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

This study is looking at new ways to help people with early psychosis (a mental health condition that can cause changes in thinking, feelings, and behavior) manage their mood. Researchers are testing if a smartphone app can use information from your phone to figure out when you might need support. When it senses you might be feeling down, the app will offer short mindfulness exercises (a way to focus on the present moment) or psychoeducation (information to help you understand and manage your emotions). This study aims to see if these app-based tools are practical and helpful. You might be able to join if you are 18-50 years old, have a history of a psychotic disorder, and currently have mild or greater symptoms of depression or anxiety. The study will look at how many people stay in the study, how often they use the app, and if they find it acceptable and helpful. The study status is unclear.

Study design
This is an interventional pilot study planning to enroll 10 participants. It uses a micro-randomized trial (MRT) design to test different interventions.
What's involved
The study will measure retention rate, EMA (Ecological Momentary Assessment) completion rate, and participant acceptability and satisfaction at 10 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 10 weeks after starting the study interventions.

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NCT07503093

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

Not Yet Recruiting
NAAges 18–50InterventionalTreatment
Mclean Hospital
~10 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Smartphone-based Mindfulness ExerciseSmartphone-based PsychoeducationNeutral Control Message

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Retention Rate
Measured over 10 weeks
+2 more outcomes measured
Psychosis
Anxiety
Depression
Rumination
1 sites across 1 states
Massachusetts1

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Eligibility criteria

Inclusion

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

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
  • Retention Rate10 weeks

    Proportion of enrolled participants who completed the full 10 week study protocol, including both Phase 1 and Phase 2.

  • EMA Completion Rate10 weeks

    Proportion of ecological momentary assessment (EMA) prompts answered by participants out of the total number delivered during Phase 1 and Phase 2.

  • Participant Acceptability and SatisfactionWeek 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.