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Идёт набор NCT04732676

Efficacy of a Smartphone App. Designed to Manage Craving & Individual Predictors of Substance Use/Addictive Behavior

Без фазы С лечением Addiction

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: Smartphone application.
Кому может быть актуально
Состояния в реестре: Addiction. 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

Efficacy of a Smartphone App Designed to Manage Craving and Individual Predictors of Substance Use / Addictive Behavior Among Individuals With Addictive Disorders

Обзор

Test the Efficacy of a smartphone application designed to manage craving and individual predictors of substance use / addictive behavior among individuals with addictive disorders

Подробное описание

This translational project is the clinical application of research results from the University of Bordeaux, Sanpsy Lab, CNRS USR3413 - on individual predictors of substance use. This project will test the efficacy of a smartphone application to help subjects concerned about reducing or stopping their substance use / behavioral addiction.

This new therapeutic tool, designed by University of Bordeaux, Sanpsy Lab, CNRS USR3413 - to manage craving and individual predictors of use, will offer the possibility of an easy to-use and personalized intervention accessible to the greatest number of subjects.

Based on our previous results that supports that, for all types of addiction, craving and individual cues are a significant drive for use in people with addiction, the application tested in this study was designed to be used among people presenting various types of addiction (substance and behavioral addictions). The application will also evaluate all concurrent substance uses and addictive behaviors to identify and prevent risk of addiction transfers.

Вмешательства

  • Другое Smartphone application
    Ecological Momentary Assessment (EMA) : ambulatory assessment of behaviors/symptoms in real-time on smartphones

Первичные конечные точки

  • The decrease of main problematic substance use / addictive behavior [Срок оценки: 4 weeks]
Вторичные конечные точки (7)
  • Efficacy of the intervention in reduction on addiction severity (ASI) and craving for primary addiction, [Срок оценки: At 1-month and 4-month follow-up]
  • Factors associated with application efficacy among initial addiction severity (ASI), initial craving for primary addiction, type of primary addiction, comorbid psychiatric disorders (MINI), and addiction treatment (ASI and TSR) [Срок оценки: inclusion]
  • Temporal evolution of craving and substance use/addictive behaviors The evolution and temporal trajectories of craving intensity, substances use/addictive behaviors measured with EMA in daily life [Срок оценки: 4 weeks]
  • Feasibility of the smartphone application as assessed by use of the app (EMA responses) and drop-out rates [Срок оценки: at 1-month]
  • Acceptability of the smartphone app assessed by AES, D-WAI and u-MARS [Срок оценки: at 1-month]
  • Impact on subsequent standard treatment at 4-month follow -up [Срок оценки: at 4-month follow-up]
  • Acceptability of the smartphone app assessed by AES, D-WAI and u-MARS [Срок оценки: at 1-mont]

Критерии участия

Критерии включения

  • Participants requesting help for substance or behavioral addiction in one of the participating specialized addiction treatment centers, and with more than 1-month-delay before treatment admission
  • Age >= 18 years of age
  • With at least one substance or behavioral addiction (DSM-5 criteria)
  • Affiliated person or beneficiary of a social security scheme.
  • Free, informed and written consent signed by the participant and the investigator

Критерии исключения

  • Medical, psychiatric or addiction condition that warrants immediate treatment intervention
  • Patients with somatic, cognitive or other disorders preventing the use of the device (deafness, impaired vision, illiteracy....)
  • Difficulty in understanding and / or writing French
  • Not familiar with the use of smartphone
  • Individuals participating in another study that includes an ongoing exclusion period
  • Be deprived of liberty due to an ongoing legal procedure
  • Individuals under legal protection
  • Be under guardianship or under curatorship

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • Centre Hospitalier Charles PERRENS — Bordeaux

Публикации

  • Serre F, Moriceau S, Donnadieu L, Forcier C, Garnier H, Alexandre JM, Dupuy L, Philip P, Levavasseur Y, De Sevin E, Auriacombe M; for Craving-Manager RCT investigator group. The Craving-Manager smartphone app designed to diagnose substance use/addictive disorders, and manage craving and individual predictors of relapse: a study protocol for a multicenter randomized controlled trial. Front Psychiat PMID 37255691

Идентификаторы

NCT: NCT04732676 · 2020-A01707-32

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗