Меню
Набор скоро начнётся NCT07711860

Mindfulness for Lonely Older Adults With Emigrant Children

Без фазы С лечением Loneliness Sleep Quality Quality of Life Stress

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: Intervention, Active Control.
Кому может быть актуально
Состояния в реестре: Loneliness, Sleep Quality, Quality of Life, Stress. Базовые параметры: 65 лет — 75 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
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Feasibility and Acceptability of Implementation of Mindfulness-Based Intervention for Community-Dwelling Older Adults With Emigrant Children Suffering From Loneliness: A Pilot Randomized Controlled Trial

Обзор

This study is to examine the feasibility of a proposed mindfulness-based intervention (MBI) and study methodology for future main study.

Подробное описание

The goal of this 3-arm randomized controlled trial is to examine the feasibility of a proposed mindfulness-based intervention (MBI) and study methodology for future main study. It will identify the acceptability, feasibility, and potential effectiveness of the MBI for lonely older adults (OAs) with emigrant children. The main questions it aims to answer are:

1. To what extent is the MBI study process feasible and acceptable for lonely OAs whose children have emigrated? 2. Do subjects in the intervention group show significant improvements in loneliness levels, sleep quality, stress levels, and quality of life (QoL) during follow-up assessments at weeks 12 and 24 compared to baseline? 3. How practical and effective is the recruitment process for enrolling the target study subjects?

Researchers will compare lonely adults with or without out emigrant children to see if MBI to reduce the loneliness level.

Participants will attend a 12-week programme with 8-section face-to-face MBI training, guided by 7 mindfulness video clips plus 4 individual support phone calls, and follow-up at week 12 and 24. In addition, an individual semi-structured interview will be carried out to explore the experience and perceived programme effects of the intervention.

Вмешательства

  • Поведенческое Intervention
    Eight MBI lessons, and receive seven instant messages individually and four phone calls in 12-week to enhance and guide home self-practice
  • Другое Active Control
    Eight health education and craft sessions, seven instant messages individually, four phone calls, and maintain usual activities without participating in mind-body exercise/ activities or stress reduction programme in 12-week

Первичные конечные точки

  • Feasibility of Mindfulness-based Intervention (MBI) [Срок оценки: After the 12-week MBI training]
  • Acceptability of the Mindfulness-based Intervention (MBI) [Срок оценки: After the 12-week MBI training]
Вторичные конечные точки (7)
  • Loneliness [Срок оценки: Baseline, week 12 and week 24]
  • Sleep quality [Срок оценки: Baseline, week 12 and week 24]
  • Stress level [Срок оценки: Baseline, week 12 and week 24]
  • Participants' Quality of Life [Срок оценки: Baseline, week 12 and week 24]
  • Mindfulness [Срок оценки: Baseline, week 12 and week 24]
  • Cardiometabolic outcomes [Срок оценки: Baseline, week 12 and week 24]
  • Others [Срок оценки: Baseline, week 12 and week 24]

Критерии участия

Критерии включения

  • Chinese adults aged 65 to 75 years,
  • able to communicate and understand Cantonese (class will be held in Cantonese),
  • OAs with or without emigrant children,
  • feeling of loneliness (3-item UCLA ≥6) \[25\], and
  • living in public housing, reliant on pension, savings, or living in subvented housing.

Критерии исключения

  • Acute or severe physical symptoms such as impaired mobility, COPD or respiratory failure, uncontrolled epilepsy, and severe chronic pain syndrome,
  • Abbreviated Mental Test (AMT)< 6 \[26\],
  • met DSM-V TR criteria for treated or untreated major depressive disorder, bipolar disorder, cyclothymic disorder and/or on regular medication treatment,
  • have significant suicidal risk, and
  • previous experience in instructor-led mindfulness training within the half year prior to the commencement of the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Другое

Центры проведения

Гонконг · 1 центр
  • Hong Kong Metropolitan University — Гонконг

Идентификаторы

NCT: NCT07711860 · HE-HMRF2025/10 · 23240241

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗