Mindfulness-Based Neurofeedback for Borderline Personality Disorder

(MIND-BPD Trial)

Overseen By Sarah K Fineberg, MD PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must not be taking: Benzodiazepines, Opiates

Disqualifiers: Psychotic disorder, Bipolar I, Autism, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 20 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mindfulness-based neurofeedback, which uses brain activity to boost mindfulness, can enhance therapy benefits for adults with Borderline Personality Disorder (BPD). Participants will receive a session of real-time brain imaging feedback, followed by 20 weeks of online therapy. The trial includes one group receiving mindfulness-based feedback and another receiving standard feedback for comparison. It is ideal for those diagnosed with BPD who are not currently in DBT therapy and can maintain stable medications and therapy during the study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of potentially effective therapies.

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

No, you don't have to stop taking your current medications, but you need to keep them constant during the study.

What prior data suggests that mindfulness-based neurofeedback is safe for individuals with Borderline Personality Disorder?

Research shows that mindfulness-based neurofeedback is being explored to help people with Borderline Personality Disorder (BPD). This treatment uses real-time brain scans to provide feedback during mindfulness exercises. Studies have found that patients generally receive mindfulness-based methods well.

In other studies on similar neurofeedback techniques, participants reported few side effects. The technology used, such as fMRI (a type of brain scan), is safe and non-invasive. Although the current study is still in progress, past safety records suggest that this treatment is likely low-risk. This is promising for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about mindfulness-based neurofeedback for Borderline Personality Disorder (BPD) because it offers a novel approach by combining mindfulness practices with neurofeedback, potentially altering brain activity patterns associated with BPD. Unlike traditional treatments like Dialectical Behavior Therapy (DBT) alone, this method uniquely integrates real-time brain monitoring to enhance self-regulation skills. This innovative approach aims to provide more immediate and lasting improvements in emotional regulation and interpersonal effectiveness, which are core challenges for individuals with BPD.

What evidence suggests that mindfulness-based neurofeedback is effective for Borderline Personality Disorder?

Research has shown that mindfulness training is an important part of Dialectical Behavior Therapy (DBT), one of the best treatments for Borderline Personality Disorder (BPD). In this trial, participants will receive either Mindfulness-based Neurofeedback (mbNF) or control Neurofeedback. Mindfulness-based Neurofeedback builds on mindfulness by using real-time brain feedback to potentially enhance the benefits of DBT. Early studies suggest it may help people with BPD by improving emotional control and reducing symptoms. Although specific data on mbNF's effectiveness for BPD is limited, its foundation in proven mindfulness techniques supports its potential. Researchers are currently studying this method to determine if it can improve therapy outcomes for people with BPD. ^{1 2 4 5 6}

Who Is on the Research Team?

Sarah K Fineberg, MD PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults with Borderline Personality Disorder (BPD) who are seeking to enhance their psychotherapy outcomes. Specific eligibility criteria details were not provided, so interested individuals should contact the study organizers for more information.

Inclusion Criteria

Meets criteria for BPD on semi-structured clinical interview

Able to provide written informed consent

Fluent in English

Exclusion Criteria

I am not taking any sedatives like benzodiazepines or opiates during the day.

Current DBT psychotherapy outside the study

Lifetime primary psychotic disorder or Bipolar I disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neurofeedback Session

Participants undergo one session of mindfulness-based or control fMRI neurofeedback

1 day

1 visit (in-person)

Treatment

Participants engage in 20 weeks of remote online weekly Dialectical Behavior Therapy skills group

20 weeks

Follow-up

Participants are monitored for changes in functional connectivity and mindfulness immediately after neurofeedback

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness-based Neurofeedback

Trial Overview The trial is examining if mindfulness-based real-time fMRI neurofeedback (mbNF) can improve the effectiveness of established psychotherapy methods for BPD compared to a control neurofeedback.

How Is the Trial Designed?

Group I: mindfulness-based Neurofeedback Experimental Treatment 1 Intervention

Participants will participate in one session of mindfulness-based fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.

Group II: control Neurofeedback Experimental Treatment 1 Intervention

Participants will participate in one session of control fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Connecticut Mental Health Center

Collaborator

Trials

2

Recruited

160+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06446765

Mindfulness-based Neurofeedback to Augment ... The purpose of this study is to test the ability of mindfulness-based real time functional magnetic resonance imaging (fMRI) neurofeedback (mbNF) to increase ...

2. reporter.nih.gov reporter.nih.gov/project-details/11175460

Project Details Mindfulness training is at the core of one of the best-evidenced BPD treatments, Dialectical Behavior Therapy (DBT), and mediates some of the therapeutic change ...

3. trialx.com trialx.com/clinical-trials/listings/297733/mindfulness-based-neurofeedback-to-augment-psychotherapy-for-adults-with-borderline-personality-disorder/

Mindfulness-based Neurofeedback to Augment ... The purpose of this study is to test the ability of mindfulness-based real time functional magnetic resonance imaging (fMRI) neurofeedback (mbNF) ...

4. withpower.com withpower.com/trial/phase-2-personality-disorders-1-2025-8f8c6

Mindfulness-Based Neurofeedback for Borderline ... The MIND-BPD medical study, being run by Yale University, is evaluating whether Mindfulness-based Neurofeedback will have tolerable side effects & efficacy ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06446765?cond=%22Borderline%20Personality%20Disorder%22&aggFilters=status:not%20rec&rank=8

Mindfulness-based Neurofeedback to Augment ... The purpose of this study is to test the ability of mindfulness-based real time functional magnetic resonance imaging (fMRI) neurofeedback (mbNF) to increase ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10172541/

Biofeedback and Treatment for Borderline Personality Disorder By using biofeedback, individuals with borderline personality disorder may gain skills to increase self-awareness, improve emotion regulation, and enhance ...