Health TrialsbyHealthPanel

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

ConditionBorderline Personality Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorYale University

About 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

current DBT psychotherapy outside the study

lifetime primary psychotic disorder

manic episode in the last one year

developmental disorder (e.g. autism)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: mindfulness-based NeurofeedbackExperimental treatment 1 intervention
Group B: control NeurofeedbackOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in within-Default Mode Network (DMN) resting state functional connectivity after one session of neurofeedback (NF)

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.

Time frame
From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day
2

Change in DMN-Frontoparietal Control Network (FPCN) anticorrelation in resting state functional connectivity data after one session of neurofeedback

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

Time frame
From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day

Secondary outcomes

1

Change from baseline in state mindfulness on State Mindfulness Scale (SMS) score on same day after neurofeedback.

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).

Time frame
From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Connecticut Mental Health Center

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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