Telehealth Music Therapy for Adults With Endocrine Disorder and Depression

NCT07413874 | Not Yet Recruiting

• 1 other identifier: HS-26-178
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Type 1 Diabetes; Hashimoto Disease; Graves Disease; Addison Disease; Autoimmune Polyglandular Syndrome Type III; Depression; Endocrine System Diseases

Keywords

type 1 diabetes; music therapy; behavioral health; psychosocial; diabetes; behavioral intervention; quality of life; telehealth

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• European Quality of Life 5-Dimension(5D) 5-Level (5L) (EQ-5D-5L)

  Baseline and 8-week post treatment initiation

• Change in Depressive Symptoms as Measured by Patient Health Questionnaire-9 (PHQ-9) Score

  Baseline and 8-week post treatment initiation

• Change in Anxiety-related Symptoms as Measured by Generalized Anxiety Disorder-7 (GAD-7) Score

  Baseline and 8-week post treatment initiation

Study Arms (1)

Intervention: Telehealth Music Therapy

EXPERIMENTAL

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

Interventions

Telehealth Resource Oriented Music Therapy BEHAVIORAL

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.

Intervention: Telehealth Music Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Appalachian State University: lead
• Meredith Wilson Foundation: collaborator
• University of North Carolina, Chapel Hill: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hashimoto Disease; Graves Disease; Addison Disease; Polyendocrinopathies, Autoimmune; Depression; Endocrine System Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Thyroiditis, Autoimmune; Thyroiditis; Thyroid Diseases; Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Hyperthyroidism; Adrenal Insufficiency; Adrenal Gland Diseases; Behavioral Symptoms; Behavior

Study Officials

• Melody Schwantes, PhD, MT-BC

  Appalachian State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melody Schwantes, PhD, MT-BC

CONTACT

828-262-8216; ms18994@appstate.edu

Vanessa Jewell, PhD, OTR/L

CONTACT

919-843-4472; vanessa_jewell@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking possible
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share