AnxietyNCT06021821
A Randomized-Controlled Trial to Investigate the Effect of a Novel Music Therapy Application to Reduce Anxiety and Stress
A study testing SoundMind App and Spotify Playlist in people with Anxiety and Depression, run by SoundMind at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Stress
- What is being tested?
- SoundMind App and Spotify Playlist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2023to 26 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- SoundMind App, Spotify Playlist
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoundMind AppOther
he SoundMind application uses binaural beats to encourage relaxation, focus, and alertness.
Spotify PlaylistOther
Participants will listen to a "calm vibes" playlist by Spotify.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will listen to the SoundMind app for 20 minutes per day, ideally during a moment of stress. Receives: 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. Receives: Other: Spotify Playlist |
| Control Group | No intervention | This group will have no tasks prescribed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (1)
Changes in participant-perceived sleep quality. [Baseline to Week 6]
Survey-based assessment of participants' perception of their sleep quality.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start29 May 2023
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-group study.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- SoundMind
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021821
- Sponsor's protocol ID
- 20288
- Status last verified
- Aug 2023
- First submitted
- 27 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-Controlled Trial to Investigate the Effect of a Novel Music Therapy Application to Reduce Anxiety and Stress
- ClinicalTrials.gov ID
- NCT06021821
- Acronym / sponsor ID
- 20288
- Conditions
- Anxiety, Depression, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- SoundMindIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 29 May 2023 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-group study.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: SoundMind AppParticipants will listen to the SoundMind app for 20 minutes per day, ideally during a moment of stress. |
| Spotify Group | Active comparator | Other: Spotify PlaylistParticipants will listen to a specified Spotify playlist for 20 minutes per day, ideally during a moment of stress. |
| Control Group | No intervention | –This group will have no tasks prescribed. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SoundMind Apphe SoundMind application uses binaural beats to encourage relaxation, focus, and alertness. | Other | Intervention Group |
| Spotify PlaylistParticipants will listen to a "calm vibes" playlist by Spotify. | Other | Spotify Group |
Primary outcome
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
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
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.
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.
1 secondary outcome
Changes in participant-perceived sleep quality. [Baseline to Week 6]
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SoundMind App and Spotify Playlist in people with Anxiety and Depression, run by SoundMind at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores on the Generalized Anxiety Disorder 7-item scale (GAD-7). [Baseline to Week 6] (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.