Borderline Personality DisorderPhase 2MIND-BPDNCT06446765
Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
A Phase 2 study testing mindfulness-based Neurofeedback in people with Borderline Personality Disorder, run by Yale University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- mindfulness-based Neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2025to 30 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
Official title: Mindfulness-based Neurofeedback to Augment Dialectical Behavior Therapy (DBT) for Adults With Borderline Personality Disorder (Aim 1)
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).
Read the detailed description
The focus of this study is Aim 1.
- Conditions
- Borderline Personality Disorder
- Being tested
- mindfulness-based Neurofeedback, control Neurofeedback
- Keywords
- fMRI neurofeedback, mindfulness
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based NeurofeedbackBehavioural
Participants will complete one session of mindfulness-based fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group.
control NeurofeedbackOther
Participants will complete one session of control fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group.
| Study group | Role | What they receive |
|---|---|---|
| mindfulness-based Neurofeedback | Experimental | Participants will participate in one session of mindfulness-based fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group. Receives: Behavioral: mindfulness-based Neurofeedback |
| control Neurofeedback | Other | Participants will participate in one session of control fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group. Receives: Other: control Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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).
Measured: From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start13 Mar 2025
- Primary completion14 Jul 2026
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Connecticut Mental Health Center, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sarah K Fineberg, MD PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446765
- Sponsor's protocol ID
- 2000037582
- Other IDs
- 1R61MH135009-01A1
- Acronym
- MIND-BPD
- Status last verified
- Oct 2026
- First submitted
- 30 May 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Sharing will occur as required by NIMH through the National Data Archive.
Publications
Jones KG, Vandewouw MM, Awasthi J, Alario AA, Bauer C, Brewer B, Campbell NA, Denning D, Greene KD, Hammoud J, Hinds O, Huffman S, Maerker C, Paprotna S, Qiu M, Swinchoski B, Taylor A, Waite E, Wighton P, Whaley M, Papa J, Dixon-Gordon K, Hampson M, Whitfield-Gabrieli S, Fineberg SK. A protocol for MIndfulness-based Neurofeedback to augment DBT psychotherapy for adults with Borderline Personality Disorder (MIND-BPD). PLoS One. 2026 Mar 20;21(3):e0338002. doi: 10.1371/journal.pone.0338002. eCollection 2026.
PubMed 41860884Jones KG, Vandewouw MM, Awasthi J, Alario AA, Bauer C, Brewer B, Campbell N, Denning D, Greene KD, Hammoud J, Hinds O, Huffman S, Maerker C, Paprotna S, Qiu M, Swinchoski B, Taylor A, Waite E, Wighton P, Whaley M, Papa J, Gordon KD, Hampson M, Whitfield-Gabrieli S, Fineberg SK. A protocol for MIndfulness-based Neurofeedback to augment DBT psychotherapy for adults with Borderline Personality Disorder (MIND-BPD). medRxiv [Preprint]. 2025 Nov 19:2025.11.18.25340531. doi: 10.1101/2025.11.18.25340531.
PubMed 41332880
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Neurofeedback to Augment Dialectical Behavior Therapy (DBT) for Adults With Borderline Personality Disorder (Aim 1)
- ClinicalTrials.gov ID
- NCT06446765
- Acronym / sponsor ID
- MIND-BPD / 2000037582
- Conditions
- Borderline Personality Disorder
- Keywords
- fMRI neurofeedback, mindfulness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Connecticut Mental Health Center, National Institute of Mental Health (NIMH)
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 14 Jul 2026 (actual)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The focus of this study is Aim 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mindfulness-based Neurofeedback | Experimental | Behavioral: mindfulness-based NeurofeedbackParticipants will participate in one session of mindfulness-based fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group. |
| control Neurofeedback | Other | Other: control NeurofeedbackParticipants will participate in one session of control fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness-based NeurofeedbackParticipants will complete one session of mindfulness-based fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group. | Behavioural | mindfulness-based Neurofeedback |
| control NeurofeedbackParticipants will complete one session of control fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group. | Other | control Neurofeedback |
Primary outcome
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.
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Derived from this study: PubMed 41860884Jones KG, Vandewouw MM, Awasthi J, Alario AA, Bauer C, Brewer B, Campbell NA, Denning D, Greene KD, Hammoud J, Hinds O, Huffman S, Maerker C, Paprotna S, Qiu M, Swinchoski B, Taylor A, Waite E, Wighton P, Whaley M, Papa J, Dixon-Gordon K, Hampson M, Whitfield-Gabrieli S, Fineberg SK. A protocol for MIndfulness-based Neurofeedback to augment DBT psychotherapy for adults with Borderline Personality Disorder (MIND-BPD). PLoS One. 2026 Mar 20;21(3):e0338002. doi: 10.1371/journal.pone.0338002. eCollection 2026.
- Derived from this study: PubMed 41332880Jones KG, Vandewouw MM, Awasthi J, Alario AA, Bauer C, Brewer B, Campbell N, Denning D, Greene KD, Hammoud J, Hinds O, Huffman S, Maerker C, Paprotna S, Qiu M, Swinchoski B, Taylor A, Waite E, Wighton P, Whaley M, Papa J, Gordon KD, Hampson M, Whitfield-Gabrieli S, Fineberg SK. A protocol for MIndfulness-based Neurofeedback to augment DBT psychotherapy for adults with Borderline Personality Disorder (MIND-BPD). medRxiv [Preprint]. 2025 Nov 19:2025.11.18.25340531. doi: 10.1101/2025.11.18.25340531.
- Individual participant dataSharing planned: Yes. Sharing will occur as required by NIMH through the National Data Archive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah K Fineberg, MD PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mindfulness-based Neurofeedback in people with Borderline Personality Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06446765, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.