What side effects are associated with this type of intervention?

Mindfulness meditation and similar interventions, such as Mindfulness-Based Stress Reduction (MBSR), are generally considered safe with minimal side effects. However, some individuals may experience temporary increases in anxiety, emotional discomfort, or distress as they become more aware of their thoughts and feelings. Rarely, individuals with severe depression or trauma histories might experience exacerbation of symptoms. It is important for patients to discuss these potential side effects with their healthcare provider to ensure the treatment is appropriate for their specific condition.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, and serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine and duloxetine. These medications primarily work by altering neurotransmitter levels in the brain to improve mood and reduce depressive symptoms. While mindfulness meditation, such as the TARA trial, is not a pharmacological treatment, it aims to reduce depression by enhancing brain connectivity and resilience, offering a complementary approach to traditional medication.

What other types of research exist?

Promising novel alternatives to TARA for treating depression in 2024 include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in reducing depression symptoms by modulating brain activity. 2) Cognitive Behavioral Therapy (CBT), particularly digital or app-based CBT, which offers accessible and effective treatment for depression. 3) Exercise programs, especially aerobic exercise, which have been demonstrated to improve both brain function and mood. 4) Mindfulness-Based Cognitive Therapy (MBCT), which combines mindfulness practices with cognitive therapy techniques to prevent depression relapse.

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Behavioural Intervention

Meditation for Depression

N/A

Recruiting

Led By Tony T Yang, MD, 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

Be younger than 65 years old

Must not have

Subjects younger or older than 14-18 years old

Subjects who are taking any psychotropic medication other than one of the first-line selective serotonin reuptake inhibitor (SSRI) antidepressant medications (i.e., fluoxetine, escitalopram, sertraline)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline/randomization and 12 weeks after baseline/randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how mindfulness meditation affects brain connectivity and depression in teens. The goal is to see if meditation can strengthen brain areas that help regulate emotions and reduce depression symptoms. Teens will practice meditation, and researchers will measure changes in their brain and mood. The program uses a framework drawn from neuroscience, mindfulness, yoga, and modern psychotherapeutic techniques to promote emotional health.

Who is the study for?

This trial is for teens aged 14-18 with depression, who are under a healthcare provider's care and can use Zoom for remote participation. They must not have significant medical or mental health conditions other than depression or anxiety, not be on certain medications, without MRI contraindications like metal implants, and not currently practicing mindfulness.

What is being tested?

The study tests if meditation training (TARA) affects brain connectivity and reduces depression in adolescents. It compares changes in the putamen region of the brain and self-rated depression symptoms between those receiving TARA and an active control group using psycho-education.

What are the potential side effects?

Since this trial involves meditation training rather than medication, traditional side effects are minimal to none. However, participants may experience emotional discomfort when discussing personal issues during sessions.

Eligibility Criteria

Exclusion Criteria

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

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I am not between the ages of 14 and 18.

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I am only taking an SSRI antidepressant like fluoxetine, escitalopram, or sertraline.

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I have been practicing mindfulness or yoga regularly for the last 2 months.

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I am unable or unwilling to consent to participate in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline/randomization and 12 weeks after baseline/randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline/randomization and 12 weeks after baseline/randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline/randomization and 12 weeks after baseline/randomization for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Putamen node strength

Secondary study objectives

Change in Depression Symptoms

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental: TARA TrainingExperimental Treatment1 Intervention

Behavioral: Training for Awareness, Resilience, and Action (TARA) This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)

Group II: Control: Psycho-EducationActive Control1 Intervention

Behavioral: Training for Awareness, Resilience, and Action (TARA) without the mindfulness meditation components This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA) without the mindfulness meditation components

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TARA

2014

N/A

~30

0 / 4Eligibility 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 pharmacotherapy, psychotherapy, and non-pharmacologic interventions like mindfulness meditation. Antidepressants, such as SSRIs and SNRIs, work by increasing the levels of neurotransmitters like serotonin and norepinephrine in the brain, which can improve mood and emotional stability. Cognitive Behavioral Therapy (CBT) helps patients identify and change negative thought patterns and behaviors. Mindfulness meditation, as studied in the TARA trial, aims to increase connectivity in brain regions like the putamen, which is associated with emotional regulation and reward processing. This can lead to reduced depression symptoms by promoting better stress management and emotional resilience. Understanding these mechanisms helps patients and clinicians choose the most appropriate treatment, potentially leading to more effective and personalized care.