Mindfulness-Based Neurofeedback for Borderline Personality Disorder

(MIND-BPD Trial)

Overseen By Sarah K Fineberg, MD PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must not be taking: Benzodiazepines, Opiates

Disqualifiers: Psychotic disorder, Bipolar I, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 20 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Sarah K Fineberg, MD PhD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adults with Borderline Personality Disorder (BPD) who are seeking to enhance their psychotherapy outcomes. Specific eligibility criteria details were not provided, so interested individuals should contact the study organizers for more information.

Inclusion Criteria

Meets criteria for BPD on semi-structured clinical interview

I can keep my current medications and therapy stable during the study.

Able to provide written informed consent

Exclusion Criteria

I am not taking any sedatives like benzodiazepines or opiates during the day.

History of major medical or neurologic disorder

Active suicidal ideation with intent or plan in the past 3 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neurofeedback Session

Participants undergo one session of mindfulness-based or control fMRI neurofeedback

1 day

1 visit (in-person)

Treatment

Participants engage in 20 weeks of remote online weekly Dialectical Behavior Therapy skills group

20 weeks

Follow-up

Participants are monitored for changes in functional connectivity and mindfulness immediately after neurofeedback

1 day

Treatment Details

Interventions

• Mindfulness-based Neurofeedback

Trial Overview The trial is examining if mindfulness-based real-time fMRI neurofeedback (mbNF) can improve the effectiveness of established psychotherapy methods for BPD compared to a control neurofeedback.

Participant Groups

Group I: mindfulness-based Neurofeedback Experimental Treatment 1 Intervention

Participants will participate in one session of mindfulness-based fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.

Group II: control Neurofeedback Experimental Treatment 1 Intervention

Participants will participate in one session of control fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Connecticut Mental Health Center

Collaborator

Trials

2

Recruited

160+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+