About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
self-reported depression
self-reported autoimmune endocrine disease
18-65 years of age
have a device that supports the Zoom platform (camera and audio)
Disqualifiers
intellectual or developmental disability
no auto-immune disease
no depression
lack of access to device
Trial design
Single group
Treatments tested in this trial
Telehealth Resource Oriented Music Therapy
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
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.
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.
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.
Sponsors and contacts
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Appalachian State University
Lead sponsor
University of North Carolina, Chapel Hill
Collaborator
University of California, San Francisco
Collaborator