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Набор скоро начнётся NCT07503093

Pilot Study of Sensor-Informed Smartphone-based Mental Health Interventions for Mood in Early Psychosis

Без фазы С лечением Psychosis Anxiety Depression Rumination

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-based Mindfulness Exercise, Smartphone-based Psychoeducation, Neutral Control Message.
Кому может быть актуально
Состояния в реестре: Psychosis, Anxiety, Depression, Rumination. Базовые параметры: 18 лет — 50 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
США
Следующий шаг
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Официальное название

Development of Sensor-Informed Smartphone-Based Mental Health Intervention for Early Psychosis

Обзор

The aim of this trial is to evaluate the feasibility and preliminary efficacy of using passive smartphone sensors to detect moments of heightened negative mood and inform the timing of brief mental health interventions, such as mindfulness exercises and psychoeducation, in adults with early psychosis.

Подробное описание

Negative mood symptoms are highly prevalent in early psychosis and strongly linked to long-term functional impairment and risk of relapse. Smartphone-based interventions offer a scalable and accessible solution for delivering personalized mental health support in daily life.

The goal of this micro randomized trial (MRT) is to evaluate the feasibility of using passive smartphone sensor data and machine learning to identify optimal moments for delivering smartphone app-based brief mental health interventions such as mindfulness exercises and psychoeducation, specifically moments when individuals are both most in need of support and most receptive to it.

The primary aim of this pilot study is to assess the feasibility and acceptability of the MRT study design, including recruitment and retention rates, EMA adherence, and participant feedback gathered through qualitative exit interviews to inform future design improvements. A secondary aim is to evaluate the feasibility of training an idiographic machine learning model using passive smartphone sensor data to detect moments of heightened negative affect. An exploratory aim is to estimate preliminary intervention effect sizes to inform a future fully powered clinical trial and to identify contextual factors associated with participant engagement.

Вмешательства

  • Поведенческое Smartphone-based Mindfulness Exercise
    A brief approximately 1 minute video guided mindfulness based breathing exercise designed to anchor attention to the present moment and reduce negative affect in the moment by guiding participants through a structured breathing technique.
  • Поведенческое Smartphone-based Psychoeducation
    A brief text or video based psychoeducation message delivered via the smartphone app. Content covers the nature of emotions and emotion regulation strategies, aimed at improving emotional awareness and coping skills in the moment.
  • Поведенческое Neutral Control Message
    A brief text or video based message containing random facts delivered via the MetricWire smartphone app. This serves as an active control condition to allow comparison with the active intervention conditions.

Первичные конечные точки

  • Retention Rate [Срок оценки: 10 weeks]
  • EMA Completion Rate [Срок оценки: 10 weeks]
  • Participant Acceptability and Satisfaction [Срок оценки: Week 10]
Вторичные конечные точки (3)
  • Proximal Change in Negative Affect [Срок оценки: 4 weeks]
  • Patient Health Questionnaire-8 (PHQ-8) [Срок оценки: 4 weeks]
  • Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

  • Age 18-50 years
  • History of DSM-5 psychotic disorder (e.g., schizophrenia, schizoaffective disorder, psychosis not otherwise specified)
  • Current elevated mood symptoms, defined as mild or greater depressive symptoms (Patient Health Questionnaire-8 score ≥5) or anxiety symptoms (Generalized Anxiety Disorder-7 score ≥5)
  • Own a personal iPhone or Android smartphone
  • Willing and able to provide informed consent
  • English-speaking

Критерии исключения

  • Active suicidal ideation with both intent and a specific plan.
  • Current substance use disorder requiring acute treatment
  • Diagnosis of neurodevelopmental disorder that would impair ability to use smartphone app or complete study procedures
  • Traumatic brain injury with significant cognitive impairment

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
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • McLean Hospital — Belmont

Идентификаторы

NCT: NCT07503093 · 2026P000491

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗