Pilot Study of Sensor-Informed Smartphone-based Mental Health Interventions for Mood in Early Psychosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smartphone-based Mindfulness Exercise, Smartphone-based Psychoeducation, Neutral Control Message.
- Who it may be relevant to
- Registry conditions: Psychosis, Anxiety, Depression, Rumination. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of Sensor-Informed Smartphone-Based Mental Health Intervention for Early Psychosis
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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. - Behavioral 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. - Behavioral 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.
Primary outcome measures
- Retention Rate [Time frame: 10 weeks]
- EMA Completion Rate [Time frame: 10 weeks]
- Participant Acceptability and Satisfaction [Time frame: Week 10]
Secondary outcome measures (3)
- Proximal Change in Negative Affect [Time frame: 4 weeks]
- Patient Health Questionnaire-8 (PHQ-8) [Time frame: 4 weeks]
- Generalized Anxiety Disorder-7 (GAD-7) [Time frame: 4 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- McLean Hospital — Belmont
Identifiers
NCT: NCT07503093 · 2026P000491