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

Brown University

Status

Completed

Conditions

Depression

Anxiety

Treatments

Behavioral: Growth, Empowerment, and Mindfulness (GEM)

Study type

Interventional

Funder types

Other

Identifiers

NCT07546799

STUDY00001023

Details and patient eligibility

About

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

Enrollment

44 patients

Sex

All

Ages

18 to 24 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18-24
Reside in the US
Experiences of psychosocial forms of early life adversity, defined as saying yes to at least one of these following questions:
1. Did you ever miss school due to fear of being bullied?
2. Were you ever injured or threatened with a weapon or otherwise assaulted by a peer at school?
3. Were you ever physically attacked, hit, hurt, or injured by a parent, primary caregiver, or guardian?
4. Were you ever touched sexually against your wishes or forced to touch someone else sexually?
5. Were you ever forced to engage in sexual intercourse?
6. Were you ever forced to have sex or were you ever sexually abused (e.g., being touched or fondled by an adult?)
Experience more than minimal symptoms of anxiety (GAD-7 score of 5 or higher) and/or mild to moderately severe depression symptoms (PHQ-9 score between 5-19)
Not currently in mental health treatment
Being willing to answer 3-4 short surveys daily, each 2-5 mins
Being willing to engage in recommended daily mindfulness practices for 4-6 weeks
Have not been extensively exposed to mindfulness, defined as meditation retreat experience, consistent mindfulness practice (> once/week) within the past 6 months, or prior participation in a mindfulness course/program

Exclusion criteria

At imminent risk of suicide
Have a current diagnosis of Major Depressive Disorder
Meet the criteria for Major Depressive Episode based on the MINI-Major Depressive Episode module at screening
Score 20 or higher on Alcohol Use Disorders Identification Test (AUDIT) at screening
Score 25 or higher on Drug Use Disorders Identification Test (DUDIT) at screening
Have a history of psychotic disorder (e.g., schizophrenia) or psychotic episode
Have ever been diagnosed with bipolar disorder