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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Use of the soundBrilliance app (enhanced music, natural visuals, spoken guidance) over 12 weeks, targeting use of 4 days or more per week.
Colorado State University
Fort Collins, Colorado, United States
RECRUITINGCreighton University
Omaha, Nebraska, United States
RECRUITINGReno Running Company
Reno, Nevada, United States
RECRUITINGChange 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
Robert Mele (VP of Clinical Research & Testing Operations), B.Eng
CONTACT
Justin C Hayes (Manager, Research & Testing Operations), MA
CONTACT
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