An interventional study of Telehealth Resource Oriented Music Therapy in Type 1 Diabetes, Hashimoto Disease and Graves Disease, sponsored by Appalachian State University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Appalachian State University · Not applicable, Interventional, and Supportive care
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:
Participants will:
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
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 10 is below the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Appalachian State University is the lead sponsor of 41 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8-week post treatment initiation
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 8-week post treatment initiation
Plan to share: No — 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.
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Dec 2026, 5 months after the start.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 5 months is below that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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Appalachian State University