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Your phone could soon sense when you're down and offer help — study tests app for early psychosis

NCT ID NCT07503093

Symptom relief Sponsor: Mclean Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test whether smartphone sensors can detect when someone with early psychosis is feeling anxious or depressed and then offer a short mindfulness or psychoeducation exercise. Ten adults aged 18–50 with early psychosis and mild mood symptoms will use the app for 10 weeks. The goal is to see if this approach is feasible and acceptable, not yet to prove it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Smartphone-based mindfulness exercises and psychoeducation
What this could lead to
If it works, this could point toward a practical, low-cost way to help people with early psychosis manage anxiety and depression in real time.
What could go wrong
This is a very small early feasibility study with only 10 people, so results may not apply widely. The interventions are brief and may not be strong enough to produce lasting change.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder Depression depressive disorder psychotic disorder Psychotic Disorders rumination disorder Rumination Syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety Depression Psychosis Rumination

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • McLean Hospital

    Belmont, Massachusetts, 02478, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.