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

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Mclean Hospital
Study ID
NCT07503093
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Smartphone-based Mindfulness Exercise — BEHAVIORAL
    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.
  • Smartphone-based Psychoeducation — BEHAVIORAL
    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.
  • Neutral Control Message — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
May 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Retention Rate [ Time Frame: 10 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
McLean HospitalBelmontMassachusetts02478-

Find similar trials in Belmont, MA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
McLean Hospital· Belmont, MA

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