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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Mindfulness-Based Neurofeedback for Depression?

Research shows that real-time fMRI neurofeedback can help people with depression by teaching them to control brain areas linked to positive emotions, leading to improved symptoms. Additionally, mindfulness-based neurofeedback has been shown to reduce depressive symptoms by helping individuals manage brain networks involved in rumination and emotional regulation. ^{1 2 3 4 5}

Is mindfulness-based fMRI neurofeedback safe for humans?

Mindfulness-based fMRI neurofeedback has been studied in both healthy individuals and those with depression, showing it to be a non-invasive approach with no reported safety concerns in the studies reviewed. It involves using brain imaging to provide feedback, helping participants regulate brain activity, and has been tested in adolescents and adults without adverse effects. ^{1 2 3 5 6}

How is the treatment Mindfulness-Based Neurofeedback for Depression different from other treatments for depression?

Mindfulness-Based Neurofeedback for Depression is unique because it uses real-time brain imaging to help patients learn to regulate specific brain networks associated with depression, such as the default mode network, through mindfulness meditation. This approach is non-invasive and targets the neural mechanisms underlying depressive symptoms, which is different from traditional drug or talk therapies. ^{2 3 5 6 7}

Eligibility Criteria

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 am between 13 and 18 years old.

I have been diagnosed with major depressive disorder.

Exclusion Criteria

MRI contraindications

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

I have a history of seizures.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

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

Mediation analysis of triple networks revealed functional feature of mindfulness from real-time fMRI neurofeedback. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based real-time fMRI neurofeedback: a randomized controlled trial to optimize dosing for depressed adolescents. [2023]

4. Switzerland 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. [2022]

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

Real-time self-regulation of emotion networks in patients with depression. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Reducing default mode network connectivity with mindfulness-based fMRI neurofeedback: a pilot study among adolescents with affective disorder history. [2023]

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

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