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RecruitingNCT07538427Updated Apr 20, 2026

Enhancing Health in Rural Populations: Music as Therapy

An interventional study of Music Based Intervention in Stress, Generalized Anxiety and Chronic Pain, sponsored by Northern Arizona University. Recruiting at 2 sites in United States. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Northern Arizona University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Stress
  • Generalized Anxiety
  • Chronic Pain
  • Depression Disorder

Keywords

  • Music-based intervention
  • Active music therapy
  • Drumming
  • Non-pharmacological intervention
  • behavioral therapy
  • Aging populations
  • Community-based intervention
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • residency at one of the two elder care facilities
  • ability to communicate in English.

Exclusion criteria

Exclusion Criteria:

  • not a resident at one of the two elder care facilities
  • inability to communicate in English.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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.

    Behavioral: Music Based Intervention

Interventions

  • BehavioralMusic Based Intervention

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to the end of treatment at 6 weeks.

  2. 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).

    Time frame: From enrollment to 6 weeks (post-intervention)

  3. 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.

    Time frame: From enrollment to 6 weeks (post-intervention).

  4. 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.

    Time frame: From enrollment to 6 weeks (end of intervention)

06

Study locations

2 of 2 sites recruiting
  • Haven Health Flagstaff
    Flagstaff, Arizona 86001, United States
    Recruiting
  • The Peaks
    Flagstaff, Arizona 86001, United States
    Recruiting
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 7, 2026
  • Informed consent form · Jul 21, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — 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.

08

Registry details

Key details

Study ID
NCT07538427
Lead sponsor
Northern Arizona University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Responsible party
Sponsor
First posted
Apr 20, 2026
Start date
Mar 12, 2026
Primary completion
May 30, 2027 (estimated)
Completion
May 30, 2027 (estimated)
Last update
Apr 20, 2026

Study contacts

Ariel L Roddy, PhD
Contact
ariel.roddy@nau.edu
248 298 6978

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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