Telehealth Music Therapy for Adults With Endocrine Disorder and Depression
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Telehealth Resource Oriented Music Therapy.
- Кому может быть актуально
- Состояния в реестре: Type 1 Diabetes, Hashimoto Disease, Graves Disease, Addison Disease. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Telehealth Music Therapy for Adults With Endocrine System Based Autoimmune Disease and a Depressive Disorder: An Intervention Development Study
Обзор
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
Подробное описание
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
Вмешательства
- Поведенческое 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.
Первичные конечные точки
- Percentage of Families Consented Versus Approached [Срок оценки: 8-week post treatment initiation]
- Number and Percentage of Intervention Group Condition Participants Retained vs Enrolled [Срок оценки: 8-week post treatment initiation]
- Number and Percentage of Surveys Completed by Participants Who Completed the Study [Срок оценки: 8-week post treatment initiation]
- Number and Percentage of attendance at telehealth sessions [Срок оценки: 8-week post treatment initiation]
- Number and percentage of participants enrolled for the different recruitment strategies [Срок оценки: 8-week post treatment initiation]
- Telehealth Satisfaction Survey [Срок оценки: 8-week post treatment initiation]
- Training Satisfaction Rating Scale [Срок оценки: 8-week post treatment initiation]
- Study Specific Interview Guide [Срок оценки: 8-week post treatment initiation]
Вторичные конечные точки (3)
- European Quality of Life 5-Dimension(5D) 5-Level (5L) (EQ-5D-5L) [Срок оценки: Baseline and 8-week post treatment initiation]
- Change in Depressive Symptoms as Measured by Patient Health Questionnaire-9 (PHQ-9) Score [Срок оценки: Baseline and 8-week post treatment initiation]
- Change in Anxiety-related Symptoms as Measured by Generalized Anxiety Disorder-7 (GAD-7) Score [Срок оценки: Baseline and 8-week post treatment initiation]
Критерии участия
Критерии включения
- self-reported depression
- self-reported autoimmune endocrine disease
- 18-65 years of age
- have a device that supports the Zoom platform (camera and audio)
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- Appalachian State University — Boone
Идентификаторы
NCT: NCT07413874 · HS-26-178