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NCT Number: NCT07546799

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Personal Satisfaction Psychological Well-Being

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brown University

Providence, Rhode Island, 02912, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Did you ever miss school due to fear of being bullied?
  • Were you ever injured or threatened with a weapon or otherwise assaulted by a peer at school?
  • Were you ever physically attacked, hit, hurt, or injured by a parent, primary caregiver, or guardian?
  • Were you ever touched sexually against your wishes or forced to touch someone else sexually?
  • Were you ever forced to engage in sexual intercourse?
  • 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

Treatment and study plan

Growth, Empowerment, and Mindfulness (GEM)

Behavioral

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.

Primary outcomes

  1. Study Recruitment Feasibility as Measured by Participant Recruitment Rates

    Time frame: During 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.

  2. Study Retention Feasibility as Measured by Participant Retention Rates

    Time frame: Baseline, 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.

  3. Intervention Engagement Feasibility as Measured by Participant Engagement with Intervention

    Time frame: During 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.

  4. Intervention Acceptability as Measured by Client Satisfaction Questionnaire (CSQ-8)

    Time frame: 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.

  5. Intervention Acceptability as Measured by Session Evaluation Form

    Time frame: Post-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.

  6. Application of Mindfulness Practices as Measured by Applied Mindfulness Process Scale (AMPS)

    Time frame: 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.

Secondary outcomes

  1. Anxiety Symptoms as Measured by General Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline, Post-intervention (week 5), and 3-month Follow-up

    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.

  2. Depression Symptoms as Measured by Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline, Post-intervention (week 5), and 3-month Follow-up

    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.

  3. 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

    Time frame: Baseline, Post-intervention (week 5), and 3-month Follow-up

    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.

  4. The percentage (%) of participants meeting DSM-5 criteria for a Major Depressive Episode as Assessed by Mini International Neuropsychiatric Interview (MINI) Generalized Anxiety Module

    Time frame: Baseline, Post-intervention (week 5), and 3-month Follow-up

    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.

  5. Anxiety-Related Functional Impairment as Measured by Overall Anxiety Severity and Impairment Scale (OASIS)

    Time frame: Baseline, Post-intervention (week 5), 3-month Follow-up

    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.

  6. Depression-Related Functional Impairment as Measured by Overall Depression Severity and Impairment Scale (ODSIS)

    Time frame: Baseline, Post-intervention (week 5), 3-month Follow-up

    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.

Other outcomes

  1. Interoceptive Awareness as Assessed by Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2)

    Time frame: Baseline, Post-intervention (week 5), 3-month Follow-up

    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.

  2. Decentering as Measured by Experiences Questionnaire (EQ)

    Time frame: Baseline, Post-intervention (week 5), 3-month Follow-up

    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.

  3. Rumination as Measured by Perseverative Thinking Questionnaire (PTQ)

    Time frame: Baseline, Post-intervention (week 5), 3-month Follow-up

    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.

  4. Mindset about Psychological Distress as Assessed by Theories of Psychological Distress Scale

    Time frame: Baseline, Post-intervention (week 5), 3-month Follow-up

    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.

  5. Mindset about Emotion as Assessed by Theories of Emotion Scale

    Time frame: Baseline, Post-intervention (week 5), 3-month Follow-up

    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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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