Meditative Neurofeedback for Depression

(MediNF Trial)

Overseen By Jyoti Mishra, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Substance abuse, Psychotic disorders, Bipolar, Suicidal behaviors

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

27 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help people with depression through meditative neurofeedback (MediNF). This method combines breathing-focused meditation with brain feedback to improve mood. Participants will attend 10 sessions, practicing meditation while receiving real-time brain activity information to enhance their performance. The trial targets individuals with moderate depression who do not have substance abuse, psychotic disorders, or bipolar disorder. As an unphased trial, it provides a unique opportunity to explore innovative treatments for depression.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this meditative neurofeedback intervention is safe for depression?

Research on neurofeedback, including the meditative neurofeedback used in this trial, shows it is generally safe. Studies have found that neurofeedback does not cause serious side effects, meaning most people do not experience harm from it.

Neurofeedback provides information about brain activity to help individuals learn to control it. It has been used to improve mood and mental performance. While not entirely risk-free, most people tolerate it well.

Studies examining neurofeedback for conditions like depression have reported no severe adverse reactions. This finding reassures those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Meditative Neurofeedback, or MediNF, is unique because it combines meditative practices with neurofeedback to target depression. Unlike traditional treatments like antidepressants or psychotherapy, MediNF provides real-time feedback on brain activity to enhance meditative performance, potentially offering a more interactive and personalized approach. Researchers are excited because this technique may help improve emotional regulation and mental focus more quickly and effectively than existing methods.

What evidence suggests that MediNF might be an effective treatment for depression?

Research has shown that neurofeedback can help reduce symptoms of depression. Some studies suggest that this method can improve memory and thinking speed in people with major depression. In one study, 75% of participants with depression used the techniques learned from neurofeedback in their daily lives after just four weeks. Specifically, patients demonstrated significant improvements in both thinking and mood after training with EEG-based neurofeedback. While it may not work for everyone, many report feeling better after this type of treatment. Participants in this trial will engage in a breath-focused meditative practice with frontal brain connectivity neurofeedback, known as MediNF, to enhance performance over 10 sessions. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with moderate depression as measured by the PHQ9, a common symptom rating tool. It's not suitable for those who are acutely suicidal, currently abusing substances, or diagnosed with psychotic disorders or bipolar disorder.

Inclusion Criteria

Moderate depression per PHQ9 symptom ratings

Exclusion Criteria

Psychotic disorders

Displaying acutely suicidal behaviors

Active substance abuse/dependence

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 10-session meditative neurofeedback intervention to alleviate depressive symptoms

8 weeks

10 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MediNF

Trial Overview The study is testing MediNF, a meditative neurofeedback intervention designed to improve mood in people suffering from depression. This open-label single-arm study means all participants receive the same treatment without a comparison group.

How Is the Trial Designed?

Group I: MediNF Experimental Treatment 1 Intervention

Over 10-sessions participants will engage in a breath-focused meditative practice with frontal brain connectivity neurofeedback provided to enhance performance.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

Neurofeedback training significantly improved working memory performance and processing speed in patients with major depressive disorder (MDD), as evidenced by a study involving 40 participants undergoing eight training sessions compared to a control group of 20.

The training led to increased upper alpha power in the brain, particularly in the subgenual anterior cingulate cortex, indicating a specific brain area involved in the cognitive improvements observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled study on the cognitive effect of alpha neurofeedback training in patients with major depressive disorder. Escolano, C., Navarro-Gil, M., Garcia-Campayo, J., et al.[2022]

Neurofeedback training has shown promise as an additional treatment for major depressive disorder (MDD), with 24 studies involving 480 patients indicating that participants experienced greater symptom improvement compared to control groups.

Despite the positive findings, many studies lacked adherence to high-quality research standards, highlighting the need for better experimental designs and reporting practices in future neurofeedback research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback training in major depressive disorder: A systematic review of clinical efficacy, study quality and reporting practices. Trambaiolli, LR., Kohl, SH., Linden, DEJ., et al.[2021]

Real-time functional magnetic resonance imaging-based neurofeedback (rt-fMRI NF) is a promising technique for treating depression by training individuals to self-regulate brain areas like the amygdala, which is often overactive in response to negative stimuli.

Initial randomized controlled trials show promising results for rt-fMRI NF in improving emotional processing, but further research is needed to determine the best methods, target regions, and training durations for lasting clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Application of Real-Time fMRI-Based Neurofeedback for Depression. Mathiak, K., Keller, M.[2021]

Neurofeedback shows promise as a complementary treatment for depression, with a review of 21 studies indicating that all six original experimental studies reported positive outcomes.

The new neurofeedback protocol developed in this study combines existing techniques and has shown favorable results in a small clinical trial with one participant, suggesting potential for further research and application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new neurofeedback protocol for depression. Dias, AM., van Deusen, A.[2019]

A novel closed-loop neurofeedback procedure was tested on 15 participants with major depressive disorder and 12 healthy controls, showing that it can help reduce negative attentional bias in those with depression.

Participants with major depressive disorder experienced a decrease in depression severity after neurofeedback training, suggesting this technique could be a promising treatment for future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cloud-Based Functional Magnetic Resonance Imaging Neurofeedback to Reduce the Negative Attentional Bias in Depression: A Proof-of-Concept Study. Mennen, AC., Turk-Browne, NB., Wallace, G., et al.[2022]

The study found that EEG neurofeedback (EEG-NFB) using 'Anxiety' feedback led to a significantly greater improvement in brain activity related to depression compared to 'Moving Art', suggesting that emotionally evocative feedback options may enhance treatment efficacy.

Motivation did not significantly influence the performance in EEG-NFB training, indicating that the type of feedback used may be more critical for success than the participant's motivation level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Four Different EEG-Neurofeedback Reinforcement Types in Healthy Individuals - A Pilot Study. Mergl, R., Karch, S., Henl, J., et al.[2022]

In a study of 20 drug-free patients with mild to moderate depression, both real-time fMRI neurofeedback and cognitive behavioral therapy (CBT) were effective in reducing depressive symptoms, but neurofeedback was not found to be superior to CBT.

The neurofeedback group showed a continuous improvement in self-regulation skills over the treatment sessions, indicating a potential learning effect, while a trend suggested that CBT might lead to greater overall improvement in depression symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time fMRI neurofeedback compared to cognitive behavioral therapy in a pilot study for the treatment of mild and moderate depression. Mel'nikov, MY., Bezmaternykh, DD., Savelov, AA., et al.[2023]

In a study of 24 adults with treatment-resistant depression (TRD), neurofeedback training combined with medication significantly reduced depressive symptoms and improved functional recovery over 12 weeks, with response and remission rates of 58.3% and 50.0%, respectively.

The neurofeedback group showed greater improvements in depression scores and quality of life compared to the medication-only group, suggesting that neurofeedback may be an effective augmentation treatment for TRD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback Treatment on Depressive Symptoms and Functional Recovery in Treatment-Resistant Patients with Major Depressive Disorder: an Open-Label Pilot Study. Lee, YJ., Lee, GW., Seo, WS., et al.[2020]

The study will investigate the efficacy of standardized low-resolution electromagnetic tomography (sLORETA) neurofeedback targeting key brain networks in 60 participants with internalizing disorders (IDs) over 4 weeks, aiming to improve symptoms and restore normal brain function.

Participants will be randomly assigned to different training groups, including genuine neurofeedback and sham training, with outcomes measured through patient-reported outcomes and neurophysiological assessments, providing insights into the relationship between brain activity and symptom changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infraslow closed-loop brain training for anxiety and depression (ISAD): a protocol for a randomized, double-blind, sham-controlled pilot trial in adult females with internalizing disorders. Perez, TM., Glue, P., Adhia, DB., et al.[2022]

In a study involving 23 patients with comorbid major depressive disorder and anxiety, a high beta down-training neurofeedback protocol effectively reduced high beta activity in the brain, which was associated with decreased severity of cognitive depression.

The training showed positive results across multiple sessions, confirming that the neurofeedback approach is trainable and can lead to meaningful changes in brain activity related to emotional regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The learning effects and curves during high beta down-training neurofeedback for patients with major depressive disorder. Chen, TC., Lin, IM.[2021]

A study involving 608 participants across 28 experiments found that including a pre-training no-feedback run significantly improves neurofeedback performance, likely by helping participants become familiar with the setup and tasks.

Patients showed better neurofeedback performance than healthy participants, possibly due to higher motivation and the need to regulate dysfunctional brain signals, suggesting that tailoring neurofeedback interventions for clinical populations could enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of real-time fMRI neurofeedback performance and improvement - A machine learning mega-analysis. Haugg, A., Renz, FM., Nicholson, AA., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06675240

Meditative Neurofeedback for Depression (MediNF) Study Overview​​ The goal of this open-label single-arm study is to test whether a 10-session meditative neurofeedback intervention significantly alleviates ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10356125/

Effects of neurofeedback on major depressive disorder Neurofeedback can reduce depression symptoms in patients; however, not all patients respond to the treatment.

3. withpower.com withpower.com/trial/phase-depression-10-2024-3611c

Meditative Neurofeedback for Depression (MediNF Trial) Neurofeedback training significantly improved working memory performance and processing speed in patients with major depressive disorder (MDD), as evidenced by ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12264674/

Effectiveness of fMRI-based Neurofeedback Therapy on ... At the 4-week follow-up, 75% of individuals with depression reported effectively applying the strategies they had learned to their daily lives, while 55% ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S092549272300001X

Review of EEG-based neurofeedback as a therapeutic ... Patients with depression have shown significant cognitive, clinical and neural improvements following EEG-NF training. •. EEG-NF training may be an effective ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4892319/

Neurofeedback: A Comprehensive Review on System Design ... Neurofeedback training is used to increase alpha and theta, while inhibit faster beta frequencies, produces significant improvements in depression (Budzynski, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1053811923001465

An investigation of the effectiveness of neurofeedback ... A meta-analysis of neurofeedback training (NFT) in healthy adults showed an overall positive effect on motor performance.

8. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1323485/full

Systematic review and meta-analysis of neurofeedback ... Based on newer published studies and the outcomes measured, NF has demonstrated a clinically meaningful effect size, with an increased effect size at follow-up.