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

NCT Number	NCT07546799
Lead Sponsor	Brown University
Conditions	Anxiety, Depression
Enrollment	44 participants
Start Date	2026-03-24
Primary Completion	2026-08-02 (estimated)
Study Completion	2026-08-02 (estimated)
Updated on ClinicalTrials.gov	2026-05-12