StressNCT07538427
Enhancing Health in Rural Populations: Music as Therapy
A study testing Music Based Intervention in people with Stress and Generalized Anxiety, run by Northern Arizona University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress, Generalized Anxiety, Chronic Pain
- What is being tested?
- Music Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Mar 2026to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- residency at one of the two elder care facilities
- ability to communicate in English.
Who cannot join
- not a resident at one of the two elder care facilities
- inability to communicate in English.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Haven Health Flagstaff
Flagstaff, Arizona, 86001
Chelsea Seck, 928-779-6931, chelseaseck@havenhg.com
- Recruiting
The Peaks
Flagstaff, Arizona, 86001
Frances Bryant, 928-774-7106, frances.bryant@thepeaks.org
About this study
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.
- Conditions
- Stress, Generalized Anxiety, Chronic Pain, Depression Disorder
- Being tested
- Music Based Intervention
- Keywords
- Music-based intervention, Active music therapy, Drumming, Non-pharmacological intervention, behavioral therapy, Aging populations, Community-based intervention
- Medical subject headings
- Generalized Anxiety Disorder, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Based InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Music Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From enrollment to 6 weeks (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start12 Mar 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Arizona University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538427
- Sponsor's protocol ID
- 2185298-9
- Other IDs
- 5U54MD012388-09
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Roddy AL, Mommaerts K, Maniglia R, Roddy J, Yarbrough C, Baldwin JA. A Culturally Grounded Music-Based Intervention for Indigenous Older Adults in Long-Term Care: Protocol for a Mixed Methods Pilot Study. JMIR Res Protoc. 2026 Sep 1;15:e104850. doi: 10.2196/104850.
PubMed 42678901
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Health in Rural Populations: Music as Therapy
- ClinicalTrials.gov ID
- NCT07538427
- Acronym / sponsor ID
- 2185298-9
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northern Arizona UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 20 Apr 2026 (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 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music-Based Intervention Group | Experimental | Behavioral: Music Based InterventionParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- residency at one of the two elder care facilities
- ability to communicate in English.
Key exclusion criteria (2 listed)
- not a resident at one of the two elder care facilities
- inability to communicate in English.
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 |
|---|---|---|
| Music Based InterventionParticipants 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. | Behavioural | Music-Based Intervention Group |
Primary outcome
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.
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).
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Derived from this study: PubMed 42678901Roddy AL, Mommaerts K, Maniglia R, Roddy J, Yarbrough C, Baldwin JA. A Culturally Grounded Music-Based Intervention for Indigenous Older Adults in Long-Term Care: Protocol for a Mixed Methods Pilot Study. JMIR Res Protoc. 2026 Sep 1;15:e104850. doi: 10.2196/104850.
- Individual participant dataSharing planned: 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.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Based Intervention in people with Stress and Generalized Anxiety, run by Northern Arizona University at 2 sites in United States.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ariel L Roddy, PhD (248 298 6978, ariel.roddy@nau.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS-10) (time frame: From enrollment to the end of treatment at 6 weeks.). The study lists 4 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 NCT07538427, which also lists 1 linked publication.
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 20 Apr 2026.