Clinical trial NCT06021821: A Randomized-Controlled Trial to Investigate the Effect of a Novel Music Therapy Application to Reduce Anxiety and Stress
Official title: A Randomized-Controlled Trial to Investigate the Effect of a Novel Music Therapy Application to Reduce Anxiety and Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Stress
Lead sponsor: SoundMind
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-09-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-group study.
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Change in scores on the Generalized Anxiety Disorder 7-item scale (GAD-7). [Baseline to Week 6]
timeFrame: 6 weeks
measure: Change in scores on the Patient Health Questionnaire-9 (PHQ-9). [Baseline to Week 6]
timeFrame: 6 weeks
measure: Change in scores on the Perceived Stress Scale (PSS). [Baseline to Week 6]
timeFrame: 6 weeks
measure: Change in scores on the World Health Organization Well-Being Index (WHO-5). [Baseline to Week 6]
timeFrame: 6 weeks
Secondary outcomes:
measure: Changes in participant-perceived sleep quality. [Baseline to Week 6]
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: