The Impact of Enhanced Music & Natural Visuals on Emotional Health

Official title

Impacts of Music, Audio Enhancements, Audio Guidance, and Visuals on Physical and Emotional Well-being. (Emotional Health - Longitudinal 1 Randomized, Controlled Multi-center Study)

Overview

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

• Device soundBrilliance 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.

Primary outcome measures

• Change in State Trait Anxiety Inventory - State (STAI-S) between treatment vs control groups. [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. [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. [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).]

Secondary outcome measures (12)

• Change in Perceived Stress (PSS - 10 item) between treatment vs control groups. [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. [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. [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 [Time frame: Baseline throughout the 12 week protocol. (0, 2, ... 12 weeks).]
• Planned Sub-group Analysis of Sex [Time frame: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).]
• Planned Sub-group Analysis of baseline scores of PSS [Time frame: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).]
• Planned Sub-group Analysis of baseline scores of STAI-Trait Anxiety [Time frame: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).]
• Planned Sub-group Analysis of baseline scores of Cantril's Ladder [Time frame: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).]
• Planned Sub-group Analysis of baseline scores of MAIA [Time frame: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).]
• Planned Sub-group Analysis of baseline scores of MAAS [Time frame: Baseline throughout the 12-week protocol. (0, 2, ... 12 weeks).]
• Summarization of subjective Tolerance of stimuli [Time frame: Tolerance data collected at completion of sessions, over the duration of 12-week protocol.]
• Summarization of subjective Satisfaction with stimuli [Time frame: Satisfaction data collected at completion of sessions, over the duration of 12-week protocol.]

Eligibility criteria

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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 3 centers

• Colorado State University — Fort Collins
• Creighton University — Omaha
• Reno Running Company — Reno

Publications

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

Identifiers

NCT: NCT07676110 · SBEMHL001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗