PsychosisNCT07503093
Pilot Study of Sensor-Informed Smartphone-based Mental Health Interventions for Mood in Early Psychosis
A study testing Smartphone-based Mindfulness Exercise and Smartphone-based Psychoeducation in people with Psychosis and Anxiety, run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Psychosis, Anxiety, Depression
- What is being tested?
- Smartphone-based Mindfulness Exercise and Smartphone-based Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2027to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development of Sensor-Informed Smartphone-Based Mental Health Intervention for Early Psychosis
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.
Read the detailed description
Negative mood symptoms are highly prevalent in early psychosis and strongly linked to long-term functional impairment and risk of relapse. Smartphone-based interventions offer a scalable and accessible solution for delivering personalized mental health support in daily life.
The goal of this micro randomized trial (MRT) is to evaluate the feasibility of using passive smartphone sensor data and machine learning to identify optimal moments for delivering smartphone app-based brief mental health interventions such as mindfulness exercises and psychoeducation, specifically moments when individuals are both most in need of support and most receptive to it.
The primary aim of this pilot study is to assess the feasibility and acceptability of the MRT study design, including recruitment and retention rates, EMA adherence, and participant feedback gathered through qualitative exit interviews to inform future design improvements. A secondary aim is to evaluate the feasibility of training an idiographic machine learning model using passive smartphone sensor data to detect moments of heightened negative affect. An exploratory aim is to estimate preliminary intervention effect sizes to inform a future fully powered clinical trial and to identify contextual factors associated with participant engagement.
- Conditions
- Psychosis, Anxiety, Depression, Rumination
- Being tested
- Smartphone-based Mindfulness Exercise, Smartphone-based Psychoeducation, Neutral Control Message
- Keywords
- Mirco-Randomized Study, Mobile Health, Psychosis, Digital Mental Health, Negative Mood, Digital Phenotyping, Passive Sensors
- Medical subject headings
- Psychotic Disorders, Anxiety Disorders, Depression, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based Mindfulness ExerciseBehavioural
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 PsychoeducationBehavioural
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 MessageBehavioural
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 group | Role | What they receive |
|---|---|---|
| Within-Person Micro-randomization | Other | 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). Receives: Behavioral: Smartphone-based Mindfulness Exercise; Behavioral: Smartphone-based Psychoeducation; Behavioral: Neutral Control Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate
Proportion of enrolled participants who completed the full 10 week study protocol, including both Phase 1 and Phase 2.
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: Week 10
Secondary outcomes (3)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start15 Jan 2027 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This 10 week study has two phases. In Phase 1 (Weeks 1 to 4), participants complete four daily ecological momentary assessments of mood while passive smartphone sensor data including GPS, accelerometer, and phone usage patterns is collected continuously. Data from Phase 1 are used to train a personalized idiographic machine learning model to detect moments of heightened negative mood for each participant. After a one week break, Phase 2 (Weeks 6 to 9) uses a micro randomized trial (MRT) design, a within person experimental design in which each participant serves as their own control through repeated randomizations. Participants are randomly assigned four times per day to one of four conditions: mindfulness exercise, psychoeducation, neutral control. Brief EMA mood ratings are completed before and after each randomization event to measure proximal changes in negative mood.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoonho Chung, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503093
- Sponsor's protocol ID
- 2026P000491
- Status last verified
- Sep 2026
- First submitted
- 25 Mar 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small pilot feasibility study with a sample size of 10 participants. Individual participant data will not be shared given the limited sample size, the exploratory and preliminary nature of the study, and the sensitive nature of the data collected. In particular, the study collects passive smartphone sensor data including GPS location data, which is inherently poses potential privacy risks. Findings from this pilot will inform the design of a future fully powered trial, at which point a formal data sharing plan will be developed.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Sensor-Informed Smartphone-Based Mental Health Intervention for Early Psychosis
- ClinicalTrials.gov ID
- NCT07503093
- Acronym / sponsor ID
- 2026P000491
- Conditions
- Psychosis, Anxiety, Depression, Rumination
- Keywords
- Mirco-Randomized Study, Mobile Health, Psychosis, Digital Mental Health, Negative Mood, Digital Phenotyping, Passive Sensors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Negative mood symptoms are highly prevalent in early psychosis and strongly linked to long-term functional impairment and risk of relapse. Smartphone-based interventions offer a scalable and accessible solution for delivering personalized mental health support in daily life.
The goal of this micro randomized trial (MRT) is to evaluate the feasibility of using passive smartphone sensor data and machine learning to identify optimal moments for delivering smartphone app-based brief mental health interventions such as mindfulness exercises and psychoeducation, specifically moments when individuals are both most in need of support and most receptive to it.
The primary aim of this pilot study is to assess the feasibility and acceptability of the MRT study design, including recruitment and retention rates, EMA adherence, and participant feedback gathered through qualitative exit interviews to inform future design improvements. A secondary aim is to evaluate the feasibility of training an idiographic machine learning model using passive smartphone sensor data to detect moments of heightened negative affect. An exploratory aim is to estimate preliminary intervention effect sizes to inform a future fully powered clinical trial and to identify contextual factors associated with participant engagement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This 10 week study has two phases. In Phase 1 (Weeks 1 to 4), participants complete four daily ecological momentary assessments of mood while passive smartphone sensor data including GPS, accelerometer, and phone usage patterns is collected continuously. Data from Phase 1 are used to train a personalized idiographic machine learning model to detect moments of heightened negative mood for each participant. After a one week break, Phase 2 (Weeks 6 to 9) uses a micro randomized trial (MRT) design, a within person experimental design in which each participant serves as their own control through repeated randomizations. Participants are randomly assigned four times per day to one of four conditions: mindfulness exercise, psychoeducation, neutral control. Brief EMA mood ratings are completed before and after each randomization event to measure proximal changes in negative mood.
| Arm | Type | Receives |
|---|---|---|
| Within-Person Micro-randomization | Other | Behavioral: Smartphone-based Mindfulness Exercise, Behavioral: Smartphone-based Psychoeducation, Behavioral: Neutral Control MessageEach 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-based Mindfulness ExerciseA 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. | Behavioural | Within-Person Micro-randomization |
| Smartphone-based PsychoeducationA 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. | Behavioural | Within-Person Micro-randomization |
| Neutral Control MessageA 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. | Behavioural | Within-Person Micro-randomization |
Primary outcome
Retention Rate
Time frame: 10 weeks
Proportion of enrolled participants who completed the full 10 week study protocol, including both Phase 1 and Phase 2.
EMA Completion Rate
Time frame: 10 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 Satisfaction
Time frame: Week 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.
3 secondary outcomes
Proximal Change in Negative Affect
Time frame: 4 weeks
Patient Health Questionnaire-8 (PHQ-8)
Time frame: 4 weeks
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. This is a small pilot feasibility study with a sample size of 10 participants. Individual participant data will not be shared given the limited sample size, the exploratory and preliminary nature of the study, and the sensitive nature of the data collected. In particular, the study collects passive smartphone sensor data including GPS location data, which is inherently poses potential privacy risks. Findings from this pilot will inform the design of a future fully powered trial, at which point a formal data sharing plan will be developed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-based Mindfulness Exercise and Smartphone-based Psychoeducation in people with Psychosis and Anxiety, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yoonho Chung, PhD (617-855-2854, ychung3@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rate (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.