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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
44
The Growth, Empowerment, and Mindfulness (GEM) intervention is a structured, mindfulness-based intervention designed to offer support for young adults with early life adversities and their negative behavioral health consequences through the development of awareness, emotion regulation, and adaptive coping skills. Through psychoeducation content, group practice Zoom sessions, and formal and informal mindfulness practices, GEM is aimed at helping participants build foundational mindfulness and self-compassion skills, increase interoceptive awareness, reduce experiential avoidance and de-centering, improve emotion regulation and decrease rumination, and integrate mindfulness skills into daily life. The content of the GEM intervention was developed with community feedback from relevant Community Advisory Board members.
Brown University
Providence, Rhode Island, United States
Study Recruitment Feasibility as Measured by Participant Recruitment Rates
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.
Time frame: During recruitment period of study, up to 3 months
Study Retention Feasibility as Measured by Participant Retention Rates
Participant retention rates will be assessed as the percentage (%) of enrolled participants who complete study assessments at each time point (baseline, post-intervention, and 3-month follow-up). This will be data will be collected using assessment completion records maintained by the research team, which document participant completion of assessments. This retention rate will be used to evaluate the feasibility of the GEM intervention.
Time frame: Baseline, Post-intervention (week 5), and 3-month Follow-up
Intervention Engagement Feasibility as Measured by Participant Engagement with Intervention
Participant engagement with the GEM intervention (i.e., adherence to the intervention) will be assessed as the percentage (%) of prescribed intervention activities completed by participants over the study period. This data will be collected using GEM application logs and session attendance records maintained by the research team. This engagement data will be used to evaluate the feasibility of the GEM intervention.
Time frame: During intervention period (4 weeks)
Intervention Acceptability as Measured by Client Satisfaction Questionnaire (CSQ-8)
The validated 8-item Client Satisfaction Questionnaire (CSQ-8) will be used to measure the acceptability of the GEM intervention. Participants rate each item on a four-point Likert scale. Total scores for the CSQ-8 range from 8 to 32, with higher scores indicating higher satisfaction with the intervention.
Time frame: Post-intervention (week 5)
Intervention Acceptability as Measured by Session Evaluation Form
Session evaluation form (a self-developed measure) will be used to measure the acceptability of the GEM intervention. The instrument consists of 10 questions, rated on a four-point Likert scale. Total scores range from 10 to 40, with higher scores indicating higher satisfaction with the intervention.
Time frame: Post-intervention (week 5)
Application of Mindfulness Practices as Measured by Applied Mindfulness Process Scale (AMPS)
The validated Applied Mindfulness Process Scale (AMPS) will be used to measure participants' application of mindfulness practices. Participants rate 15 statements on a five-point Likert scale. Total scores for AMPS range from 0 to 60, with higher scores indicating more frequent application of mindfulness practices when facing challenges in daily life.
Time frame: Post-intervention (week 5) and 3-month Follow-up
Anxiety Symptoms as Measured by General Anxiety Disorder-7 (GAD-7)
The validated General Anxiety Disorder-7 (GAD-7) scale will be used to measure participants' anxiety symptoms. Participants rate 7 statements on a four-point Likert scale. Total scores for GAD-7 range from 0 to 21, with higher scores indicating more severe levels of anxiety symptoms.
Time frame: Baseline, Post-intervention (week 5), and 3-month Follow-up
Depression Symptoms as Measured by Patient Health Questionnaire-9 (PHQ-9)
The validated Patient Health Questionnaire-9 (PHQ-9) scale will be used to measure participants' depression symptoms. Participants rate 9 statements on a four-point Likert scale. Total scores for GAD-7 range from 0 to 27, with higher scores indicating more severe levels of depression symptoms.
Time frame: Baseline, Post-intervention (week 5), and 3-month Follow-up
The percentage (%) of participants meeting DSM-5 criteria for a Major Depressive Episode as Assessed by Mini International Neuropsychiatric Interview (MINI) Major Depressive Episode Module
The percentage (%) of participants meeting DSM-5 criteria for a Major Depressive Episode will be measured using the Major Depressive Episode module of the Mini-International Neuropsychiatric Interview (MINI). The MINI Major Depressive Episode module consits of 14 yes/no questions, and it will be administered verbally by a trained research assistant.
Time frame: Baseline, Post-intervention (week 5), and 3-month Follow-up
The percentage (%) of participants meeting DSM-5 criteria for a Major Depressive Episode as Assessed by Mini International Neuropsychiatric Interview (MINI) Generalized Anxiety Module
The percentage (%) of participants meeting DSM-5 criteria for Generalized Anxiety Disorder will be measured using the Generalized Anxiety module of the Mini-International Neuropsychiatric Interview (MINI). The MINI Generalized Anxiety module consists of 10 yes/no questions, and it will be administered verbally by a trained research assistant.
Time frame: Baseline, Post-intervention (week 5), and 3-month Follow-up
Anxiety-Related Functional Impairment as Measured by Overall Anxiety Severity and Impairment Scale (OASIS)
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The validated Overall Anxiety Severity and Impairment Scale (OASIS) scale will be used to measure participants' anxiety-related functional impairment. Participants rate 5 statements on a five-point Likert scale. Total scores for OASIS range from 0 to 20, with higher scores indicating higher levels of anxiety-related functional impairment.
Time frame: Baseline, Post-intervention (week 5), 3-month Follow-up
Depression-Related Functional Impairment as Measured by Overall Depression Severity and Impairment Scale (ODSIS)
The validated Overall Depression Severity and Impairment Scale (ODSIS) scale will be used to measure participants' depression-related functional impairment. Participants rate 5 statements on a five-point Likert scale. Total scores for ODSIS range from 0 to 20, with higher scores indicating higher levels of depression-related functional impairment.
Time frame: Baseline, Post-intervention (week 5), 3-month Follow-up