Mindfulness-Based Neurofeedback for Depression

(mbNF Trial)

Recruiting at 2 trial locations

Overseen By Emma Wool, BA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must be taking: Antidepressants

Must not be taking: Psychotropics

Disqualifiers: Psychotic disorders, Bipolar, Substance use, others

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

Compensation: Varies

Number of Visits: 9

Duration: 1 session

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help adolescents with major depression by targeting rumination, a thought pattern that can worsen the condition. It combines fMRI neurofeedback—a high-tech brain training therapy that displays real-time brain activity—with mindfulness training to alter the involved brain circuits. Participants will engage in either a 15-minute or 30-minute mindfulness-based session. Teens aged 13-18 who are fluent in English and currently experiencing major depression may be suitable candidates, particularly if they have noticed persistent negative thinking. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could lead to new treatment approaches.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does allow the use of antidepressant medication. Other psychotropic medications are not allowed.

What prior data suggests that this mindfulness-based neurofeedback intervention is safe for adolescents with depression?

Research shows that fMRI neurofeedback, like the kind used in this study, is generally safe. Previous studies on this treatment for depression indicate a good safety record, with few reports of serious side effects. The treatment uses brain scans to guide mental exercises and is non-invasive, avoiding surgery or entering the body.

fMRI neurofeedback has been extensively studied for depression. It has been shown to help reduce symptoms without causing significant harm to participants. Other research indicates that people tolerate this treatment well, and it is safer than some alternatives. While every treatment carries risks, past studies suggest that fMRI neurofeedback is a safe choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about mindfulness-based neurofeedback (mbNF) for depression because it offers a unique combination of mindfulness training with real-time brain feedback using fMRI technology. Unlike typical treatments like antidepressants or talk therapy, mbNF allows patients to see and control their brain activity, potentially leading to faster and more personalized results. The trial explores two distinct approaches: a 15-minute session and a more intensive 30-minute session, which could reveal the optimal duration needed for effective treatment. This innovative method could open new doors for depression management by directly engaging the brain's activity in real time.

What evidence suggests that this neurofeedback technique is effective for depression?

Research has shown that fMRI neurofeedback can help with depression, particularly for those who don't respond well to other treatments. This method changes brain function by adjusting activity in key areas like the insula, which is linked to emotions and self-awareness. Early findings suggest that real-time neurofeedback reduces repetitive negative thinking, a major factor in depression. A review of previous studies shows that this treatment is generally safe and can significantly reduce symptoms in people with depression. In this trial, participants will receive either a 15-minute or a 30-minute session of mindfulness-based neurofeedback (mbNF) alongside mindfulness training. Overall, fMRI neurofeedback appears promising for improving mental health by directly affecting brain function. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

English fluency

I have been diagnosed with major depressive disorder.

I have given my consent, or if under 18, I and my guardian have consented.

Exclusion Criteria

MRI contraindications

I am taking medication for mental health that is not an antidepressant.

I have a history of seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mindfulness Training

Participants complete a ~45-minute mindfulness training outside the MRI scanner

1 session

1 visit (in-person)

Treatment

Participants receive mindfulness-based real-time fMRI neurofeedback (mbNF) with either a 15-minute or 30-minute session

1 session

1 visit (in-person)

Follow-up

Participants are monitored for changes in depression and rumination symptoms post-treatment

1 month

Ecological momentary assessment over a 7-day period

What Are the Treatments Tested in This Trial?

Interventions

• fMRI Neurofeedback

Trial Overview 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.

How Is the Trial Designed?

Group I: 15-Minute mbNF Active Control 1 Intervention

Participants receiving mindfulness training and 15-minute session of mbNF

Group II: 30-Minute mbNF Active Control 1 Intervention

Participants receiving mindfulness training and 30-minute session of mbNF

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Northeastern University

Collaborator

Trials

103

Recruited

72,600+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A proof-of-concept study involving 9 adolescents with a history of depression or anxiety showed that mindfulness-based fMRI neurofeedback (mbNF) can effectively reduce hyperconnectivity in the default mode network (DMN), which is linked to depressive symptoms.

Participants who engaged in mbNF demonstrated significant reductions in DMN connectivity, which correlated with increased mindfulness, suggesting that this intervention may help modulate brain networks associated with depression in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing default mode network connectivity with mindfulness-based fMRI neurofeedback: a pilot study among adolescents with affective disorder history. Zhang, J., Raya, J., Morfini, F., et al.[2023]

This study found that the connection between the salience network (SN) and the default-mode network (DMN), mediated by the central executive network (CEN), is linked to mindfulness levels in participants, indicating a potential neural feature of mindfulness.

Real-time functional MRI neurofeedback (rtfMRI-NF) training significantly enhanced this connection in participants who received contingent feedback based on their own brain activity, suggesting that rtfMRI-NF can be an effective tool for improving mindfulness through targeted brain network engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediation analysis of triple networks revealed functional feature of mindfulness from real-time fMRI neurofeedback. Kim, HC., Tegethoff, M., Meinlschmidt, G., et al.[2019]

This study involves 90 adolescents aged 13-18 with Major Depressive Disorder (MDD) to test mindfulness-based real-time fMRI neurofeedback (mbNF) as a new treatment to reduce depressive symptoms by targeting the default mode network (DMN).

The research aims to determine if mbNF can effectively decrease functional connectivity within the DMN, with a focus on comparing the effects of 15 vs. 30 minutes of neurofeedback, potentially leading to better treatment options for adolescents with MDD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based real-time fMRI neurofeedback: a randomized controlled trial to optimize dosing for depressed adolescents. Bloom, PA., Pagliaccio, D., Zhang, J., et al.[2023]

Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-NF) shows a medium-sized effect on neural activity during training and a large effect on neural activity after training, indicating its potential to influence brain function in psychiatric disorders.

Behavioral outcomes from rtfMRI-NF, such as symptom reduction, show a small effect size, suggesting that while rtfMRI-NF can impact brain activity, its effects on behavior may be less pronounced and require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of real-time functional magnetic resonance imaging neurofeedback for psychiatric illness: A meta-analysis of brain and behavioral outcomes. Dudek, E., Dodell-Feder, D.[2022]

In a proof-of-concept study involving eight patients with depression, those who used fMRI-based neurofeedback to enhance brain activity in areas linked to positive emotions showed significant improvement in their depression symptoms, as measured by the Hamilton Rating Scale for Depression.

A control group that practiced the same cognitive strategies without neurofeedback did not experience any clinical improvement, suggesting that the neurofeedback technique may be a promising new approach for enhancing treatment outcomes in depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time self-regulation of emotion networks in patients with depression. Linden, DE., Habes, I., Johnston, SJ., et al.[2022]

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]

A real-time fMRI neurofeedback system was developed to help patients with depression achieve a 'happiness emotional brain state' by training them to match their neural activity to that of a healthy participant, showing improvements in classifier accuracy and clinical symptoms after 4 training sessions over 2 weeks.

Seven female patients with mild to moderate depression experienced significant clinical improvements, as measured by standardized evaluations and self-reports, which persisted even 10 days after the intervention, indicating potential for this noninvasive approach in treating depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A real-time fMRI neurofeedback system for the clinical alleviation of depression with a subject-independent classification of brain states: A proof of principle study. Pereira, JA., Ray, A., Rana, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10580563/

Mindfulness-based real-time fMRI neurofeedback Preliminary results from a recent proof-of-concept trial suggest reduced rumination among depressed adults following real-time neurofeedback targeting PCC ...

2. nature.com nature.com/articles/s41398-025-03382-8

a systematic review of real-time fMRI neurofeedback ... We found that rtfMRI-based NF training is efficient for modulating insula activity and its associated behavioral/symptom-related and neural changes.

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

Effectiveness of fMRI-based Neurofeedback Therapy on ... This systematic review explores the efficacy of fMRI-based neurofeedback as an alternative treatment for individuals with depression who do not respond well ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1388245724002888

fMRI neurofeedback for the modulation of the neural ... fMRI neurofeedback shows promise as a modulatory technique for depression, with the potential to induce significant changes in neural activity and connectivity ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05640089

NCT05640089 | FMRI-neurofeedback in Depression Previous studies with fMRI-neurofeedback in depression have demonstrated a good safety profile and considerable symptom reduction. The goal of this clinical ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37848857/

Mindfulness-based real-time fMRI neurofeedback - PubMed Mindfulness-based real-time fMRI neurofeedback: a randomized controlled trial to optimize dosing for depressed adolescents · Abstract.

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A systematic review of fMRI neurofeedback reporting and ... Depression is the most investigated disorder in the field of fMRI neurofeedback, followed by addiction and neurodegenerative disorders. B) Registered clinical ...

8. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.231143

Functional MRI Neurofeedback Outperforms Cognitive ... Real-time fMRI neurofeedback therapy led to a greater reduction in tinnitus distress than the current standard treatment of CBT.