The Impact of Enhanced Music & Natural Visuals on Emotional Health

NCT07676110 | Recruiting FDA Device

• 1 other identifier: SBEMHL001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Emotion Management Skills; Lifestyle, Healthy; Lifestyle Intervention; Recovery; Exercise and Recovery; Exercise Training; Anxiety and Mood Disorders; Sleep; Motivation; Comfort; Pain Management; Rehabilitation; Creativity and Mindfulness

Keywords

Music; Visuals; Visual Imagery; Biophysical Stimuli; Emotional Health; Emotional Management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (15)

• Change in Perceived Stress (PSS - 10 item) between treatment vs control groups.

  Baseline and at week 12 (0, 12 weeks post-baseline).

• Change in Quality of Life (Cantril's Ladder) between treatment vs control groups.

  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.

  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

  Baseline throughout the 12 week protocol. (0, 2, ... 12 weeks).

• Planned Sub-group Analysis of Sex

  Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).

Other Outcomes (5)

• Change in Heart Rate Variability (Root Mean Square Successive Differences; RMSSD) between pre to post session in treatment group.

  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.

  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.

  Continuous measurement throughout study sessions for all sessions completed during the 12-week protocol

Study Arms (2)

Group A - Intervention

ACTIVE COMPARATOR

Group A will be given access to the intervention (use of the soundBrillinace app) for 12 weeks

Device: soundBrilliance software application - Emotional Health

Group B

NO INTERVENTION

Group B will receive no intervention (behavior as usual) for 12 weeks.

Interventions

soundBrilliance software application - Emotional Health DEVICE

Use of the soundBrilliance app (enhanced music, natural visuals, spoken guidance) over 12 weeks, targeting use of 4 days or more per week.

Group A - Intervention

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• soundBrilliance LLC: lead
• Creighton University: collaborator
• Creighton University Medical Center: collaborator

Study Sites (3)

Colorado State University

Fort Collins, Colorado, 80523, United States

RECRUITING

Creighton University

Omaha, Nebraska, 68178, United States

RECRUITING

Reno Running Company

Reno, Nevada, 89511, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 37882971 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 11914441 BACKGROUND

• Spielberger, C. D. (1983). Manual for the State-Trait Anxiety Inventory: STAI (Form Y). Palo Alto, CA: Mind Garden.

  BACKGROUND

• 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.

  PMID: 1393159 BACKGROUND

• 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.

  PMID: 25346996 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Anxiety Disorders; Mood Disorders; Agnosia; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction

Study Officials

• Jason S Doescher, MD

  soundBrilliance LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Mele (VP of Clinical Research & Testing Operations), B.Eng

CONTACT

7752444866; rob.mele@soundBrilliance.com

Justin C Hayes (Manager, Research & Testing Operations), MA

CONTACT

515-777-4591; justin.hayes@soundBrilliance.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Group A will be given access to the intervention (use of the soundBrilliance app) for 12 weeks. Group B will receive no intervention (behavior as usual) for 12 weeks. Sub-groups within the cohort such as low-no trait anxiety or stress as measured by State Trait Anxiety Inventory - Trait (STAI-T) and Perceived Stress Scale (PSS) categories respectively, will also be analyzed for differences. Subgroups also include age and sex. Statistical models will include baseline age, sex, STAI-T and PSS categories, treatment arm and time as predictors. Physiological measures will be taken on a select sub-group of participant in the treatment arm. At completion of 12 weeks, Group A will be invited to continue the intervention for a further 12 weeks and Group B will be invited to crossover to receive the intervention for 12 weeks.

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: June 30, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)