Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder (MIND-BPD)

June 8, 2026 updated by: Yale University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The focus of this study is Aim 1.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Connecticut Mental Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mindfulness-based Neurofeedback
Participants will participate in one session of mindfulness-based fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.
Behavioral: mindfulness-based Neurofeedback
Participants will complete one session of mindfulness-based fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group.
Other: control Neurofeedback
Participants will participate in one session of control fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.
Other: control Neurofeedback
Participants will complete one session of control fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in within-Default Mode Network (DMN) resting state functional connectivity after one session of neurofeedback (NF)
Time Frame: 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.
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
Time Frame: 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
From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in state mindfulness on State Mindfulness Scale (SMS) score on same day after neurofeedback.
Time Frame: 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).
From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute of Mental Health (NIMH)
Connecticut Mental Health Center

Investigators

  • Principal Investigator: Sarah K Fineberg, MD PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2025

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000037582
  • 1R61MH135009-01A1 (U.S. NIH Grant/Contract: NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sharing will occur as required by NIMH through the National Data Archive.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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