Anxiety / Depression / Growth, Empowerment, and Mindfulness (GEM) · Interventional Study

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

ClinicalTrials.gov · September 9, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for a single-arm feasibility study (n=44) of GEM, a mindfulness-based, app-delivered intervention for young adults with early life adversity and mental health symptoms. The study has completed recruitment and is examining feasibility, acceptability, engagement, and preliminary efficacy; no outcome results are reported in this registry entry.

What was studied

Interventional, Single Group, Open label, Prevention purpose. Anxiety, Depression; age from 18 Years; to 24 Years. Intervention: Growth, Empowerment, and Mindfulness (GEM). n = 44. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

Single-arm feasibility study with 44 participants examining recruitment, retention, engagement, and acceptability of a novel mindfulness intervention; no results yet posted in registry.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Study Recruitment Feasibility as Measured by Participant Recruitment Rates (assessed at During recruitment period of study, up to 3 months); Study Retention Feasibility as Measured by Participant Retention Rates (assessed at Baseline, Post-intervention (week 5), and 3-month Follow-up); Intervention Engagement Feasibility as Measured by Participant Engagement with Intervention (assessed at During intervention period (4 weeks)); Intervention Acceptability as Measured by Client Satisfaction Questionnaire (CSQ-8) (assessed at Post-intervention (week 5)); Intervention Acc…

DesignInterventional, Single Group, Open label, Prevention purpose

PopulationAnxiety, Depression; age from 18 Years; to 24 Years

Sample size44

InterventionGrowth, Empowerment, and Mindfulness (GEM)

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment44

Study typeSingle-arm interventional

Primary outcome domainsRecruitment feasibility, retention feasibility, engagement feasibility, acceptability (CSQ-8 and Session Evaluation Form), application of mindfulness (AMPS)

Intervention period4 weeks

Follow-up duration3 months post-intervention

Caveats

No results are posted in this registry record; clinical outcomes and efficacy findings are not yet available
Single-arm design without control group limits causal inference about intervention efficacy
Feasibility and acceptability findings may not be generalizable to other settings or populations
Primary outcomes focus on process measures (recruitment, retention, engagement) rather than clinical efficacy

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Single-arm feasibility design; no comparator or control group specified

Directness

moderate

Targets anxiety and depression in young adults with early life adversity; outcomes include feasibility, acceptability, and preliminary efficacy

Consistency

insufficient

Registry record only; no results reported for consistency assessment

Risk of bias

insufficient

Absence of control group and blinding noted; registry does not describe bias mitigation

Sample adequacy

limited

44 participants enrolled; sample size appropriate for feasibility but not efficacy testing

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07546799). This is a study registration, not published results. Lead sponsor: Brown University. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 44 participants (ACTUAL). Conditions: Anxiety, Depression. Interventions: BEHAVIORAL: Growth, Empowerment, and Mindfulness (GEM). Primary outcome measures: Study Recruitment Feasibility as Measured by Participant Recruitment Rates , During recruitment period of study, up to 3 months; Study Retention Feasibility as Measured by Participant Retention Rates , Baseline, Post-intervention (week 5), and 3-month Follow-up; Intervention Engagement Feasibility as Measured by Participant Engagement with Intervention , During intervention period (4 weeks); Intervention Acceptability as Measured by Client Satisfaction Questionnaire (CSQ-8) , Post-intervention (week 5); Intervention Acceptability as Measured by Session Evaluation Form , Post-intervention (week 5); Application of Mindfulness Practices as Measured by Applied Mindfulness Process Scale (AMPS) , Post-intervention (week 5) and 3-month Follow-up. Brief 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). 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

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

AnxietyNCT07546799DepressionGrowth, Empowerment, and Mindfulness (GEM)Brown University