The Impact of Enhanced Music & Natural Visuals on Emotional Health

Impacts of Music, Audio Enhancements, Audio Guidance, and Visuals on Physical and Emotional Well-being. (Emotional Health - Longitudinal 1 Randomized, Controlled Multi-center Study)

The investigators are conducting research on factors related to the self-regulation of mood and arousal states across a range of everyday activities as well as different levels of stress. Behavioral interventions-such as meditation, listening to music, or visualizing art or nature-offer important alternatives and/or adjunctive strategies to pharmaceutical tools or other mechanisms supporting physical and emotional well-being. This research will expand on the knowledge base regarding the impact of biophysical stimulation and/or frame of mind on an individual's self-directed management of physical and emotional health. Motivation, confidence, and composure are critical aspects of self-efficacy, framing a person's mindset to make healthy choices across daily activities.

The research in this protocol is carried out across multiple sites and studies by means of digital tools and a consistent participant experience workflow. Together, these resources are intended to support individuals across multiple self-directed experiences utilized in the maintenance of their basic health. Before, during, and after session experiences, the participant provides objective (physiological) responses and/or subjective (self-report) responses and reflections; some studies also include interviews or focus groups. The combined set of responses can be summarized, connected to other measures, and input to machine learning models to improve personalization of stimuli. By studying the effects of soundBrilliance experiences across a variety of contexts and participant samples, the investigators can better refine each element of the stimulus to improve satisfaction, tolerance, and targeted outcomes.

Study Overview

• Status: Recruiting
• Conditions: Sleep; Rehabilitation; Recovery; Pain Management; Exercise Training; Motivation; Lifestyle Intervention; Lifestyle, Healthy; Comfort; Anxiety and Mood Disorders; Emotion Management Skills; Exercise and Recovery; Creativity and Mindfulness
• Intervention / Treatment: Device: soundBrilliance software application - Emotional Health

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Mele (VP of Clinical Research & Testing Operations), B.Eng; Phone Number: 1 7752444866; Email: rob.mele@soundBrilliance.com
• Study Contact Backup: Name: Justin C Hayes (Manager, Research & Testing Operations), MA; Phone Number: 515-777-4591; Email: justin.hayes@soundBrilliance.com

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80523
      • Recruiting
      • Colorado State University
      • Contact: Blythe LaGasse, PhD; Phone Number: 970-491-4042; Email: blagasse@colostate.edu
  • Nebraska
    • Omaha, Nebraska, United States, 68178
      • Recruiting
      • Creighton University
      • Contact: Ryan Batenhorst, EdD; Phone Number: 402-730-6632; Email: RyanBatenhorst@creighton.edu
      • Contact: Thomas L Lenz, PharmD; Phone Number: 402-280-3144; Email: ThomasLenz@creighton.edu
  • Nevada
    • Reno, Nevada, United States, 89511
      • Recruiting
      • Reno Running Company
      • Contact: Anna Costello; Phone Number: 775-303-5845; Email: Anna.Costello@WashoeSchools.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• You are 13 years of age or older
• You can read, write, and speak English at a 5th-grade level or higher
• You are legally capable of providing informed consent (adult participants) or capable of providing assent (child participants)
• To the best of your knowledge, you are willing and able to commit to the session(s) and activities of this study
• You are willing and able to use the sound-delivery and data-collection apparatus of this study
• You are willing to use your own personal equipment. Depending on the study, you may need to have your own ear buds/headphones and/or a "smart" device with internet and/or Bluetooth access (e.g., smartphone, iPad).
• You have normal hearing in both ears.
• You never experience ringing noises or buzzing sensations in your ears (tinnitus)
• You do not use a heart/cardiac pacemaker and do not have any history of cardiac rhythm disturbances, such as cardiac conduction delays or blocks
• You have no known history of fainting, fainting, spells or seizures, spinning sensations, or trouble with balance (medical terms include epilepsy, seizures, syncope, vertigo, nystagmus)
• You do not use of any of the following medications: Beta blockers, steroids, ephedrine, acute anti-anxiety medication (e.g., benzodiazepines such as diazepam/Valium, lorazepam/Ativan or clonazepam/Klonopin), or acute or chronic pain medications (including narcotics and codeine)
• For any study session, you will not be under the influence of any substances that could prevent safe participation and will not have consumed e.g., alcohol, THC, Psilocybin, or other mood-altering drugs in the 12 hours preceding the session.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A - Intervention; Group A will be given access to the intervention (use of the soundBrillinace app) for 12 weeks	Device: soundBrilliance software application - Emotional Health; Use of the soundBrilliance app (enhanced music, natural visuals, spoken guidance) over 12 weeks, targeting use of 4 days or more per week.
No Intervention: Group B; Group B will receive no intervention (behavior as usual) for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in State Trait Anxiety Inventory - State (STAI-S) between treatment vs control groups.	The 20 item STAI-S, a self-report survey reflecting current symptoms of anxiety, will be given to both groups at baseline and at 2-week intervals through the duration of the 12-week protocol. The difference in group mean change of STAI-S from baseline across 2-week milestones will be estimated.	Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).
Change in Patient Health Questionnaire (8 question; PHQ-8) between treatment vs control groups.	The 8 item PHQ-8, a self-report survey reflecting current symptoms of depression, will be given to both groups at baseline and at 20week intervals through the duration of the 12-week protocol. The difference in group mean change of PHQ-8 from baseline across 2-week milestones will be estimated.	Baseline and at 2-week intervals over the duration of the 12-week protocol (0, 2, 4, 6, 8, 10, 12-week post-baseline).
Change in Positive and Negative Affect Schedule (20 item; PANAS-SF) between treatment vs control groups.	The 20 item PANAS-SF will be given to both groups at baseline and at 2-week intervals through the duration of the 12-week protocol. The difference in group mean change of positive and negative affect scores from baseline across 2-week milestones will be estimated.	Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Perceived Stress (PSS - 10 item) between treatment vs control groups.	The 10 item PSS will be given to both groups at baseline and at 12-week protocol completion. The difference in group mean change of STAI-S from baseline across 2-week milestones will be estimated.	Baseline and at week 12 (0, 12 weeks post-baseline).
Change in Quality of Life (Cantril's Ladder) between treatment vs control groups.	Cantril's Ladder, a quality of life (QoL) measure, will be given to both groups at baseline and at the conclusion of the 12-week protocol (week 12). The difference in group mean change of QoL from baseline to post-study will be estimated.	Baseline and at week 12 (0, 12 weeks post-baseline).
Change in Beck Depression Inventory-II (21 item; BDI-II) between treatment vs control groups.	The 21 item BDI-II will be given to participants in a cohort supervised by a clinical sub-investigator providing ongoing care. The BDI-II will be given to both groups at baseline and at 2-week intervals through the duration of the 12-week protocol. The difference in group mean change of composite scores from baseline across 2-week milestones will be estimated.	Baseline and at 2-week intervals over the duration of 12-week protocol (0, 2, 4, 6, 8, 10, 12 weeks post-baseline).
Planned Sub-group Analysis of Age	We will do subgroup analysis with contrasts by age in years, for groups 13-17, 18-29, 30-49, 50+	Baseline throughout the 12 week protocol. (0, 2, ... 12 weeks).
Planned Sub-group Analysis of Sex	We will do subgroup analysis with contrasts by sex for groups male versus female.	Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
Planned Sub-group Analysis of baseline scores of PSS	We will do subgroup analysis with contrasts by PSS (Perceived Stress Scale survey) baseline score for groups categorized into Low, Moderate, and High perceived stress.	Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
Planned Sub-group Analysis of baseline scores of STAI-Trait Anxiety	We will do subgroup analysis with contrasts by STAI-Trait Anxiety baseline score for groups categorized into Low or No, Moderate, and High perceived anxiety and combinations thereof such as Low or No versus Moderate and High.	Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
Planned Sub-group Analysis of baseline scores of Cantril's Ladder	We will do subgroup analysis with contrasts by Cantril's Ladder for the linear relationship between predictor and outcome.	Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
Planned Sub-group Analysis of baseline scores of MAIA	We will do subgroup analysis with contrasts by MAIA (Multidimensional Assessment of Interoceptive Awareness survey) baseline score for groups categorized into Low (below 25th percentile), Average (25th to 75th percentile) and High (above 75th percentile) and combinations thereof such as Low versus Average and High.	Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
Planned Sub-group Analysis of baseline scores of MAAS	We will do subgroup analysis with contrasts by MAAS (Mindful Attention Awareness Scale survey) for the linear relationship between predictor and outcome.	Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).
Summarization of subjective Tolerance of stimuli	Subjects have the option to report subjective tolerance of stimuli on a per-session basis. These data will be reported using descriptive statistics such as counts (n's) and percentages of reports as well as summarized free-text responses.	Tolerance data collected at completion of sessions, over the duration of 12-week protocol.
Summarization of subjective Satisfaction with stimuli	Subjects have the option to report their satisfaction with stimuli on a per-session basis. These data will be reported using descriptive statistics such as mean and standard deviation of 6-point Likert scale responses as well as summarized free-text responses.	Satisfaction data collected at completion of sessions, over the duration of 12-week protocol.
Change in Positive and Negative Affect Schedule (20 item; PANAS-SF) from baseline pre and post session.	The 20 item PANAS-SF, a self-report survey, will be an optional measure for the treatment group for each session pre and post stimuli through the duration of the 12-week protocol. The change in scores from baseline to post session will be assessed over time.	Pre and post stimuli for each treatment session over the duration of 12-week protocol
Change in State Trait Anxiety Inventory - State (6 item; STAI-S) from baseline pre and post session.	The 6-item STAI-S, a self-report survey reflecting current symptoms of anxiety, will be an optional measure for the treatment group for each session pre and post stimuli through the duration of the 12-week protocol. The change in scores from baseline to post session will be assessed over time.	Pre and post stimuli for each treatment session over the duration of 12-week protocol.
Change in Modified Russel Circumplex (2 item; MRC Arousal & Valence axis)	The 2-item MRC, a self-report survey reflecting Arousal level (9-point Likert from Low Energy to High Energy) and Valence (9-point Likert from Unpleasant to Pleasant), will be an optional measure for the treatment group for each session pre and post stimuli through the duration of the 12-week protocol. The change in ratings from baseline to post session will be assessed over time.	Pre and post stimuli for each treatment session over the duration of 12-week protocol

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Heart Rate Variability (Root Mean Square Successive Differences; RMSSD) between pre to post session in treatment group.	A commercial-grade ECG device will be used to measure continuous heart rate throughout the duration of each study session. RMSSD will be measured before and after each session, for the purposes of estimating average pre-post change (delta) in treatment groups.	Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol.
Change in Sympathetic Nervous System (SNS) activation between pre to post session in treatment group.	A commercial-grade ECG device will be used to measure continuous heart rate throughout the duration of each study session. SNS will be measured before and after each session, for the purposes of estimating average pre-post change (delta) in treatment groups.	Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol.
Change in Parasympathetic Nervous System (PNS) activation between pre to post session in treatment group.	A commercial-grade ECG device will be used to measure continuous heart rate throughout the duration of each study session. PNS will be measured before and after each session, for the purposes of estimating average pre-post change (delta) in treatment groups.	Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol
Change in Stress Index between pre to post session in treatment group.	A commercial-grade ECG device will be used to measure continuous heart rate throughout the duration of each study session. Stress Index (SI) will be measured before and after each session, for the purposes of estimating average pre-post change (delta) in treatment groups.	Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol.
Beneficial change in both physiological and psychometric outcomes	For the outcomes that have both categorical and continuous interpretations. Changes from categorical baseline conditions will be tested using McNemar's Test (Shift Table).	Pre-post change measurements throughout study sessions for all sessions completed during the 12-week protocol.

Collaborators and Investigators

• Sponsor: soundBrilliance LLC
• Collaborators: Creighton University; Creighton University Medical Center
• Investigators: Principal Investigator: Jason S Doescher, MD, soundBrilliance LLC

Publications and helpful links

General Publications

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
• Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.
• Taylor JM. Psychometric analysis of the Ten-Item Perceived Stress Scale. Psychol Assess. 2015 Mar;27(1):90-101. doi: 10.1037/a0038100. Epub 2014 Oct 27.
• Thompson, E. R. (2007). Development and validation of an internationally reliable short-form of the positive and negative affect schedule (PANAS). Journal of Cross-Cultural Psychology, 38(2), 227-242.
• Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
• Mohammed SEE, Warner G. The Cantril Ladder as a Measure of Well-Being and Life Satisfaction Among Refugee Youth Experiencing Symptoms of Post-Traumatic Stress. J Immigr Minor Health. 2024 Jun;26(3):539-545. doi: 10.1007/s10903-023-01563-5. Epub 2023 Oct 26.
• Spielberger, C. D. (1983). Manual for the State-Trait Anxiety Inventory: STAI (Form Y). Palo Alto, CA: Mind Garden.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 1, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Music; Emotional Health; Visuals; Visual Imagery; Biophysical Stimuli; Emotional Management
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Personal Satisfaction; Anxiety Disorders; Mood Disorders; Agnosia; Psychological Well-Being; Motor Activity
• Other Study ID Numbers: SBEMHL001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes