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

NCT06021821 | Completed

• 1 other identifier: 20288
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Stress

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Changes in participant-perceived sleep quality. [Baseline to Week 6]

  6 weeks

Study Arms (3)

Intervention Group

EXPERIMENTAL

Participants will listen to the SoundMind app for 20 minutes per day, ideally during a moment of stress.

Other: SoundMind App

Spotify Group

ACTIVE COMPARATOR

Participants will listen to a specified Spotify playlist for 20 minutes per day, ideally during a moment of stress.

Other: Spotify Playlist

Control Group

NO INTERVENTION

This group will have no tasks prescribed.

Interventions

SoundMind App OTHER

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

Intervention Group

Spotify Playlist OTHER

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

Spotify Group

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SoundMind: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three-group study.

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 1, 2023
• Study Start: May 29, 2023
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

US (1)