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

April 1, 2026 updated by: Yoonho Chung, Mclean Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yoonho Chung, PhD
  • Phone Number: 617-855-2854
  • Email: ychung3@mgb.org

Study Contact Backup

  • Name: Justin T Baker, MD, PhD
  • Phone Number: 617-855-3913
  • Email: jtbaker@mgb.org

Study Locations

  • United States
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Within-Person Micro-randomization
Each 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention Rate
Time Frame: 10 weeks
Proportion of enrolled participants who completed the full 10 week study protocol, including both Phase 1 and Phase 2.
10 weeks
EMA Completion Rate
Time Frame: 10 weeks
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
Time Frame: Week 10
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proximal Change in Negative Affect
Time Frame: 4 weeks
Change in self reported negative affect from pre to post intervention phone-based ecological momentary assessment at each randomization event during the micro-randomized trial. Negative affect is assessed using a visual analog scale (0 to 100) measuring sadness, anxiousness, irritability, and rumination. Active intervention conditions (mindfulness and psychoeducation) are compared to neutral control conditions to generate preliminary effect size estimates.
4 weeks
Patient Health Questionnaire-8 (PHQ-8)
Time Frame: 4 weeks
All participants complete the Patient Health Questionnaire-8 (PHQ-8), an 8-item self-report measure of depressive symptom severity, at the start and at the end of the study. Each item is rated on a scale of 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 24. Higher scores indicate greater depressive symptom burden.
4 weeks
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 4 weeks
All participants complete the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report measure of anxiety symptom severity, at the start and at the end of the study. Each item is rated on a scale of 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 21. Higher scores indicate greater anxiety symptom burdens.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mclean Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026P000491

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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