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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06446765
Acronym
MIND-BPD
Enrollment
150
Registered
2024-06-06
Start date
2025-03-13
Completion date
2026-10-30
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder

Keywords

fMRI neurofeedback, mindfulness

Brief 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).

Detailed description

The focus of this study is Aim 1.

Interventions

BEHAVIORALmindfulness-based Neurofeedback

Participants will complete one session of mindfulness-based fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group.

OTHERcontrol Neurofeedback

Participants will complete one session of control fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group.

Sponsors

Yale University
Lead SponsorOTHER
Connecticut Mental Health Center
CollaboratorUNKNOWN
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 dayDefined 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 neurofeedbackFrom baseline (immediately before neurofeedback) to immediately after neurofeedback on the same dayDefined 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

MeasureTime frameDescription
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 dayThe 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).

Countries

United States

Contacts

CONTACTSarah K Fineberg, MD PhD
sarah.fineberg@yale.edu203-974-7265
PRINCIPAL_INVESTIGATORSarah K Fineberg, MD PhD

Yale University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026