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NCT07503093
Pilot Study of Sensor-Informed Smartphone-based Mental Health Interventions for Mood in Early Psychosis
Conditions: Psychosis, Anxiety, Depression, Rumination
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: Mclean Hospital
Location: McLean Hospital Belmont Massachusetts
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07503093). StuddyBuddy aggregates publicly available trial information.