Smartphone-based Interventions for Psychosis

YC
JT
Overseen ByJustin T Baker, MD, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Mclean Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 50 years old.
* 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)
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1

Participants engage in micro-randomized trials using smartphone-based interventions to assess feasibility and acceptability

5 weeks
Daily interactions via smartphone app

Phase 2

Continuation of micro-randomized trials with focus on training machine learning models and assessing intervention effects

5 weeks
Daily interactions via smartphone app

Follow-up

Participants are monitored for feedback and satisfaction through qualitative exit interviews

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Sensor-Informed Smartphone-based Mental Health Interventions

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Within-Person Micro-randomizationExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials
221
Recruited
22,500+