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临床试验/NCT07503093
NCT07503093尚未招募不适用

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

Mclean Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
10
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yoonho Chung

Principal Investigator

Mclean Hospital

研究点 (1)

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