Mindfulness-Based Intervention for Mental Health
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Who Is on the Research Team?
Shufang Sun, PhD
Principal Investigator
Brown University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants engage in the GEM intervention, which includes app-based content, mindfulness practices, weekly Zoom sessions, and ecological momentary intervention delivery
Post-intervention Assessment
Participants complete post-intervention assessments to evaluate the efficacy and acceptability of the GEM intervention
Follow-up
Participants are monitored for psychological and behavioral outcomes, including depression and anxiety, and complete 3-month follow-up assessments
What Are the Treatments Tested in This Trial?
Interventions
- Growth, Empowerment, and Mindfulness (GEM)
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brown University
Lead Sponsor
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