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NCT Number: NCT07413874

Telehealth Music Therapy for Adults With Endocrine Disorder and Depression

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 to fill out a questionnaire with some basic information, answers about depression, quality of life, and potential anxiety, and a question about how they 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

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Key information

About this study

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.

The investigators 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 them 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 and post-intervention (8-weeks). Additionally, the investigators 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, the investigators 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Families Consented Versus Approached

    Time frame: 8-week post treatment initiation

    One feasibility measure was to evaluate the number and percentage of families consented compared to those approached for participation in the study.

  2. Number and Percentage of Intervention Group Condition Participants Retained vs Enrolled

    Time frame: 8-week post treatment initiation

    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.

  3. Number and Percentage of Surveys Completed by Participants Who Completed the Study

    Time frame: 8-week post treatment initiation

    Number and Percentage of surveys over time completed by participants who completed the study.

  4. Number and Percentage of attendance at telehealth sessions

    Time frame: 8-week post treatment initiation

    The total number/amount of sessions attended out of the total number of sessions available, reported as both the total number and the percentage.

  5. Number and percentage of participants enrolled for the different recruitment strategies

    Time frame: 8-week post treatment initiation

    For each recruitment strategy, the researchers will document the total number and percentage of how many families were eligible, approached, and enrolled

  6. Telehealth Satisfaction Survey

    Time frame: 8-week post treatment initiation

    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.

  7. Training Satisfaction Rating Scale

    Time frame: 8-week post treatment initiation

    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. Study Specific Interview Guide

    Time frame: 8-week post treatment initiation

    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.

Secondary outcomes

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

    Time frame: Baseline and 8-week post treatment initiation

    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.

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

    Time frame: Baseline and 8-week post treatment initiation

    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.

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

    Time frame: Baseline and 8-week post treatment initiation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Melody Schwantes, PhD, MT-BC

CONTACT

[email protected]

828-262-8216

Vanessa Jewell, PhD, OTR/L

CONTACT

[email protected]

919-843-4472

Sponsors and collaborators

Lead sponsor

Appalachian State University

Other

Collaborators

  • University of California, San Francisco
  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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