Type 1 DiabetesNCT07413874
Telehealth Music Therapy for Adults With Endocrine Disorder and Depression
A study testing Telehealth Resource Oriented Music Therapy in people with Type 1 Diabetes and Hashimoto Disease, run by Appalachian State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes, Hashimoto Disease, Graves Disease
- What is being tested?
- Telehealth Resource Oriented Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-reported depression
- self-reported autoimmune endocrine disease
- 18-65 years of age
- have a device that supports the Zoom platform (camera and audio)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Appalachian State University
Boone, North Carolina, 28608
Melody Schwantes, PhD, +1-828-262-8216, ms18994@appstate.edu
Vanessa Jewel, PhD, +1919-843-4463, vanessa_jewell@med.unc.edu
About this study
Official title: 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
Read more
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
Read the 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.
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
- Conditions
- Type 1 Diabetes, Hashimoto Disease, Graves Disease, Addison Disease, Autoimmune Polyglandular Syndrome Type III, Depression
- Being tested
- Telehealth Resource Oriented Music Therapy
- Keywords
- type 1 diabetes, music therapy, behavioral health, psychosocial, diabetes, behavioral intervention, quality of life, telehealth
- Medical subject headings
- Diabetes Mellitus, Type 1, Hashimoto Disease, Graves Disease, Addison Disease, Polyendocrinopathies, Autoimmune, Depression, Endocrine System Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Resource Oriented Music TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Telehealth Resource Oriented Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8-week post treatment initiation
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8-week post treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start16 Jul 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melody Schwantes, PhD, MT-BC, Principal investigator, Appalachian State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413874
- Sponsor's protocol ID
- HS-26-178
- Status last verified
- Jul 2026
- First submitted
- 10 Feb 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Music Therapy for Adults With Endocrine System Based Autoimmune Disease and a Depressive Disorder: An Intervention Development Study
- ClinicalTrials.gov ID
- NCT07413874
- Acronym / sponsor ID
- HS-26-178
- Conditions
- Type 1 Diabetes, Hashimoto Disease, Graves Disease, Addison Disease, Autoimmune Polyglandular Syndrome Type III, Depression
- Keywords
- type 1 diabetes, music therapy, behavioral health, psychosocial, diabetes, behavioral intervention, quality of life, telehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, University of California, San Francisco
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention: Telehealth Music Therapy | Experimental | Behavioral: Telehealth Resource Oriented Music Therapy10 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- self-reported depression
- self-reported autoimmune endocrine disease
- 18-65 years of age
- have a device that supports the Zoom platform (camera and audio)
Key exclusion criteria (6 listed)
- intellectual or developmental disability
- no auto-immune disease
- no depression
- lack of access to device
- under the age of 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth Resource Oriented Music TherapyThe 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. | Behavioural | Intervention: Telehealth Music Therapy |
Primary outcome
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.
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.
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.
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.
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
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.
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.
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.
3 secondary outcomes
European Quality of Life 5-Dimension(5D) 5-Level (5L) (EQ-5D-5L)
Time frame: Baseline and 8-week post treatment initiation
Change in Depressive Symptoms as Measured by Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline and 8-week post treatment initiation
Change in Anxiety-related Symptoms as Measured by Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: Baseline and 8-week post treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melody Schwantes, PhD, MT-BC principal investigator
Appalachian State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Resource Oriented Music Therapy in people with Type 1 Diabetes and Hashimoto Disease, run by Appalachian State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melody Schwantes, PhD, MT-BC (828-262-8216, ms18994@appstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Families Consented Versus Approached (time frame: 8-week post treatment initiation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.