
• Dose: 1 guided session per week, approximately 30 minutes each, with daily RTM content between sessions
• Delivery: Remote digital platform, with an onboarding session and support contact as appropriate

What participants do↑ top

1. Complete consent, screening, and baseline questionnaires.
2. Choose several songs that are familiar, personally meaningful, and emotionally safe, as guided by the facilitator.
3. Receive guidance to create a small approved playlist to support achieving specific emotional and physiological outcomes.
4. Choose a simple grounding gesture, such as placing a hand over the chest, resting hands on the abdomen, or using a comfortable seated posture, to focus attention.
5. Complete guided sessions using music, breathing prompts, and their grounding gesture.
6. Report comfort, emotional response, music suitability, and usability after each session.
7. Complete a closing interview or structured feedback survey.

Key outcomes↑ top

Suggested success criteria↑ top

These should be finalized before launch, but a reasonable starting point is:

• At least 75% of enrolled participants complete the ten-week pilot.
• At least 70% complete seven or more of the ten sessions.
• At least 80% can select or be supported to select emotionally safe music.
• No unexpected serious intervention-related adverse events.
• Most participants rate the experience as understandable and acceptable.
• The team can identify clear product changes from participant feedback.

Safety approach↑ top

• Music choices are screened for associations with trauma, acute grief, self-harm, substance-use triggers, or severe agitation.
• Participants can skip a song, stop a session, switch to neutral audio, or return to natural breathing at any time.
• Instructions emphasize gentle, non-forced breathing; participants stop pacing if dizzy, panicky, or uncomfortable.
• People with acute psychiatric instability or imminent suicide risk are referred for immediate clinical evaluation rather than enrolled in a self-regulation pilot.

Deliverables↑ top

• Revised onboarding workflow
• Music-selection and music-safety checklist
• Revised session scripts and grounding-gesture guide
• Preliminary engagement dashboard
• Feasibility report for partners and IRB planning
• Decision memo defining whether SoundBridge is ready for a randomized trial

What this study would and would not show↑ top

This pilot would show whether the SoundBridge experience is usable, acceptable, and appropriate to test further. It would not prove that SoundBridge treats anxiety or depression.

Working title↑ top

A Randomized Controlled Trial of SoundBridge: Personalized Music-Guided Paced Breathing for Adults With Mild to Moderate Anxiety and/or Depressive Symptoms

Purpose↑ top

This study evaluates whether the complete SoundBridge protocol shows greater improvement in anxiety symptoms and engagement than an active comparison condition that provides the same amount of breathing instruction, time, audio exposure, and app contact.

Study question↑ top

Compared with guided paced breathing paired with neutral audio, does SoundBridge’s combination of user-selected music and a personalized grounding gesture improve anxiety outcomes and practice adherence?

Proposed design↑ top

• Design: Two-arm, parallel-group randomized controlled trial
• Participants: Approximately 160 adults, randomized 1:1
• Duration: 10 sessions over 10 weeks — one guided session per week, approximately 30 minutes, with daily RTM content between sessions
• Follow-up: Week 16 from baseline (six weeks after the final session)
• Delivery: Remote or hybrid, depending on partner-site workflow
• Population: Adults with mild to moderate anxiety and/or depressive symptoms, with appropriate screening and referral pathways

Study arms↑ top

SoundBridge session structure↑ top

Core outcomes↑ top

Primary hypothesis↑ top

Participants assigned to SoundBridge will show a greater reduction in GAD-7 score from baseline to week 10 than participants in the active comparison group.

Secondary hypotheses↑ top

• SoundBridge participants will complete more sessions and practice more minutes.
• SoundBridge participants will report greater immediate post-session calm and perceived control.
• SoundBridge will show promising effects on depressive symptoms, perceived stress, sleep, and well-being.
• Engagement, personal relevance of music, breathing-pace adherence, and exploratory autonomic measures may help explain outcome differences.

Planned analysis↑ top

The primary analysis would compare change over time between groups using an intention-to-treat mixed-effects model. This method includes available repeated measurements and estimates the group-by-time difference while accounting for the fact that each participant contributes multiple observations.

The key output for investors and partners is not simply whether a p-value is below a threshold. The study should report:

• Estimated difference between groups
• 95% confidence interval
• Standardized effect size
• Completion and retention rates
• Safety events and reasons for discontinuation
• Which participant characteristics predict stronger engagement or response

Why an active comparison matters↑ top

A credible comparison protects against overinterpreting improvements that may come from time, expectancy, structured attention, generic relaxation, or simply being asked to practice. Both groups receive paced breathing and supportive app contact; the difference is whether the breathing experience is paired with personally meaningful music and a personalized grounding cue.

What this study would and would not show↑ top

A well-conducted RCT can provide preliminary evidence on comparative effectiveness and feasibility for wider implementation. It should not claim that SoundBridge directly measures or causes dopamine release unless a separate, appropriately designed neuroimaging study measures dopamine directly.

Working title↑ top

Understanding How SoundBridge Works: A Component and Mechanism Study of Music Personalization, Paced Breathing, and Grounding Cues

Purpose↑ top

After feasibility is established, the next research question is not only “Does SoundBridge work?” but “Which parts of SoundBridge drive engagement and benefit, for whom, and under what conditions?”

This investigation is designed to prevent a common mistake in digital health: treating a multi-component experience as a black box. It evaluates whether personal music relevance, breathing performance, and grounding cues each contribute measurable value.

Study question↑ top

How do personalized music, paced breathing, and grounding gestures influence engagement, immediate regulation, and longer-term symptom change?

Recommended design↑ top

A 2×2 factorial randomized trial, performed after the two-arm RCT demonstrates feasibility.

• Participants: Approximately 240–400, depending on the effect sizes and variance observed in Investigation 2
• Duration: 10 weeks of intervention plus follow-up, on the same weekly-session and daily-RTM schedule as Investigation 2
• Factors:
  • Music: user-selected/autobiographically relevant music versus neutral study-selected instrumental music
  • Grounding cue: personalized grounding gesture versus standardized start prompt without individualized movement
• Breathing guidance: Provided to all groups, so the effect of personalization and cueing can be estimated on top of a common paced-breathing foundation

Four groups↑ top

What this design can answer↑ top

• Does personally meaningful music improve retention, return behavior, perceived reward, or symptom outcomes?
• Does a personalized grounding gesture improve focus, ease of initiation, or regular practice?
• Do music personalization and grounding gestures amplify one another?
• Does actual adherence to a comfortable slow breathing pace relate to changes in immediate distress or HRV?
• Which participants benefit most: those with stronger music-memory connections, greater baseline stress, different levels of depression/anxiety, or different music preferences?

Mechanism measures↑ top

Optional neuroscience substudy↑ top

A later, separately funded substudy could recruit a smaller sample for EEG during listening and paced breathing. This could test pre-specified neural tracking of the auditory/respiratory rhythm and compare personalized with neutral music.

A dopamine claim would require a far more resource-intensive PET design and should not be a prerequisite for demonstrating clinical usefulness. In product and partner communications, use language such as “reward-related engagement” and “music-evoked pleasure” unless dopamine is directly measured.

Analysis approach↑ top

The factorial design estimates:

• The average effect of personalized music.
• The average effect of the personalized grounding gesture.
• The interaction between the two elements.
• Whether improvement is statistically associated with engagement, music relevance, actual breathing pace, or exploratory HRV change.

This creates an evidence-driven product roadmap: retain components that add value, simplify components that do not, and identify the participant profiles best suited to the program.

What this study would and would not show↑ top

This investigation can identify plausible active ingredients and help optimize the program. Even with sophisticated mediation analysis, it should describe mechanisms as hypothesized or exploratory unless those mechanisms are independently manipulated and directly measured.

FQHC partners can play an essential role in testing whether SoundBridge fits real-world workflows and expands access to low-burden supportive care.

Potential FQHC use case↑ top

SoundBridge could be evaluated as an adjunctive, skills-based digital program for adults with mild to moderate anxiety and/or depressive symptoms who are receiving primary care, integrated behavioral health, care management, or community-health-worker support.

Suggested workflow↑ top

1. Referral and screening: A primary-care or behavioral-health team identifies potentially eligible adults and completes standard clinical safety screening.
2. Enrollment and onboarding: A trained coordinator or community health worker supports consent, music selection, app setup, and first-session orientation.
3. Self-guided practice: Participants complete scheduled sessions at home or in a private onsite setting.
4. Light-touch monitoring: The platform identifies noncompletion, distress flags, music changes, and symptom worsening for review by designated staff.
5. Clinical escalation: The partner organization retains responsibility for clinical assessment, medication, psychotherapy, crisis response, and referral to higher levels of care.
6. Outcome review: Aggregate reports show engagement, symptom trends, retention, implementation barriers, and safety events.

FQHC-relevant outcomes↑ top

• Reach across language, age, insurance, race/ethnicity, geography, and digital-access groups
• Enrollment and completion rates
• Staff time required per participant
• Technology and onboarding barriers
• Change in validated anxiety/depression measures
• Behavioral-health referral uptake and continuity of care
• Patient experience, cultural acceptability, and perceived dignity
• Safety events and escalation needs
• Cost and implementation feasibility

Equity and accessibility requirements↑ top

• Provide language access and translated materials as appropriate.
• Offer alternatives for people who cannot or do not wish to use personally meaningful music.
• Support hearing accommodations, captions/visual breathing guidance, low-bandwidth access, and device-access pathways.
• Avoid assuming a specific genre, culture, spiritual tradition, or relationship to music.
• Use a participant-led music-selection process and allow song replacement without explanation.
• Monitor whether engagement and outcomes differ by demographic or access group; do not treat aggregate success as equitable success.

Appropriate current language↑ top

• “SoundBridge is a personalized, music-guided paced-breathing program under evaluation for emotional self-regulation, engagement, and symptom support.”
• “The program combines personally meaningful music, gentle paced breathing, and a repeatable grounding cue.”
• “Personally meaningful music may support motivation and return to practice.”
• “Slow-paced breathing may support short-term autonomic regulation and perceived calm.”
• “SoundBridge is being designed and evaluated as an adjunctive, skills-based experience—not a replacement for clinical assessment, psychotherapy, medication management, or crisis services.”

Language to avoid before supporting evidence↑ top

• “SoundBridge releases dopamine.”
• “SoundBridge entrains brain waves after seven minutes.”
• “A specific BPM treats anxiety or depression.”
• “SoundBridge cures, prevents, diagnoses, or treats a mental-health disorder.”
• “The grounding gesture is neuro-linguistic programming.”
• “Personalized music is inherently safe or calming for every person.”

Why this distinction matters↑ top

Music-related reward, autobiographical memory, respiratory–cardiac coupling, and rhythmic neural tracking are meaningful research areas. They are not interchangeable. A responsible evidence program measures the specific outcome it claims to influence and clearly distinguishes user experience, physiology, clinical symptoms, and neuroscience mechanisms.

• SoundBridge must include clear crisis instructions and clinical escalation pathways appropriate to each partner site.
• The protocol should screen for acute suicide risk, mania/psychosis, severe symptom deterioration, severe substance-related instability, and other presentations requiring higher-level care.
• Participants should be able to stop a session, return to natural breathing, remove a song, substitute neutral audio, or opt out of gesture-based practice at any time.
• Breath instructions should emphasize comfort rather than force. Dizziness, tingling, panic, chest discomfort, or air hunger require stopping the paced exercise and following clinical guidance.
• Music preferences and autobiographical associations are sensitive data. Data collection should follow HIPAA and applicable state/privacy requirements, minimize unnecessary collection, and use role-based access and encryption.
• Every formal study requires IRB review, prospective trial registration where applicable, consent materials, a data and safety monitoring plan proportional to risk, and qualified clinical oversight.

Slow-paced breathing has been studied as a means of influencing short-term respiratory–cardiac coupling and heart-rate-variability measures. Reviews commonly describe approximately 5–7 breaths per minute as a practical range, while also emphasizing individual variability and the need to monitor actual breathing performance.

Peer-reviewed music research supports the importance of personal preference, emotional salience, familiarity, and autobiographical memory in music experience. Highly pleasurable self-selected music has been associated with reward-system dopamine findings in laboratory neuroimaging research; this does not establish that a consumer intervention directly causes dopamine release.

SPIRIT 2025 and CONSORT 2025 provide recognized standards for writing randomized-trial protocols and transparently reporting completed trials.