A Randomized-Controlled Trial to Investigate the Effect of a Novel Music Therapy Application to Reduce Anxiety and Stress

Study Overview
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Brief Summary
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This virtual, open-label, three-group, randomized-controlled trial will last six weeks. Participants will be allocated into three groups; the Intervention Group, Spotify Group, and Control Group. All participants will complete a baseline questionnaire before completing their designated regime daily for six weeks. In addition, participants will complete study-specific surveys and validated questionnaires at the end of each week (Week 1, 2, 3, 4, 5 & 6). The study will include 75 [participants in total, 25 per group, who all have self-reported concerns around anxiety, stress, or depression. Questionnaires will be used to monitor sleep, cognitive ability, and changes in symptoms of anxiety, depression, and stress. Both study-specific questionnaires and validated questionnaires will be utilized, including the Generalized Anxiety Disorder Assessment (GAD-7), the 9-question Patient Health Questionnaire (PHQ-9), Perceived Stress Scale (PSS), and The World Health Organisation- Five Well-Being Index (WHO-5). Likert scale responses will be examined from baseline to each check-in. Participant responses on product feedback will be presented as % scores.

Official Title
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A Randomized-Controlled Trial to Investigate the Effect of a Novel Music Therapy Application to Reduce Anxiety and Stress

Conditions
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Anxiety, Depression, Stress

Intervention / Treatment
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* Other: SoundMind App
* Other: Spotify Playlist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Between 18-28 years of age Self-reported concerns around anxiety, stress, or depression Generally healthy - don't live with any uncontrolled chronic disease Must have headphones Exclusion Criteria: Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders Women who are pregnant, breastfeeding or attempting to become pregnant Unwilling to follow the study protocol Testing any other product for any other research studies at the same time History of epilepsy or seizures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three-group study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants will listen to the SoundMind app for 20 minutes per day, ideally during a moment of stress. | Other: SoundMind App<br>* he SoundMind application uses binaural beats to encourage relaxation, focus, and alertness.<br>|
| Active Comparator: Spotify Group<br>Participants will listen to a specified Spotify playlist for 20 minutes per day, ideally during a moment of stress. | Other: Spotify Playlist<br>* Participants will listen to a calm vibes playlist by Spotify.<br>|
| No Intervention: Control Group<br>This group will have no tasks prescribed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores on the Generalized Anxiety Disorder 7-item scale (GAD-7). [Baseline to Week 6] | The GAD-7 is a self-report questionnaire used to assess the severity of generalized anxiety disorder. It consists of seven questions that ask about the frequency and intensity of common symptoms of anxiety over the past two weeks. Each question is scored on a scale from 0 to 3, with the total scores ranging from 0 to 21. The scoring is typically interpreted as follows: 0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15-21: Severe anxiety | 6 weeks | 
| Change in scores on the Patient Health Questionnaire-9 (PHQ-9). [Baseline to Week 6] | The PHQ-9 is a self-report questionnaire used to assess the severity of depression symptoms. Each question is scored on a scale from 0 to 3, with the total scores ranging from 0 to 27. The scoring is typically interpreted as follows: 0-4: Minimal depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression | 6 weeks | 
| Change in scores on the Perceived Stress Scale (PSS). [Baseline to Week 6] | The PSS is a widely used self-report questionnaire designed to measure an individual's perception of stress in their life. Higher scores indicate higher perceived stress. | 6 weeks | 
| Change in scores on the World Health Organization Well-Being Index (WHO-5). [Baseline to Week 6] | The WHO-5, or World Health Organization Well-Being Index, is a self-reported questionnaire used to measure psychological well-being and mood. Respondents are asked to rate statements on a scale from 0 to 5, where 0 indicates at no time and 5 indicates all of the time. The scores are summed, resulting in a total score that can range from 0 to 25. A total score of 0-13 suggests poor well-being and a higher risk of depression. A total score of 14-17 indicates moderate well-being. A total score of 18-25 suggests good well-being. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in participant-perceived sleep quality. [Baseline to Week 6] | Survey-based assessment of participants' perception of their sleep quality. | 6 weeks |