Pilot Study of Sensor-Informed Smartphone-based Mental Health Interventions for Mood in Early Psychosis: A Micro-Randomized Trial
Development of Sensor-Informed Smartphone-Based Mental Health Intervention for Early Psychosis
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2026
CompletedFirst Posted
Study publicly available on registry
March 31, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
March 31, 2026
March 1, 2026
1 year
March 25, 2026
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Retention Rate
Proportion of enrolled participants who completed the full 10 week study protocol, including both Phase 1 and Phase 2.
10 weeks
EMA Completion Rate
Proportion of ecological momentary assessment (EMA) prompts answered by participants out of the total number delivered during Phase 1 and Phase 2.
10 weeks
Participant Acceptability and Satisfaction
Participant acceptability and satisfaction with the study app and intervention content, assessed through a structured qualitative exit interview and feedback questionnaire at the end of the study.
Week 10
Secondary Outcomes (3)
Proximal Change in Negative Affect
4 weeks
Patient Health Questionnaire-9 (PHQ-9)
4 weeks
Generalized Anxiety Disorder-7 (GAD-7)
4 weeks
Study Arms (1)
Within-Person Micro-randomization
OTHEREach participant is randomized four times per day to receive one of four conditions with equal probability (33.3% each): a mindfulness exercise, psychoeducation, a neutral control message. A brief EMA is completed before and after each randomization event to measure proximal changes in mood (sadness, anxiety, irritability, stress, rumination).
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mclean Hospitallead
Study Sites (1)
McLean Hospital
Belmont, Massachusetts, 02478, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor
Study Record Dates
First Submitted
March 25, 2026
First Posted
March 31, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
This is a small pilot feasibility study with a sample size of 10 participants. Individual participant data will not be shared given the limited sample size, the exploratory and preliminary nature of the study, and the sensitive nature of the data collected. In particular, the study collects passive smartphone sensor data including GPS location data, which is inherently poses potential privacy risks. Findings from this pilot will inform the design of a future fully powered trial, at which point a formal data sharing plan will be developed.