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Mindfulness-Based Intervention for Mental Health

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Overseen ByGEM
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Brown University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new mindfulness-based program called Growth, Empowerment, and Mindfulness (GEM), designed to help young adults manage mental health challenges such as anxiety and depression. Delivered through an app, it includes mindfulness exercises, group sessions, and daily feedback. The trial aims to determine if participants find the program engaging and helpful in improving mental health and sleep while reducing negative thoughts. Young adults in the U.S. who have faced early life adversities and experience anxiety or depression symptoms might be a good fit, especially if they haven't tried mindfulness practices before. Participants will use an app, attend sessions, and wear a Fitbit to track sleep. As an unphased trial, this study offers a unique opportunity to explore innovative mental health strategies and contribute to valuable research.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since participants cannot be in mental health treatment, it might imply that certain medications related to mental health treatment could be restricted.

What prior data suggests that this mindfulness-based intervention is safe?

Research has shown that mindfulness programs, such as the Growth, Empowerment, and Mindfulness (GEM) program, are generally easy for participants to handle. The GEM program aims to assist young adults, particularly those who have encountered early life challenges. Similar studies have reported very few negative effects from these programs. Many participants experience improvements in mental health issues like anxiety and depression. This trial primarily assesses the program's practicality and acceptability, indicating it is expected to be safe. However, individual experiences may vary, so participants should monitor their feelings throughout the program.12345

Why are researchers excited about this trial?

Researchers are excited about the Growth, Empowerment, and Mindfulness (GEM) intervention because it offers a holistic alternative to traditional mental health treatments like medication and cognitive-behavioral therapy. Unlike these standard approaches, GEM emphasizes personal growth and empowerment through mindfulness practices, which can help individuals develop emotional resilience and self-awareness. This method is particularly appealing as it aims not just to reduce symptoms but to enhance overall well-being, offering a potentially transformative impact on mental health.

What evidence suggests that the GEM intervention might be effective for mental health?

Research has shown that mindfulness activities can help reduce anxiety and depression. One study found that an online mindfulness program significantly lowered anxiety, depression, and stress in people with these symptoms. Mindfulness also builds resilience and emotional well-being. The Growth, Empowerment, and Mindfulness (GEM) program, which participants in this trial will receive, aims to harness these benefits by combining mindfulness with empowerment techniques. Although specific results for GEM are not yet available, its foundation in proven mindfulness methods suggests it could improve mental health.12367

Who Is on the Research Team?

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Shufang Sun, PhD

Principal Investigator

Brown University

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-24 in the US who have experienced significant early life adversity (such as abuse or bullying), currently have mild to moderately severe depression and/or anxiety, and are not receiving mental health treatment.

Inclusion Criteria

I have been physically hurt by a parent or caregiver.
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?
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 3 months

Intervention

Participants engage in the GEM intervention, which includes app-based content, mindfulness practices, weekly Zoom sessions, and ecological momentary intervention delivery

4 weeks
Weekly Zoom group sessions

Post-intervention Assessment

Participants complete post-intervention assessments to evaluate the efficacy and acceptability of the GEM intervention

1 week

Follow-up

Participants are monitored for psychological and behavioral outcomes, including depression and anxiety, and complete 3-month follow-up assessments

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Growth, Empowerment, and Mindfulness (GEM)

Trial Overview

The study tests an app-based mindfulness program called GEM, which includes mindfulness exercises, group Zoom sessions, daily check-ins, and sleep tracking with a Fitbit. The goal is to see if this approach helps improve mental health in young adults with difficult childhood experiences.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Growth, Empowerment, and Mindfulness (GEM)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials
480
Recruited
724,000+

Citations

A Mindfulness-based Intervention to Address Mental ...

Will GEM intervention demonstrate preliminary efficacy in improving outcome measures including depression, anxiety? Are improvements in mindfulness and sleep, ...

A Mindfulness-based Intervention to Address Mental Health in ...

Will GEM intervention demonstrate preliminary efficacy in improving outcome measures including depression, anxiety? Are improvements in ...

Development of a growth and empowerment tool (GEM-Youth ...

The Growth and Empowerment Measure was developed by and for Aboriginal and Torres Strait Islander adults to measure social and emotional ...

Anxiety & Depression Association of America

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

(PDF) Psychometric Validation of the Growth and ...

The Growth and Empowerment Measure (GEM) was developed to measure change in dimensions of empowerment as defined and described by Aboriginal Australians.

Project Details

Evidence suggests increasing self-compassion among GM people could decrease depression and anxiety by reducing shame and rumination, but the full mindful self- ...

Mindfulness-Based Intervention for Mental Health

This N/A medical study run by Brown University is evaluating whether Growth, Empowerment, and Mindfulness (GEM) will have tolerable side ...