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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:
Participants will be asked to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Growth, Empowerment, and Mindfulness (GEM) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Growth, Empowerment, and Mindfulness (GEM) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Post-intervention (week 5), and 3-month Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Interoceptive Awareness as Assessed by Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) | The validated Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) scale will be used to measure participants' interoceptive awareness. Participants rate 37 statements on a six-point Likert scale. Total scores for OASIS range from 0 to 185, with higher scores indicating higher levels of interoceptive awareness. |
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Shufang Sun, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02912 | United States |
Following data collection, cleaning, and analysis, we plan to publish deidentified quantitative data at an open science data repository (e.g., Open Science Framework). De-identified qualitative data will be available upon request to the study PI.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 3, 2026 | Mar 10, 2026 |
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| 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. | 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. | 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. | 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. | 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. | Baseline, Post-intervention (week 5), and 3-month Follow-up |
| Anxiety-Related Functional Impairment as Measured by Overall Anxiety Severity and Impairment Scale (OASIS) | 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. | 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. | Baseline, Post-intervention (week 5), 3-month Follow-up |
| Baseline, Post-intervention (week 5), 3-month Follow-up |
| Decentering as Measured by Experiences Questionnaire (EQ) | The validated Experiences Questionnaire (EQ) scale will be used to measure participants' decentering. Participants rate 11 statements on a five-point Likert scale. Total scores for OASIS range from 11 to 55, with higher scores indicating greater trait levels of decentering. | Baseline, Post-intervention (week 5), 3-month Follow-up |
| Rumination as Measured by Perseverative Thinking Questionnaire (PTQ) | The validated Perseverative Thinking Questionnaire (PTQ) scale will be used to measure participants' rumination. Participants rate 15 statements on a five-point Likert scale. Total scores for PTQ range from 0 to 60, with higher scores indicating higher levels of rumination. | Baseline, Post-intervention (week 5), 3-month Follow-up |
| Mindset about Psychological Distress as Assessed by Theories of Psychological Distress Scale | Theories of Psychological Distress scale (adapted from the validated Theories of Anxiety scale) will be used to measure an individual's mindset about the malleability of their psychological distress, distinguishing between a fixed mindset (psychological distress is unchangeable) and a growth mindset (psychological distress can be changed). Participants rate 4 statements on a six-point Likert scale. Total scores for Theories of Psychological Distress scale range from 4 to 24, with higher scores indicating higher likelihood of having a fixed mindset. | Baseline, Post-intervention (week 5), 3-month Follow-up |
| Mindset about Emotion as Assessed by Theories of Emotion Scale | Theories of Emotion scale (adapted from the validated Theories of Anxiety scale) will be used to measure an individual's mindset about the malleability of their emotions, distinguishing between a fixed mindset (emotions are unchangeable) and a growth mindset (emotions can be changed). Participants rate 4 statements on a six-point Likert scale. Total scores for Theories of Emotion scale range from 4 to 24, with higher scores indicating higher likelihood of having a fixed mindset. | Baseline, Post-intervention (week 5), 3-month Follow-up |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2026 | Mar 10, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 13, 2026 | Mar 10, 2026 | ICF_002.pdf |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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| ID | Term |
|---|---|
| D006128 | Growth |
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D048788 | Growth and Development |
| D010829 | Physiological Phenomena |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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