- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07538427
Enhancing Health in Rural Populations: Music as Therapy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ariel L Roddy, PhD
- Phone Number: 248 298 6978
- Email: ariel.roddy@nau.edu
Study Locations
-
-
Arizona
-
Flagstaff, Arizona, United States, 86001
- Recruiting
- Haven Health Flagstaff
-
Contact:
- Chelsea Seck
- Phone Number: 928-779-6931
- Email: chelseaseck@havenhg.com
-
Flagstaff, Arizona, United States, 86001
- Recruiting
- The Peaks
-
Contact:
- Frances Bryant
- Phone Number: 928-774-7106
- Email: frances.bryant@thepeaks.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- residency at one of the two elder care facilities
- ability to communicate in English.
Exclusion Criteria:
- not a resident at one of the two elder care facilities
- inability to communicate in English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music-Based Intervention Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Scale (PSS-10)
Time Frame: From enrollment to the end of treatment at 6 weeks.
|
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)
Time Frame: From enrollment to 6 weeks (post-intervention)
|
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)
Time Frame: From enrollment to 6 weeks (post-intervention).
|
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)
Time Frame: From enrollment to 6 weeks (end of intervention)
|
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.
|
From enrollment to 6 weeks (end of intervention)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2185298-9
- 5U54MD012388-09 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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