NCT07538427

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Mar 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Mar 2026May 2027

Study Start

First participant enrolled

March 12, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 1, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

April 1, 2026

Last Update Submit

April 15, 2026

Conditions

Keywords

Music-based interventionActive music therapyDrummingNon-pharmacological interventionbehavioral therapyAging populationsCommunity-based intervention

Outcome Measures

Primary Outcomes (4)

  • 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.

    From enrollment to 6 weeks (end of intervention)

Study Arms (1)

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.

Behavioral: Music Based Intervention

Interventions

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.

Music-Based Intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haven Health Flagstaff

Flagstaff, Arizona, 86001, United States

RECRUITING

The Peaks

Flagstaff, Arizona, 86001, United States

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety DisorderChronic Pain

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ariel L Roddy, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 20, 2026

Study Start

March 12, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

May 30, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations