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

NCT06446765 — Phase 2, Active not recruiting, 46 participants, Yale University

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Mindfulness-based Neurofeedback to Augment Dialectical Behavior Therapy (DBT) for Adults With Borderline Personality Disorder (Aim 1)

RegistryNCT06446765, acronym MIND-BPD
StatusActive not recruiting
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment46 (Actual)
SponsorYale University (Other); collaborators: Connecticut Mental Health Center, National Institute of Mental Health (NIMH)
ConditionsBorderline Personality Disorder
Interventionsmindfulness-based Neurofeedback, control Neurofeedback (Behavioral, other)
Datesstart 2025-03-13, primary completion 2026-07-14, completion 2027-03-30 (estimated), first posted 2024-06-06, last updated 2026-10-19
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Borderline Personality Disorder All trials of mindfulness-based Neurofeedback All trials of control Neurofeedback

-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).

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+Detailed description

The focus of this study is Aim 1.

+Arms and interventions

ArmTypeInterventionsDescription
mindfulness-based NeurofeedbackExperimentalBehavioral: mindfulness-based NeurofeedbackParticipants will participate in one session of mindfulness-based fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.
control NeurofeedbackOtherOther: control NeurofeedbackParticipants will participate in one session of control fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.
  • mindfulness-based Neurofeedback (Behavioral): Participants will complete one session of mindfulness-based fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group.
  • control Neurofeedback (Other): Participants will complete one session of control fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group.

+Outcome measures

Primary outcomes

  • Change in within-Default Mode Network (DMN) resting state functional connectivity after one session of neurofeedback (NF) [From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day]: Defined as within-DMN connectivity as the resting state seed-based connectivity between core nodes of medial prefrontal cortex (mPFC) and posterior cingulate cortex (PCC). Change = post-NF within-DMN connectivity - pre-NF within-DMN connectivity.
  • Change in DMN-Frontoparietal Control Network (FPCN) anticorrelation in resting state functional connectivity data after one session of neurofeedback [From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day]: Defined as DMN-FPCN anticorrelation as the fMRI seed-based connectivity from mPFC to dorsolateral prefrontal cortex (dlPFC)). Change = post-NF mPFC-dlPFC anticorrelation - pre-NF mPFC-dlPFC anticorrelation

Secondary outcomes

  • Change from baseline in state mindfulness on State Mindfulness Scale (SMS) score on same day after neurofeedback. [From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day]: The State Mindfulness Scale (SMS) is a validated self-reported 21 item instrument assessing state mindfulness over the past 15 minutes. Possible scores range from 21 (not mindful) to 105 (very mindful).

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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.

+Locations (1)

FacilityCityCountryStatus
Connecticut Mental Health CenterNew Haven, ConnecticutUnited States

+Publications

  • Results publication: Jones KG, Vandewouw MM, Awasthi J, Alario AA, Bauer C, Brewer B, Campbell NA, Denning D, Greene KD, Hammoud J, Hinds O, Huffman S, Maerker C, Paprotna S, Qiu M, Swinchoski B, Taylor A, Waite E, Wighton P, Whaley M, Papa J, Dixon-Gordon K, Hampson M, Whitfield-Gabrieli S, Fineberg SK. A protocol for MIndfulness-based Neurofeedback to augment DBT psychotherapy for adults with Borderline Personality Disorder (MIND-BPD). PLoS One. 2026 Mar 20;21(3):e0338002. doi: 10.1371/journal.pone.0338002. eCollection 2026. PMID 41860884
  • Results publication: Jones KG, Vandewouw MM, Awasthi J, Alario AA, Bauer C, Brewer B, Campbell N, Denning D, Greene KD, Hammoud J, Hinds O, Huffman S, Maerker C, Paprotna S, Qiu M, Swinchoski B, Taylor A, Waite E, Wighton P, Whaley M, Papa J, Gordon KD, Hampson M, Whitfield-Gabrieli S, Fineberg SK. A protocol for MIndfulness-based Neurofeedback to augment DBT psychotherapy for adults with Borderline Personality Disorder (MIND-BPD). medRxiv [Preprint]. 2025 Nov 19:2025.11.18.25340531. doi: 10.1101/2025.11.18.25340531. PMID 41332880

+Investigators

+Funding

NIH grants: R61MH135009