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Can an online therapy course steady young minds at risk of psychosis?

NCT ID NCT06928935

Symptom relief Sponsor: Centre for Addiction and Mental Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing an 8-week online program that teaches mindfulness, emotional regulation, distress tolerance, and interpersonal skills to people aged 14 to 35 who show early signs of psychosis risk. Participants are randomly assigned to the digital dialectical behaviour therapy program or to usual care. The study measures whether people sign up, stay enrolled, complete the modules, and find the program usable and satisfying, while also tracking changes in symptoms and functioning.

What this could mean

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

Active substance
an 8-week self-guided online dialectical behaviour therapy program with weekly digital navigator check-ins
What this could lead to
If it works, this could offer young people at risk of psychosis a flexible, online way to build emotional regulation skills and possibly ease symptoms before a first episode.
What could go wrong
This is a small feasibility study of 60 people, so it cannot prove the program works. Participants may not finish the modules, and online therapy may not suit everyone.

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 60 people

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

Started

Apr 2026

Expected to finish

Jan 2028

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

14 to 35 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: 1. Be 14-35 years old. 2. Being competent and willing to consent to study participation. 3. Meets CHR criteria for a psychosis risk syndrome based on the Structured Interview for Psychosis Risk Syndromes (SIPS) within the past 3 years. Exclusion Criteria: 1. Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of psychotic disorder (e.g., schizophrenia spectrum disorder, mood disorder with psychotic features) 2. Diagnosis of intellectual disability 3. Severe developmental disorder 4. Acute suicidality requiring immediate life-saving intervention (i.e., inpatient psychiatric care). 5. Receiving any additional psychotherapy interventions or structured digital mental health support during the study period.

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As listed by the trial registrant

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

Clinical high risk for psychosis (CHR)

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

  • Centre for Addiction and Mental Health

    RECRUITING

    Toronto, Ontario, M6J1H4, Canada

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