Can a mindfulness app soothe young minds scarred by early trauma?

NCT ID NCT07546799

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Updated 1 time

Summary

This study tests a mindfulness program (called GEM) delivered through an app and weekly group video calls. It aims to see if young adults (ages 18-24) who have faced early life hardships find the program helpful and easy to use. The study also checks if the program reduces symptoms of anxiety and depression. Participants wear a Fitbit to track sleep and complete surveys over several weeks.

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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

44 people

The number who actually took part.

Started

Mar 2026

Finished

Aug 2026

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 24 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 18-24 * Reside in the US * Experiences of psychosocial forms of early life adversity, defined as saying yes to at least one of these following questions: 1. Did you ever miss school due to fear of being bullied? 2. Were you ever injured or threatened with a weapon or otherwise assaulted by a peer at school? 3. Were you ever physically attacked, hit, hurt, or injured by a parent, primary caregiver, or guardian? 4. Were you ever touched sexually against your wishes or forced to touch someone else sexually? 5. Were you ever forced to engage in sexual intercourse? 6. Were you ever forced to have sex or were you ever sexually abused (e.g., being touched or fondled by an adult?) * Experience more than minimal symptoms of anxiety (GAD-7 score of 5 or higher) and/or mild to moderately severe depression symptoms (PHQ-9 score between 5-19) * Not currently in mental health treatment * Being willing to answer 3-4 short surveys daily, each 2-5 mins * Being willing to engage in recommended daily mindfulness practices for 4-6 weeks * Have not been extensively exposed to mindfulness, defined as meditation retreat experience, consistent mindfulness practice (\> once/week) within the past 6 months, or prior participation in a mindfulness course/program Exclusion Criteria: * At imminent risk of suicide * Have a current diagnosis of Major Depressive Disorder * Meet the criteria for Major Depressive Episode based on the MINI-Major Depressive Episode module at screening * Score 20 or higher on Alcohol Use Disorders Identification Test (AUDIT) at screening * Score 25 or higher on Drug Use Disorders Identification Test (DUDIT) at screening * Have a history of psychotic disorder (e.g., schizophrenia) or psychotic episode * Have ever been diagnosed with bipolar disorder

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder Depression depressive disorder Psychological Well-Being

As listed by the trial registrant

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

Contacts and locations

Locations

  • Brown University

    Providence, Rhode Island, 02912, United States

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