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Набор скоро начнётся NCT07406880

Positive Psychology - Based EMl for Enhancing Well-Being

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: Ecological Momentary Intervention, Active Control.
Кому может быть актуально
Состояния в реестре: Healthy Participants Study. Базовые параметры: от 18 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 →
Официальное название

Positive Psychology-Based Ecological Momentary Intervention for Well-Being in College Students: A Randomized Controlled Trial

Обзор

This study aims to evaluate the acceptability and effectiveness of a positive psychology-based ecological momentary intervention (EMI) for enhancing well-being in college students. A three-arm randomized controlled trial (RCT) will assess the impact of a dynamic EMI that delivers personalized exercises when participants' real-time affect or well-being scores fall below a predefined threshold, compared to control conditions. Primary outcomes include changes in well-being and mental health, evaluated through a mixed-methods approach combining quantitative measures and qualitative interviews.

Подробное описание

This study aims to evaluate a Positive Psychology-based Ecological Momentary Intervention (EMI) designed to enhance well-being among college students. A three-arm randomized controlled trial (RCT) will be conducted to examine the intervention's effectiveness. The EMI integrates core positive psychology practices-such as gratitude, mindfulness, and acts of kindness-and is delivered through a mobile application in real time. The intervention features a dynamic, adaptive algorithm that provides personalized exercises when participants' real-time affect or well-being scores fall below a predefined threshold. Primary outcomes include changes in well-being and mental health . A mixed-methods design will be employed, combining quantitative assessments at baseline, post-intervention, and one-month follow-up with qualitative post-intervention interviews to gain an in-depth understanding of the intervention's impact and user experience.

Вмешательства

  • Поведенческое Ecological Momentary Intervention
    This is a smartphone-based ecological momentary intervention (EMI) that delivers psychological exercises (e.g., gratitude, mindfulness) in an adaptive, "as-needed" manner. Twice daily, the app algorithm assesses a participant's self-reported momentary affect and well-being. If the scores fall below a preset, moderate threshold, a corresponding intervention exercise is automatically triggered. The goal is to provide personalized support at moments of greatest need.
  • Поведенческое Active Control
    This is a smartphone-based ecological momentary intervention (EMI) that delivers the same suite of psychological exercises on a fixed schedule, regardless of the user's current state. Participants are prompted to complete all six available exercises twice daily. This intervention controls for the general effects of exposure to the exercise content and engagement with the app, allowing for a comparison with the adaptive, algorithm-guided EMI.

Первичные конечные точки

  • Affect [Срок оценки: Baseline (pre-intervention); Immediately after the intervention (2 week after baseline)); 1-month follow-up (1 month after intervention)]
  • Happiness [Срок оценки: Baseline (pre-intervention); Immediately after the intervention (2 weeks after baseline); 1-month follow-up (1 month after intervention)]
  • Flourishing [Срок оценки: Baseline (pre-intervention); Immediately after the intervention (2 weeks after baseline); 1-month follow-up (1 month after intervention)]
  • Satisfaction with Life [Срок оценки: Baseline (pre-intervention); Immediately after the intervention (2 weeks after baseline); 1-month follow-up (1 month after intervention)]
  • Psychological distress [Срок оценки: Baseline (pre-intervention); Immediately after the intervention (2 weeks after baseline); 1-month follow-up (1 month after intervention]
Вторичные конечные точки (5)
  • State Subjective Happiness [Срок оценки: During the 14-day intervention period, this measurement is conducted twice per day as part of the momentary assessments, and once each evening as part of the Daily Diary assessment at 9:00 PM.]
  • State affect [Срок оценки: During the 14-day intervention period, this measurement is conducted twice per day as part of the momentary assessments, and once each evening as part of the Daily Diary assessment at 9:00 PM.]
  • State Well-Being [Срок оценки: During the 14-day intervention period, this measure is also administered each evening at 9:00 PM as part of the Daily Diary assessment.]
  • State Anxiety and Depression [Срок оценки: During the 14-day intervention period, this measure is also administered each evening at 9:00 PM as part of the Daily Diary assessment.]
  • State Stress [Срок оценки: During the 14-day intervention period, this measure is also administered each evening at 9:00 PM as part of the Daily Diary assessment.]

Критерии участия

Критерии включения

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

Критерии исключения

  • Unable to use a smartphone.
  • 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
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

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

Идентификаторы

NCT: NCT07406880 · HSEARS20231201008-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗