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

Trial Summary

What is the purpose of this trial?

The goal of this open-label single-arm study is to test a meditative neurofeedback intervention for depressed mood.

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 data supports the effectiveness of the treatment MediNF, Meditative Neurofeedback, for depression?

Research shows that neurofeedback, a key component of MediNF, can help reduce depressive symptoms and improve self-regulation skills in patients with depression. Studies have demonstrated that neurofeedback can lead to improvements in behavior and clinical symptoms, suggesting its potential as an effective treatment for depression. ^{1 2 3 4 5}

Is Meditative Neurofeedback safe for humans?

Research on neurofeedback, including Meditative Neurofeedback, suggests it is generally safe for humans, with studies showing it can be used without serious side effects in treating conditions like depression and anxiety. ^{1 5 6 7 8}

How is the Meditative Neurofeedback treatment different from other depression treatments?

Meditative Neurofeedback (MediNF) is unique because it combines neurofeedback, which uses brain activity monitoring to help patients learn self-regulation, with meditation techniques to address depression. Unlike traditional medication or talk therapy, this treatment focuses on training the brain to change its activity patterns through real-time feedback and meditation, potentially offering a non-invasive and drug-free option for managing depressive symptoms. ^{1 2 9 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

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 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]

References

1. Korea (South) 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of Four Different EEG-Neurofeedback Reinforcement Types in Healthy Individuals - A Pilot Study. [2022]

3. Germany 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Predictors of real-time fMRI neurofeedback performance and improvement - A machine learning mega-analysis. [2021]

5. United States 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. [2022]

6. England 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. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Neurofeedback training in major depressive disorder: A systematic review of clinical efficacy, study quality and reporting practices. [2021]

9. England pubmed.ncbi.nlm.nih.gov

A new neurofeedback protocol for depression. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Clinical Application of Real-Time fMRI-Based Neurofeedback for Depression. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

A controlled study on the cognitive effect of alpha neurofeedback training in patients with major depressive disorder. [2022]