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

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

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.

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.

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