What is the mechanism of action of this treatment?

Common treatments for depression, such as cognitive behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT), work by altering thought patterns and increasing awareness to reduce negative thinking and improve emotional regulation. Electroconvulsive therapy (ECT) involves electrical stimulation of the brain to induce changes in brain chemistry that can rapidly alleviate severe depressive symptoms. The trial on mindfulness-based real-time fMRI neurofeedback aims to modify brain circuits associated with rumination, a key factor in depression, by providing real-time feedback to help patients regulate their brain activity. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options and sets realistic expectations for outcomes.

What side effects are associated with this type of intervention?

Mindfulness-based interventions and cognitive-behavioral therapy (CBT) for depression are generally well-tolerated with minimal side effects, primarily involving temporary emotional discomfort as patients confront distressing thoughts. In contrast, pharmacotherapy, such as antidepressants, can have a range of side effects including nausea, weight gain, sexual dysfunction, insomnia, dry mouth, blurred vision, and increased anxiety. It's important for patients to discuss these potential side effects with their healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

FDA-approved treatments for depression primarily include pharmacotherapy with SSRIs (e.g., fluoxetine, sertraline), SNRIs (e.g., venlafaxine, duloxetine), and atypical antidepressants (e.g., bupropion, mirtazapine). Augmentation strategies often involve antipsychotics (e.g., aripiprazole, quetiapine). Non-pharmacological treatments like cognitive-behavioral therapy (CBT) and electroconvulsive therapy (ECT) are also well-established. While innovative approaches like mindfulness-based real-time fMRI neurofeedback are being studied, they are not yet FDA-approved as standalone treatments for depression.

What other types of research exist?

Promising novel alternatives to Mindfulness-Based Real-Time fMRI Neurofeedback for depression in 2024 include: 1) Deep Brain Stimulation (DBS), particularly targeting areas like the subcallosal cingulate and anterior limb of the internal capsule, which has shown efficacy in treatment-resistant depression. 2) Cognitive Behavioral Therapy for Insomnia (CBT-I), which can improve sleep-related quality of life and psychological well-being, potentially benefiting depression symptoms. 3) Mind-body therapies such as guided imagery, hypnosis, and biofeedback, which are useful in treating various conditions and may support depression treatment as adjunct therapies.

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Behavioural Intervention

Mindfulness-Based Neurofeedback for Depression (mbNF Trial)

N/A

Recruiting

Research Sponsored by Columbia University

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-month

Awards & highlights

No Placebo-Only Group

Summary

This trial uses real-time brain scans to help depressed adolescents practice mindfulness and control their brain activity. It targets teens with major depression who don't respond well to current treatments. By seeing their brain activity live, they can reduce negative thinking patterns that worsen depression.

Who is the study for?

This trial is for adolescents aged 13-18 with major depressive disorder (MDD) who can give informed consent and have parental permission if under 18. Participants must speak English fluently and be in at least the third stage of puberty. Those with an IQ below 80, severe mental health disorders, recent substance abuse, or conditions that make MRI scans unsafe cannot join.

What is being tested?

The study tests a new treatment combining mindfulness practices with real-time feedback from fMRI brain scans to target rumination—a repetitive focus on negative thoughts—in depressed teens. The goal is to see if this approach changes brain activity related to rumination and improves depression symptoms.

What are the potential side effects?

Since the intervention involves mindfulness exercises and non-invasive brain imaging, there are minimal expected side effects. However, some participants might experience discomfort during the MRI scan or find focusing on their thoughts during mindfulness practice challenging.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Within-person Default Mode Network (DMN) Connectivity

Secondary study objectives

Interviewer-Assessed Depression Symptoms

Mental Depression

Self-Reported Rumination

Other study objectives

Default Mode Network (DMN) and Frontoparietal Control Network (FPCN) Connectivity

Ecological Momentary Assessment of Depression Symptoms

Ecological Momentary Assessment of Mindfulness

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: 15-Minute mbNFActive Control1 Intervention

Participants receiving mindfulness training and 15-minute session of mbNF

Group II: 30-Minute mbNFActive Control1 Intervention

Participants receiving mindfulness training and 30-minute session of mbNF

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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, such as cognitive behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT), work by altering thought patterns and increasing awareness to reduce negative thinking and improve emotional regulation. Electroconvulsive therapy (ECT) involves electrical stimulation of the brain to induce changes in brain chemistry that can rapidly alleviate severe depressive symptoms. The trial on mindfulness-based real-time fMRI neurofeedback aims to modify brain circuits associated with rumination, a key factor in depression, by providing real-time feedback to help patients regulate their brain activity. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options and sets realistic expectations for outcomes.

Treatment of Psychiatric Problems After Traumatic Brain Injury.Can magnetic resonance imaging enhance the assessment of potential new treatments for cognitive impairment in mood disorders? A systematic review and position paper by the International Society for Bipolar Disorders Targeting Cognition Task Force.Biomarkers for Deep Brain Stimulation in Animal Models of Depression.