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NCT Number: NCT06446765

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

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location status: Recruiting

Location contact

Sarah K Fineberg, MD/PhD

CONTACT

[email protected]

203-974-7265

About this study

The focus of this study is Aim 1.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah K Fineberg, MD PhD

CONTACT

[email protected]

203-974-7265

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: MIND-BPD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2024
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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