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

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ClinicalTrials.gov Identifier: NCT06021821
Recruitment Status : Completed
First Posted : September 1, 2023
Last Update Posted : September 1, 2023
Sponsor:
Collaborator:
Citruslabs
Information provided by (Responsible Party):
SoundMind

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Anxiety Depression Stress Other: SoundMind App Other: Spotify Playlist Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three-group study.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized-Controlled Trial to Investigate the Effect of a Novel Music Therapy Application to Reduce Anxiety and Stress
Actual Study Start Date : May 29, 2023
Actual Primary Completion Date : July 26, 2023
Actual Study Completion Date : July 26, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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


Outcome Measures
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Primary Outcome Measures :
  1. Change in scores on the Generalized Anxiety Disorder 7-item scale (GAD-7). [Baseline to Week 6] [ Time Frame: 6 weeks ]

    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


  2. Change in scores on the Patient Health Questionnaire-9 (PHQ-9). [Baseline to Week 6] [ Time Frame: 6 weeks ]

    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


  3. Change in scores on the Perceived Stress Scale (PSS). [Baseline to Week 6] [ Time Frame: 6 weeks ]
    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.

  4. Change in scores on the World Health Organization Well-Being Index (WHO-5). [Baseline to Week 6] [ Time Frame: 6 weeks ]

    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.



Secondary Outcome Measures :
  1. Changes in participant-perceived sleep quality. [Baseline to Week 6] [ Time Frame: 6 weeks ]
    Survey-based assessment of participants' perception of their sleep quality.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06021821


Locations
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United States, California
Citruslabs
Santa Monica, California, United States, 90404
Sponsors and Collaborators
SoundMind
Citruslabs
More Information
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Responsible Party: SoundMind
ClinicalTrials.gov Identifier: NCT06021821    
Other Study ID Numbers: 20288
First Posted: September 1, 2023    Key Record Dates
Last Update Posted: September 1, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders