RecruitingPhase 2

Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder

United States150 participantsStarted 2025-03-13

Plain-language summary

The purpose of this study is to test the ability of mindfulness-based real time functional magnetic resonance imaging (fMRI) neurofeedback (mbNF) to increase the benefits of evidence-based psychotherapy for adults with Borderline Personality Disorder (BPD).

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * age 18-60, * be able to provide written informed consent, * meet criteria for BPD on semi-structured clinical interview, * able to plan to keep any prescribed medications and psychotherapy constant during the study * fluent in English. Exclusion criteria: * current DBT psychotherapy outside the study * lifetime primary psychotic disorder * manic episode in the last one year * developmental disorder (e.g. autism) * history of learning disorder * severe substance use disorder in the last 3 months * active suicidal ideation with intent or plan in the past 3 months * history of major medical or neurologic disorder * MRI contraindications, including pregnancy * poor performance on reading task (WRAT \> 11 errors) * newly prescribed medications in the past 8 weeks * daytime sedating medications (e.g. benzodiazepines, opiates, sedating neuroleptics) * any scheduled daily benzodiazepines * change in psychotherapy type or frequency in the past 12 weeks. * At the discretion of the study PI Eligibility will be determined by study personnel.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in within-Default Mode Network (DMN) resting state functional connectivity after one session of neurofeedback (NF)

Timeframe: From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day

Change in DMN-Frontoparietal Control Network (FPCN) anticorrelation in resting state functional connectivity data after one session of neurofeedback

Timeframe: From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day

Trial details

NCT IDNCT06446765

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-30

Contact for this trial

Sarah K Fineberg, MD PhD

203-974-7265 sarah.fineberg@yale.edu

View on ClinicalTrials.gov More Borderline Personality Disorder trials

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in within-Default Mode Network (DMN) resting state functional connectivity after one session of neurofeedback (NF)

Timeframe: From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day

Change in DMN-Frontoparietal Control Network (FPCN) anticorrelation in resting state functional connectivity data after one session of neurofeedback

Timeframe: From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day