Health TrialsbyHealthPanel

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

ConditionsPsychosisAnxietyDepressionRumination
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMclean Hospital

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Within-Person Micro-randomizationOther 3 interventions

Trial outcomes

Primary outcomes

1

Retention Rate

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

Time frame
10 weeks
2

EMA Completion Rate

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

Time frame
10 weeks
3

Participant Acceptability and Satisfaction

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.

Time frame
Week 10

Secondary outcomes

1

Proximal Change in Negative Affect

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.

Time frame
4 weeks
2

Patient Health Questionnaire-8 (PHQ-8)

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.

Time frame
4 weeks
3

Generalized Anxiety Disorder-7 (GAD-7)

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.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mclean Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: