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NCT07546799 · ClinicalTrials.gov registry record · NA
Growth, Empowerment, and Mindfulness (GEM): A Mindfulness-based Intervention to Address Mental Health in Young Adults With Early Life Adversity
A NA study, sponsored by Brown University.
- Active
- Registry status
- NA
- Development phase
- 44
- Enrollment target
NCT07546799: Active NA study, sponsored by Brown University.
NCT07546799 is a NA study that is active but no longer recruiting, run by Brown University. The registered enrollment target is 44 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07546799, a NA study, is active but no longer recruiting, sponsored by Brown University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
Study 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
Primary Outcome
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.
Interventions
- BEHAVIORAL Growth, Empowerment, and Mindfulness (GEM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2026-03-24 |
| Est. Completion | 2026-08-02 |
| Phase | NA |
What the registry record for NCT07546799 still lists
NCT07546799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Growth, Empowerment, and Mindfulness (GEM) is the first listed.
NCT07546799 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07546799 about?
NCT07546799 is a clinical study titled "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...
What is the current status of trial NCT07546799?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 44 participants. The study started on 2026-03-24. Estimated completion is 2026-08-02.
What interventions are being tested in trial NCT07546799?
The interventions under investigation include: Growth, Empowerment, and Mindfulness (GEM) (BEHAVIORAL).
Who is sponsoring clinical trial NCT07546799?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07546799's enrollment target sits among peer trials
44 1423rd of 2000 higher than 566 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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