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Набор скоро начнётся NCT07666594

Mobile App-Based Yoga and Meditation in Rheumatoid Arthritis

Без фазы С лечением Rheumatoid Arthritis (RA) Anxiety Depression Anxiety Disorder Mobile Health Technology (mHealth)

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: Mobile App-Based Yoga and Meditation.
Кому может быть актуально
Состояния в реестре: Rheumatoid Arthritis (RA), Anxiety, Depression Anxiety Disorder, Mobile Health Technology (mHealth). 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

Effectiveness of a Mobile Application-Based Yoga and Meditation Program in Patients With Rheumatoid Arthritis: A Single-Blind Randomized Controlled Trial.

Обзор

The goal of this single-blind, randomized controlled trial is to evaluate the clinical effectiveness and short-term economic impact of a mobile application-based, personalized yoga and meditation program in adult patients with Rheumatoid Arthritis (RA). The main questions it aims to answer are: Does an 8-week digital yoga and meditation intervention reduce anxiety and improve other clinical/psychological outcomes (such as depression, pulmonary function, reaction time, quality of life, and stress) compared to standard medical care? Does this digital intervention reduce short-term healthcare utilization and associated direct medical costs? Researchers will compare the Mobile App Group (receiving personalized yoga and meditation via the Meditopia app) to a Control Group (receiving usual medical care) to evaluate the effectiveness and cost-efficiency of the intervention. Participants in the experimental group will: Use a mobile application to practice 15-30 minutes of yoga and 15-30 minutes of meditation daily, at least 4 days a week over an 8-week period. Complete clinical, psychometric, and economic assessments at baseline, week 4, and week 8.

Вмешательства

  • Поведенческое Mobile App-Based Yoga and Meditation
    The intervention consists of an 8-week individualized program. It includes yoga sequences selected by a physiotherapist based on the patient's functional capacity and joint mobility. It also includes mindfulness-based and emotion regulation-focused meditation content selected by a clinical psychologist. Participants are expected to practice for 15-30 minutes of yoga and 15-30 minutes of meditation daily, at least 4 days a week.The intervention is delivered through the Meditopia mobile applicatio

Первичные конечные точки

  • Hospital Anxiety and Depression Scale - Anxiety (HADS-A) [Срок оценки: Baseline (T0), Week 4 (T1), and Week 8 (T2).]
Вторичные конечные точки (12)
  • Perceived Stress Scale (PSS-10) [Срок оценки: Baseline (T0), Week 4 (T1), and Week 8 (T2)]
  • Fatigue Severity Scale (FSS) [Срок оценки: Baseline and Week 8]
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline (T0), Week 4 (T1), and Week 8 (T2)]
  • Rheumatoid Arthritis Quality of Life (RAQOL) [Срок оценки: Baseline (T0), Week 4 (T1), and Week 8 (T2)]
  • Chronic Illness Self-Management (CISM) Scale [Срок оценки: Baseline (T0) and Week 8 (T2)]
  • Forced Vital Capacity (FVC) [Срок оценки: Baseline (T0), Week 4 (T1), and Week 8 (T2)]
  • Forced Expiratory Volume in 1 Second (FEV1) [Срок оценки: Baseline (T0), Week 4 (T1), and Week 8 (T2)]
  • FEV1/FVC Ratio [Срок оценки: Baseline (T0), Week 4 (T1), and Week 8 (T2)]
  • Peak Expiratory Flow (PEF) [Срок оценки: Baseline (T0), Week 4 (T1), and Week 8 (T2)]
  • Visual Reaction Time (BlazePod) [Срок оценки: Baseline (T0), Week 4 (T1), and Week 8 (T2)]
  • Total Direct Healthcare Costs (Partial Cost Analysis) [Срок оценки: Baseline (T0) and Week 8 (T2)]
  • System Usability Scale (SUS) [Срок оценки: At the end of the 8-week intervention]

Критерии участия

Критерии включения

  • Adults aged between 18 and 65 years.
  • Diagnosed with Rheumatoid Arthritis (RA) by a rheumatologist.
  • Disease in a stable phase (remission or low disease activity).
  • Access to a smartphone or tablet and sufficient proficiency in using mobile applications.
  • Cognitive sufficiency to provide written and verbal informed consent in Turkish.

Критерии исключения

  • Presence of acute RA flare-ups.
  • Severe psychiatric diagnoses (e.g., psychosis, bipolar disorder, or severe major depression).
  • Severe cognitive impairment or dementia.
  • Pregnancy.
  • Regular practice of meditation or mindfulness within the last 6 months.
  • Participation in any other stress management program within the last 3 months.
  • Receipt of mental health services within the last 6 months.

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
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Internal Med — Istanbul

Идентификаторы

NCT: NCT07666594 · IUC-2025-641

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗