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Growth, Empowerment, and Mindfulness (GEM) for Young Adults with Early Life Adversity

This study is testing a program called Growth, Empowerment, and Mindfulness (GEM). It's an app-based program that uses mindfulness techniques to help young adults (ages 18-24) who have experienced difficult situations early in life. The goal is to see if GEM can help with mental health challenges like anxiety and depression, and improve how people manage their emotions. Researchers want to find out if young adults will find the GEM program easy to use and helpful. They also want to see if it can make a positive difference in their anxiety and depression levels. The study plans to enroll 44 participants, but its current status is unclear.

Study design
This is a single-arm feasibility study, meaning all 44 participants will receive the GEM intervention. It is not specified if this study is blinded or randomized.
What's involved
Participants will engage with the GEM intervention for 4 weeks. They will also complete assessments at the beginning, after the intervention (week 5), and at a 3-month follow-up.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3 months after the intervention ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07546799

Growth, Empowerment, and Mindfulness (GEM): A Mindfulness-based Intervention to Address Mental Health in Young Adults With Early Life Adversity

Completed
NAAges 18–24InterventionalPrevention
Brown University
~44 participants
Updated 2026-09-09 on ClinicalTrials.gov
What's tested:Growth, Empowerment, and Mindfulness (GEM)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Study Recruitment Feasibility as Measured by Participant Recruitment Rates
Measured over During recruitment period of study, up to 3 months
+5 more outcomes measured

Conditions

Anxiety
Depression

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NCT07546799

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Brown University

    Providence, Rhode Islandno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Shufang Sun, PhD · PRINCIPAL_INVESTIGATOR · Brown University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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:
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

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

What this trial measures

  • Study Recruitment Feasibility as Measured by Participant Recruitment RatesDuring recruitment period of study, up to 3 months

    Participant recruitment will be assessed as the percentage (%) of eligible individuals who enroll in the study out of the total number of individuals screened for eligibility. This data will be collected using tracking sheets maintained by the research team, which document the number of individuals assessed for eligibility and those who subsequently consent and enroll. This recruitment rate will be used to evaluate the feasibility of the GEM study/intervention.

  • Study Retention Feasibility as Measured by Participant Retention RatesBaseline, Post-intervention (week 5), and 3-month Follow-up

    Participant retention rates will be assessed as the percentage (%) of enrolled participants who complete study assessments at each time point (baseline, post-intervention, and 3-month follow-up). This will be data will be collected using assessment completion records maintained by the research team, which document participant completion of assessments. This retention rate will be used to evaluate the feasibility of the GEM intervention.

  • Intervention Engagement Feasibility as Measured by Participant Engagement with InterventionDuring intervention period (4 weeks)

    Participant engagement with the GEM intervention (i.e., adherence to the intervention) will be assessed as the percentage (%) of prescribed intervention activities completed by participants over the study period. This data will be collected using GEM application logs and session attendance records maintained by the research team. This engagement data will be used to evaluate the feasibility of the GEM intervention.

  • Intervention Acceptability as Measured by Client Satisfaction Questionnaire (CSQ-8)Post-intervention (week 5)

    The validated 8-item Client Satisfaction Questionnaire (CSQ-8) will be used to measure the acceptability of the GEM intervention. Participants rate each item on a four-point Likert scale. Total scores for the CSQ-8 range from 8 to 32, with higher scores indicating higher satisfaction with the intervention.

  • Intervention Acceptability as Measured by Session Evaluation FormPost-intervention (week 5)

    Session evaluation form (a self-developed measure) will be used to measure the acceptability of the GEM intervention. The instrument consists of 10 questions, rated on a four-point Likert scale. Total scores range from 10 to 40, with higher scores indicating higher satisfaction with the intervention.

  • Application of Mindfulness Practices as Measured by Applied Mindfulness Process Scale (AMPS)Post-intervention (week 5) and 3-month Follow-up

    The validated Applied Mindfulness Process Scale (AMPS) will be used to measure participants' application of mindfulness practices. Participants rate 15 statements on a five-point Likert scale. Total scores for AMPS range from 0 to 60, with higher scores indicating more frequent application of mindfulness practices when facing challenges in daily life.