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Идёт набор NCT07746427

Digital Mindfulness Meditation in Adolescents With Atopic Dermatitis

Без фазы С лечением Atopic Dermatitis Eczema

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: Digital App Mindfulness Meditation, Mindfulness Meditation Sheet.
Кому может быть актуально
Состояния в реестре: Atopic Dermatitis, Eczema. Базовые параметры: 12 лет — 17 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 →
Официальное название

Outcomes of a Digital Mindfulness Meditation App-Based Intervention in Adolescents With Moderate to Severe Atopic Dermatitis (MIND-AD)

Обзор

Atopic dermatitis is well reported to have a significant impact on well-being in adolescents with atopic dermatitis, without clear recommendations for intervention. The investigators aim to identify an accessible, effective digital health intervention for these patients. The investigators hypothesize that regular use of a digital mindfulness meditation app will improve disease control and quality of life in adolescents with moderate to severe atopic dermatitis based on validated survey measures.

Подробное описание

Atopic dermatitis (AD) is a significant chronic, relapsing, remitting, disease affecting children and adolescents, in terms of prevalence and impact on patient quality of life. Ten percent of individuals in the United States have AD, with prevalence peaking during childhood and adolescence. Over the past 25 years, prevalence of AD in has increased from 8% to 12%. Atopic dermatitis is known to significantly impact patient quality of life. Pruritis is known to be among the most burdensome symptoms. Many patients report severe pruritis significantly affecting sleep. Children and adolescents with AD are more likely to have depression, anxiety, and decreased well-being.

While there are increasing options for medical therapy for AD including new topical agents (i.e. Ruxolitinib) and biological agents (i.e. Dupilumab), refractory cases resulting in pruritus and decreased sleep quality would benefit from yet to be identified accessible digital behavioral interventions to improve quality of life in patients with AD, especially in adolescents where AD is more likely to be associated with depression, anxiety, and decreased well-being.

Mindfulness and meditation are known tools that can improve sleep, stress, anxiety, depression, and physical symptoms including pain. Mindfulness is defined as the act of keeping one's attention to the present moment without judgement and with acceptance. Meditation is one way to practice mindfulness, using the breath or walking as a focal point. There are numerous studies showing the benefits of mindfulness and meditation in adults, but this data is more limited in children and adolescents.

There are digital mindfulness meditation apps that are readily accessible to the general population for learning mindfulness and incorporating a meditation practice into day-to-day life in a digitally accessible manner. There are multiple studies investigating psychological interventions in patients with AD, however to the investigators' knowledge none include mindfulness meditation or an accessible app-based intervention in adolescents. Digital mindfulness meditation apps have been shown to be effective in reducing stress, improving sleep, and decreasing physical symptoms such as pain. Users of digital mindfulness meditation apps have reported satisfaction with ease of use and overall enjoyment of the app.

Patients with AD, especially adolescents, have been reported to have a high psychological burden of disease and an easy to use, accessible digital app intervention designed to be used a few times a week for a short period of time has a potential to have a significant impact on anxiety, depression, pruritus, sleep, and disease outcomes in adolescents with AD.

Objective 1: To measure self-reported disease control before and after a digital mindfulness meditation app-based intervention in adolescents with moderate-to-severe atopic dermatitis (AD). The investigators will administer the Atopic Dermatitis Control Tool (ADCT), a brief, validated, and easily scored 6-question survey to adolescents age 12-17 with moderate-to-severe atopic dermatitis at the start and end of the one-month study period comparing intervention (digital mindfulness meditation) to control (receipt of a mindfulness meditation information sheet).

Objective 2: To evaluate the impact of a digital mindfulness meditation app-based intervention on quality of life in adolescents with moderate-to-severe AD. The investigators will administer the Teenager's Quality of Life Index (T-QoL) an 18-question, self-explanatory, validated survey on quality of life in dermatologic conditions for adolescents that evaluates self-image, physical well-being and future aspirations, and psychological impact and relationships to study participants at the start and end of the one-month study period comparing intervention (digital mindfulness meditation) to control (receipt of a mindfulness meditation information sheet).

Вмешательства

  • Поведенческое Digital App Mindfulness Meditation
    Regular use of a digital mindfulness meditation app 3-4 times per week for 10-15 minutes each session.
  • Поведенческое Mindfulness Meditation Sheet
    Participants will read an informational handout on mindfulness meditation at the start of the study.

Первичные конечные точки

  • Mean Atopic Dermatitis Control Tool (ADCT) score. [Срок оценки: Pre and post 1 month study observation period.]
  • Mean Teenager Quality of Life (T-QoL) Index score [Срок оценки: Pre and post 1 month study observation period.]
Вторичные конечные точки (1)
  • Number of participants who found the digital app modality to be useful and accessible [Срок оценки: 1 month post study observation period]

Критерии участия

Критерии включения

  • Adolescents age 12-17 years.
  • Atopic dermatitis refractory to standard topical treatment including topical steroids or topical calcineurin inhibitors.
  • Moderate to severe atopic dermatitis via PO-SCORAD score on enrollment.

Критерии исключения

  • Started on a biologic agent (i.e. dupxient) within the past 3 months.
  • Mild atopic dermatitis via PO-SCORAD score on enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Weill Cornell Medicine — New York
  • Columbia University Irving Medical Center — New York

Идентификаторы

NCT: NCT07746427 · 25-12029628

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗