Telehealth Music Therapy for Adults With Endocrine Disorder and Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAppalachian State University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Intervention: Telehealth Music TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Appalachian State University

Lead sponsor

University of North Carolina, Chapel Hill

Collaborator

University of California, San Francisco

Collaborator