Recruiting
Phase 2

Mindfulness-Based Neurofeedback

Sponsor:

Yale University

Code:

NCT06446765

Conditions

Borderline Personality Disorder

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

mindfulness-based Neurofeedback

control Neurofeedback

Study Details

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).

Conditions

Borderline Personality Disorder

Study ID

NCT06446765

Start date

Mar 13, 2025

Status verified date

Jun, 2026

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

mindfulness-based Neurofeedback

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

control Neurofeedback

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

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Sarah K Fineberg, MD PhD

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

Locations

Connecticut Mental Health Center

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Sarah K Fineberg, MD/PhD

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

More Information

Sponsor

Yale University

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • fMRI neurofeedback
  • mindfulness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-09.