Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
NCT ID: NCT06446765
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2025-03-13
2026-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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 participate in one session of control fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.
control Neurofeedback
Participants will complete one session of control fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* lifetime primary psychotic disorder or Bipolar I disorder
* developmental disorder (e.g. autism)
* history of learning disorder
* moderate or severe substance use disorder in the last 6 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.
18 Years
60 Years
ALL
No
Sponsors
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Connecticut Mental Health Center
UNKNOWN
National Institute of Mental Health (NIMH)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Sarah K Fineberg, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Connecticut Mental Health Center
New Haven, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2000037582
Identifier Type: -
Identifier Source: org_study_id
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