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Идёт набор NCT05074901

Virtual Agents-based Digital Interventions to Improve Health

Без фазы С лечением Mental Disorder Mental Stress Insomnia Depression

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: digital behavioral intervention.
Кому может быть актуально
Состояния в реестре: Mental Disorder, Mental Stress, Insomnia, Depression. 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
Франция
Следующий шаг
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Официальное название

Acceptance and Efficacy of a Smartphone-based App Using a Conversational Agent to Monitor Health Status and/or Deliver Behavioral Intervention to Reduce Psycho-social Stress

Обзор

KANOPEE is a free smartphone application providing screening, follow-up tools and autonomous digital interventions to lower psycho-social stress and its repercussions on sleep and behaviors in the general population. Additionally, KANOPEE permits an adaptation of the intervention to the subject (i.e., an adapted waiting period, frequency, and content), enabling to perform innovative trial conditions. The objective of this long-term study is to evaluate the efficacy of KANOPEE on users among the French general population exposed to psycho-social stress.

Подробное описание

KANOPEE was designed by sleep specialists and psychiatrists to propose autonomous interventions to improve sleep, physical activity and substance abuse ; aiming at lowering psycho-social stress's repercussions. The app provides weekly interactions with a virtual companion.

At each interaction, users answer standardized questionnaires (e.g., Insomnia Severity Index, Cigarette Dependence Scale) enabling to characterize users' health status (i.e;, the severity of the complaints) and evolution over time, and therefore provide adapted interventions based on the literature (e.g., digital Cognitive Behavioral Therapies, diaries, sleep hygiene recommendations, motivational interviewing).

The app is freely available to the general population in France, enabling very large sample size, and the possibility to perform non-randomized trials depending on the selected interventions by the users and the subject's group.

Вмешательства

  • Поведенческое digital behavioral intervention
    interaction with a conversational agent to implement physical and cognitive programs

Первичные конечные точки

  • Sleep complaints [Срок оценки: weekly, from the downloading of the app until two weeks after the end of the intervention]
  • Fatigue complaints [Срок оценки: weekly, from the downloading of the app until two weeks after the end of the intervention]
  • Depression and anxiety complaints [Срок оценки: weekly, from the downloading of the app until two weeks after the end of the intervention]
Вторичные конечные точки (8)
  • Total Sleep Time [Срок оценки: daily, from the downloading of the app until two weeks after the end of the intervention]
  • Sleep Efficiency [Срок оценки: daily, from the downloading of the app until two weeks after the end of the intervention]
  • Time In Bed [Срок оценки: daily, from the downloading of the app until two weeks after the end of the intervention]
  • Sleep Onset Latency [Срок оценки: daily, from the downloading of the app until two weeks after the end of the intervention]
  • Wakefulness After Sleep Onset [Срок оценки: daily, from the downloading of the app until two weeks after the end of the intervention]
  • Number of Awakenings [Срок оценки: daily, from the downloading of the app until two weeks after the end of the intervention]
  • number of episodes of craving [Срок оценки: daily, from the downloading of the app until two weeks after the end of the intervention]
  • amount of substance usage [Срок оценки: daily, from the downloading of the app until two weeks after the end of the intervention]

Критерии участия

Критерии включения

  • Being aged 18 years old and over (the app is available for younger users but their data will not be analyzed)
  • having downloaded the app
  • having a smartphone Android or Iphone
  • being located in France
  • having accepted the electronic informed consent

Критерии исключения

  • having clicked on the "emergency button" (in the app, there is a warning message : this app is not for emergency situations. If you need an urgent psychological support, click here")
  • having downloaded the app but without answering any questionnaire

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Франция · 1 центр
  • University of Bordeaux — Bordeaux

Публикации

  • Sagaspe P, Sanchez-Ortuno MM, Dupuy L, Pecune F, Coelho J, Micoulaud-Franchi JA, Levavasseur Y, de Sevin E, Chanteclair A, Philip P, Salles N. Perceptions and Effectiveness of a Fully Automated Brief Behavioral Insomnia Therapy, Delivered by a Virtual Companion, in Older and Young Adults. Innov Aging. 2024 Sep 24;9(2):igae086. doi: 10.1093/geroni/igae086. eCollection 2025. PMID 40206328

Идентификаторы

NCT: NCT05074901 · CHUBX2020GSP0102

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗