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Набор скоро начнётся NCT07669805

Social Prescribing for a Mindful Lifestyle

Без фазы С лечением Depression and/or Anxiety in the Mild-to-moderate Range Loneliness Social Isolation

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: Mindfulness Lifestyle Social Prescribing Program.
Кому может быть актуально
Состояния в реестре: Depression and/or Anxiety in the Mild-to-moderate Range, Loneliness, Social Isolation. Базовые параметры: от 55 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
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The goal of this clinical trial is to evaluate the effectiveness of an 8-week mindfulness lifestyle social prescribing program in community-dwelling older adults aged 55 and older. The main questions it aims to answer are: To establish a mindfulness lifestyle social prescribing model applied to the psychological and social health promotion of middle-aged and older populations. To evaluate the effectiveness of the intervention on improving depressive symptoms, loneliness, and quality of life in this population. Participants will receive an 8-week group intervention program, with each weekly session lasting approximately 3 hours. The structured curriculum integrates mindfulness awareness, body scanning, mindfulness stretching, breathing training, healthy dietary education, and art practices (such as herbal therapy and leaf printing). Researchers will collect and evaluate data from pre- and post-intervention assessments to measure changes in depressive symptoms, loneliness risk, and overall quality of life.

Подробное описание

This clinical trial implements an 8-week mindfulness lifestyle social prescribing program designed to enhance the psychological and social well-being of community-dwelling older adults. The intervention integrates mindfulness practices with healthy lifestyle modifications to address sub-healthy states, such as depressive symptoms and social isolation, which traditional clinical models often fail to fully resolve.

The structured 8-week group curriculum meets weekly for 3 hours per session. The program systematically incorporates mindfulness awareness, body scanning, mindfulness stretching, breathing training, healthy dietary education, and art practices (including herbal therapy and leaf printing).

The program is delivered by a multidisciplinary team of geriatricians, geriatric case managers, nutritionists, exercise instructors, and trained volunteers to ensure comprehensive support.

Research procedures involve a pre- and post-intervention assessment design. Participants will undergo standardized evaluations before the commencement of the first session (Week 1) and upon the completion of the program (Week 8). These assessments will objectively measure changes in depressive symptoms, the risk of loneliness, and overall quality of life to determine the effect of this social prescribing model.

Вмешательства

  • Поведенческое Mindfulness Lifestyle Social Prescribing Program
    An 8-week, once-weekly, 3-hour group program designed for middle-aged and older adults. The structured curriculum integrates mindfulness awareness, body scanning, mindfulness stretching, breathing training, healthy dietary education, and art practices (such as herbal therapy and leaf printing). It is delivered by a multidisciplinary team including geriatricians, case managers, dietitians, exercise instructors, and volunteers.

Первичные конечные точки

  • Changes in Geriatric Depression Scale (GDS-15) score [Срок оценки: Baseline and Week 8]
  • Changes in UCLA Loneliness Scale score [Срок оценки: Baseline and Week 8]
  • Changes in WHOQOL-BREF questionnaire score [Срок оценки: Baseline and Week 8]

Критерии участия

Критерии включения

  • People aged 55 years or older.
  • People with a Geriatric Depression Scale (GDS-15) score of 7-10 or a UCLA Loneliness Scale Version 3 score of 35-64.
  • People can understand the research process, meet the requirements of the research, and can sign the informed consent and participate in the project.

Критерии исключения

  • People that are unable to cooperate with the project or follow-up.
  • According to the PI's judgment, people with severe or poorly controlled conditions include ongoing acute diseases, severe infections, severe abnormal laboratory tests, or serious medical conditions with the following systems: cardiovascular, pulmonary, hepatic, nervous, mental, metabolic, renal, musculoskeletal, gastrointestinal, etc.
  • People with severe depression, risk of self-harm, severe cognitive impairment (dementia), visual or hearing impairment, and disabilities that prevent the completion of the project and assessment.
  • People are currently or expected to join any other physical training courses or nutrition intervention plans during the project period.
  • Others are based on the judgment of the PI that participating in this project may adversely affect the safety of the subjects, hinder the progress of the experiment, or interfere with the evaluation of the outcomes of the project.

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
Организация здравоохранения

Центры проведения

Тайвань · 1 центр
  • Buddhist Tzu Chi General Hospital — Hualien City

Публикации

  • Holt-Lunstad J, Smith TB, Baker M, Harris T, Stephenson D. Loneliness and social isolation as risk factors for mortality: a meta-analytic review. Perspect Psychol Sci. 2015 Mar;10(2):227-37. doi: 10.1177/1745691614568352. PMID 25910392
  • Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316. PMID 20668659
  • Paquet C, Whitehead J, Shah R, Adams AM, Dooley D, Spreng RN, Aunio AL, Dube L. Social Prescription Interventions Addressing Social Isolation and Loneliness in Older Adults: Meta-Review Integrating On-the-Ground Resources. J Med Internet Res. 2023 May 17;25:e40213. doi: 10.2196/40213. PMID 37195738

Идентификаторы

NCT: NCT07669805 · IRB115-107-A

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗