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

SoundMind

Status: Completed

Conditions: Depression; Anxiety; Stress

Treatments: Other: Spotify Playlist; Other: SoundMind App

Study type: Interventional

Funder types: Industry

Identifiers

NCT06021821

20288

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 28 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Intervention Group

Experimental group

Description:

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

Treatment:

Other: SoundMind App

Spotify Group

Active Comparator group

Description:

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

Treatment:

Other: Spotify Playlist

Control Group

No Intervention group

Description:

This group will have no tasks prescribed.