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Идёт набор NCT06722287

Mobile Intervention for Mental Health of Family Caregivers in Thailand

Без фазы С лечением Depressive Symptoms, Generalized Anxiety, or Psychological 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: Caregiver Mental Health Mobile Application (CAMMA) Intervention, Usual Care Group.
Кому может быть актуально
Состояния в реестре: Depressive Symptoms, Generalized Anxiety, or Psychological Stress. Базовые параметры: 18 лет — 80 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
Таиланд
Следующий шаг
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Официальное название

Mobile Application for Early Detection and Intervention to Reduce Psychological Distress in Informal Family Caregivers of Community-dwelling Adults With Chronic Disorders in Thailand

Обзор

The primary objective of this study is to evaluate the effectiveness of the CAMMA intervention in reducing psychological distress among family caregivers of adults with chronic conditions in Thailand. Psychological distress is operationalized as depressive symptoms, anxiety symptoms, and perceived stress.

Подробное описание

The R33 randomized controlled trial will test whether CAMMA leads to meaningful reductions in depressive symptoms, anxiety, and perceived stress among family caregivers, compared with an active control condition. Consistent with the underlying caregiving risk framework, the trial will also examine hypothesized mediators-including self-care skills, caregiving self-efficacy, caregiver burden, and engagement with intervention components-to clarify mechanisms of action.

By embedding the intervention within existing service delivery structures and engaging frontline care managers and community care givers as active participants, the R33 trial is designed to generate evidence that is both clinically meaningful and implementation-relevant. This approach responds directly to the need for scalable, sustainable strategies to support caregiver mental health in low- and middle-income country settings and provides a strong empirical foundation for future dissemination and scale-up.

Вмешательства

  • Поведенческое Caregiver Mental Health Mobile Application (CAMMA) Intervention
    12-week system-integrated digital intervention including caregiver-facing mental health self-monitoring tools, self-care and caregiving support modules, facilitated peer interaction, and standardized triage/referral workflows supported by Care Manager / Community Caregiver digital interfaces. Engagement prompts and monitoring dashboards are used to support sustained use.
  • Поведенческое Usual Care Group
    12-week enhanced usual care including general health education materials and facilitated group discussions; no access to CAMMA's caregiver mental health monitoring, caregiver-specific self-care module

Первичные конечные точки

  • Depressive Symptoms [Срок оценки: At baseline (during about 2 weeks after consent and prior to initiation of study condition procedures), post-intervention (at the conclusion of the 12-week intervention period), and follow-up (approximately 3 months after completion of the intervention)]
  • Anxiety Symptoms [Срок оценки: At baseline (during about 2 weeks after consent and prior to initiation of study condition procedures), post-intervention (at the conclusion of the 12-week intervention period), and follow-up (approximately 3 months after completion of the intervention)]
  • Perceived Stress [Срок оценки: At baseline (during about 2 weeks after consent and prior to initiation of study condition procedures), post-intervention (at the conclusion of the 12-week intervention period), and follow-up (approximately 3 months after completion of the intervention)]

Критерии участия

Критерии включения

  • Adult (age 18 +) family caregiver (CG)
  • Has a minimum of 4 months of experience as a caregiver and provides at least 4 hours a day of care to the care recipient (CR);
  • Access to a mobile device with internet access

Критерии исключения

  • Caregiver who refuses to provide informed consent

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
Четверное слепое
Основная цель
Организация здравоохранения

Центры проведения

Таиланд · 1 центр
  • Ministry of Public Health — Bangkok

Идентификаторы

NCT: NCT06722287 · 2023P001212 · 4R33MH131043-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗