Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Creighton University | OTHER |
| Creighton University Medical Center | OTHER |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Intervention | Active Comparator | Group A will be given access to the intervention (use of the soundBrillinace app) for 12 weeks |
|
| Group B | No Intervention | Group B will receive no intervention (behavior as usual) for 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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). |
| 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). |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
-
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Mele (VP of Clinical Research & Testing Operations), B.Eng | Contact | 7752444866 | 1 | rob.mele@soundBrilliance.com |
| Justin C Hayes (Manager, Research & Testing Operations), MA | Contact | 515-777-4591 | justin.hayes@soundBrilliance.com |
| Name | Affiliation | Role |
|---|---|---|
| Jason S Doescher, MD | soundBrilliance LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado State University | Recruiting | Fort Collins | Colorado | 80523 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37882971 | Background | 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. | |
| 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. | ||
| 11914441 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 22, 2026 | Apr 30, 2026 |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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. |
| Creighton University | Recruiting | Omaha | Nebraska | 68178 | United States |
|
| Reno Running Company | Recruiting | Reno | Nevada | 89511 | United States |
|
| 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. |
| Background | Spielberger, C. D. (1983). Manual for the State-Trait Anxiety Inventory: STAI (Form Y). Palo Alto, CA: Mind Garden. |
| 1393159 | 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. |
| 25346996 | 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. |
| 6668417 | 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. |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2026 | Apr 30, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Assent Form - 13 years or older | Feb 23, 2026 | Apr 30, 2026 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent Form - Adult | Mar 17, 2026 | Apr 30, 2026 | ICF_003.pdf |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D001008 | Anxiety Disorders |
| D019964 | Mood Disorders |
| D000377 | Agnosia |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010549 | Personal Satisfaction |
Not provided
Not provided