Anxiety and Mood Disorders, Comfort, Creativity and Mindfulness, Emotion Management Skills, Exercise and Recovery, Exercise Training, Lifestyle, Healthy, Lifestyle Intervention, Motivation, Pain Management, Recovery, Rehabilitation, Sleep
Conditions
Keywords
Music, Visuals, Visual Imagery, Biophysical Stimuli, Emotional Health, Emotional Management
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.
Interventions
DEVICEsoundBrilliance 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.
Sponsors
soundBrilliance LLC
Creighton University
Creighton University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Positive and Negative Affect Schedule (20 item; PANAS-SF) 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). | 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. |
| Change in State Trait Anxiety Inventory - State (STAI-S) 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). | 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. |
| Change in Patient Health Questionnaire (8 question; PHQ-8) between treatment vs control groups. | Baseline and at 2-week intervals over the duration of the 12-week protocol (0, 2, 4, 6, 8, 10, 12-week post-baseline). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Planned Sub-group Analysis of baseline scores of MAIA | Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks). | 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. |
| Planned Sub-group Analysis of baseline scores of MAAS | Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks). | We will do subgroup analysis with contrasts by MAAS (Mindful Attention Awareness Scale survey) for the linear relationship between predictor and outcome. |
| Summarization of subjective Tolerance of stimuli | Tolerance data collected at completion of sessions, over the duration of 12-week protocol. | 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. |
| Summarization of subjective Satisfaction with stimuli | Satisfaction data collected at completion of sessions, over the duration of 12-week protocol. | 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. |
| Change in Positive and Negative Affect Schedule (20 item; PANAS-SF) from baseline pre and post session. | Pre and post stimuli for each treatment session over the duration of 12-week protocol | 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. |
| Change in State Trait Anxiety Inventory - State (6 item; STAI-S) from baseline pre and post session. | Pre and post stimuli for each treatment session over the duration of 12-week protocol. | 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. |
| Planned Sub-group Analysis of baseline scores of PSS | Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks). | 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. |
| Change in Perceived Stress (PSS - 10 item) between treatment vs control groups. | Baseline and at week 12 (0, 12 weeks post-baseline). | 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. |
| Change in Quality of Life (Cantril's Ladder) between treatment vs control groups. | Baseline and at week 12 (0, 12 weeks post-baseline). | 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. |
| 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). | 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. |
| Planned Sub-group Analysis of Age | Baseline throughout the 12 week protocol. (0, 2, ... 12 weeks). | We will do subgroup analysis with contrasts by age in years, for groups 13-17, 18-29, 30-49, 50+ |
| Change in Modified Russel Circumplex (2 item; MRC Arousal & Valence axis) | Pre and post stimuli for each treatment session over the duration of 12-week protocol | 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. |
| Planned Sub-group Analysis of Sex | Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks). | We will do subgroup analysis with contrasts by sex for groups male versus female. |
| Planned Sub-group Analysis of baseline scores of STAI-Trait Anxiety | Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks). | 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. |
| Planned Sub-group Analysis of baseline scores of Cantril's Ladder | Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks). | We will do subgroup analysis with contrasts by Cantril's Ladder for the linear relationship between predictor and outcome. |
Countries
United States
Contacts
CONTACTRobert Mele (VP of Clinical Research & Testing Operations), B.Eng
CONTACTJustin C Hayes (Manager, Research & Testing Operations), MA
PRINCIPAL_INVESTIGATORJason S Doescher, MD
soundBrilliance LLC
Outcome results
None listed