What is the mechanism of action of this treatment?

The most common treatments for depression include antidepressant medications and psychotherapies such as Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT). Antidepressants, like selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), work by increasing the levels of neurotransmitters in the brain, which can help improve mood and emotional state. CBT focuses on changing negative thought patterns and behaviors that contribute to depression, while MBCT combines these cognitive strategies with mindfulness practices to help patients stay present and reduce the risk of relapse. These treatments are crucial for depression patients as they address both the biological and psychological aspects of the disorder, providing a comprehensive approach to managing and preventing depressive episodes.

What side effects are associated with this type of intervention?

Common treatments for depression, such as cognitive-behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT), are generally well-tolerated with minimal side effects. Some patients may experience initial increases in anxiety or emotional discomfort as they confront distressing thoughts and feelings. The commitment to regular practice and therapy sessions can be challenging, potentially leading to frustration or dropout. Long-term adherence is crucial for sustained benefits, and lack of ongoing practice may result in the return of depressive symptoms.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine, and atypical antidepressants like bupropion. These medications are often used in conjunction with psychotherapies such as Cognitive Behavioral Therapy (CBT) to prevent relapse in Major Depressive Disorder (MDD). While MBCT itself is not a medication, it is a therapeutic approach that combines mindfulness training with CBT techniques, and has shown efficacy in preventing relapse in patients with recurrent MDD.

What other types of research exist?

Promising, novel alternatives to Mindfulness Based Cognitive Therapy (MBCT) for depression patients include: 1) Virtual Mindfulness Training, which offers a cost-effective and accessible format for delivering mindfulness and cognitive-behavioral strategies. 2) Dialectical Behavior Therapy (DBT), which combines cognitive-behavioral techniques with mindfulness and emotional regulation skills. 3) Transcranial Magnetic Stimulation (TMS), a non-invasive brain stimulation technique that has shown efficacy in treating depression. 4) Ketamine-assisted psychotherapy, which uses low doses of ketamine to enhance the effects of psychotherapy for treatment-resistant depression.

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Virtual Mindfulness Training for Depression

N/A

Waitlist Available

Led By Lu Shi, Ph.D.

Research Sponsored by Clemson University

Eligibility Criteria Checklist

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

Must have

be over 18 years of age

have a SCID confirmed diagnosis of a prior MDD episode

Must not have

an active diagnosis of Bipolar Disorder

an acute episode of MDD (met two or more MDD criteria in the past two weeks)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a low-cost, online version of Mindfulness Based Cognitive Therapy (MBCT) for people who have recovered from depression. The goal is to see if this virtual program can help prevent depression from returning by teaching mindfulness and cognitive-behavioral skills. The study will measure the effectiveness of the virtual MBCT program. Mindfulness-based cognitive therapy (MBCT) was originally developed to prevent relapse in recurrent depression and has been adapted for various mental health conditions.

Who is the study for?

Adults over 18 with a past diagnosis of Major Depressive Disorder (MDD), living in upstate South Carolina or Prisma Health beneficiaries, who can attend virtual sessions and have at least a 6th-grade level of English literacy. Excluded are those with current psychosis, dementia, severe brain injury, active suicidality, harmful behaviors needing clinical management, prior MBCT treatment completion or attendance.

What is being tested?

The trial is testing the effectiveness of Mindfulness Based Cognitive Therapy (MBCT) delivered virtually as a low-cost option for preventing depression relapse. Participants will either receive this intervention or be placed on a waitlist (treatment as usual). The study aims to measure changes in depression severity and overall mental health.

What are the potential side effects?

While MBCT typically has minimal side effects compared to medication-based treatments, participants may experience emotional discomfort when confronting difficult thoughts and feelings during mindfulness exercises.

Eligibility Criteria

Inclusion Criteria

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

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I am over 18 years old.

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I have been diagnosed with major depression before.

Exclusion Criteria

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

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I have been diagnosed with Bipolar Disorder.

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I have experienced symptoms of major depression recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) 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 Depression Severity

Change in Psychiatric Distress

Secondary study objectives

Change in Adherence to Medication Assisted Treatment (MAT)

Mindfulness

Change in Frequency of major depressive disorder relapse episodes

+4 more

Other study objectives

Change in Emotion regulation

Change in Savoring

Intervention fidelity

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: MBCT InterventionExperimental Treatment1 Intervention

Eight weekly two-hour mindful MBCT intervention sessions led by a trained healthcare provider. Post-intervention, the experimental group will receive treatment as usual.

Group II: Wait List ControlActive Control1 Intervention

Participants will engage in treatment as usual during the baseline period. After the experimental group completes the MBCT intervention, the wait list control group will complete the MBCT intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MBCT Intervention

2022

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

The most common treatments for depression include antidepressant medications and psychotherapies such as Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT). Antidepressants, like selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), work by increasing the levels of neurotransmitters in the brain, which can help improve mood and emotional state. CBT focuses on changing negative thought patterns and behaviors that contribute to depression, while MBCT combines these cognitive strategies with mindfulness practices to help patients stay present and reduce the risk of relapse. These treatments are crucial for depression patients as they address both the biological and psychological aspects of the disorder, providing a comprehensive approach to managing and preventing depressive episodes.