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Borderline Personality DisorderNeuroDBTNCT06882330

Neural Mechanisms of Dialectical Behavioral Therapy in Patients with Borderline Personality Disorder

A study testing Dialectical behavior therapy in people with Borderline Personality Disorder, run by Masarykova Univerzita at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research examines the behavioral and neural mechanisms of dialectical behavior therapy (DBT) effect in patients with borderline personality disorder (BPD). Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Borderline Personality Disorder
What is being tested?
Dialectical behavior therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteCzechia
Study dates
27 Aug 2020to 15 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

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 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • diagnosis of borderline personality disorder according to Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria (rated by Structured Clinical Interview for DSM-5 for Personality Disorders, BPD section)
  • minimum age 16, informed consent of the patient
  • informed consent of patient's legal representative in case of patients under age 18
  • more than one self-injury incident and/or suicidal attempt in the past six months
  • diagnosis of borderline personality disorder according to Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria (rated by Structured Clinical Interview for DSM-5 for Personality Disorders, BPD section)
  • minimum age 16, informed consent of the patient
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  • informed consent of patient's legal representative in case of patients under age 18
  • more than one self-injury incident and/or suicidal attempt in the past six months
  • minimum age 16, informed consent of the patient
  • informed consent of patient's legal representative in case of patients under age 18

Who cannot join

  • neurological disorder
  • comorbid affective disorder or schizophrenia-related disorder
  • intelligence quotient<70
  • contraindications for MRI measurement
  • pregnancy
  • body mass index under 15
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  • BPD-C group:
  • completing a DBT program or attending DBT-based therapy
  • neurological disorder
  • comorbid affective disorder or schizophrenia-related disorder
  • intelligence quotient<70
  • contraindications for MRI measurement
  • pregnancy
  • body mass index under 15
  • HC group:
  • mental health problems
  • history of self-injury or/and suicidal attempt
  • neurological disorder
  • intelligence quotient<70
  • contraindications for MRI measurement
  • pregnancy
  • body mass index under 15

Trial locations and contacts

1 site in 1 country.

Czechia1 site
  • University Hospital Brno and Faculty of Medicine, Masaryk University

    Brno, Czech Republic, 62500

Other trials in Czechia

About this study

This research examines the behavioral and neural mechanisms of dialectical behavior therapy (DBT) effect in patients with borderline personality disorder (BPD).

Read the detailed description

This project aims to evaluate the behavioral and neural mechanisms of dialectical behavior therapy (DBT) effect in patients with borderline personality disorder (BPD). The project includes three subject groups: patients with BPD undergoing the DBT program (BPD-DBT), control patients with BPD on the waiting list for the program (BPD-control), and healthy controls (HC). Patients in the BPD-DBT group undergo a 24-week DBT program in an outpatient setting. All participants undergo a test battery comprising of self-report measures, clinical evaluation and fMRI and EEG measurement in the week before the DBT program beginning (T1), after 24 weeks (follow-up, T3), and at 24 weeks after T3 (follow-up, T4). The BPD-DBT group undergoes another assessment at T2 (after 12 weeks) to monitor selected symptoms during the DBT program by a short set of questionnaires.

Being tested
Dialectical behavior therapy
Keywords
Dialectical behavior therapy, Borderline personality disorder, Therapy effectiveness
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.

  • Dialectical behavior therapyBehavioural

    A complex psychotherapy program for patients with borderline personality disorder.

Study groups in NCT06882330
Study groupRoleWhat they receive
BPD-DBT group - patients undergoing DBT program.ExperimentalPatients with BPD undergoing Dialectical behavioral therapy (DBT) program with all the standard DBT modules (individual therapy 1 hour per week, skill groups 1.5 hours twice per week, phone coaching as needed, and consultation team 1.5 hours per week). The program lasts a total of 24 weeks in total including two 12-week runs of skills training. Four individual pretreatment sessions precede the program before the start of the main program part.
Receives: Behavioral: Dialectical behavior therapy
BPD-C group - patients undergoing treatment as usual (TAU)No interventionPatients with BPD who are on the waiting list and who receive treatment as usual (typically standard individual psychotherapy not specifically focused on BPD treatment and/or psychiatric treatment).
HC group: healthy controlsNo interventionHealthy controls matched to the BPD-DBT group for age and education. Participants without mental health problems and/or a history of self-harm or suicidal behavior. This group receives no psychotherapy or psychiatric treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decrease of borderline symptoms

    significant decrease of symptoms measured by Borderline Symptoms List-23

    Measured: From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).

  2. Decrease of self-injury incidents and suicidal attempts

    significant decrease of self-injury incidents and suicidal attempts assessed by semi-structured interview Lifetime - Suicide Attempt Self-Injury Count

    Measured: From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.

Secondary outcomes (16)
  1. Decrease in the number of days spent in the hospital

    significant decrease of days spent in the hospital assessed by semi-structured interview -Treatment History Interview

    Measured: From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.

  2. Ecological momentary assessment of emotional variability

    EMA assesses respondents' emotions in their natural environment. They complete short questionnaires every hour from 9 AM to 9 PM for two days. First, they rate their ability to identify their current emotion (0-100). Then, they choose an emotion or select "An emotion I cannot name" / "No emotion." Next, they rate its intensity (0-100). Finally, they rate their control over the emotion and how overwhelming it feels (both 0-100).

    Measured: From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.

  3. Increase in reasons for living

    significant increase in reasons for living measured by Brief Reasons for Living Inventory 10

    Measured: From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).

  4. Decrease of impulsivity

    significant decrease of impulsivity measured by UPPS-P questionnaire

    Measured: From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).

  5. Increase of mindfulness

    sifnigicant increase of mindfulness measured by Five Facet Mindfulness Questionnaire

    Measured: From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).

  6. Decrease of rejection sensitivity

    significant decrease of rejection sensitivity measured by Rejection Sensitivity RS-Adult questionnaire

    Measured: From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).

  7. Decrease of dissociation symptoms

    significant decrease of dissociation symptoms measured by Multiscale Dissociation Inventory

    Measured: From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).

  8. Decrease of anxiety

    significant decrease of anxiety symptoms measured by Beck Anxiety Inventory

    Measured: From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).

  9. Decrease of depression ranking

    significant decrease of depression symptoms measured by Beck Depression Inventory II, and MADRS clinical rating

    Measured: From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).

  10. Increase of emotion regulation

    significant increase of emotion regulation measured by Difficulties in emotion regulation scale, and ecological momentary assessment

    Measured: From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).

  11. Changes in fMRI neural activity during "Faces task"

    Significant changes in fMRI neural activity during the "Faces task". During the task, participants view images of faces expressing negative emotions or scrambled versions of the same images as a neutral control. The task is presented in pseudorandomized blocks, with each face displayed for a fixed duration. To maintain attention, participants respond based on the basis of face gender or frame color.

    Measured: From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.

  12. Changes in fMRI neural activity during fMRI neurofeedback

    fMRI neurofeedback is used to measure changes in fMRI neural activity. During fMRI neurofeedback, patients try to regulate their emotions according to the direction of the arrows (up or down). They receive feedback on how well they are regulating their emotions through a colour scale.

    Measured: From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.

  13. Changes in fMRI neural activity during Cyberball task

    The Cyberball task is used to measure changes in fMRI neural activity. Participants play a virtual ball-tossing game, believing they are interacting with two other players, though the game is pre-programmed. They control a hand on the screen to pass the ball, while the co-players are represented by animated figures with names and photographs to enhance ecological validity. There are three conditions: inclusion, exclusion, and overinclusion.

    Measured: From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.

  14. Changes in frontal asymmetry during social exclusion measured by EEG

    EEG is used to assess changes in frontal asymmetry during Cyberball task in fMRI. Frontal asymmetry: EEG alpha power localized in frontal scalp electrodes and differences between left and right hemisphere.

    Measured: From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.

  15. Changes in ECG during fMRI

    The Brain Products EEG/ExG system is used to assess heart rate variability. Heart rate variability: Mean R-R interval and standard deviation of R-R intervals evaluated in whole fMRI measurement in standard heart beats removing abnormal beats. R peaks detection performed in one channel recording localized on the chest.

    Measured: From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.

  16. Changes in skin conductance during fMRI

    The Brain Products EEG/ExG system is used to assess changes in skin conductance and monitor the participant's emotional state during the experimental measurement.

    Measured: From baseline (T1), the third assessment takes place 24 weeks after T1 (T3), and the fourth assessment takes place 24 weeks after T3 (T4). The second assessment (T2) is not included in this outcome measure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2025
  2. Study start27 Aug 2020
  3. Primary completion10 Aug 2023
  4. Study completion15 Aug 2023

Resources

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06882330
Sponsor's protocol ID
NU20-04-00410
Acronym
NeuroDBT
Status last verified
Feb 2025
First submitted
28 Feb 2025
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD in anonymized form will be shared upon reasonable request after approval of principal investigator.

Questions about this trial

What is this clinical trial studying?

A study testing Dialectical behavior therapy in people with Borderline Personality Disorder, run by Masarykova Univerzita at 1 site in Czechia.

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 10 inclusion and 22 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: finished, as of the sponsor's last update on 18 Mar 2025. 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 Czechia. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Decrease of borderline symptoms (time frame: From baseline (T1), a second assessment takes place after 12 weeks (T2), the third assessment takes place 12 weeks after T2 (T3), and the fourth assessment takes place 24 weeks after T3 (T4).). 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?
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 18 Mar 2025.

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