GEM Mindfulness Trial for Young Adults With Early Life Adversity
ClinicalTrials.gov Studies
Summary
This ClinicalTrials.gov registry entry documents a single-arm feasibility study (NCT07546799) evaluating the Growth, Empowerment, and Mindfulness (GEM) intervention, an app-delivered mindfulness-based program for young adults (ages 18–30) with early life adversities. Participants will engage with app-based content, Zoom group sessions, and ecological momentary assessments over a multi-week period, with follow-up at 3 months. The trial measures feasibility, acceptability, and preliminary efficacy for anxiety and depression outcomes.
“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).”
About this source
ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.
What changed
This ClinicalTrials.gov registry entry records a new single-arm feasibility trial, NCT07546799, examining the GEM (Growth, Empowerment, and Mindfulness) app-delivered mindfulness intervention in young adults (18–30 years) with early life adversities. Participants will complete app-based sessions, weekly Zoom group meetings, daily ecological momentary assessments, and Fitbit-based sleep monitoring, with assessments at baseline, post-intervention, and 3-month follow-up. The trial measures feasibility (engagement), acceptability (quantitative and qualitative feedback), and preliminary efficacy for depression and anxiety as primary outcomes, with rumination, mindfulness, and sleep as proposed mechanisms of action.
For clinical researchers, healthcare providers, and technology companies involved in digital mental health, this trial may inform future app-based intervention design and regulatory submissions for digital therapeutics. Institutions conducting similar mindfulness or digital mental health research should monitor outcomes data as the study progresses toward completion.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Growth, Empowerment, and Mindfulness (GEM): A Mindfulness-based Intervention to Address Mental Health in Young Adults With Early Life Adversity
N/A NCT07546799 Kind: NA Apr 23, 2026
Abstract
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
Conditions: Anxiety, Depression
Interventions: Growth, Empowerment, and Mindfulness (GEM)
Mentioned entities
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.