An interventional study of soundBrilliance software application - Emotional Health in Emotion Management Skills, Lifestyle, Healthy and Lifestyle Intervention, sponsored by soundBrilliance LLC. Recruiting at 3 sites in United States. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by soundBrilliance LLC · Not applicable, Interventional, and Treatment
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.
561 studies on the registry are indexed under Mood Disorders; 105 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 419 interventional studies indexed under Mood Disorders.
Browse Mood Disorders studies →This is the only study on the registry with soundBrilliance LLC as lead sponsor.
Compared within Mood Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 will receive no intervention (behavior as usual) for 12 weeks.
Use of the soundBrilliance app (enhanced music, natural visuals, spoken guidance) over 12 weeks, targeting use of 4 days or more per week.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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+
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre and post stimuli for each treatment session over the duration of 12-week protocol
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Pre-post change measurements throughout study sessions for all sessions completed during the 12-week protocol.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started May 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.
Of 162 interventional studies with no phase under Mood Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
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