AnxietyNCT07546799
Growth, Empowerment, and Mindfulness (GEM): A Mindfulness-based Intervention to Address Mental Health in Young Adults With Early Life Adversity
A study testing Growth, Empowerment, and Mindfulness (GEM) in people with Anxiety and Depression, run by Brown University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Growth, Empowerment, and Mindfulness (GEM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2026to 16 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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?
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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
- Conditions
- Anxiety, Depression
- Being tested
- Growth, Empowerment, and Mindfulness (GEM)
- Keywords
- Mindfulness-based intervention, Young adults, Early life adversity, Mental health
- Medical subject headings
- Anxiety Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth, Empowerment, and Mindfulness (GEM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Growth, Empowerment, and Mindfulness (GEM) | Experimental | Not described Receives: Behavioral: Growth, Empowerment, and Mindfulness (GEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (week 5) and 3-month Follow-up
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Post-intervention (week 5), 3-month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start24 Mar 2026
- Primary completion16 Aug 2026
- Study completion16 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shufang Sun, Brown University
- Investigators
- Shufang Sun, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546799
- Sponsor's protocol ID
- STUDY00001023
- Status last verified
- Sep 2026
- First submitted
- 10 Mar 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth, Empowerment, and Mindfulness (GEM): Pilot Trial of a Mindfulness-based Intervention to Address Mental Health in Young Adults With Early Life Adversities
- ClinicalTrials.gov ID
- NCT07546799
- Acronym / sponsor ID
- STUDY00001023
- Conditions
- Anxiety, Depression
- Keywords
- Mindfulness-based intervention, Young adults, Early life adversity, Mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 16 Aug 2026 (actual)
- Study completion
- 16 Aug 2026 (actual)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Growth, Empowerment, and Mindfulness (GEM) | Experimental | Behavioral: Growth, Empowerment, and Mindfulness (GEM) |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Growth, Empowerment, and Mindfulness (GEM) |
Primary outcome
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.
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.
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.
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.
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.
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.
6 secondary outcomes
Anxiety Symptoms as Measured by General Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, Post-intervention (week 5), and 3-month Follow-up
Depression Symptoms as Measured by Patient Health Questionnaire-9 (PHQ-9)
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 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 as Assessed by Mini International Neuropsychiatric Interview (MINI) Generalized Anxiety Module
Time frame: Baseline, Post-intervention (week 5), and 3-month Follow-up
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shufang Sun, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth, Empowerment, and Mindfulness (GEM) in people with Anxiety and Depression, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Recruitment Feasibility as Measured by Participant Recruitment Rates (time frame: During recruitment period of study, up to 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.