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Набор скоро начнётся NCT06843395

ACT-based EMI in College Students

Без фазы С лечением Healthy Participants Study

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: ACT-based ecological momentary intervention, Mood monitoring.
Кому может быть актуально
Состояния в реестре: Healthy Participants Study. Базовые параметры: Без ограничений · 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
Китай
Следующий шаг
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Официальное название

Assessing the Feasibility, Acceptability and Effectiveness of an Transdiagnostic Acceptance and Commitment Therapy-based Ecological Momentary Intervention in College Students: a Pilot Randomized Controlled Trial

Обзор

This study aims to evaluate the acceptability and effectiveness of a transdiagnostic, Acceptance and Commitment Therapy (ACT)-based ecological momentary intervention (EMI) among college students. A mixed-methods pilot randomized controlled trial (RCT) will be conducted to assess its impact on psychological flexibility, well-being and mental health outcomes.

Подробное описание

Mental health issues are prevalent among college students, yet traditional interventions often face barriers related to accessibility and engagement. This study explores the feasibility, acceptability, and preliminary effectiveness of a transdiagnostic ACT-based EMI designed to deliver in-the-moment psychological support via digital platforms. A mixed-methods pilot RCT will be conducted, with participants randomly assigned to either the ACT-based EMI group or a mood monitoring group. Quantitative measures will assess changes in psychological flexibility, stress, anxiety, depression, and well-being, while qualitative interviews will provide insights into user experience, engagement, and perceived benefits or barriers. Findings from this study will inform the optimization of ACT-based digital interventions for college students and contribute to the growing field of personalized, technology-assisted mental health care.

Вмешательства

  • Поведенческое ACT-based ecological momentary intervention
    The intervention is based on Acceptance and Commitment Therapy (ACT) and includes the six core processes (being present, acceptance, defusion, self-as-content, values, and taking action). It is delivered in the form of an ecological momentary intervention (EMI), lasting for 7 days with two sessions per day. The intervention aims to enhance mental health, well-being, and psychological flexibility.
  • Другое Mood monitoring
    Participants do not receive any intervention. During the intervention period, they only need to complete ecological momentary assessments twice a day.

Первичные конечные точки

  • Overall mental health [Срок оценки: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)]
  • Psychological distress [Срок оценки: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)]
  • Mental well-being [Срок оценки: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)]
  • Psychological flexibility and inflexibility [Срок оценки: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)]
  • Acceptability [Срок оценки: post-intervention (one week after baseline)]
Вторичные конечные точки (9)
  • State anxiety and depression [Срок оценки: During the 7-day intervention period, measurements are conducted twice per day.]
  • State stress [Срок оценки: During the 7-day intervention period, measurements are conducted twice per day.]
  • State well-being [Срок оценки: During the 7-day intervention period, measurements are conducted twice per day.]
  • State subjective happiness [Срок оценки: During the 7-day intervention period, measurements are conducted twice per day.]
  • State affect [Срок оценки: During the 7-day intervention period, measurements are conducted twice per day.]
  • State psychological flexibility [Срок оценки: During the 7-day intervention period, measurements are conducted twice per day.]
  • State psychological inflexibility [Срок оценки: During the 7-day intervention period, measurements are conducted twice per day.]
  • State suicide ideation [Срок оценки: During the 7-day intervention period, measurements are conducted twice per day.]
  • Suicide ideation [Срок оценки: Baseline (pre-intervention); Immediately after the intervention (1 week after baseline); 1-month follow-up (1 month after intervention)]

Критерии участия

Критерии включения

  • Participants in our study are healthy college students
  • have smartphone, and have access to the internet

Критерии исключения

  • currently participating in another research
  • have significant cognitive impairment that prevents participation in the research

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT06843395 · HSEARS20250214003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗