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Can a smartphone app help teens with lupus and depression stay on track?

NCT ID NCT05693571

Knowledge-focused Sponsor: Montefiore Medical Center 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study aims to understand how depression symptoms, like loss of interest, may make it harder for teens and young adults with lupus to keep up with their medical care. Researchers will also test a mobile health app designed to provide education and connect users to their care team. About 40 participants aged 15-24 from the Bronx will complete questionnaires and some will try the app for 6 months to see if it is feasible and acceptable.

What this could mean

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

Active substance
Valera mobile health application
What this could lead to
If successful, this could point toward a practical tool to help teens with lupus stay engaged in their care and manage depression symptoms.
What could go wrong
This is a small, early pilot study with only 40 participants, so results may not apply to everyone. The app's benefits are not yet proven.

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

48 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Feb 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

15 to 25 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: * Participants 15-25 years old meeting American College of Rheumatology (ACR) Revised SLE Classification Criteria and/or European League Against Rheumatism/ACR Classification Criteria and/or 2012 SLE International Collaborating Clinic Criteria and followed at the Children's Hospital at Montefiore. * Must be diagnosed with SLE before 19 years of age (based on Childhood-onset systemic lupus erythematosus (cSLE) definition) Exclusion Criteria: * Non-Spanish or non-English speaking * Participants anticipating transitioning to an outside rheumatologist for lupus care within the period of study follow-up * Current psychotic disorders. However, attention-deficit/hyperactivity disorder, anxiety disorders, obsessive-compulsive disorder, posttraumatic stress disorder, eating disorders, and substance abuse disorders are not uncommon among adolescents and young adults (AYA) and will be allowed. Suicidal ideations (SI) and self-injurious acts (cutting) are common in depression and will be allowed (defined as passive SI).

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder pediatric systemic lupus erythematosus systemic lupus erythematosus

As listed by the trial registrant

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

Depression Lupus erythematosus, systemic

Contacts and locations

Locations

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

More trials for these conditions

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