Can a mindfulness app soothe young minds scarred by early trauma?
NCT ID NCT07546799
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
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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
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44 people
The number who actually took part.
- Started
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Mar 2026
- Finished
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Aug 2026
- Lead sponsor
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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
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18 to 24 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brown University
Providence, Rhode Island, 02912, United States
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