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Набор скоро начнётся NCT06351800

The PredictPlusPrevent Study

Без фазы С лечением Depression Anxiety Disorders

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: Predictplusprevent intervention, Psychoeducational intervention.
Кому может быть актуально
Состояния в реестре: Depression, Anxiety Disorders. Базовые параметры: 18 лет — 55 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Universal Prevention of Depression and Anxiety in the General Population Through a Personalized Intervention Based on Risk Algorithms, ICTs, and Decision Support Systems: Randomized Controlled Trial. The "PredictPlusPrevent" Study

Обзор

Objective: To design, develop, and evaluate a personalized intervention for the universal prevention of depression and anxiety in the general population based on risk algorithms, ICTs, and decision support systems (DSS). Methods: A double-blind, parallel-group, randomized controlled trial with a twelve-month follow-up. The entire process of recruitment, random allocation, intervention, and follow-up will be conducted through the 'PredictPlusPrevent' platform and its associated apps. Following a media campaign, at least 9,000 Spanish participants aged 18 to 55 years without depression and/or anxiety at baseline will be randomly assigned to the intervention or active control group "PredictPlusPrevent". The "PredictPlusPrevent" intervention will be self-guided and implemented through participants' smartphones via an app; it will have a biopsychosocial and multi-component approach (8 modules: physical exercise, improving sleep, expanding relationships, problem-solving, improving communication, assertiveness, decision-making, and managing thoughts). The "PredictPlusPrevent" intervention is based on validated risk algorithms for depression and anxiety and a DSS that will help participants develop their own personalized depression prevention plans, which they will implement themselves while the platform monitors and provides feedback. The active control "PredictPlusPrevent" will include information from the risk algorithms and 24 self-help booklets. The primary outcome will be the incidence of new cases of depression and/or anxiety assessed using the PRIME-MD questionnaire, and secondary outcomes will include reductions in depression (PHQ-9) and anxiety symptoms (GAD-7), probability of depression and anxiety risk (predictD and predictA algorithms), and physical and mental quality of life (SF-12).

Вмешательства

  • Поведенческое Predictplusprevent intervention
    The intervention is based on validated risk algorithms to predict depression and anxiety and includes: 1) Mobile applications as main user's interface; 2) a DSS that helps participants to develop their own personalized plans to prevent (PPP) depression and/or anxiety; 3) eight intervention modules (the core of the system) including activities to prevent depression and anxiety, to be proposed and monitoring by the DSS. The intervention is biopsychosocial and multi-component, including the followi
  • Другое Psychoeducational intervention
    To know the level of risk of experiencing depression and/or anxiety in the next 12 months. In addition, participants assigned to this intervention will have free access to the 24 self-help pamphlets for preventing depression and anxiety.

Первичные конечные точки

  • Incidence of depression and/or anxiety disorders. [Срок оценки: 12 months]
Вторичные конечные точки (5)
  • Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). [Срок оценки: 12 months]
  • Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7). [Срок оценки: 12 months]
  • Probability of depression measured by the Spanish predictD risk algorithm. [Срок оценки: 12 months]
  • Probability of anxiety measured by the Spanish predictA risk algorithm. [Срок оценки: 12 months]
  • Quality of life measured by the 12-item Short Form (SF-12). [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • Age between 18 and 55 years.
  • Participants must have a smartphone for their own use in the next year.

Критерии исключения

  • Not signing the informed consent.
  • Having depression and/or anxiety at baseline according to the PRIME-MD questionnaire.
  • Living outside of Spain.
  • Having a severe mental disorder (psychosis, bipolar disorder, addictions, etc.), a terminal illness or cognitive impairment (dementia).
  • Difficulties in understanding Spanish.

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
Тройное слепое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06351800 · PE-0280-2018

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗