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Breathing your way to better mental health: new app trial for psychosis

NCT ID NCT07628699

Symptom relief Sponsor: The University of Hong Kong 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a 5-week digital breathing program (heart rate variability biofeedback) to see if it improves well-being in people with first episode psychosis. 80 participants will either do the breathing exercises or listen to music. The goal is to reduce symptoms like depression and paranoia.

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 80 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Aug 2026

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 55 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: * Patients with first-episode-psychosis who have been in treatment for less than 5 years * Inclusive of affective and non-affective psychosis * Aged 18-55 * A diagnosis of schizophrenia-spectrum disorders or affective psychosis including schizoaffective disorder, bipolar affective disorders and depression with psychosis based on DSM V diagnostic criteria * Able to provide written informed consent. * Patients should be stable but with symptoms present * Score a minimum of 7 on the Calgary Depression Scale. Exclusion Criteria: * Any organic neurological or cardiac conditions * Prescription of cardiovascular medication * Active severe suicidal ideation * Diabetes as this can affect HRV * Current substance abuse * An ECG will be performed on each participant prior to joining the study to exclude undiagnosed cardiac conditions

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As listed by the trial registrant

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

First episode psychosis (FEP)

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

  • Queen Mary Hospital/University of Hong Kong

    Hong Kong, SAR China, Hong Kong

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