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Completed

NCT Number: NCT06021821

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Stress

Age range

18 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SoundMind App

Other

he SoundMind application uses binaural beats to encourage relaxation, focus, and alertness.

Spotify Playlist

Other

Participants will listen to a "calm vibes" playlist by Spotify.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

SoundMind

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2023
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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