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

NCT ID: NCT06021821

Last Updated: 2023-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-29

Study Completion Date

2023-07-26

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.

Detailed Description

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Conditions

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Anxiety Depression Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three-group study.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

SoundMind App

Intervention Type OTHER

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

Spotify Group

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

Group Type ACTIVE_COMPARATOR

Spotify Playlist

Intervention Type OTHER

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

Control Group

This group will have no tasks prescribed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SoundMind App

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

Intervention Type OTHER

Spotify Playlist

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Citruslabs

INDUSTRY

Sponsor Role collaborator

SoundMind

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Citruslabs

Santa Monica, California, United States

Site Status

Countries

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United States

Other Identifiers

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20288

Identifier Type: -

Identifier Source: org_study_id

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