Telehealth Music Therapy for Adults With Endocrine Disorder and Depression

Telehealth Music Therapy for Adults With Endocrine System Based Autoimmune Disease and a Depressive Disorder: An Intervention Development Study

The goal of this clinical trial is to explore if a telehealth music therapy intervention helps with quality of life, depression symptoms, anxiety symptoms. It will also explore the participants' relationship to music. The main questions it aims to answer are:

• Refine and tailor the music therapy intervention to fit the specific needs of adults living with an autoimmune disease and depression.
• Examine the feasibility of the study protocol to support a future full-scale trial
• Examine how music therapy impacts quality of life, depression symptoms, and anxiety symptoms
• Explore how music therapy impacts one's relationship to music

Participants will:

• have a short interview where you'll fill out a questionnaire with some basic information, answers about your depression, quality of life, and potential anxiety, and a question about how you feel about music at the start and end of the sessions
• attend 8 weekly sessions, approximately 30-45 minutes each, with a board certified music therapist over telehealth/Zoom
• answer a few questions about the music therapy intervention

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Endocrine System Diseases; Type 1 Diabetes; Graves Disease; Hashimoto Disease; Addison Disease; Autoimmune Polyglandular Syndrome Type III
• Intervention / Treatment: Behavioral: Telehealth Resource Oriented Music Therapy

Detailed Description

Of all known chronic illnesses in the United States, it is reported that autoimmune diseases (AD) are the third most common cause, with an estimated five to eight percent of the population living with one or more AD. Adults living with AD often face chronic health challenges, including increased stress, anxiety, pain, discomfort, social isolation, and depression. Additional evidence supports the use of music therapy to supplement traditional pharmacotherapies to improve physical and mental well-being of people with numerous disease states such as trait anxiety, state anxiety, mood disorders, psychological distress, behavioral and emotional problems, and depression. However, there is limited research examining intervention development of music therapy to address psychosocial symptoms of autoimmune diseases.

We propose to conduct an intervention development study with 8-10 adults with a) an autoimmune endocrine disease and b) depression to examine an 8-week telehealth music therapy intervention, enabling us to refine research procedures for a future high priority, full-scale efficacy clinical trial. All participants will receive an 8-week music therapy intervention and usual care, as provided by their medical team (medication management, therapy, and appropriate support for self-management). Collection of outcome measures will occur at baseline, post-intervention (8-weeks), Additionally, we will complete interviews with the participants at the end of the intervention to gain perspectives on intervention and study protocol.

Aim 1 Refine and tailor the 8-week telehealth music therapy intervention to fit the specific, individual needs of adults living with and autoimmune endocrine disease and depression. Using community-engaged research methods, we will accomplish this aim through an iterative process of a) engagement of an advisory panel of adults with AD to provide critical input on the 8-week music therapy intervention prior to, during, and after the intervention delivery; b) refinement of the conceptual framework; and c) interviews with the participants at intervention completion for intervention and study design acceptability.

Adults living with autoimmune diseases and mental health conditions are at a higher risk for adverse health events. Feasibility studies are required to assess innovative interventions to promote their overall health and well-being, to provide the foundation for full-scale complementary health clinical trials that can effectively transform the standards of care for autoimmune diseases, and to advance health in under-resourced communities.

Adults with autoimmune disorders need practitioners who are trained in the impacts of these conditions on physical, social, and emotional wellbeing, utilizing an engaging approach that music therapy (MT) offers. Providing adults living with autoimmune diseases and depression/anxiety services that are specifically tailored to individuals and using a more accessible approach of telehealth has the potential to support adult empowerment, resilience, and coping strategies required to manage chronic condition

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melody Schwantes, PhD, MT-BC; Phone Number: 828-262-8216; Email: ms18994@appstate.edu
• Study Contact Backup: Name: Vanessa Jewell, PhD, OTR/L; Phone Number: 919-843-4472; Email: vanessa_jewell@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• self-reported depression
• self-reported autoimmune endocrine disease
• 18-65 years of age
• have a device that supports the Zoom platform (camera and audio)

Exclusion Criteria:

• intellectual or developmental disability
• no auto-immune disease
• no depression
• lack of access to device
• under the age of 18 years
• over the age of 65 years

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: Telehealth Music Therapy; 10 participants will receive the telehealth music therapy intervention. This is an 8-week study utilizing a resource-oriented approach keeping the principles of empowerment philosophy, self-determination, collaboration, recovery-oriented or salutogenesis ways of working, and utilizing music as a health resource.	Behavioral: Telehealth Resource Oriented Music Therapy; The interventions used during the sessions may include any of the following: Creating play lists, Song discussion, Song writing, Improvisation/Electronic music creation, Music assisted relaxation, Music listening journal, and Music combined with art creation as a form of receptive music therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Families Consented Versus Approached	One feasibility measure was to evaluate the number and percentage of families consented compared to those approached for participation in the study.	8-week post treatment initiation
Number and Percentage of Intervention Group Condition Participants Retained vs Enrolled	Number and Percentage of Intervention Group participants retained in the study compared to those enrolled. Retention is defined as participants who completed post-intervention assessments.	8-week post treatment initiation
Number and Percentage of Surveys Completed by Participants Who Completed the Study	Number and Percentage of surveys over time completed by participants who completed the study.	8-week post treatment initiation
Number and Percentage of attendance at telehealth sessions	The total number/amount of sessions attended out of the total number of sessions available, reported as both the total number and the percentage.	8-week post treatment initiation
Number and percentage of participants enrolled for the different recruitment strategies	For each recruitment strategy, the researchers will document the total number and percentage of how many families were eligible, approached, and enrolled	8-week post treatment initiation
Telehealth Satisfaction Survey	A self-reported questionnaire for participants to rate how satisfied they were with the telehealth sessions (a measure of study acceptability). It includes 10 questions with 1-4 ratings, with higher scores indicating higher levels of satisfaction.	8-week post treatment initiation
Training Satisfaction Rating Scale	A self-reported questionnaire for participants to rate their satisfaction with the Music Therapy intervention. It includes the following subdomains: Objectives and content (3 questions); Method of training context (6 questions); Usefulness and overall rating (3 questions). Items are rated on a 1-5 scale, with higher scores indicating higher levels of acceptability.	8-week post treatment initiation
Study Specific Interview Guide	A semi-structured interview guide to qualitatively assess feasibility and acceptability of the Music Therapy intervention framework. It includes questions related to recruitment and enrollment (3 questions); scheduling and time commitment (3 questions); assessments and data collection (3 questions); technology use (2 questions); overall burden/ease (2 questions); perceived value of the intervention ( 2 questions); engagement and enjoyment (2 questions); format delivery (2 questions); relevance to family's life (2 questions); therapist interaction (2 questions); rural context (2 questions); modules and content (3 questions); habit & routine focus of the intervention (3 questions); perceived changes/impact (2 questions); recommendations for improvement (2 questions); and overall reflections (2 questions). Qualitative results will be reported by each sub-domain.	8-week post treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
European Quality of Life 5-Dimension(5D) 5-Level (5L) (EQ-5D-5L)	Patient reported health-related quality of life scores using the EQ-5D-5L instrument. EQ-5D-5L is a preference-based measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores from each of the five dimensions range from 1 to 5. Total score ranges from 5 to 25, where higher scores indicate worse health status.	Baseline and 8-week post treatment initiation
Change in Depressive Symptoms as Measured by Patient Health Questionnaire-9 (PHQ-9) Score	The PHQ-9 has a total range of 0-27, where 0 = No depression, 1-4 = Minimal depression, 5-9 = Mild depression, 10-14 = Moderate depression, 15-19 = Moderately severe depression, 20-27 = Severe depression. A negative score change indicates a decrease in depressive symptoms and a positive score change indicates an increase in depressive symptoms.	Baseline and 8-week post treatment initiation
Change in Anxiety-related Symptoms as Measured by Generalized Anxiety Disorder-7 (GAD-7) Score	GAD-7 total score for the seven items ranges from 0 to 21, calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." A total score of 0-4 = minimal anxiety, 5-9 = mild anxiety, 10-14 = moderate anxiety, 15-21 = severe anxiety. A negative score change indicates a decrease in anxiety symptoms and a positive score change indicates an increase in anxiety symptoms.	Baseline and 8-week post treatment initiation

Collaborators and Investigators

• Sponsor: Appalachian State University
• Collaborators: University of North Carolina, Chapel Hill; Meredith Wilson Foundation
• Investigators: Principal Investigator: Melody Schwantes, PhD, MT-BC, Appalachian State University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: diabetes; behavioral intervention; quality of life; music therapy; psychosocial; type 1 diabetes; telehealth; behavioral health
• Additional Relevant MeSH Terms: Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Glucose Metabolism Disorders; Eye Diseases; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Adrenal Gland Diseases; Thyroid Diseases; Thyroiditis, Autoimmune; Thyroiditis; Adrenal Insufficiency; Behavior; Nutritional and Metabolic Diseases; Depression; Diabetes Mellitus; Diabetes Mellitus, Type 1; Graves Disease; Endocrine System Diseases; Hashimoto Disease; Polyendocrinopathies, Autoimmune; Addison Disease
• Other Study ID Numbers: HS-26-178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets generated and analyzed during the current study are not publicly available due to the sensitive nature of the clinical data, which includes participant health records regarding endocrine autoimmune disorders and depression. Given the small sample size and the telehealth-based nature of the intervention, there is a heightened risk of participant re-identification. Data may be made available from the principal investigator upon reasonable request, subject to approval by the Institutional Review Board and the execution of a formal Data Use Agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No