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

Growth, Empowerment, and Mindfulness (GEM): Pilot Trial of a Mindfulness-based Intervention to Address Mental Health in Young Adults With Early Life Adversities

The goal of this clinical trial (single-arm feasibility study) is to examine the feasibility, acceptability, and preliminary efficacy of a mindfulness-based, app-delivered intervention to address mental health and emotion regulation challenges in young adults with early life adversities (ELAs).

The main questions it aims to answer is:

- Will young adults find the Growth, Empowerment, and Mindfulness (GEM) intervention to be both feasible and acceptable, as demonstrated by participants' engagement and quantitative/qualitative feedback?

Additionally, it aims to answer:

• Will GEM intervention demonstrate preliminary efficacy in improving outcome measures including depression, anxiety?
• Are improvements in mindfulness and sleep, as well as reductions in rumination, mechanisms of action underlying the improvements in psychological and behavioral outcomes of the intervention?

Participants will be asked to:

• participate in GEM, which integrates app-based intervention content, formal and informal mindfulness practices, weekly Zoom group sessions, and ecological momentary intervention (EMI) delivery
• complete baseline, post-intervention, and 3-month follow-up assessments
• complete weekly assessments and daily ecological momentary assessments (EMAs) during the intervention delivery
• wear Fitbit for researchers to collect sleep-related data

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: Growth, Empowerment, and Mindfulness (GEM)

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Growth, Empowerment, and Mindfulness (GEM)

Behavioral: Growth, Empowerment, and Mindfulness (GEM); The Growth, Empowerment, and Mindfulness (GEM) intervention is a structured, mindfulness-based intervention designed to offer support for young adults with early life adversities and their negative behavioral health consequences through the development of awareness, emotion regulation, and adaptive coping skills. Through psychoeducation content, group practice Zoom sessions, and formal and informal mindfulness practices, GEM is aimed at helping participants build foundational mindfulness and self-compassion skills, increase interoceptive awareness, reduce experiential avoidance and de-centering, improve emotion regulation and decrease rumination, and integrate mindfulness skills into daily life. The content of the GEM intervention was developed with community feedback from relevant Community Advisory Board members.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Recruitment Feasibility as Measured by Participant Recruitment Rates	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.	During recruitment period of study, up to 3 months
Study Retention Feasibility as Measured by Participant Retention Rates	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.	Baseline, Post-intervention (week 5), and 3-month Follow-up
Intervention Engagement Feasibility as Measured by Participant Engagement with Intervention	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.	During intervention period (4 weeks)
Intervention Acceptability as Measured by Client Satisfaction Questionnaire (CSQ-8)	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.	Post-intervention (week 5)
Intervention Acceptability as Measured by Session Evaluation Form	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.	Post-intervention (week 5)
Application of Mindfulness Practices as Measured by Applied Mindfulness Process Scale (AMPS)	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.	Post-intervention (week 5) and 3-month Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Symptoms as Measured by General Anxiety Disorder-7 (GAD-7)	The validated General Anxiety Disorder-7 (GAD-7) scale will be used to measure participants' anxiety symptoms. Participants rate 7 statements on a four-point Likert scale. Total scores for GAD-7 range from 0 to 21, with higher scores indicating more severe levels of anxiety symptoms.	Baseline, Post-intervention (week 5), and 3-month Follow-up
Depression Symptoms as Measured by Patient Health Questionnaire-9 (PHQ-9)	The validated Patient Health Questionnaire-9 (PHQ-9) scale will be used to measure participants' depression symptoms. Participants rate 9 statements on a four-point Likert scale. Total scores for GAD-7 range from 0 to 27, with higher scores indicating more severe levels of depression symptoms.	Baseline, Post-intervention (week 5), and 3-month Follow-up
The percentage (%) of participants meeting DSM-5 criteria for a Major Depressive Episode as Assessed by Mini International Neuropsychiatric Interview (MINI) Major Depressive Episode Module	The percentage (%) of participants meeting DSM-5 criteria for a Major Depressive Episode will be measured using the Major Depressive Episode module of the Mini-International Neuropsychiatric Interview (MINI). The MINI Major Depressive Episode module consits of 14 yes/no questions, and it will be administered verbally by a trained research assistant.	Baseline, Post-intervention (week 5), and 3-month Follow-up
The percentage (%) of participants meeting DSM-5 criteria for a Major Depressive Episode as Assessed by Mini International Neuropsychiatric Interview (MINI) Generalized Anxiety Module	The percentage (%) of participants meeting DSM-5 criteria for Generalized Anxiety Disorder will be measured using the Generalized Anxiety module of the Mini-International Neuropsychiatric Interview (MINI). The MINI Generalized Anxiety module consists of 10 yes/no questions, and it will be administered verbally by a trained research assistant.	Baseline, Post-intervention (week 5), and 3-month Follow-up
Anxiety-Related Functional Impairment as Measured by Overall Anxiety Severity and Impairment Scale (OASIS)	The validated Overall Anxiety Severity and Impairment Scale (OASIS) scale will be used to measure participants' anxiety-related functional impairment. Participants rate 5 statements on a five-point Likert scale. Total scores for OASIS range from 0 to 20, with higher scores indicating higher levels of anxiety-related functional impairment.	Baseline, Post-intervention (week 5), 3-month Follow-up
Depression-Related Functional Impairment as Measured by Overall Depression Severity and Impairment Scale (ODSIS)	The validated Overall Depression Severity and Impairment Scale (ODSIS) scale will be used to measure participants' depression-related functional impairment. Participants rate 5 statements on a five-point Likert scale. Total scores for ODSIS range from 0 to 20, with higher scores indicating higher levels of depression-related functional impairment.	Baseline, Post-intervention (week 5), 3-month Follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interoceptive Awareness as Assessed by Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2)	The validated Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) scale will be used to measure participants' interoceptive awareness. Participants rate 37 statements on a six-point Likert scale. Total scores for OASIS range from 0 to 185, with higher scores indicating higher levels of interoceptive awareness.	Baseline, Post-intervention (week 5), 3-month Follow-up
Decentering as Measured by Experiences Questionnaire (EQ)	The validated Experiences Questionnaire (EQ) scale will be used to measure participants' decentering. Participants rate 11 statements on a five-point Likert scale. Total scores for OASIS range from 11 to 55, with higher scores indicating greater trait levels of decentering.	Baseline, Post-intervention (week 5), 3-month Follow-up
Rumination as Measured by Perseverative Thinking Questionnaire (PTQ)	The validated Perseverative Thinking Questionnaire (PTQ) scale will be used to measure participants' rumination. Participants rate 15 statements on a five-point Likert scale. Total scores for PTQ range from 0 to 60, with higher scores indicating higher levels of rumination.	Baseline, Post-intervention (week 5), 3-month Follow-up
Mindset about Psychological Distress as Assessed by Theories of Psychological Distress Scale	Theories of Psychological Distress scale (adapted from the validated Theories of Anxiety scale) will be used to measure an individual's mindset about the malleability of their psychological distress, distinguishing between a fixed mindset (psychological distress is unchangeable) and a growth mindset (psychological distress can be changed). Participants rate 4 statements on a six-point Likert scale. Total scores for Theories of Psychological Distress scale range from 4 to 24, with higher scores indicating higher likelihood of having a fixed mindset.	Baseline, Post-intervention (week 5), 3-month Follow-up
Mindset about Emotion as Assessed by Theories of Emotion Scale	Theories of Emotion scale (adapted from the validated Theories of Anxiety scale) will be used to measure an individual's mindset about the malleability of their emotions, distinguishing between a fixed mindset (emotions are unchangeable) and a growth mindset (emotions can be changed). Participants rate 4 statements on a six-point Likert scale. Total scores for Theories of Emotion scale range from 4 to 24, with higher scores indicating higher likelihood of having a fixed mindset.	Baseline, Post-intervention (week 5), 3-month Follow-up

Collaborators and Investigators

• Sponsor: Brown University
• Investigators: Principal Investigator: Shufang Sun, PhD, Brown University

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2026
• Primary Completion (Estimated): August 2, 2026
• Study Completion (Estimated): August 2, 2026

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Mental health; Young adults; Mindfulness-based intervention; Early life adversity
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction; Anxiety Disorders; Depression; Psychological Well-Being; Physiological Phenomena; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Growth and Development; Mindfulness; Growth
• Other Study ID Numbers: STUDY00001023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Following data collection, cleaning, and analysis, we plan to publish deidentified quantitative data at an open science data repository (e.g., Open Science Framework). De-identified qualitative data will be available upon request to the study PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No