What side effects are associated with this type of intervention?

Mindfulness-based practices like Mindfulness-Based Stress Reduction (MBSR) and Cognitive Behavioral Therapy (CBT) generally have minimal side effects, with some individuals experiencing temporary increases in anxiety or emotional discomfort as they confront distressing thoughts and feelings. Pharmacological treatments for depression, such as SSRIs and SNRIs, can have side effects including nausea, weight gain, sexual dysfunction, insomnia, and increased risk of suicidal thoughts, particularly in young adults. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of depression, including selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, sertraline, and escitalopram. These medications are commonly used due to their efficacy and tolerability. In addition to pharmacotherapy, mindfulness-based practices, such as Mindfulness-Based Cognitive Therapy (MBCT), have shown promise in clinical trials as an adjunctive treatment for depression. While mindfulness practices themselves are not FDA-approved treatments, they are often recommended alongside pharmacotherapy to enhance overall treatment outcomes.

What other types of research exist?

Promising novel alternatives to mindfulness-based practices for depression patients include: 1) Cognitive Behavioral Therapy (CBT), which remains a gold standard with strong evidence for efficacy. 2) Interpersonal Therapy (IPT), which focuses on improving interpersonal relationships and social functioning. 3) Acceptance and Commitment Therapy (ACT), which uses acceptance and mindfulness strategies mixed with commitment and behavior-change strategies. 4) Digital and online therapy platforms, which provide accessible and flexible treatment options. 5) Pharmacological advancements, such as novel antidepressants and adjunctive treatments like ketamine or esketamine for treatment-resistant depression.

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Mindfulness Practices for Stress Due to Child Adversity (Fully Remote Trial) (EMMA Trial)

Verified Trial

N/A

Waitlist Available

Led By Stefanie E Mayer, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

female sex and gender identity (to control for sex and gender differences in stress responses and health outcomes)

age 30-50 (to examine intervention effects on health outcomes in midlife)

Must not have

Major psychiatric condition, including psychosis/schizophrenia, bipolar disorder, post-traumatic stress disorder, eating disorders, alcohol/substance use, major depression (PHQ-9 ≥ 15), and self-harm or suicidal ideation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up anticipated study period of 12 months

Summary

This trial tests mindfulness practices in women aged 30-50 with early life adversity. Participants engage in mindfulness activities regularly over a period of time. The goal is to see if these practices are practical and if participants stick with them.

Who is the study for?

This trial is for women aged 30-50 with a history of childhood adversity and mild depressive symptoms, who own a smartphone. They must have experienced at least two adverse childhood events but cannot be on certain medications or have major medical/psychiatric conditions, nor can they be pregnant or current smokers.

What is being tested?

The study tests if brief mindfulness practices improve well-being in midlife women with past adversity. Participants are randomly assigned to either Mindful Activity (guided exercises) or Mindful Awareness (self-monitoring thoughts/feelings), using an app twice daily for 8 weeks.

What are the potential side effects?

Mindfulness practices are generally considered safe but may sometimes bring up uncomfortable emotions or memories, especially in individuals with a history of trauma. It's important to report any distressing feelings during the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I identify as female.

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I am between 30 and 50 years old.

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You have experienced at least two negative events during your childhood.

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I have mild depression symptoms.

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You need to have a smartphone to use an app for assessments and interventions.

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I identify as female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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You have a serious mental health condition like schizophrenia, bipolar disorder, or severe depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ anticipated study period of 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~anticipated study period of 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and anticipated study period of 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of the intervention will be measured with an adapted version of the Treatment Acceptability Questionnaire (TAQ).

Adherence, as measured by the percentage of assigned and completed intervention group practices.

Feasibility, as indicated by numbers of participants screened (completed web-based screener and phone screener), eligible based on web-based screener and phone screener, consented, randomized to treatment, and retained at follow-up.

Secondary study objectives

Change in depressive symptoms, as measured by the total score on the 9-item Patient Health Questionnaire (PHQ-9).

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Mindful Activity groupExperimental Treatment1 Intervention

Participants complete mindfulness and compassion-based practices via the study app.

Group II: Mindful Awareness groupPlacebo Group1 Intervention

Participants monitor and report their thoughts and feelings via the study app.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness and compassion-based practices; approximately 5-10 minutes two times/day

2022

N/A

~80

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression include Cognitive Behavioral Therapy (CBT), Mindfulness-Based Stress Reduction (MBSR), and pharmacotherapy with antidepressants. CBT works by helping patients identify and change negative thought patterns and behaviors, which can improve mood and reduce symptoms of depression. MBSR focuses on increasing awareness and acceptance of the present moment, which can help patients manage stress and reduce depressive symptoms. Antidepressants, such as SSRIs and SNRIs, work by altering the levels of neurotransmitters in the brain, which can improve mood and emotional regulation. These treatments are important for depression patients as they offer different approaches to managing symptoms, allowing for personalized and effective care.