DepressionNCT06557759
30-Minutes of Listening to Calming Music on Attendees of a Workshop Session at a Local Conference
A study testing Listening to Calming Music in people with Depression and Anxiety, run by University of Florida.
Trial summary
The goal of this clinical trial is to explore possible benefits and mechanisms through which listening to music can improve health and wellness. The main goals of the study are: To investigate whether pre-survey measures of autonomic reactivity relate to the overall functioning of participants. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Autonomic Dysregulation
- What is being tested?
- Listening to Calming Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2024to 1 Apr 2025
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 89
- Proficient in English
- Attendees of an online workshop session at the Global Exchange Conference
Who cannot join
- Over the age of 89
About this study
Official title: The Effect of Listening to 30-Minutes of Calming Music on Mental Health Professionals
The goal of this clinical trial is to explore possible benefits and mechanisms through which listening to music can improve health and wellness. The main goals of the study are:
- To investigate whether pre-survey measures of autonomic reactivity relate to the overall functioning of participants.
- To examine the immediate effects of listening to the music.
- To identify individual characteristics that influence the immediate effects of listening to the music.
Read more
Participants will:
- complete the online pre-assessment measures assessing their adversity history, psychiatric symptomatology, autonomic reactivity, embodiment, and perceived social connection.
- Listen to the brief music demo
- Listen to the full 30-minute music session.
- Complete the online post-assessment measures assessing psychiatric symptomatology, autonomic reactivity, embodiment, and perceived social connection.
Read the detailed description
It is the specific intent of this proposal to experimentally explore the possible benefits and mechanisms through which listening to the music can influence emotional health, embodiment, and autonomic functioning. This will be accomplished by our team by using well-validated self-report measures of mental health and autonomic reactivity.
Specific Aims:
Specific Aim 1: To investigate whether pre-intervention measures of ANS reactivity relate to the overall functioning of the participants.
•We will examine measures of autonomic reactivity to prior mental health and medical adversity, embodiment, and emotional and physical health.
Specific Aim 2: To identify the immediate effects of listening to the music •We will explore whether listening to the music leads to improvements in the functioning. First, we will compare the participants who opted to leave after the brief music demonstration to the participants who stayed for the additional 30-minutes of music. Next, we will focus on improvements following listening to the music.
Specific Aim 3: To identify individual characteristics that influence the effectiveness of listening to the music immediately
•We will explore the impact of specific vulnerability and resiliency factors (e.g., prior mental and medical adversity) on how well mental health providers benefit from listening to the music immediately.
Experimental design
- Participation is limited to those attending the Global Exchange Conference
- The participants will complete pre- and post-assessments that involve online measures.
- Music will be provided first in a brief music demo and then again in a 30-minute session.
- Between-subject analyses will compare those who listened only to the brief demo and withdrew participation against those who remained and listened to the 30-minutes of music to determine if those who listened to the 30-minutes of music exhibit greater improvements than those who did not. Within-subject analyses will determine the potential benefits of listening to the music for all participants.
- Conditions
- Depression, Anxiety, Autonomic Dysregulation
- Being tested
- Listening to Calming Music
- Keywords
- Polyvagal Theory, Trauma, Adversity, Anxiety, Depression, Mental Health, Emotional Health, Music, Social Connection, Embodiment, Autonomic Reactivity, Body Sensations, Relaxation
- Medical subject headings
- Depression, Anxiety Disorders, Primary Dysautonomias, Wounds and Injuries, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to Calming MusicBehavioural
Participants will listen to calming music, which may enhance health and wellness by reducing autonomic reactivity and improving bodily awareness, brain-body connection, and emotional wellbeing.
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | Participants will be asked to listen to the brief music demo and the 30-minute music session. The pre- and post-assessments will require participants to complete a 5-10-minute online survey. Receives: Behavioral: Listening to Calming Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Change in Autonomic Reactivity using the Body Perceptions Inventory Short Form
This 20-item measure is scored on a 5-point Likert scale (never = 1, occasionally = 2, sometimes = 3, usually = 4, always = 5). Items are summed to determine total autonomic reactivity score, with the higher scores indicating greater autonomic reactivity
Measured: From baseline through study completion, an average of 1 day
Measuring change in Body Sensations using the Neuroception of Psychological Safety Scale
This 8-item body sensations subscale is scored on a 5-point likert scale. Items are summed together to create a total subscale, with higher scores relecting internal sensations of the body in a state of calm capturing the feelings of relaxation in the face and the body, steady heartbeat and breath, and settled stomach.
Measured: From baseline through study completion, an average of 1 day
Assessing the Impact of Adversity History on the Effectiveness of Listening to Music
This measure assesses the impact of six types of traumatic experiences (childhood adverse experiences, childhood maltreatment, intimate partner maltreatment, other person maltreatment, life-threatening situations, sudden losses, and person health situations). Each item is scored on a 5-point Likert scale (did not occur = 0, occurred and no impact on my life = 1 to big impact on my life = 4). Items are summed to determine total impact scores.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start8 Oct 2024 (estimated)
- Primary completion9 Nov 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Why it stopped: Conference canceled due to hurricane
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The participants will listen to the brief music demo together after completing the pre-assessment. After the demo is completed, participants will listen to the 30-minutes of music. For those who opt out of listening to the 30-minutes of music, they will be asked to complete the post-assessment as they exit. Following the 30-minute music session, the remaining participants will be asked to complete the post-assessment.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lourdes P Dale, PhD, Principal investigator, UF College of Medicine Jacksonville, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557759
- Sponsor's protocol ID
- IRB202401167
- Status last verified
- Dec 2024
- First submitted
- 6 Aug 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be available to protect the privacy of participants.
Publications
Dale LP, Davidson C, Kolacz J. (2020). The Adverse and Traumatic Experiences Scale.
Cabrera A, Kolacz J, Pailhez G, Bulbena-Cabre A, Bulbena A, Porges SW. Assessing body awareness and autonomic reactivity: Factor structure and psychometric properties of the Body Perception Questionnaire-Short Form (BPQ-SF). Int J Methods Psychiatr Res. 2018 Jun;27(2):e1596. doi: 10.1002/mpr.1596. Epub 2017 Nov 28.
PubMed 29193423Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Morton L, Cogan N, Kolacz J, Calderwood C, Nikolic M, Bacon T, Pathe E, Williams D, Porges SW. A new measure of feeling safe: Developing psychometric properties of the Neuroception of Psychological Safety Scale (NPSS). Psychol Trauma. 2024 May;16(4):701-708. doi: 10.1037/tra0001313. Epub 2022 Jul 18.
PubMed 35849369Kroenke, K., & Spitzer, R. L. (2002). Patient Health Questionnaire-8 (PHQ-8)
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening to 30-Minutes of Calming Music on Mental Health Professionals
- ClinicalTrials.gov ID
- NCT06557759
- Acronym / sponsor ID
- IRB202401167
- Conditions
- Depression, Anxiety, Autonomic Dysregulation
- Keywords
- Polyvagal Theory, Trauma, Adversity, Anxiety, Depression, Mental Health, Emotional Health, Music
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Conference canceled due to hurricane
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 8 Oct 2024 (estimated)
- Primary completion
- 9 Nov 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 16 Aug 2024 (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.
The goal of this clinical trial is to explore possible benefits and mechanisms through which listening to music can improve health and wellness. The main goals of the study are:
- To investigate whether pre-survey measures of autonomic reactivity relate to the overall functioning of participants.
- To examine the immediate effects of listening to the music.
- To identify individual characteristics that influence the immediate effects of listening to the music.
Participants will:
- complete the online pre-assessment measures assessing their adversity history, psychiatric symptomatology, autonomic reactivity, embodiment, and perceived social connection.
- Listen to the brief music demo
- Listen to the full 30-minute music session.
- Complete the online post-assessment measures assessing psychiatric symptomatology, autonomic reactivity, embodiment, and perceived social connection.
Detailed description
It is the specific intent of this proposal to experimentally explore the possible benefits and mechanisms through which listening to the music can influence emotional health, embodiment, and autonomic functioning. This will be accomplished by our team by using well-validated self-report measures of mental health and autonomic reactivity.
Specific Aims:
Specific Aim 1: To investigate whether pre-intervention measures of ANS reactivity relate to the overall functioning of the participants.
•We will examine measures of autonomic reactivity to prior mental health and medical adversity, embodiment, and emotional and physical health.
Specific Aim 2: To identify the immediate effects of listening to the music •We will explore whether listening to the music leads to improvements in the functioning. First, we will compare the participants who opted to leave after the brief music demonstration to the participants who stayed for the additional 30-minutes of music. Next, we will focus on improvements following listening to the music.
Specific Aim 3: To identify individual characteristics that influence the effectiveness of listening to the music immediately
•We will explore the impact of specific vulnerability and resiliency factors (e.g., prior mental and medical adversity) on how well mental health providers benefit from listening to the music immediately.
Experimental design
- Participation is limited to those attending the Global Exchange Conference
- The participants will complete pre- and post-assessments that involve online measures.
- Music will be provided first in a brief music demo and then again in a 30-minute session.
- Between-subject analyses will compare those who listened only to the brief demo and withdrew participation against those who remained and listened to the 30-minutes of music to determine if those who listened to the 30-minutes of music exhibit greater improvements than those who did not. Within-subject analyses will determine the potential benefits of listening to the music for all participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The participants will listen to the brief music demo together after completing the pre-assessment. After the demo is completed, participants will listen to the 30-minutes of music. For those who opt out of listening to the 30-minutes of music, they will be asked to complete the post-assessment as they exit. Following the 30-minute music session, the remaining participants will be asked to complete the post-assessment.
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Behavioral: Listening to Calming MusicParticipants will be asked to listen to the brief music demo and the 30-minute music session. The pre- and post-assessments will require participants to complete a 5-10-minute online survey. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18 and 89
- Proficient in English
- Attendees of an online workshop session at the Global Exchange Conference
Key exclusion criteria (1 listed)
- Over the age of 89
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 |
|---|---|---|
| Listening to Calming MusicParticipants will listen to calming music, which may enhance health and wellness by reducing autonomic reactivity and improving bodily awareness, brain-body connection, and emotional wellbeing. | Behavioural | Music |
Primary outcome
Measuring Change in Autonomic Reactivity using the Body Perceptions Inventory Short Form
Time frame: From baseline through study completion, an average of 1 day
This 20-item measure is scored on a 5-point Likert scale (never = 1, occasionally = 2, sometimes = 3, usually = 4, always = 5). Items are summed to determine total autonomic reactivity score, with the higher scores indicating greater autonomic reactivity
Measuring change in Body Sensations using the Neuroception of Psychological Safety Scale
Time frame: From baseline through study completion, an average of 1 day
This 8-item body sensations subscale is scored on a 5-point likert scale. Items are summed together to create a total subscale, with higher scores relecting internal sensations of the body in a state of calm capturing the feelings of relaxation in the face and the body, steady heartbeat and breath, and settled stomach.
Assessing the Impact of Adversity History on the Effectiveness of Listening to Music
Time frame: Baseline
This measure assesses the impact of six types of traumatic experiences (childhood adverse experiences, childhood maltreatment, intimate partner maltreatment, other person maltreatment, life-threatening situations, sudden losses, and person health situations). Each item is scored on a 5-point Likert scale (did not occur = 0, occurred and no impact on my life = 1 to big impact on my life = 4). Items are summed to determine total impact scores.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- BackgroundDale LP, Davidson C, Kolacz J. (2020). The Adverse and Traumatic Experiences Scale.
- Background: PubMed 29193423Cabrera A, Kolacz J, Pailhez G, Bulbena-Cabre A, Bulbena A, Porges SW. Assessing body awareness and autonomic reactivity: Factor structure and psychometric properties of the Body Perception Questionnaire-Short Form (BPQ-SF). Int J Methods Psychiatr Res. 2018 Jun;27(2):e1596. doi: 10.1002/mpr.1596. Epub 2017 Nov 28.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 35849369Morton L, Cogan N, Kolacz J, Calderwood C, Nikolic M, Bacon T, Pathe E, Williams D, Porges SW. A new measure of feeling safe: Developing psychometric properties of the Neuroception of Psychological Safety Scale (NPSS). Psychol Trauma. 2024 May;16(4):701-708. doi: 10.1037/tra0001313. Epub 2022 Jul 18.
- BackgroundKroenke, K., & Spitzer, R. L. (2002). Patient Health Questionnaire-8 (PHQ-8)
- Individual participant dataSharing planned: No. IPD will not be available to protect the privacy of participants.
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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.
Lourdes P Dale, PhD principal investigator
UF College of Medicine Jacksonville, Department of Psychiatry
Questions about this trial
What is this clinical trial studying?
A study testing Listening to Calming Music in people with Depression and Anxiety, run by University of Florida.
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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Measuring Change in Autonomic Reactivity using the Body Perceptions Inventory Short Form (time frame: From baseline through study completion, an average of 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06557759, which also lists 5 linked publications.
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 4 Dec 2024.