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| ID | Type | Description | Link |
|---|---|---|---|
| 5U54MD012388-09 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The goal of this clinical trial is to learn whether a music-based intervention can improve mental and physical health and strengthen coping skills among adults living in residential care settings in northern Arizona. The main questions it aims to answer are: Does participation in the music-based intervention reduce stress, anxiety, depression, and pain?, and Does participation increase the use of music as a coping strategy and improve overall well-being?
Researchers will compare participants' pre-intervention and post-intervention responses to determine whether the music classes are associated with improvements in health and coping outcomes. Participants will: Attend a 6-week music class held once per week for one hour; participate in active music activities such as drumming and rhythm exercises; complete a brief survey before and after the intervention. Some participants are also invited to complete a short interview about their experiences.
Approximately one in five adults in Arizona report symptoms of mental health disorders each year. These outcomes have been particularly challenging in rural and medically underserved areas, where long-term care residents face elevated risks of chronic stress, cognitive decline, and social isolation. Older adults with memory-related impairments are especially vulnerable to the loss of meaningful interpersonal and sensory engagement.
Music-based interventions (MBIs) have demonstrated strong potential to support both cognitive and emotional well-being. Active music-making may improve physical symptoms (e.g., chronic pain) and reduce mental health symptoms (e.g., anxiety, stress, depression). However, there is limited research examining how familiarity, personalization, and continuity of musical exposure influence intervention outcomes among older adults.
Older adults with cognitive impairment-particularly those living in long-term care-often experience reduced autonomy, fragmented social networks, and limited access to non-pharmacological therapies that support holistic well-being. This project responds to that gap by assessing how a structured MBI can engage older adults with varying levels of cognitive function. The proposed research will inform feasible, ethically grounded strategies for delivering a 6-week music-based intervention in ways that are meaningful, safe, and responsive to the needs of aging populations. Our central hypothesis is that participation in the MBI will improve stress, anxiety, depressive symptoms, reduce chronic pain, and increase coping skills to manage health conditions among all participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music-Based Intervention Group | Experimental | Participants will engage in a 6-week music-based intervention consisting of one 60-minute session per week. Sessions include active music participation such as drumming, rhythm exercises, and music practices designed to improve stress, anxiety, depression, pain, and coping outcomes among adults in residential care settings. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Based Intervention | Behavioral | Participants will engage in a 6-week culturally grounded music-based intervention consisting of one 60-minute session per week. Sessions include active music participation such as drumming, rhythm exercises, and Indigenous music practices designed to improve stress, anxiety, depression, pain, and coping outcomes among adults in residential care settings. |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale (PSS-10) | The Perceived Stress Scale (PSS) is a classic stress assessment instrument. The tool, while originally developed in 1983, remains a popular choice for helping us understand how different situations affect our feelings and our perceived stress. The questions in this scale ask about feelings and thoughts during the last month. PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | From enrollment to the end of treatment at 6 weeks. |
| The Generalized Anxiety Disorder 2-item (GAD-2) | The Generalized Anxiety Disorder 2-item (GAD-2) is an ultra-brief, 2-question screening tool used in primary care to detect generalized anxiety disorder. The total score range for the Generalized Anxiety Disorder 2-item (GAD-2) screening tool is 0 to 6, with a score of 3 or higher identifying possible cases of generalized anxiety disorder (and other common anxiety disorders). | From enrollment to 6 weeks (post-intervention) |
| Patient Health Questionnaire-2 (PHQ-2) | The Patient Health Questionnaire-2 (PHQ-2) is a brief, two-question screening tool used to assess depression by measuring the frequency of depressed mood and anhedonia over the past two weeks with a total score ranging from 0 to 6. It assesses the frequency of depressed mood and anhedonia over the past two weeks, with a cut-point of 3 or greater often indicating a need for further evaluation. | From enrollment to 6 weeks (post-intervention). |
| Chronic Pain Grade Scale (CPGS) | The purpose of the Chronic Pain Grade Scale (CPGS) was to give doctors a standard with which to work when comparing pain and health. The CPGS classifies pain severity into five hierarchical categories-Grade 0 to Grade IV-based on pain intensity and disability over the past 3-6 months. It typically uses 0-10 Likert scales for individual items, calculating subscores for intensity and disability (0-100) to determine the grade. Higher scores indicate higher intensity and disability related to pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ariel L Roddy, PhD | Contact | 248 298 6978 | ariel.roddy@nau.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haven Health Flagstaff | Recruiting | Flagstaff | Arizona | 86001 | United States |
Individual participant data will not be shared due to the small sample size, the inclusion of qualitative interview data, and the potential risk of participant re-identification within residential care and recovery settings. Given the community-engaged nature of the study and the involvement of potentially vulnerable populations, data sharing decisions will prioritize participant confidentiality, community trust, and applicable IRB and community partner agreements.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2026 | Apr 7, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 21, 2025 | Apr 7, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| From enrollment to 6 weeks (end of intervention) |
| The Peaks | Recruiting | Flagstaff | Arizona | 86001 | United States |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |