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| Name | Class |
|---|---|
| The Miriam Hospital | OTHER |
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The goal of this clinical trial is to learn about the effectiveness of a music-based intervention as a bereavement strategy for individuals who are a part of the Loss of Spouse/Life Partner Grief Support Group at HopeHealth, a healthcare organization in Providence, Rhode Island that specializes in home care, hospice care, palliative care, and grief support. The main question it ams to answer is:
Participants will undergo the following main tasks:
The death of a loved one is a universal experience and one of life's greatest stressors. Although most bereaved individuals navigate through intense acute grief that lessens with time, approximately 10% develop prolonged grief disorder (PGD), characterized by persistent mental distress, maladaptive thoughts, avoidance behaviors, and impaired functionality. The COVID-19 pandemic has potentially increased PGD cases, and individuals on the grief spectrum face risks for various medical and psychological issues. Given that PGD was only recently recognized in the DSM-5 in 2022 and effective bereavement strategies are lacking, research in this area is crucial. Music-based interventions have shown promise in enhancing recovery in diverse settings, including cancer treatment and dementia care, by reducing anxiety and distress and engaging cognitive and social functions. However, studies on music's role in bereavement are limited. Recent research on expressive arts therapies suggests that music could be a valuable tool in supporting grieving individuals, highlighting the need to explore its potential in facilitating the grief journey.
The goals of this project are three-fold:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Creating Musical Playlist | Experimental | Participants created a musical playlist over 1 week based on themes and emotions from their grief journey. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Creating Musical Playlist | Other | Personal music playlist for therapeutic listening and sharing with other individuals in bereavement |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Music's Impact on Mental Health and Well-Being | A vetted question with study directors serves to measure if using music as a medium to express participants' grief has any impact on mental health and well-being before and after the music playlist creation experience. The minimum value is "Music impacts my mental health and well-being in a negative way" and the maximum value is "Music impacts my mental health and well-being in a positive way." The maximum value means a better outcome. | Baseline and Week 1 |
| Change from Baseline in the Importance of Music in Participant's Life | Vetted questions with study directors serve to measure the importance of music in participants' life before and after the music playlist creation experience. These questions also examine the likelihood of participants to continue listening to their playlists after the project conclusion as a therapeutic resource. The minimum value is "very unimportant" and the maximum value is "very important." The maximum value means a better outcome. | Baseline and Week 1 |
| Qualitative Learning Moments After Music Playlist Creation | Vetted questions with study directors ask participants to reflect on their overall experience on creating and listening to their musical playlist. The questions ask participants to elaborate on how the exercise has helped them process/navigate/provide a new perspective to their grief experience. The study investigator also asks participants to reflect on any pieces of music that particularly connected with them and why. Because these questions are qualitative in nature there are no minimum or maximum values. | Baseline and Week 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana A Wang, BA | Brown University | Principal Investigator |
| Deanna Church | HopeHealth | Study Director |
| Sarah DeCosta, LMHC | HopeHealth | Study Director |
| Fred J Schiffman, MD | Brown University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HopeHealth | Providence | Rhode Island | 02904 | United States |
There is no plan to make IPD available to other researchers. All collected data will be kept internal to the investigator on the project.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 29, 2024 | May 31, 2024 | Prot_000.pdf |
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